Evaluation of a Transfusion Therapy Using Whole Blood in the Management of Coagulopathy in Patients With Acute Traumatic Hemorrhage

Trauma Clinical Trial

— T-STORHM  

Official title:

Evaluation of a Transfusion Therapy Using Whole Blood Versus Fractionated Blood Products in the Management of Coagulopathy in Patients Admitted to Hospital for Acute Traumatic Hemorrhage

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04431999
• Other study ID #: 2019-A02706-51
• Status: Recruiting
• Phase: Phase 3
• Start date: December 4, 2021
• Est. completion date: September 2025

Study information

• Verified date: May 2023
• Source: Direction Centrale du Service de Santé des Armées
• Contact: Sylvain AUSSET
• Phone: +33 4 72 36 40 01
• Email: sylvain.ausset[@]def.gouv.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: September 2025
• Est. primary completion date: September 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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 on the prediction of the practitioner (clinical diagnosis) in charge of the treatment of the injured person of the need to transfuse at least 4 PRBCs within 6 hours after the admission of the trauma patient

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...)

Related Conditions & MeSH terms

• Acute Hemorrhage
• Blood Coagulation Disorders
• Coagulopathy
• Hemorrhage
• Hemostatic Disorders
• Trauma

Intervention

Drug:
• Whole blood transfusion
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.
• Fractionated 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.

Locations

Country	Name	City	State
France	CHU de La Cavale Blanche - Brest	Brest
France	HIA Percy	Clamart
France	CHU de Grenoble	Grenoble
France	CHU de La Pitié-Salpêtrière	Paris
France	CHU du Kremlin Bicêtre	Paris
France	HIA Sainte Anne	Toulon

Sponsors (3)

Lead Sponsor	Collaborator
Direction Centrale du Service de Santé des Armées	Floralis, TIMC-IMAG

Country where clinical trial is conducted

France, 

References & Publications (62)

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* Note: There are 62 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	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).	6 hours following hospital admission
Secondary	Effectiveness of circulatory resuscitation	Proportion of patients with lactate clearance > 20% per hour at H2.	2 hours following hospital admission
Secondary	Mortality	Number of deaths.	2 hours following hospital admission and Day 30 (or the last day of hospitalization)
Secondary	Mortality / Morbidity	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.	24 hours following hospital admission
Secondary	Impact on timeframe to obtain blood products	Time to obtain product ratios in accordance with recommendations.	2 and 6 hours following hospital admission
Secondary	Impact on time to start transfusion therapy	Time to start transfusion therapy.	Time between admission and transfusion therapy
Secondary	Evolution of coagulopathy.	All the parameters of the thrombelastography (TEG) (R/CK, alpha/CK, MA/CRT, LY30/CK, FF/CRT) allow to evaluate the coagulopathy.	At inclusion, 2, 6 and 24 hours following hospital admission
Secondary	Evolution of coagulopathy	All the parameters of the coagulation (PT, APTT, fibrinogene) allow to evaluate the coagulopathy.	At inclusion, 2, 6 and 24 hours following hospital admission.
Secondary	Tolerance of whole blood transfusion	Hemolysis marker rate	Day 1, Day 2
Secondary	Labile blood products transfused in the first 24 hours	Number of bags administered	24 hours following hospital admission
Secondary	Cost of the strategy	Direct costs of transfusion and the cost of the ICU stay	Day 30 (or the last day of hospitalization)
Secondary	Biobank establishment	To constitute biobank for biological measurements in research hemorrhagic shock pathophysiology of transfusion resuscitation.	Through study completion, an average of 3 years
Secondary	Ancillary study n°1 : recirculation of storage microerythrocytes	Rate of storage microerythrocytes, monocyte quantification and phenotyping, splenic ultrasound	before and after transfusion resuscitation, Day 30 (or the last day of hospitalization).
Secondary	Ancillary study n°2 : evolution of microcirculation during transfusion resuscitation of hemorrhagic shock.	Optical imaging technique of microvascular content to detect flow anomalies in microvessels.	During the transfusion resuscitation