Coagulopathy, Nosocomial Pneumonia
Conditions
Brief summary
The purpose of this study is to determine the effect of antioxidant vitamins (vitamins C and E) on the development of coagulation derangements and nosocomial pneumonia after severe trauma in patients.
Interventions
DIETARY_SUPPLEMENTVitamin C
DIETARY_SUPPLEMENTVitamin E
DIETARY_SUPPLEMENTSaline (for Vitamin C)
0.9% saline administered to mimic Vitamin C
DRUGPlacebo (for Vitamin E)
Sugar pill administered to mimic Vitamin E
Sponsors
University of Alabama at Birmingham
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult trauma patients admitted to the emergency department at the University of Alabama at Birmingham (UAB) Hospital * Blunt or penetrating injury * UAB highest trauma activation
Exclusion criteria
* Age \< 19 years of age * Patients with known bleeding diathesis or who are concurrently taking anticoagulant medication * Patients with known liver disease * Minor patients * Pregnant patients (known or suspected pregnancy) * Patients who are incarcerated * Patients who lack a surrogate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Coagulation Abnormalities | From enrollment up to 3 days | Coagulation parameters are evaluated using standard functional tests (prothrombin time (PT), partial thromboplastin time (PTT), fibrinogen and platelet count)and point of care functional analysis using thromboelastogram (TEG-ROTEM). A blood sample is collected upon arrival in the emergency department at 0 hours only and analyzed for markers of activation of coagulation, inflammation, and levels of vitamin C/E. |
| Number of Subjects With Ventilator-associated Pneumonia. | From enrollment to 3 days | Number of subjects diagnosed with pneumonia and requiring ventilator support. |
| Number of Subjects With Organ Injury | From enrollment to 3 days | Any injury to internal organs (thoracic, abdominal or cranial cavity) |
| Number of Total Blood Product Transfusions | From enrollment to 3 days | the number of blood product transfusions for all subjects in each group over the course of 3 days. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Number of Days in ICU. | from enrollment up to 60 days post enrollment | the mean number of days each subject was in the ICU in each arm |
| Number of Protocol Violations Per Arm. | from enrollment up to 60 days post enrollment | The number of times that there was a deviation or violation from how the protocol was to be implemented. |
| Mean Number of Hospital Stay Days. | from enrollment up to 60 days post enrollment | The mean number of days subjects were in the hospital in each arm of the study |
| Number of Subjects Surviving to Day 28 | from enrollment up to 28 days post enrollment | Number of subjects that survived to day 28 after enrollment |
| Number of Subjects With 60-day Survival | from enrollment up to 60 days post enrollment | Number of subjects in each arm that survived to day 60 |
| Mean Number of Ventilator-free Days for Subjects | from enrollment up to 60 days post enrollment | The mean number of ventilator free days (not on ventilator) for subjects in each arm |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Vitamins C and E Vitamin C (1,000 mg i.v.) and Vitamin E (1,000 IU p.o. via the naso-gastric tube) administered every 8 hours starting within one hour after admission to the Emergency department for up to 5 days or until discharge from the ICU, whichever comes first.
Vitamin C
Vitamin E | 6 |
| 0.9% Saline and Sugar Pill 100 ml of 0.9% saline (for i.v. Vitamin C) and a p.o. placebo (sugar pill for the p.o. Vitamin E) administered every 8 hours starting within one hour after admission to the Emergency department for up to 5 days or until discharge from the ICU, whichever comes first.
Saline (for Vitamin C): 0.9% saline administered to mimic Vitamin C
Placebo (for Vitamin E): Sugar pill administered to mimic Vitamin E | 5 |
| Total | 11 |
Baseline characteristics
| Characteristic | Vitamins C and E | 0.9% Saline and Sugar Pill | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 6 Participants | 5 Participants | 11 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 4 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 6 Participants | 1 Participants | 7 Participants |
| Region of Enrollment United States | 6 participants | 5 participants | 11 participants |
| Sex: Female, Male Female | 2 Participants | 0 Participants | 2 Participants |
| Sex: Female, Male Male | 4 Participants | 5 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Number of Participants With Coagulation Abnormalities
Coagulation parameters are evaluated using standard functional tests (prothrombin time (PT), partial thromboplastin time (PTT), fibrinogen and platelet count)and point of care functional analysis using thromboelastogram (TEG-ROTEM). A blood sample is collected upon arrival in the emergency department at 0 hours only and analyzed for markers of activation of coagulation, inflammation, and levels of vitamin C/E.
