Acute Hemorrhage, Coagulopathy, Trauma
Conditions
Keywords
Whole Blood, Acute traumatic coagulopathy, Transfusion
Brief summary
The prognosis of traumatized hemorrhages is correlated with the nature of transfusion therapy: a 50% reduction in mortality for an early and massive supply of plasma, and 20% for an early and massive supply of platelets. However, this strategy encounters logistical difficulties, particularly in a context of collective emergency (attacks). The use of whole blood, widely documented by the Armed Forces, improves the availability of plasma and platelets, and simplifies handling by the various actors in the chain. T-STORHM is a randomized, controlled, parallel clinical trial.This study tests non-inferiority of whole blood transfusion therapy in the management of coagulopathy in patients with acute traumatic hemorrhage.
Detailed description
In recent years, terrorist attacks have confronted the investigator's healthcare system with a massive influx of victims of war weapon injuries. This new fact makes the efficiency of transfusion therapy crucial: hemorrhage is the leading cause of death from weapons of war, and the high number of victims of each attack changes the logistical approach. The logistical problems with transfusion therapy, including red blood cell (PRBCs), plasma and platelet concentrates, are the speed of delivery and availability. Using whole blood is a pragmatic solution to overcome these problems. This solution has been used for many years by the French Army to ensure platelet transfusion in traumatic hemorrhages The hypothesis of the T-STORHM study is that the use of whole blood is a solution in a context of civil trauma not effective less than component therapy (PRBCs, plasma and platelet concentrates) in the management of coagulopathy in patients admitted to hospital for traumatic hemorrhage.
Interventions
Severe trauma patients with a life threatening bleeding will be managed with 3 whole blood bags for the 1st and 2nd pack. The later packs will consist of 3 packed red blood cells (PRBCs), 3 plasma units and 1 dose of platelets.
DRUGFractionated blood products transfusion
Severe trauma patients with a life threatening bleeding will be managed with 3 packed red blood cells (PRBCs), 3 lyophilised plasma units and 1 dose of platelets for the 1st. The 2nd pack will consist of 3 packed red blood cells (PRBCs) and 3 lyophilised plasma units. Then, the later pack will consist of 3 packed red blood cells (PRBCs), 3 plasma units and 1 dose of platelets.
Sponsors
Direction Centrale du Service de Santé des Armées
TIMC-IMAG
Floralis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Multicenter, Controlled, Randomized, Open Labe Therapeutic Trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Severe trauma patients requiring the initiation of a massive transfusion protocol determined on 1. At least two Red flag score factors (according to pre-hospital data) : * Suspected pelvic fracture * Shock index (FC / PAS)\> = 1 * Microdose hemoglobin \<13g * Average blood pressure \<70 mmHg * Need for prehospital tracheal intubation 2. AND at least two criteria of the Assessment of Blood Consumption (ABC) score established at the patient's arrival: * Penetrating trauma * Focused Abdominal Sonography for Trauma (FAST) echo positive * Blood pressure \<90 mmHg * Respiratory rate \>120 bpm 3. AND/OR after clinical assessment and on the prediction of the practitioner in charge of the treatment of the injured person of the need to transfuse during the emergency management of the injured person
Exclusion criteria
* Non-traumatic hemorrhage * Patients transfused with more than two PRBCs before the initiation of the massive transfusion protocol. * Anti-coagulation treatment * Pregnancy * Age \< 18 years * Patient refusing administration of blood products * Patient transferred from another hospital * Patient nor transported by a physician-staffed prehospital emergency medical system * Burn patient (≥30% of body surface). * Patient under specific known transfusion protocol (for example : allo immunization...)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Non inferiority on the correction of coagulopathy, during emergency transfusion of bleeding trauma using whole blood compared to the use of component therapy (packed red blood cells, plasma units and platelets). | 6 hours following hospital admission | This outcome is measured on the correction of traumatic coagulopathy, measured by the value of a viscoelastometric parameter : the maximum amplitude (MA) (measured by a thromboelastogram). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effectiveness of circulatory resuscitation | 2 hours following hospital admission | Proportion of patients with lactate clearance \> 20% per hour at H2. |
| Mortality | 2 hours following hospital admission and Day 30 (or the last day of hospitalization) | Number of deaths. |
| Mortality / Morbidity | 24 hours following hospital admission | Composite endpoint : Number of deaths at H24 or impairment of vital functions with a Sequential Organ Failure Assessment (SOFA) score greater than or equal to 12. |
| Impact on timeframe to obtain blood products | 2 and 6 hours following hospital admission | Time to obtain product ratios in accordance with recommendations. |
| Impact on time to start transfusion therapy | Time between admission and transfusion therapy | Time to start transfusion therapy. |
| Evolution of coagulopathy. | At inclusion, 2, 6 and 24 hours following hospital admission | All the parameters of the thrombelastography (TEG) (R/CK, alpha/CK, MA/CRT, LY30/CK, MA/CFF and TEG-ACT/CRT) allow to evaluate the coagulopathy. |
| Evolution of coagulopathy | At inclusion, 2, 6 and 24 hours following hospital admission. | All the parameters of the coagulation (PT, APTT, fibrinogene) allow to evaluate the coagulopathy. |
| Tolerance of whole blood transfusion | Day 1, Day 2 | Hemolysis marker rate |
| Labile blood products transfused in the first 24 hours | 24 hours following hospital admission | Number of bags administered |
| Cost of the strategy | Day 30 (or the last day of hospitalization) | Direct costs of transfusion and the cost of the ICU stay |
| Biobank establishment | Through study completion, an average of 3 years | To constitute biobank for biological measurements in research hemorrhagic shock pathophysiology of transfusion resuscitation. |
Countries
France
Contacts
STUDY_DIRECTORGuillaume PELÉE DE SAINT MAURICE
Direction Centrale du Service de Santé des Armées (DCSSA)
PRINCIPAL_INVESTIGATORSylvain AUSSET
Institution Nationale des Invalides
PRINCIPAL_INVESTIGATORJean-Luc BOSSON
Statistical and methodological investigator - Laboratoire TIMC UMR 5525 CNRS Equipe Themas
Outcome results
None listed