Status:
COMPLETED
Fibrinogen in the Initial Resuscitation of Severe Trauma (FiiRST)
Lead Sponsor:
Sunnybrook Health Sciences Centre
Conditions:
Trauma
Injury
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
Trauma is the leading cause of death in people 44 years of age or younger. After major trauma, such as following high-speed motor vehicle collision, bleeding coupled with clotting defects is responsib...
Eligibility Criteria
Inclusion
- 1\. Injured trauma (penetrating or blunt) patients who are at risk of significant bleeding, defined as: i. Systolic blood pressure (SBP) ≤ 100mmHg at any time from the injury scene until 30min after hospital admission AND ii. Red blood cell transfusion has been ordered by the trauma team leader (or delegate)
Exclusion
- Patients in shock which the etiology is purely not related to bleeding:
- i. Cardiogenic (myocardial or valvular dysfunction); ii. Distributive (septic, anaphylactic, acute adrenal insufficiency and neurogenic) and iii. Obstructive (cardiac tamponade, tension pneumothorax and massive pulmonary emboli).
- Severe head injury, defined as any of the following:
- i. Glasgow coma scale (GCS) of 3 due to severe traumatic brain injury (TBI); ii. TBI with clear indication of immediate neurosurgical intervention based on clinical findings (mechanism of trauma associated with focal signs such as anisocoria with fixed pupil) or on CT results (bleeding causing mass effect); iii. Unsalvageable head injury such as through-through gunshot wound to the head, open skull fracture with exposure/loss of brain tissue; as per the trauma team or neurosurgery initial clinical assessment or as per initial CT of the head findings;
- Known complete or incomplete spinal cord injury;
- Known hereditary or acquired coagulopathies unrelated to the trauma resuscitation (e.g. known hepatic dysfunction);
- Use of anticoagulant medications such as warfarin, low-molecular weight heparin, and direct thrombin and factor Xa inhibitors;
- Moribund with evidence of unsalvageable injuries and withdrawal of care, as per the trauma team;
- Received blood products prior to admission;
- Patients with estimated body weight under 50Kg;
- Patients with known or suspected pregnancy;
- Patients arriving more than 6hr after injury.
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT02203968
Start Date
October 1 2014
End Date
December 1 2015
Last Update
April 14 2016
Active Locations (1)
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1
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N3M5