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NCT Number: NCT04431999

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

CHU de La Cavale Blanche - Brest, Brest, France

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Severe trauma patients requiring the initiation of a massive transfusion protocol determined on

  • 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
  • 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
  • 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...)

Treatment and study plan

Whole blood transfusion

Drug

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

Drug

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.

Primary outcomes

  1. 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).

    Time frame: 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 outcomes

  1. Effectiveness of circulatory resuscitation

    Time frame: 2 hours following hospital admission

    Proportion of patients with lactate clearance > 20% per hour at H2.

  2. Mortality

    Time frame: 2 hours following hospital admission and Day 30 (or the last day of hospitalization)

    Number of deaths.

  3. Mortality / Morbidity

    Time frame: 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.

  4. Impact on timeframe to obtain blood products

    Time frame: 2 and 6 hours following hospital admission

    Time to obtain product ratios in accordance with recommendations.

  5. Impact on time to start transfusion therapy

    Time frame: Time between admission and transfusion therapy

    Time to start transfusion therapy.

  6. Evolution of coagulopathy.

    Time frame: 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.

  7. Evolution of coagulopathy

    Time frame: At inclusion, 2, 6 and 24 hours following hospital admission.

    All the parameters of the coagulation (PT, APTT, fibrinogene) allow to evaluate the coagulopathy.

  8. Tolerance of whole blood transfusion

    Time frame: Day 1, Day 2

    Hemolysis marker rate

  9. Labile blood products transfused in the first 24 hours

    Time frame: 24 hours following hospital admission

    Number of bags administered

  10. Cost of the strategy

    Time frame: Day 30 (or the last day of hospitalization)

    Direct costs of transfusion and the cost of the ICU stay

  11. Biobank establishment

    Time frame: Through study completion, an average of 3 years

    To constitute biobank for biological measurements in research hemorrhagic shock pathophysiology of transfusion resuscitation.

Sponsors and collaborators

Lead sponsor

Direction Centrale du Service de Santé des Armées

Other

Collaborators

  • Floralis
  • TIMC-IMAG

Registry information

Official study 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

Acronym: T-STORHM

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Jun 16, 2020
Registry last updated
Jan 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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