Hemorrhagic Shock, Trauma
Conditions
Keywords
coagulopathy, hemorrhagic shock, plasma, blood product transfusion
Brief summary
Bleeding is the most avoidable cause of death in trauma patients. Up to one-third of severely injured trauma patients are found to be coagulopathic and forty percent of the mortality following severe injury is due to uncontrollable hemorrhage in the setting of coagulopathy. It has been established that early administration of fresh frozen plasma decreases mortality following severe injury, replacing lost coagulation factors, improving the coagulopathy and restoring blood volume. This study will determine if giving plasma to severely injured trauma patients during ambulance transport versus after arrival to the hospital will help reduce hemorrhage, thus decreasing both total blood product administration and mortality.
Detailed description
Study Design: Severely injured trauma patients with a systolic blood pressure (SBP) ≤ 70 or SBP ≤ 90 with a heart rate ≥ 108 bpm at the scene will be enrolled and randomized to receive either 2 units of frozen plasma thawed in the field or normal saline (the current standard of care), as the initial resuscitation fluid. After this initial resuscitation fluid, both groups will receive the same standard of care, including packed red blood cells, additional normal saline, or plasma as needed based on laboratory and clinical evidence of coagulopathy. Blood samples and clinical information will be collected throughout the hospital stay up to 28 days after injury.
Interventions
BIOLOGICALType AB plasma
The plasma is thawed and administered to subjects in the experimental (plasma) arm.
DRUGCrystalloid fluid (standard of care for resuscitation)
Normal saline will be give to subjects in the standard arm as the current standard of care for an initial resuscitation fluid
Sponsors
U.S. Army Medical Research and Development Command
University of Colorado, Denver
Denver Health and Hospital Authority
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age\>=18 years * Acutely injured * SBP\<70 mmHg or SBP 71-90 mmHg with heart rate (HR)\>108 beats per minute.
Exclusion criteria
* Visibly or verbally reported pregnant women * known prisoners * unsalvageable injuries (defined as asystolic or cardiopulmonary resuscitation prior to randomization) * known objection to blood products * the patient has an opt-out bracelet or, necklace or wallet card * a family member present at the scene objects to the patient's enrollment in research.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants That Died Within 28 Days Post Injury | 28 days | death within 28 days post injury (death of any cause except for death due to a second, clearly unrelated traumatic injury suffered after discharge) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Admission Coagulopathy | within 30 minutes of Emergency Department (ED) arrival | Defined as the first international normalized ratio (INR) obtained upon ED arrival. The international normalized ratio (INR) is an international standard for the prothrombin time (PT). This measures the time it takes for blood to clot. The normal range for a healthy person is 0.83-1.19. Usually, a high INR indicates a higher risk of bleeding, while a low INR suggests a higher risk of developing a clot. |
| Number of Participants With Admission Severe Coagulopathy | within 30 minutes of Emergency Department (ED) arrival | Defined as international normalized ratio (INR) \>1.3 obtained upon ED arrival. The international normalized ratio (INR) is an international standard for the prothrombin time (PT). This measures the time it takes for blood to clot. The normal range for a healthy person is 0.83-1.19. Usually, a high INR indicates a higher risk of bleeding, while a low INR suggests a higher risk of developing a clot. |
| Composite Outcome of 28-day In-hospital Mortality and Postinjury Multiple Organ Failure (MOF) Incidence | 28 days | The occurrence of in-hospital death or MOF within the first 28 days postinjury. MOF is defined using the validated Denver MOF score (Denver MOF score\>3 of simultaneously obtained scores after 48 hours postinjury). |
| Admission Acidosis | within 30 minutes of ED arrival | Admission acidosis measured by lactate upon ED arrival. |
| Number of Participants With Admission Severe Acidosis | within 30 minutes of ED arrival | Admission severe acidosis measured by lactate\>5 upon ED arrival. |
| Admission Clot Strength | within 30 minutes of ED arrival | Admission clot strength will be measured by thrombelastography G-value upon ED arrival. Clot strength measured in kilodynes per square centimetre (kdyn/cm\^2). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Adverse Outcome-free Days in a Sub-group With Less Severe Hemorrhagic Shock | Hospital stay up to 28 days. | Adverse outcome-free days in the patients with initial systolic blood pressure (SBP) 71-90 mmHg and heart rate (HR) of 108 or greater |
| Level of Haemoglobin (Hb) in a Sub-group With Less Severe Hemorrhagic Shock | Hospital stay up to 28 days. | Level of Haemoglobin (Hb) in g/dL in the patients with initial systolic blood pressure (SBP) 71-90 mmHg and heart rate (HR) of 108 or greater |
| Blood Product Transfusion in a Sub-group With Less Severe Hemorrhagic Shock | Hospital stay up to 28 days. | Transfusions of blood products in units in the patients with initial systolic blood pressure (SBP) 71-90 mmHg and heart rate (HR) of 108 or greater |
| Time to Admission and First Blood Transfusion in a Sub-group With Less Severe Hemorrhagic Shock | Hospital stay up to 28 days. | Time to Admission and First Blood Transfusion in minutes in the patients with initial systolic blood pressure (SBP) 71-90 mmHg and heart rate (HR) of 108 or greater |
| Number of Participants With Mortality, Adverse Outcome-free Days and Transfusions in a Sub-group With Severe Hemorrhagic Shock | Hospital stay up to 28 days. | Mortality, adverse outcome-free days and transfusions in the patients with initial systolic blood pressure (SBP) \<=70 mmHg |
| Number of Adverse Outcome Free Days in a Sub-group With Severe Hemorrhagic Shock | Hospital stay up to 28 days. | Adverse outcome-free days in the patients with initial systolic blood pressure (SBP) \<=70 mmHg |
| Number of Participants in a Sub-group With no Severe Traumatic Brain Injury (TBI) | Hospital stay up to 28 days. | Number of participants with mortality, adverse outcome-free days and transfusions in the patients with no severe traumatic brain injury (TBI) is defined as Abbreviated Injury Score (AIS) for Head/Neck \>=3. |
| Baseline (Field) Coagulation Factor Levels | after injury and prior to hospital arrival, at about 15 minutes after injury | defined as the first coagulation factor level obtained in the field prior to intervention Coagulation Factor Reference Ranges F2 F5 F7 F8 F9 F11 * % % % % % % 67.0 - 107.0 63.0 - 116.0 52.0 - 120.0 58.0 - 132.0 47.0 - 122.0 52.0 - 120.0 |
| Severe Adverse Events (SAE) | Hospital stay up to day 28 | Number of participants with severe adverse events (SAE) |
| Haemoglobin (Hb) Level in a Sub-group With Severe Hemorrhagic Shock | Hospital stay up to 28 days. | Haemoglobin (Hb) level in the patients with initial systolic blood pressure (SBP) \<=70 mmHg |
| Blood Product Transfusion in a Sub-group With Severe Hemorrhagic Shock | Hospital stay up to 28 days. | Number of blood products transfused in units in the patients with initial systolic blood pressure (SBP) \<=70 mmHg |
| Time to Admission and First Blood Transfusion in a Sub-group With Severe Hemorrhagic Shock | Hospital stay up to 28 days. | Time to Admission and First Blood Transfusion in the patients with initial systolic blood pressure (SBP) \<=70 mmHg |
| Haemoglobin (Hb) Level | Hospital stay up to 28 days. | Haemoglobin (Hb) level in g/dL units. |
| Number of Blood Products Transfused. | Hospital stay up to 28 days. | Number of blood products transfused in units. |
| Time to Admission and First Blood Transfusion | Hospital stay up to 28 days. | Time to admission and first blood product transfusion in minutes. |
| Exploratory Analyses in a Sub-group With Severe Traumatic Brain Injury (TBI) | Hospital stay up to 28 days. | Number of participants with 28-day mortality. Traumatic brain injury (TBI) is defined as Abbreviated Injury Score (AIS) for Head/Neck \>=3. |
| Number of Participants With Abnormal Baseline (Field) Coagulation Factor XIII Level | after injury prior to hospital arrival | defined as abnormal coagulation factor XIII level obtained in the field prior to intervention |
| Admission (First Arrival) Coagulation Factor Levels | after injury prior to hospital arrival | defined as the first coagulation factor level obtained upon ED arrival Coagulation Factor Reference Ranges F2 F5 F7 F8 F9 F11 * % % % % % % 67.0 - 107.0 63.0 - 116.0 52.0 - 120.0 58.0 - 132.0 47.0 - 122.0 52.0 - 120.0 |
| Number of Participants With Abnormal Admission Coagulation Factor XIII (Fibrin-stabilizing Factor) Level | within 30 minutes of Emergency Department (ED) arrival | defined as the first abnormal factor XIII (fibrin-stabilizing factor) level obtained upon ED arrival |
| Exploratory Analyses | Hospital stay up to 28 days. | Number of participants with 24-hour mortality, adverse outcome free days and transfusions |
| Exploratory Analyses. | Hospital stay up to 28 days. | Adverse outcome free days |
| Number of Participants With Mortality, Adverse Outcome-free Days and Transfusions in the Sub-group With Less Severe Hemorrhagic Shock | Hospital stay up to 28 days. | Mortality, adverse outcome-free days and transfusions in the patients with initial systolic blood pressure (SBP) 71-90 mmHg and heart rate (HR) of 108 or greater |
Countries
United States
Participant flow
Pre-assignment details
The enrollment and randomization occurred almost simultaneously. Once the paramedics determined the patient to be eligible, the cooler was opened and the randomization was done based on the cooler content: cooler with plasma randomized the patient to the experimental and cooler with frozen water randomized the patient to the control group.
