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TraumaPhase 3T-STORHMNCT04431999

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

A Phase 3 study testing Whole blood transfusion and Fractionated blood products transfusion in people with Trauma and Acute Hemorrhage, run by Direction Centrale du Service de Santé des Armées at 6 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Trauma, Acute Hemorrhage, Coagulopathy
What is being tested?
Whole blood transfusion and Fractionated blood products transfusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
6 sitesFrance
Study dates
4 Dec 2021to 20 Oct 2025
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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
Show all 13Show fewer
  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • 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...)

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

France6 sites

  • CHU de La Cavale Blanche - Brest

    Brest, 29200

  • HIA Percy

    Clamart, 92140

  • CHU de Grenoble

    Grenoble, 38000

  • CHU de La Pitié-Salpêtrière

    Paris, 75013

  • CHU du Kremlin Bicêtre

    Paris, 94270

  • HIA Sainte Anne

    Toulon, 83000

Other trials in France

About this study

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

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.

Read the 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.

Being tested
Whole blood transfusion, Fractionated blood products transfusion
Keywords
Whole Blood, Acute traumatic coagulopathy, Transfusion
Medical subject headings
Wounds and Injuries, Hemostatic Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Whole blood transfusionDrug

    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 transfusionDrug

    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.

Study groups in NCT04431999
Study groupRoleWhat they receive
Whole blood groupExperimentalDamage control resuscitation for trauma care using whole blood.
Receives: Drug: Whole blood transfusion
Fractionated blood products groupActive comparatorDamage control resuscitation for trauma care using component therapy.
Receives: Drug: Fractionated blood products transfusion

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    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).

    Measured: 6 hours following hospital admission

Secondary outcomes (11)

  1. Effectiveness of circulatory resuscitation

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

    Measured: 2 hours following hospital admission

  2. Mortality

    Number of deaths.

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

  3. 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.

    Measured: 24 hours following hospital admission

  4. Impact on timeframe to obtain blood products

    Time to obtain product ratios in accordance with recommendations.

    Measured: 2 and 6 hours following hospital admission

  5. Impact on time to start transfusion therapy

    Time to start transfusion therapy.

    Measured: Time between admission and transfusion therapy

  6. Evolution of coagulopathy.

    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.

    Measured: At inclusion, 2, 6 and 24 hours following hospital admission

  7. Evolution of coagulopathy

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

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

  8. Tolerance of whole blood transfusion

    Hemolysis marker rate

    Measured: Day 1, Day 2

  9. Labile blood products transfused in the first 24 hours

    Number of bags administered

    Measured: 24 hours following hospital admission

  10. Cost of the strategy

    Direct costs of transfusion and the cost of the ICU stay

    Measured: Day 30 (or the last day of hospitalization)

  11. Biobank establishment

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

    Measured: Through study completion, an average of 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jun 2020
  2. Study start4 Dec 2021
  3. Primary completion17 Oct 2025
  4. Study completion20 Oct 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Multicenter, Controlled, Randomized, Open Labe Therapeutic Trial
Masking
None (open label)
Enrolment
200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04431999
Sponsor's protocol ID
2019-A02706-51
Acronym
T-STORHM
Status last verified
Feb 2025
First submitted
28 May 2020
Last updated
26 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Spinella PC. Zero preventable deaths after traumatic injury: An achievable goal. J Trauma Acute Care Surg. 2017 Jun;82(6S Suppl 1):S2-S8. doi: 10.1097/TA.0000000000001425. No abstract available.

    PubMed 28333835

  • Bhangu A, Nepogodiev D, Doughty H, Bowley DM. Meta-analysis of plasma to red blood cell ratios and mortality in massive blood transfusions for trauma. Injury. 2013 Dec;44(12):1693-9. doi: 10.1016/j.injury.2012.07.193. Epub 2012 Sep 25.

    PubMed 23021369

  • Johansson PI, Oliveri RS, Ostrowski SR. Hemostatic resuscitation with plasma and platelets in trauma. J Emerg Trauma Shock. 2012 Apr;5(2):120-5. doi: 10.4103/0974-2700.96479.

    PubMed 22787340

  • Cap A, Hunt B. Acute traumatic coagulopathy. Curr Opin Crit Care. 2014 Dec;20(6):638-45. doi: 10.1097/MCC.0000000000000158.