Time frame: From enrollment up to 3 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Vitamins C and E | Number of Participants With Coagulation Abnormalities | 2 participants |
| 0.9% Saline and Sugar Pill | Number of Participants With Coagulation Abnormalities | 1 participants |
Primary
Number of Subjects With Organ Injury
Any injury to internal organs (thoracic, abdominal or cranial cavity)
Time frame: From enrollment to 3 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Vitamins C and E | Number of Subjects With Organ Injury | 0 participants |
| 0.9% Saline and Sugar Pill | Number of Subjects With Organ Injury | 0 participants |
Primary
Number of Subjects With Ventilator-associated Pneumonia.
Number of subjects diagnosed with pneumonia and requiring ventilator support.
Time frame: From enrollment to 3 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Vitamins C and E | Number of Subjects With Ventilator-associated Pneumonia. | 4 participants |
| 0.9% Saline and Sugar Pill | Number of Subjects With Ventilator-associated Pneumonia. | 2 participants |
Primary
Number of Total Blood Product Transfusions
the number of blood product transfusions for all subjects in each group over the course of 3 days.
Time frame: From enrollment to 3 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Vitamins C and E | Number of Total Blood Product Transfusions | 11 blood transfusions |
| 0.9% Saline and Sugar Pill | Number of Total Blood Product Transfusions | 5 blood transfusions |
Secondary
Mean Number of Days in ICU.
the mean number of days each subject was in the ICU in each arm
Time frame: from enrollment up to 60 days post enrollment
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Vitamins C and E | Mean Number of Days in ICU. | 15 days |
| 0.9% Saline and Sugar Pill | Mean Number of Days in ICU. | 11 days |
Secondary
Mean Number of Hospital Stay Days.
The mean number of days subjects were in the hospital in each arm of the study
Time frame: from enrollment up to 60 days post enrollment
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Vitamins C and E | Mean Number of Hospital Stay Days. | 18.3 days |
| 0.9% Saline and Sugar Pill | Mean Number of Hospital Stay Days. | 18.2 days |
Secondary
Mean Number of Ventilator-free Days for Subjects
The mean number of ventilator free days (not on ventilator) for subjects in each arm
Time frame: from enrollment up to 60 days post enrollment
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Vitamins C and E | Mean Number of Ventilator-free Days for Subjects | 12 days |
| 0.9% Saline and Sugar Pill | Mean Number of Ventilator-free Days for Subjects | 6.2 days |
Secondary
Number of Protocol Violations Per Arm.
The number of times that there was a deviation or violation from how the protocol was to be implemented.
Time frame: from enrollment up to 60 days post enrollment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Vitamins C and E | Number of Protocol Violations Per Arm. | 1 protocol deviations |
| 0.9% Saline and Sugar Pill | Number of Protocol Violations Per Arm. | 0 protocol deviations |
Secondary
Number of Subjects Surviving to Day 28
Number of subjects that survived to day 28 after enrollment
Time frame: from enrollment up to 28 days post enrollment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Vitamins C and E | Number of Subjects Surviving to Day 28 | 6 participants |
| 0.9% Saline and Sugar Pill | Number of Subjects Surviving to Day 28 | 5 participants |
Secondary
Number of Subjects With 60-day Survival
Number of subjects in each arm that survived to day 60
Time frame: from enrollment up to 60 days post enrollment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Vitamins C and E | Number of Subjects With 60-day Survival | 6 participants |
| 0.9% Saline and Sugar Pill | Number of Subjects With 60-day Survival | 5 participants |