Participants by arm
| Arm | Count |
|---|---|
| Plasma If the patient is randomized to experimental arm, 2 units of frozen Type AB plasma (FP24) will be thawed in the Plasmatherm Dry Thawing and Warming Device according to the operator manual as approved by the FDA in the ambulance and infusion will commence as soon as the Type AB plasma is ready, and will continue during transport to the ED. After infusion of 2 units of Type AB plasma is completed, subsequent care will proceed per institutional, Advanced Trauma Life Support (ATLS) guided resuscitation with acute packed red blood cells (pRBC) administration determined by hemodynamic response and additional blood component administration guided by rapid thrombelastography (rTEG) and coagulation panel assessment in conjunction with clinical scenario.
Type AB plasma: The plasma is thawed and administered to subjects in the experimental (plasma) arm. | 65 |
| Standard If the patient is randomized to the standard arm, the patient will be given intravenous crystalloid fluid (normal saline) as the initial resuscitation fluid with 2 large bore IVs based on the current ATLS guidelines, the standard of care. Subsequent care will proceed per institutional, ATLS guided resuscitation with acute pRBC administration determined by hemodynamic response and additional blood component administration guided by rTEG and coagulation panel assessment in conjunction with clinical scenario.
Crystalloid fluid (standard of care for resuscitation): Normal saline will be give to subjects in the standard arm as the current standard of care for an initial resuscitation fluid | 60 |
| Total | 125 |
Baseline characteristics
| Characteristic | Standard | Plasma | Total |
|---|---|---|---|
| Age, Continuous | 32.5 years | 33 years | 33 years |
| Blunt injury mechanism | 32 Participants | 30 Participants | 62 Participants |
| Body Mass Index (BMI) | 26.1 kg/m^2 | 27.1 kg/m^2 | 26.7 kg/m^2 |
| Body temperature in the field | 36 degrees Celsius | 36 degrees Celsius | 36 degrees Celsius |
| Comorbidities | 8 Participants | 10 Participants | 18 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 39 Participants | 34 Participants | 73 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 21 Participants | 31 Participants | 52 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Fibrinogen in the field | 278 mg/dL | 253 mg/dL | 268 mg/dL |
| Glasgow Coma Scale (GCS) in the field | 14 units on a scale | 14 units on a scale | 14 units on a scale |
| Haemoglobin (Hb) in the field | 14.2 g/dL | 15.1 g/dL | 14.6 g/dL |
| Heart rate (HR) in the field | 112 beats per minute (BPM) | 110 beats per minute (BPM) | 110 beats per minute (BPM) |
| International normalized ratio (INR) in the field | 1.1 ratio | 1.1 ratio | 1.1 ratio |
| International normalized ratio (INR) in the field >=1.3 | 2 Participants | 2 Participants | 4 Participants |
| Maximal Abbreviated Injury Score (AIS) abdomen and pelvis | 0 units on a scale | 0 units on a scale | 0 units on a scale |
| Maximal Abbreviated Injury Score (AIS) chest | 3 units on a scale | 1 units on a scale | 2 units on a scale |
| Maximal Abbreviated Injury Score (AIS) extremities | 0 units on a scale | 1 units on a scale | 0 units on a scale |
| Maximal Abbreviated Injury Score (AIS) for head and neck | 0 units on a scale | 0 units on a scale | 0 units on a scale |
| New Injury Severity Scale (NISS) | 27 units on a scale | 27 units on a scale | 27 units on a scale |
| Partial thromboplastin time (PTT) in the field | 26.9 seconds | 27.1 seconds | 27.1 seconds |
| Platelet count in the field | 273.5 1000 cells/microL | 300.5 1000 cells/microL | 287.5 1000 cells/microL |
| Region of Enrollment United States | 60 participants | 65 participants | 125 participants |
| Severe shock defined as systolic blood pressure (SBP) in the field <=70mmHg | 33 Participants | 44 Participants | 77 Participants |
| Sex: Female, Male Female | 9 Participants | 13 Participants | 22 Participants |
| Sex: Female, Male Male | 51 Participants | 52 Participants | 103 Participants |
| Systolic blood pressure (SBP) in the field | 70 mmHg | 64 mmHg | 68 mmHg |
| Traumatic Brain Injury (TBI) defined as AIS head >=3 | 13 Participants | 15 Participants | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 12 / 75 | 6 / 69 |
| other Total, other adverse events | 5 / 75 | 2 / 69 |
| serious Total, serious adverse events | 34 / 75 | 24 / 69 |
Outcome results
Primary
Number of Participants That Died Within 28 Days Post Injury
death within 28 days post injury (death of any cause except for death due to a second, clearly unrelated traumatic injury suffered after discharge)
Time frame: 28 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Plasma | Number of Participants That Died Within 28 Days Post Injury | 10 Participants |
| Standard | Number of Participants That Died Within 28 Days Post Injury | 6 Participants |
Secondary
Admission Acidosis
Admission acidosis measured by lactate upon ED arrival.
Time frame: within 30 minutes of ED arrival
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Plasma | Admission Acidosis | 5.5 mmol/L |
| Standard | Admission Acidosis | 4.9 mmol/L |
Secondary
Admission Acidosis
Admission acidosis will be defined by base deficit (BD) upon ED arrival.
Time frame: within 30 minutes of ED arrival
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Plasma | Admission Acidosis | 9 mEq/L |
| Standard | Admission Acidosis | 8.8 mEq/L |
Secondary
Admission Clot Strength
Admission clot strength will be measured by thrombelastography G-value upon ED arrival. Clot strength measured in kilodynes per square centimetre (kdyn/cm\^2).
Time frame: within 30 minutes of ED arrival
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Plasma | Admission Clot Strength | 7.7 kdyne/cm^2 |
| Standard | Admission Clot Strength | 7.1 kdyne/cm^2 |
Secondary
Admission Coagulopathy
Defined as the first international normalized ratio (INR) obtained upon ED arrival. The international normalized ratio (INR) is an international standard for the prothrombin time (PT). This measures the time it takes for blood to clot. The normal range for a healthy person is 0.83-1.19. Usually, a high INR indicates a higher risk of bleeding, while a low INR suggests a higher risk of developing a clot.