    PubMed 25340382

  • Cap AP, Pidcoke HF, Spinella P, Strandenes G, Borgman MA, Schreiber M, Holcomb J, Tien HC, Beckett AN, Doughty H, Woolley T, Rappold J, Ward K, Reade M, Prat N, Ausset S, Kheirabadi B, Benov A, Griffin EP, Corley JB, Simon CD, Fahie R, Jenkins D, Eastridge BJ, Stockinger Z. Damage Control Resuscitation. Mil Med. 2018 Sep 1;183(suppl_2):36-43. doi: 10.1093/milmed/usy112.

    PubMed 30189070

  • Spahn DR, Bouillon B, Cerny V, Duranteau J, Filipescu D, Hunt BJ, Komadina R, Maegele M, Nardi G, Riddez L, Samama CM, Vincent JL, Rossaint R. The European guideline on management of major bleeding and coagulopathy following trauma: fifth edition. Crit Care. 2019 Mar 27;23(1):98. doi: 10.1186/s13054-019-2347-3.

    PubMed 30917843

  • Godier A, Bacus M, Kipnis E, Tavernier B, Guidat A, Rauch A, Drumez E, Susen S, Garrigue-Huet D. Compliance with evidence-based clinical management guidelines in bleeding trauma patients. Br J Anaesth. 2016 Nov;117(5):592-600. doi: 10.1093/bja/aew317.

    PubMed 27799173

  • Stanworth SJ, Davenport R, Curry N, Seeney F, Eaglestone S, Edwards A, Martin K, Allard S, Woodford M, Lecky FE, Brohi K. Mortality from trauma haemorrhage and opportunities for improvement in transfusion practice. Br J Surg. 2016 Mar;103(4):357-65. doi: 10.1002/bjs.10052. Epub 2016 Feb 3.

    PubMed 26841720

  • Carli P, Pons F, Levraut J, Millet B, Tourtier JP, Ludes B, Lafont A, Riou B. The French emergency medical services after the Paris and Nice terrorist attacks: what have we learnt? Lancet. 2017 Dec 16;390(10113):2735-2738. doi: 10.1016/S0140-6736(17)31590-8. Epub 2017 Jul 25. No abstract available.

    PubMed 28754492

  • Eastridge BJ, Mabry RL, Seguin P, Cantrell J, Tops T, Uribe P, Mallett O, Zubko T, Oetjen-Gerdes L, Rasmussen TE, Butler FK, Kotwal RS, Holcomb JB, Wade C, Champion H, Lawnick M, Moores L, Blackbourne LH. Death on the battlefield (2001-2011): implications for the future of combat casualty care. J Trauma Acute Care Surg. 2012 Dec;73(6 Suppl 5):S431-7. doi: 10.1097/TA.0b013e3182755dcc.

    PubMed 23192066

  • Eastridge BJ, Hardin M, Cantrell J, Oetjen-Gerdes L, Zubko T, Mallak C, Wade CE, Simmons J, Mace J, Mabry R, Bolenbaucher R, Blackbourne LH. Died of wounds on the battlefield: causation and implications for improving combat casualty care. J Trauma. 2011 Jul;71(1 Suppl):S4-8. doi: 10.1097/TA.0b013e318221147b.

    PubMed 21795876

  • Glasgow S, Davenport R, Perkins Z, Tai N, Brohi K. A comprehensive review of blood product use in civilian mass casualty events. J Trauma Acute Care Surg. 2013 Sep;75(3):468-74. doi: 10.1097/TA.0b013e318298efb9. No abstract available.

    PubMed 23928738

  • Doughty H, Glasgow S, Kristoffersen E. Mass casualty events: blood transfusion emergency preparedness across the continuum of care. Transfusion. 2016 Apr;56 Suppl 2:S208-16. doi: 10.1111/trf.13488.

    PubMed 27100758

  • Glasgow SM, Allard S, Rackham R, Doughty H. Going for gold: blood planning for the London 2012 Olympic Games. Transfus Med. 2014 Jun;24(3):145-53. doi: 10.1111/tme.12116. Epub 2014 Apr 18.

    PubMed 24750387

  • Glasgow SM, Allard S, Doughty H, Spreadborough P, Watkins E. Blood and bombs: the demand and use of blood following the London Bombings of 7 July 2005--a retrospective review. Transfus Med. 2012 Aug;22(4):244-50. doi: 10.1111/j.1365-3148.2012.01173.x.

    PubMed 22809430

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Whole blood transfusion and Fractionated blood products transfusion in people with Trauma and Acute Hemorrhage, run by Direction Centrale du Service de Santé des Armées at 6 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04431999, which also lists 59 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2026.

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