Evaluation of a Transfusion Therapy Using Whole Blood in the Management of Coagulopathy in Patients With Acute Traumatic Hemorrhage (T-STORHM)

  • STATUS
    Recruiting
  • End date
    Sep 23, 2024
  • participants needed
    200
  • sponsor
    Direction Centrale du Service de Santé des Armées
Updated on 23 April 2022
coagulopathy
blood transfusion
packed red blood cells
pelvic fracture
Accepts healthy volunteers

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.

Details
Condition Trauma, Acute Hemorrhage, Coagulopathy
Treatment Whole Blood transfusion, Fractionated blood products transfusion
Clinical Study IdentifierNCT04431999
SponsorDirection Centrale du Service de Santé des Armées
Last Modified on23 April 2022

Eligibility

Yes No Not Sure

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 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)
No affiliated to the social security
Person deprived of liberty by a legal or administrative decision, person under
guardianship
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note