Time frame: within 30 minutes of Emergency Department (ED) arrival
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Plasma | Admission Coagulopathy | 1.27 ratio |
| Standard | Admission Coagulopathy | 1.15 ratio |
Secondary
Composite Outcome of 28-day In-hospital Mortality and Postinjury Multiple Organ Failure (MOF) Incidence
The occurrence of in-hospital death or MOF within the first 28 days postinjury. MOF is defined using the validated Denver MOF score (Denver MOF score\>3 of simultaneously obtained scores after 48 hours postinjury).
Time frame: 28 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Plasma | Composite Outcome of 28-day In-hospital Mortality and Postinjury Multiple Organ Failure (MOF) Incidence | 14 Participants |
| Standard | Composite Outcome of 28-day In-hospital Mortality and Postinjury Multiple Organ Failure (MOF) Incidence | 7 Participants |
Secondary
Number of Participants With Admission Severe Acidosis
Admission severe acidosis measured by lactate\>5 upon ED arrival.
Time frame: within 30 minutes of ED arrival
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Plasma | Number of Participants With Admission Severe Acidosis | 27 Participants |
| Standard | Number of Participants With Admission Severe Acidosis | 25 Participants |
Secondary
Number of Participants With Admission Severe Acidosis
Admission severe acidosis will be defined by base deficit (BD\>10) upon ED arrival.
Time frame: within 30 minutes of ED arrival
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Plasma | Number of Participants With Admission Severe Acidosis | 21 Participants |
| Standard | Number of Participants With Admission Severe Acidosis | 22 Participants |
Secondary
Number of Participants With Admission Severe Coagulopathy
Defined as international normalized ratio (INR) \>1.3 obtained upon ED arrival. The international normalized ratio (INR) is an international standard for the prothrombin time (PT). This measures the time it takes for blood to clot. The normal range for a healthy person is 0.83-1.19. Usually, a high INR indicates a higher risk of bleeding, while a low INR suggests a higher risk of developing a clot.
Time frame: within 30 minutes of Emergency Department (ED) arrival
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Plasma | Number of Participants With Admission Severe Coagulopathy | 28 Participants |
| Standard | Number of Participants With Admission Severe Coagulopathy | 14 Participants |
Post Hoc
Admission (ED) Citrated Rapid Thrombelastography (CR-TEG) Parameters.
Admission (ED) sample drawn upon ED admission and measured by citrated rapid thrombelastography (CR-TEG) clot strength measures by G value in kilodynes per square centimetre (kdyn/cm\^2).
Time frame: post-intervention and upon ED arrival
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Plasma | Admission (ED) Citrated Rapid Thrombelastography (CR-TEG) Parameters. | 7.7 kdyn/cm^2 |
| Standard | Admission (ED) Citrated Rapid Thrombelastography (CR-TEG) Parameters. | 7.1 kdyn/cm^2 |
Post Hoc
Admission (ED) Citrated Rapid Thrombelastography (CR-TEG) Parameters.
Admission (ED) sample drawn upon ED admission and measured by citrated rapid thrombelastography (CR-TEG) clot lysis 30 minutes after the maximal amplitude (MA) was finalized.
Time frame: post-intervention and upon ED arrival
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Plasma | Admission (ED) Citrated Rapid Thrombelastography (CR-TEG) Parameters. | 1.3 percentage of clot lysed at 30 minutes |
| Standard | Admission (ED) Citrated Rapid Thrombelastography (CR-TEG) Parameters. | 1.6 percentage of clot lysed at 30 minutes |
Post Hoc
Admission (ED) Citrated Rapid Thrombelastography (CR-TEG) Parameters.
Admission (ED) sample drawn upon ED admission and measured by citrated rapid thrombelastography (CR-TEG) angle measured in degrees.
Time frame: post-intervention and upon ED arrival
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Plasma | Admission (ED) Citrated Rapid Thrombelastography (CR-TEG) Parameters. | 60.5 degree |
| Standard | Admission (ED) Citrated Rapid Thrombelastography (CR-TEG) Parameters. | 58.5 degree |
Post Hoc
Admission (ED) Citrated Rapid Thrombelastography (CR-TEG) Parameters.
Admission (ED) sample drawn upon ED admission and measured by citrated rapid thrombelastography (CR-TEG) activated clotting time (ACT) in seconds.
Time frame: post-intervention and upon ED arrival
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Plasma | Admission (ED) Citrated Rapid Thrombelastography (CR-TEG) Parameters. | 128 second |
| Standard | Admission (ED) Citrated Rapid Thrombelastography (CR-TEG) Parameters. | 121 second |
Post Hoc
Admission (ED) Citrated Rapid Thrombelastography (CR-TEG) Parameters.
Admission (ED) sample drawn upon ED admission and measured by citrated rapid thrombelastography (CR-TEG) maximal amplitude (MA).
Time frame: post-intervention and upon ED arrival
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Plasma | Admission (ED) Citrated Rapid Thrombelastography (CR-TEG) Parameters. | 70.9 millimeter (mm) |
| Standard | Admission (ED) Citrated Rapid Thrombelastography (CR-TEG) Parameters. | 69.3 millimeter (mm) |
Other Pre-specified
Admission (First Arrival) Coagulation Factor Levels
defined as the first coagulation factor level obtained upon ED arrival Coagulation Factor Reference Ranges F2 F5 F7 F8 F9 F11 * % % % % % % 67.0 - 107.0 63.0 - 116.0 52.0 - 120.0 58.0 - 132.0 47.0 - 122.0 52.0 - 120.0
Time frame: after injury prior to hospital arrival
Population: Not all the timepoints are available for all the patients.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Plasma | Admission (First Arrival) Coagulation Factor Levels | Coagulation factor V (proaccelerin) | 64 percentage of activity |
| Plasma | Admission (First Arrival) Coagulation Factor Levels | Coagulation factor VIII (antihemophilic factor) | 283.4 percentage of activity |
| Plasma | Admission (First Arrival) Coagulation Factor Levels | Coagulation factor II (prothrombin) | 71 percentage of activity |
| Plasma | Admission (First Arrival) Coagulation Factor Levels | Coagulation factor IX (plasma thromboplastin comp) | 121 percentage of activity |
| Plasma | Admission (First Arrival) Coagulation Factor Levels | Coagulation factor VII (proconvertin) | 72 percentage of activity |
| Plasma | Admission (First Arrival) Coagulation Factor Levels | Coagulation factor XI (plasma thromboplastin ante) | 81 percentage of activity |
| Plasma | Admission (First Arrival) Coagulation Factor Levels | Coagulation factor I (fibrinogen) | 195 percentage of activity |
| Standard | Admission (First Arrival) Coagulation Factor Levels | Coagulation factor XI (plasma thromboplastin ante) | 109 percentage of activity |
| Standard | Admission (First Arrival) Coagulation Factor Levels | Coagulation factor I (fibrinogen) | 222 percentage of activity |
| Standard | Admission (First Arrival) Coagulation Factor Levels | Coagulation factor II (prothrombin) | 79 percentage of activity |
| Standard | Admission (First Arrival) Coagulation Factor Levels | Coagulation factor V (proaccelerin) | 69 percentage of activity |
| Standard | Admission (First Arrival) Coagulation Factor Levels | Coagulation factor VII (proconvertin) | 74 percentage of activity |
| Standard | Admission (First Arrival) Coagulation Factor Levels | Coagulation factor VIII (antihemophilic factor) | 355.2 percentage of activity |
| Standard | Admission (First Arrival) Coagulation Factor Levels | Coagulation factor IX (plasma thromboplastin comp) | 135 percentage of activity |
Other Pre-specified
Adverse Outcome-free Days in a Sub-group With Less Severe Hemorrhagic Shock
Adverse outcome-free days in the patients with initial systolic blood pressure (SBP) 71-90 mmHg and heart rate (HR) of 108 or greater
Time frame: Hospital stay up to 28 days.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Plasma | Adverse Outcome-free Days in a Sub-group With Less Severe Hemorrhagic Shock | Ventilator free days | 27 days |
| Plasma | Adverse Outcome-free Days in a Sub-group With Less Severe Hemorrhagic Shock | Intensive care unit (ICU) free days | 24 days |
| Standard | Adverse Outcome-free Days in a Sub-group With Less Severe Hemorrhagic Shock | Ventilator free days | 26 days |
| Standard | Adverse Outcome-free Days in a Sub-group With Less Severe Hemorrhagic Shock | Intensive care unit (ICU) free days | 25 days |
Post Hoc
Baseline (Field) Citrated Rapid Thrombelastography (CR-TEG) Parameters.
Baseline (field) sample drawn prior to intervention in the field and measured by citrated rapid thrombelastography (CR-TEG) activated clotting time (ACT).
Time frame: after injury and prior to hospital arrival, at about 15 minutes after injury
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Plasma | Baseline (Field) Citrated Rapid Thrombelastography (CR-TEG) Parameters. | 121 second |
| Standard | Baseline (Field) Citrated Rapid Thrombelastography (CR-TEG) Parameters. | 121 second |
Post Hoc
Baseline (Field) Citrated Rapid Thrombelastography (CR-TEG) Parameters.
Baseline (field) sample drawn prior to intervention in the field and measured by citrated rapid thrombelastography (CR-TEG). Percentage of clot lysis 30 minutes after maximal amplitude (MA) value is finalized.
Time frame: after injury and prior to hospital arrival, at about 15 minutes after injury
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Plasma | Baseline (Field) Citrated Rapid Thrombelastography (CR-TEG) Parameters. | 2.2 percentage of clot lysed at 30 minutes |
| Standard | Baseline (Field) Citrated Rapid Thrombelastography (CR-TEG) Parameters. | 1.8 percentage of clot lysed at 30 minutes |
Post Hoc
Baseline (Field) Citrated Rapid Thrombelastography (CR-TEG) Parameters.
Baseline (field) sample drawn prior to intervention in the field and measured by citrated rapid thrombelastography (CR-TEG). Clot strength measured in kilodynes per square centimetre (kdyn/cm\^2).
Time frame: after injury and prior to hospital arrival, at about 15 minutes after injury
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Plasma | Baseline (Field) Citrated Rapid Thrombelastography (CR-TEG) Parameters. | 8.2 kdyn/cm^2 |
| Standard | Baseline (Field) Citrated Rapid Thrombelastography (CR-TEG) Parameters. | 8.7 kdyn/cm^2 |
Post Hoc
Baseline (Field) Citrated Rapid Thrombelastography (CR-TEG) Parameters.
Baseline (field) sample drawn prior to intervention in the field and measured by citrated rapid thrombelastography (CR-TEG) maximum amplitude (MA).
Time frame: after injury and prior to hospital arrival, at about 15 minutes after injury
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Plasma | Baseline (Field) Citrated Rapid Thrombelastography (CR-TEG) Parameters. | 62 millimeter (mm) |
| Standard | Baseline (Field) Citrated Rapid Thrombelastography (CR-TEG) Parameters. | 63.5 millimeter (mm) |
Post Hoc
Baseline (Field) Citrated Rapid Thrombelastography (CR-TEG) Parameters.
Baseline (field) sample drawn prior to intervention in the field and measured by citrated rapid thrombelastography (CR-TEG) angle in degrees.
Time frame: after injury and prior to hospital arrival, at about 15 minutes after injury
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Plasma | Baseline (Field) Citrated Rapid Thrombelastography (CR-TEG) Parameters. | 70.6 degrees |
| Standard | Baseline (Field) Citrated Rapid Thrombelastography (CR-TEG) Parameters. | 70.6 degrees |
Other Pre-specified
Baseline (Field) Coagulation Factor Levels
defined as the first coagulation factor level obtained in the field prior to intervention Coagulation Factor Reference Ranges F2 F5 F7 F8 F9 F11 * % % % % % % 67.0 - 107.0 63.0 - 116.0 52.0 - 120.0 58.0 - 132.0 47.0 - 122.0 52.0 - 120.0
Time frame: after injury and prior to hospital arrival, at about 15 minutes after injury
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Plasma | Baseline (Field) Coagulation Factor Levels | Coagulation factor II (prothrombin) | 95 percentage of activity |
| Plasma | Baseline (Field) Coagulation Factor Levels | Coagulation factor V (proaccelerin) | 85 percentage of activity |
| Plasma | Baseline (Field) Coagulation Factor Levels | Coagulation factor VII (proconvertin) | 101.5 percentage of activity |
| Plasma | Baseline (Field) Coagulation Factor Levels | Coagulation factor VIII (antihemophilic factor) | 396.8 percentage of activity |
| Plasma | Baseline (Field) Coagulation Factor Levels | Coagulation factor IX (plasma thromboplastin comp) | 157 percentage of activity |
| Plasma | Baseline (Field) Coagulation Factor Levels | Coagulation factor XI (plasma thromboplastin ante) | 126.5 percentage of activity |
| Standard | Baseline (Field) Coagulation Factor Levels | Coagulation factor IX (plasma thromboplastin comp) | 160.5 percentage of activity |
| Standard | Baseline (Field) Coagulation Factor Levels | Coagulation factor II (prothrombin) | 98 percentage of activity |
| Standard | Baseline (Field) Coagulation Factor Levels | Coagulation factor VIII (antihemophilic factor) | 411.8 percentage of activity |
| Standard | Baseline (Field) Coagulation Factor Levels | Coagulation factor V (proaccelerin) | 91.5 percentage of activity |
| Standard | Baseline (Field) Coagulation Factor Levels | Coagulation factor XI (plasma thromboplastin ante) | 141.5 percentage of activity |
| Standard | Baseline (Field) Coagulation Factor Levels | Coagulation factor VII (proconvertin) | 89.5 percentage of activity |
Other Pre-specified
Blood Product Transfusion in a Sub-group With Less Severe Hemorrhagic Shock
Transfusions of blood products in units in the patients with initial systolic blood pressure (SBP) 71-90 mmHg and heart rate (HR) of 108 or greater
Time frame: Hospital stay up to 28 days.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Plasma | Blood Product Transfusion in a Sub-group With Less Severe Hemorrhagic Shock | Red blood cell (RBC) transfusion in 24 h | 0 units |
| Plasma | Blood Product Transfusion in a Sub-group With Less Severe Hemorrhagic Shock | Plasma transfused in 24h (excluding pre-admission) | 0 units |
| Plasma | Blood Product Transfusion in a Sub-group With Less Severe Hemorrhagic Shock | Platelets transfused in 24 h | 0 units |
| Plasma | Blood Product Transfusion in a Sub-group With Less Severe Hemorrhagic Shock | Cryoprecipitate transfused in 24 h | 0 units |
| Standard | Blood Product Transfusion in a Sub-group With Less Severe Hemorrhagic Shock | Cryoprecipitate transfused in 24 h | 0 units |
| Standard | Blood Product Transfusion in a Sub-group With Less Severe Hemorrhagic Shock | Red blood cell (RBC) transfusion in 24 h | 1 units |
| Standard | Blood Product Transfusion in a Sub-group With Less Severe Hemorrhagic Shock | Platelets transfused in 24 h | 0 units |
| Standard | Blood Product Transfusion in a Sub-group With Less Severe Hemorrhagic Shock | Plasma transfused in 24h (excluding pre-admission) | 0 units |
Other Pre-specified
Blood Product Transfusion in a Sub-group With Severe Hemorrhagic Shock
Number of blood products transfused in units in the patients with initial systolic blood pressure (SBP) \<=70 mmHg
Time frame: Hospital stay up to 28 days.
Population: Not all the timepoints are available for all the patients.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Plasma | Blood Product Transfusion in a Sub-group With Severe Hemorrhagic Shock | Red blood cell (RBC) transfusion in 24 h | 3.5 units |
| Plasma | Blood Product Transfusion in a Sub-group With Severe Hemorrhagic Shock | Plasma transfused in 24h (excluding pre-admission) | 1 units |
| Plasma | Blood Product Transfusion in a Sub-group With Severe Hemorrhagic Shock | Platelets transfused in 24 h | 0 units |
| Plasma | Blood Product Transfusion in a Sub-group With Severe Hemorrhagic Shock | Cryoprecipitate transfused in 24 h | 0 units |
| Standard | Blood Product Transfusion in a Sub-group With Severe Hemorrhagic Shock | Cryoprecipitate transfused in 24 h | 0 units |
| Standard | Blood Product Transfusion in a Sub-group With Severe Hemorrhagic Shock | Red blood cell (RBC) transfusion in 24 h | 3 units |
| Standard | Blood Product Transfusion in a Sub-group With Severe Hemorrhagic Shock | Platelets transfused in 24 h | 0 units |
| Standard | Blood Product Transfusion in a Sub-group With Severe Hemorrhagic Shock | Plasma transfused in 24h (excluding pre-admission) | 1 units |
Other Pre-specified
Exploratory Analyses
Number of participants with 24-hour mortality, adverse outcome free days and transfusions
Time frame: Hospital stay up to 28 days.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Plasma | Exploratory Analyses | 24-hour mortality | 8 Participants |
| Plasma | Exploratory Analyses | Acute lung injury (ALI) within 28 days | 18 Participants |
| Plasma | Exploratory Analyses | Acute lung injury (ALI) within 6 hours post-transf | 19 Participants |
| Plasma | Exploratory Analyses | MOF (Denver MOF score>3) | 4 Participants |
| Plasma | Exploratory Analyses | Haemoglobin (Hb)<7g/dL within 6 hours | 3 Participants |
| Plasma | Exploratory Analyses | Required red blood cell transf. within 24 hour | 36 Participants |
| Plasma | Exploratory Analyses | Massive transf. (>=10 units of RBC or death/6 hrs | 15 Participants |
| Plasma | Exploratory Analyses | Required plasma in first 24 h (not counting field) | 29 Participants |
| Plasma | Exploratory Analyses | Required platelets in first 24 h | 15 Participants |
| Plasma | Exploratory Analyses | Required cryoprecipitate in first 24 h | 8 Participants |
| Plasma | Exploratory Analyses | Required tranexamic acid (TXA) in first 6 h | 6 Participants |
| Plasma | Exploratory Analyses | Required factor VII infusion in first 24 h | 1 Participants |
| Standard | Exploratory Analyses | Required tranexamic acid (TXA) in first 6 h | 7 Participants |
| Standard | Exploratory Analyses | 24-hour mortality | 6 Participants |
| Standard | Exploratory Analyses | Massive transf. (>=10 units of RBC or death/6 hrs | 12 Participants |
| Standard | Exploratory Analyses | Acute lung injury (ALI) within 28 days | 12 Participants |
| Standard | Exploratory Analyses | Required cryoprecipitate in first 24 h | 4 Participants |
| Standard | Exploratory Analyses | Acute lung injury (ALI) within 6 hours post-transf | 22 Participants |
| Standard | Exploratory Analyses | Required plasma in first 24 h (not counting field) | 26 Participants |
| Standard | Exploratory Analyses | MOF (Denver MOF score>3) | 1 Participants |
| Standard | Exploratory Analyses | Required factor VII infusion in first 24 h | 0 Participants |
| Standard | Exploratory Analyses | Haemoglobin (Hb)<7g/dL within 6 hours | 2 Participants |
| Standard | Exploratory Analyses | Required platelets in first 24 h | 11 Participants |
| Standard | Exploratory Analyses | Required red blood cell transf. within 24 hour | 35 Participants |
Other Pre-specified
Exploratory Analyses.
Adverse outcome free days
Time frame: Hospital stay up to 28 days.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Plasma | Exploratory Analyses. | Intensive care unit (ICU) free days | 23 days |
| Plasma | Exploratory Analyses. | Ventilator free days | 26 days |
| Standard | Exploratory Analyses. | Ventilator free days | 26 days |
| Standard | Exploratory Analyses. | Intensive care unit (ICU) free days | 24 days |
Other Pre-specified
Exploratory Analyses in a Sub-group With Severe Traumatic Brain Injury (TBI)
Number of participants with 28-day mortality. Traumatic brain injury (TBI) is defined as Abbreviated Injury Score (AIS) for Head/Neck \>=3.
Time frame: Hospital stay up to 28 days.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Plasma | Exploratory Analyses in a Sub-group With Severe Traumatic Brain Injury (TBI) | 4 Participants |
| Standard | Exploratory Analyses in a Sub-group With Severe Traumatic Brain Injury (TBI) | 1 Participants |
Other Pre-specified
Haemoglobin (Hb) Level
Haemoglobin (Hb) level in g/dL units.
Time frame: Hospital stay up to 28 days.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Plasma | Haemoglobin (Hb) Level | Admission (first arrival) Haemoglobin (Hb) | 12.6 g/dL |
| Plasma | Haemoglobin (Hb) Level | Lowest Haemoglobin (Hb) in first 6 hours | 11.3 g/dL |
| Standard | Haemoglobin (Hb) Level | Admission (first arrival) Haemoglobin (Hb) | 13.5 g/dL |
| Standard | Haemoglobin (Hb) Level | Lowest Haemoglobin (Hb) in first 6 hours | 11 g/dL |
Other Pre-specified
Haemoglobin (Hb) Level in a Sub-group With Severe Hemorrhagic Shock
Haemoglobin (Hb) level in the patients with initial systolic blood pressure (SBP) \<=70 mmHg
Time frame: Hospital stay up to 28 days.
Population: Not all the timepoints are available for all the patients.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Plasma | Haemoglobin (Hb) Level in a Sub-group With Severe Hemorrhagic Shock | Admission (first arrival) Haemoglobin (Hb) | 11.8 g/dL |
| Plasma | Haemoglobin (Hb) Level in a Sub-group With Severe Hemorrhagic Shock | Lowest Haemoglobin (Hb) in first 6 hours | 11.3 g/dL |
| Standard | Haemoglobin (Hb) Level in a Sub-group With Severe Hemorrhagic Shock | Admission (first arrival) Haemoglobin (Hb) | 13.2 g/dL |
| Standard | Haemoglobin (Hb) Level in a Sub-group With Severe Hemorrhagic Shock | Lowest Haemoglobin (Hb) in first 6 hours | 10.8 g/dL |
Other Pre-specified
Level of Haemoglobin (Hb) in a Sub-group With Less Severe Hemorrhagic Shock
Level of Haemoglobin (Hb) in g/dL in the patients with initial systolic blood pressure (SBP) 71-90 mmHg and heart rate (HR) of 108 or greater
Time frame: Hospital stay up to 28 days.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Plasma | Level of Haemoglobin (Hb) in a Sub-group With Less Severe Hemorrhagic Shock | Admission (first arrival) Haemoglobin (Hb) | 14.4 g/dL |
| Plasma | Level of Haemoglobin (Hb) in a Sub-group With Less Severe Hemorrhagic Shock | Lowest Haemoglobin (Hb) in first 6 hours | 11.6 g/dL |
| Standard | Level of Haemoglobin (Hb) in a Sub-group With Less Severe Hemorrhagic Shock | Admission (first arrival) Haemoglobin (Hb) | 13.5 g/dL |
| Standard | Level of Haemoglobin (Hb) in a Sub-group With Less Severe Hemorrhagic Shock | Lowest Haemoglobin (Hb) in first 6 hours | 11.4 g/dL |
Other Pre-specified
Number of Adverse Outcome Free Days in a Sub-group With Severe Hemorrhagic Shock
Adverse outcome-free days in the patients with initial systolic blood pressure (SBP) \<=70 mmHg
Time frame: Hospital stay up to 28 days.
Population: Not all the timepoints are available for all the patients.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Plasma | Number of Adverse Outcome Free Days in a Sub-group With Severe Hemorrhagic Shock | Ventilator free days | 24.5 days |
| Plasma | Number of Adverse Outcome Free Days in a Sub-group With Severe Hemorrhagic Shock | Intensive care unit (ICU) free days | 20 days |
| Standard | Number of Adverse Outcome Free Days in a Sub-group With Severe Hemorrhagic Shock | Ventilator free days | 26 days |
| Standard | Number of Adverse Outcome Free Days in a Sub-group With Severe Hemorrhagic Shock | Intensive care unit (ICU) free days | 23 days |
Other Pre-specified
Number of Blood Products Transfused.
Number of blood products transfused in units.
Time frame: Hospital stay up to 28 days.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Plasma | Number of Blood Products Transfused. | Red blood cell (RBC) transfusion in 24 h | 2 units |
| Plasma | Number of Blood Products Transfused. | Plasma transfused in 24h (excluding pre-admission) | 0 units |
| Plasma | Number of Blood Products Transfused. | Platelets transfused in 24 h | 0 units |
| Plasma | Number of Blood Products Transfused. | Cryoprecipitate transfused in 24 h | 0 units |
| Standard | Number of Blood Products Transfused. | Cryoprecipitate transfused in 24 h | 0 units |
| Standard | Number of Blood Products Transfused. | Red blood cell (RBC) transfusion in 24 h | 1.5 units |
| Standard | Number of Blood Products Transfused. | Platelets transfused in 24 h | 0 units |
| Standard | Number of Blood Products Transfused. | Plasma transfused in 24h (excluding pre-admission) | 0 units |
Other Pre-specified
Number of Participants in a Sub-group With no Severe Traumatic Brain Injury (TBI)
Number of participants with mortality, adverse outcome-free days and transfusions in the patients with no severe traumatic brain injury (TBI) is defined as Abbreviated Injury Score (AIS) for Head/Neck \>=3.
Time frame: Hospital stay up to 28 days.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Plasma | Number of Participants in a Sub-group With no Severe Traumatic Brain Injury (TBI) | Possible transfusion associated acute lung injury | 12 Participants |
| Plasma | Number of Participants in a Sub-group With no Severe Traumatic Brain Injury (TBI) | 24-hour mortality | 6 Participants |
| Plasma | Number of Participants in a Sub-group With no Severe Traumatic Brain Injury (TBI) | Required red blood cell transfusion within 72 h | 28 Participants |
| Plasma | Number of Participants in a Sub-group With no Severe Traumatic Brain Injury (TBI) | Massive transf. (>=10 units of RBC or death/6 hrs | 10 Participants |
| Plasma | Number of Participants in a Sub-group With no Severe Traumatic Brain Injury (TBI) | Death or multiple organ failure within 28 days | 9 Participants |
| Plasma | Number of Participants in a Sub-group With no Severe Traumatic Brain Injury (TBI) | Required tranexamic acid (TXA) in first 6 h | 5 Participants |
| Plasma | Number of Participants in a Sub-group With no Severe Traumatic Brain Injury (TBI) | Acute lung injury (ALI) within 28 days | 20 Participants |
| Plasma | Number of Participants in a Sub-group With no Severe Traumatic Brain Injury (TBI) | Required factor VII infusion in first 24 h | 1 Participants |
| Plasma | Number of Participants in a Sub-group With no Severe Traumatic Brain Injury (TBI) | 28-day mortality | 6 Participants |
| Standard | Number of Participants in a Sub-group With no Severe Traumatic Brain Injury (TBI) | Required factor VII infusion in first 24 h | 0 Participants |
| Standard | Number of Participants in a Sub-group With no Severe Traumatic Brain Injury (TBI) | 28-day mortality | 5 Participants |
| Standard | Number of Participants in a Sub-group With no Severe Traumatic Brain Injury (TBI) | Death or multiple organ failure within 28 days | 6 Participants |
| Standard | Number of Participants in a Sub-group With no Severe Traumatic Brain Injury (TBI) | 24-hour mortality | 5 Participants |
| Standard | Number of Participants in a Sub-group With no Severe Traumatic Brain Injury (TBI) | Acute lung injury (ALI) within 28 days | 21 Participants |
| Standard | Number of Participants in a Sub-group With no Severe Traumatic Brain Injury (TBI) | Possible transfusion associated acute lung injury | 16 Participants |
| Standard | Number of Participants in a Sub-group With no Severe Traumatic Brain Injury (TBI) | Massive transf. (>=10 units of RBC or death/6 hrs | 10 Participants |
| Standard | Number of Participants in a Sub-group With no Severe Traumatic Brain Injury (TBI) | Required tranexamic acid (TXA) in first 6 h | 6 Participants |
| Standard | Number of Participants in a Sub-group With no Severe Traumatic Brain Injury (TBI) | Required red blood cell transfusion within 72 h | 26 Participants |
Other Pre-specified
Number of Participants With Abnormal Admission Coagulation Factor XIII (Fibrin-stabilizing Factor) Level
defined as the first abnormal factor XIII (fibrin-stabilizing factor) level obtained upon ED arrival
Time frame: within 30 minutes of Emergency Department (ED) arrival
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Plasma | Number of Participants With Abnormal Admission Coagulation Factor XIII (Fibrin-stabilizing Factor) Level | 0 Participants |
| Standard | Number of Participants With Abnormal Admission Coagulation Factor XIII (Fibrin-stabilizing Factor) Level | 2 Participants |
Other Pre-specified
Number of Participants With Abnormal Baseline (Field) Coagulation Factor XIII Level
defined as abnormal coagulation factor XIII level obtained in the field prior to intervention
Time frame: after injury prior to hospital arrival
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Plasma | Number of Participants With Abnormal Baseline (Field) Coagulation Factor XIII Level | 0 Participants |
| Standard | Number of Participants With Abnormal Baseline (Field) Coagulation Factor XIII Level | 0 Participants |
Other Pre-specified
Number of Participants With Mortality, Adverse Outcome-free Days and Transfusions in a Sub-group With Severe Hemorrhagic Shock
Mortality, adverse outcome-free days and transfusions in the patients with initial systolic blood pressure (SBP) \<=70 mmHg
Time frame: Hospital stay up to 28 days.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Plasma | Number of Participants With Mortality, Adverse Outcome-free Days and Transfusions in a Sub-group With Severe Hemorrhagic Shock | 28-day mortality | 10 Participants |
| Plasma | Number of Participants With Mortality, Adverse Outcome-free Days and Transfusions in a Sub-group With Severe Hemorrhagic Shock | Death or multiple organ failure within 28 days | 14 Participants |
| Plasma | Number of Participants With Mortality, Adverse Outcome-free Days and Transfusions in a Sub-group With Severe Hemorrhagic Shock | 24-hour mortality | 8 Participants |
| Plasma | Number of Participants With Mortality, Adverse Outcome-free Days and Transfusions in a Sub-group With Severe Hemorrhagic Shock | Acute lung injury (ALI) within 28 days | 20 Participants |
| Plasma | Number of Participants With Mortality, Adverse Outcome-free Days and Transfusions in a Sub-group With Severe Hemorrhagic Shock | Acute lung injury (ALI) within 6 h post-transfusio | 14 Participants |
| Plasma | Number of Participants With Mortality, Adverse Outcome-free Days and Transfusions in a Sub-group With Severe Hemorrhagic Shock | MOF (Denver MOF score>3) | 4 Participants |
| Plasma | Number of Participants With Mortality, Adverse Outcome-free Days and Transfusions in a Sub-group With Severe Hemorrhagic Shock | Haemoglobin (Hb)<7g/dL within 6 hours | 2 Participants |
| Plasma | Number of Participants With Mortality, Adverse Outcome-free Days and Transfusions in a Sub-group With Severe Hemorrhagic Shock | Required red blood cell transfusion within 24 h | 29 Participants |
| Plasma | Number of Participants With Mortality, Adverse Outcome-free Days and Transfusions in a Sub-group With Severe Hemorrhagic Shock | Massive transf. (>=10 units of RBC or death/6 hrs | 15 Participants |
| Plasma | Number of Participants With Mortality, Adverse Outcome-free Days and Transfusions in a Sub-group With Severe Hemorrhagic Shock | Required plasma in first 24 h (not counting field) | 26 Participants |
| Plasma | Number of Participants With Mortality, Adverse Outcome-free Days and Transfusions in a Sub-group With Severe Hemorrhagic Shock | Required platelets in first 24 h | 12 Participants |
| Plasma | Number of Participants With Mortality, Adverse Outcome-free Days and Transfusions in a Sub-group With Severe Hemorrhagic Shock | Required cryoprecipitate in first 24 h | 8 Participants |
| Plasma | Number of Participants With Mortality, Adverse Outcome-free Days and Transfusions in a Sub-group With Severe Hemorrhagic Shock | Required tranexamic acid (TXA) in first 6 h | 4 Participants |
| Plasma | Number of Participants With Mortality, Adverse Outcome-free Days and Transfusions in a Sub-group With Severe Hemorrhagic Shock | Required factor VII infusion in first 24 h | 1 Participants |
| Standard | Number of Participants With Mortality, Adverse Outcome-free Days and Transfusions in a Sub-group With Severe Hemorrhagic Shock | Required platelets in first 24 h | 4 Participants |
| Standard | Number of Participants With Mortality, Adverse Outcome-free Days and Transfusions in a Sub-group With Severe Hemorrhagic Shock | 28-day mortality | 4 Participants |
| Standard | Number of Participants With Mortality, Adverse Outcome-free Days and Transfusions in a Sub-group With Severe Hemorrhagic Shock | Required red blood cell transfusion within 24 h | 21 Participants |
| Standard | Number of Participants With Mortality, Adverse Outcome-free Days and Transfusions in a Sub-group With Severe Hemorrhagic Shock | Death or multiple organ failure within 28 days | 5 Participants |
| Standard | Number of Participants With Mortality, Adverse Outcome-free Days and Transfusions in a Sub-group With Severe Hemorrhagic Shock | Required tranexamic acid (TXA) in first 6 h | 5 Participants |
| Standard | Number of Participants With Mortality, Adverse Outcome-free Days and Transfusions in a Sub-group With Severe Hemorrhagic Shock | 24-hour mortality | 4 Participants |
| Standard | Number of Participants With Mortality, Adverse Outcome-free Days and Transfusions in a Sub-group With Severe Hemorrhagic Shock | Massive transf. (>=10 units of RBC or death/6 hrs | 7 Participants |
| Standard | Number of Participants With Mortality, Adverse Outcome-free Days and Transfusions in a Sub-group With Severe Hemorrhagic Shock | Acute lung injury (ALI) within 28 days | 18 Participants |
| Standard | Number of Participants With Mortality, Adverse Outcome-free Days and Transfusions in a Sub-group With Severe Hemorrhagic Shock | Required cryoprecipitate in first 24 h | 2 Participants |
| Standard | Number of Participants With Mortality, Adverse Outcome-free Days and Transfusions in a Sub-group With Severe Hemorrhagic Shock | Acute lung injury (ALI) within 6 h post-transfusio | 14 Participants |
| Standard | Number of Participants With Mortality, Adverse Outcome-free Days and Transfusions in a Sub-group With Severe Hemorrhagic Shock | Required plasma in first 24 h (not counting field) | 17 Participants |
| Standard | Number of Participants With Mortality, Adverse Outcome-free Days and Transfusions in a Sub-group With Severe Hemorrhagic Shock | MOF (Denver MOF score>3) | 1 Participants |
| Standard | Number of Participants With Mortality, Adverse Outcome-free Days and Transfusions in a Sub-group With Severe Hemorrhagic Shock | Required factor VII infusion in first 24 h | 0 Participants |
| Standard | Number of Participants With Mortality, Adverse Outcome-free Days and Transfusions in a Sub-group With Severe Hemorrhagic Shock | Haemoglobin (Hb)<7g/dL within 6 hours | 2 Participants |
Other Pre-specified
Number of Participants With Mortality, Adverse Outcome-free Days and Transfusions in the Sub-group With Less Severe Hemorrhagic Shock
Mortality, adverse outcome-free days and transfusions in the patients with initial systolic blood pressure (SBP) 71-90 mmHg and heart rate (HR) of 108 or greater
Time frame: Hospital stay up to 28 days.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Plasma | Number of Participants With Mortality, Adverse Outcome-free Days and Transfusions in the Sub-group With Less Severe Hemorrhagic Shock | Required tranexamic acid (TXA) in first 6 h | 2 Participants |
| Plasma | Number of Participants With Mortality, Adverse Outcome-free Days and Transfusions in the Sub-group With Less Severe Hemorrhagic Shock | 28-day mortality | 0 Participants |
| Plasma | Number of Participants With Mortality, Adverse Outcome-free Days and Transfusions in the Sub-group With Less Severe Hemorrhagic Shock | Death or multiple organ failure within 28 days | 0 Participants |
| Plasma | Number of Participants With Mortality, Adverse Outcome-free Days and Transfusions in the Sub-group With Less Severe Hemorrhagic Shock | Acute lung injury (ALI) within 28 days | 8 Participants |
| Plasma | Number of Participants With Mortality, Adverse Outcome-free Days and Transfusions in the Sub-group With Less Severe Hemorrhagic Shock | Acute lung injury (ALI) within 6 h post-transfusio | 5 Participants |
| Plasma | Number of Participants With Mortality, Adverse Outcome-free Days and Transfusions in the Sub-group With Less Severe Hemorrhagic Shock | MOF (Denver MOF score>3) | 0 Participants |
| Plasma | Number of Participants With Mortality, Adverse Outcome-free Days and Transfusions in the Sub-group With Less Severe Hemorrhagic Shock | Haemoglobin (Hb)<7g/dL within 6 hours | 1 Participants |
| Plasma | Number of Participants With Mortality, Adverse Outcome-free Days and Transfusions in the Sub-group With Less Severe Hemorrhagic Shock | Required red blood cell transfusion within 24 h | 7 Participants |
| Plasma | Number of Participants With Mortality, Adverse Outcome-free Days and Transfusions in the Sub-group With Less Severe Hemorrhagic Shock | Massive transf. (>=10 units of RBC or death/6 hrs | 0 Participants |
| Plasma | Number of Participants With Mortality, Adverse Outcome-free Days and Transfusions in the Sub-group With Less Severe Hemorrhagic Shock | Required plasma in first 24 h (not counting field) | 3 Participants |
| Plasma | Number of Participants With Mortality, Adverse Outcome-free Days and Transfusions in the Sub-group With Less Severe Hemorrhagic Shock | Required platelets in first 24 h | 1 Participants |
| Plasma | Number of Participants With Mortality, Adverse Outcome-free Days and Transfusions in the Sub-group With Less Severe Hemorrhagic Shock | Required cryoprecipitate in first 24 h | 0 Participants |
| Plasma | Number of Participants With Mortality, Adverse Outcome-free Days and Transfusions in the Sub-group With Less Severe Hemorrhagic Shock | Required factor VII infusion in first 24 h | 0 Participants |
| Standard | Number of Participants With Mortality, Adverse Outcome-free Days and Transfusions in the Sub-group With Less Severe Hemorrhagic Shock | Required platelets in first 24 h | 6 Participants |
| Standard | Number of Participants With Mortality, Adverse Outcome-free Days and Transfusions in the Sub-group With Less Severe Hemorrhagic Shock | Required red blood cell transfusion within 24 h | 14 Participants |
| Standard | Number of Participants With Mortality, Adverse Outcome-free Days and Transfusions in the Sub-group With Less Severe Hemorrhagic Shock | 28-day mortality | 2 Participants |
| Standard | Number of Participants With Mortality, Adverse Outcome-free Days and Transfusions in the Sub-group With Less Severe Hemorrhagic Shock | Required factor VII infusion in first 24 h | 0 Participants |
| Standard | Number of Participants With Mortality, Adverse Outcome-free Days and Transfusions in the Sub-group With Less Severe Hemorrhagic Shock | Death or multiple organ failure within 28 days | 2 Participants |
| Standard | Number of Participants With Mortality, Adverse Outcome-free Days and Transfusions in the Sub-group With Less Severe Hemorrhagic Shock | Massive transf. (>=10 units of RBC or death/6 hrs | 5 Participants |
| Standard | Number of Participants With Mortality, Adverse Outcome-free Days and Transfusions in the Sub-group With Less Severe Hemorrhagic Shock | Acute lung injury (ALI) within 28 days | 12 Participants |
| Standard | Number of Participants With Mortality, Adverse Outcome-free Days and Transfusions in the Sub-group With Less Severe Hemorrhagic Shock | Required cryoprecipitate in first 24 h | 2 Participants |
| Standard | Number of Participants With Mortality, Adverse Outcome-free Days and Transfusions in the Sub-group With Less Severe Hemorrhagic Shock | Acute lung injury (ALI) within 6 h post-transfusio | 8 Participants |
| Standard | Number of Participants With Mortality, Adverse Outcome-free Days and Transfusions in the Sub-group With Less Severe Hemorrhagic Shock | Required plasma in first 24 h (not counting field) | 9 Participants |
| Standard | Number of Participants With Mortality, Adverse Outcome-free Days and Transfusions in the Sub-group With Less Severe Hemorrhagic Shock | MOF (Denver MOF score>3) | 0 Participants |
| Standard | Number of Participants With Mortality, Adverse Outcome-free Days and Transfusions in the Sub-group With Less Severe Hemorrhagic Shock | Required tranexamic acid (TXA) in first 6 h | 2 Participants |
| Standard | Number of Participants With Mortality, Adverse Outcome-free Days and Transfusions in the Sub-group With Less Severe Hemorrhagic Shock | Haemoglobin (Hb)<7g/dL within 6 hours | 0 Participants |
Other Pre-specified
Severe Adverse Events (SAE)
Number of participants with severe adverse events (SAE)
Time frame: Hospital stay up to day 28
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Plasma | Severe Adverse Events (SAE) | Death | 12 Participants |
| Plasma | Severe Adverse Events (SAE) | Any SAEs | 34 Participants |
| Plasma | Severe Adverse Events (SAE) | Non-infectious and non-thromboembolic events | 15 Participants |
| Plasma | Severe Adverse Events (SAE) | Infections | 14 Participants |
| Plasma | Severe Adverse Events (SAE) | MOF (Denver MOF score>3) | 5 Participants |
| Plasma | Severe Adverse Events (SAE) | Organ failure (not MOF) | 15 Participants |
| Plasma | Severe Adverse Events (SAE) | Thromboembolic events | 4 Participants |
| Standard | Severe Adverse Events (SAE) | Organ failure (not MOF) | 13 Participants |
| Standard | Severe Adverse Events (SAE) | MOF (Denver MOF score>3) | 1 Participants |
| Standard | Severe Adverse Events (SAE) | Any SAEs | 24 Participants |
| Standard | Severe Adverse Events (SAE) | Death | 6 Participants |
| Standard | Severe Adverse Events (SAE) | Infections | 13 Participants |
| Standard | Severe Adverse Events (SAE) | Thromboembolic events | 2 Participants |
| Standard | Severe Adverse Events (SAE) | Non-infectious and non-thromboembolic events | 11 Participants |
Other Pre-specified
Time to Admission and First Blood Transfusion
Time to admission and first blood product transfusion in minutes.
Time frame: Hospital stay up to 28 days.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Plasma | Time to Admission and First Blood Transfusion | Time from injury to first unit of RBC | 46.5 minutes |
| Plasma | Time to Admission and First Blood Transfusion | Time to first plasma (including pre-admission) | 24 minutes |
| Plasma | Time to Admission and First Blood Transfusion | Time from ED admission to first unit of RBC | 16 minutes |
| Plasma | Time to Admission and First Blood Transfusion | Time from admission to first platelet transfused | 130 minutes |
| Plasma | Time to Admission and First Blood Transfusion | Time from injury to ED admission | 28 minutes |
| Standard | Time to Admission and First Blood Transfusion | Time from admission to first platelet transfused | 88 minutes |
| Standard | Time to Admission and First Blood Transfusion | Time from injury to ED admission | 24 minutes |
| Standard | Time to Admission and First Blood Transfusion | Time from injury to first unit of RBC | 37 minutes |
| Standard | Time to Admission and First Blood Transfusion | Time from ED admission to first unit of RBC | 10 minutes |
| Standard | Time to Admission and First Blood Transfusion | Time to first plasma (including pre-admission) | 58.5 minutes |
Other Pre-specified
Time to Admission and First Blood Transfusion in a Sub-group With Less Severe Hemorrhagic Shock
Time to Admission and First Blood Transfusion in minutes in the patients with initial systolic blood pressure (SBP) 71-90 mmHg and heart rate (HR) of 108 or greater
Time frame: Hospital stay up to 28 days.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Plasma | Time to Admission and First Blood Transfusion in a Sub-group With Less Severe Hemorrhagic Shock | Time from injury to ED admission | 30 minutes |
| Plasma | Time to Admission and First Blood Transfusion in a Sub-group With Less Severe Hemorrhagic Shock | Time from injury to first unit of RBC | 119.5 minutes |
| Standard | Time to Admission and First Blood Transfusion in a Sub-group With Less Severe Hemorrhagic Shock | Time from injury to ED admission | 25 minutes |
| Standard | Time to Admission and First Blood Transfusion in a Sub-group With Less Severe Hemorrhagic Shock | Time from injury to first unit of RBC | 39 minutes |
Other Pre-specified
Time to Admission and First Blood Transfusion in a Sub-group With Severe Hemorrhagic Shock
Time to Admission and First Blood Transfusion in the patients with initial systolic blood pressure (SBP) \<=70 mmHg
Time frame: Hospital stay up to 28 days.
Population: Not all the timepoints are available for all the patients.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Plasma | Time to Admission and First Blood Transfusion in a Sub-group With Severe Hemorrhagic Shock | Time from injury to ED admission | 28 minutes |
| Plasma | Time to Admission and First Blood Transfusion in a Sub-group With Severe Hemorrhagic Shock | Time from injury to first unit of RBC | 48 minutes |
| Standard | Time to Admission and First Blood Transfusion in a Sub-group With Severe Hemorrhagic Shock | Time from injury to ED admission | 23 minutes |
| Standard | Time to Admission and First Blood Transfusion in a Sub-group With Severe Hemorrhagic Shock | Time from injury to first unit of RBC | 36 minutes |