Status:
COMPLETED
The Trauma- Formula-Driven Versus Lab-Guided Study (TRFL Study)
Lead Sponsor:
Sunnybrook Health Sciences Centre
Collaborating Sponsors:
Canadian Department of National Defence
Canadian Blood Services
Conditions:
Hemorrhagic Shock
Trauma Coagulopathy
Eligibility:
All Genders
Phase:
PHASE1
PHASE2
Brief Summary
Background: Bleeding and coagulopathy still accounts for the majority of early in-hospital deaths following trauma. There have been lately several published studies suggesting that higher transfusion ...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Patients were eligible for this study if they:
- i) were adult trauma patients assessed by the trauma team; and ii) suffered either penetrating or blunt mechanism of injury; and
- were bleeding and expected to require massive transfusion (either 4 units within the next 2 hours or ≥ 10 units of RBC in 24 h) or required transfusion of un-cross matched emergency stock red blood cells; and
- had an episode of hypotension (systolic bp ≤ 90mmHg).
- Exclusion Criteria
- Patients were excluded if:
- i) they were assessed in the trauma room more than six hours after injury; or ii) they received more than two units of RBC transfusion prior to arrival; or iii) they had suffered a concomitant severe brain injury (defined as any of the following: Glasgow Coma Scale of 3 due to severe traumatic brain injury; clear indication of immediate neurosurgical intervention based on clinical findings, mechanism of trauma associated with focal signs (anisocoria, CT evidence of intracranial bleeding with mass effect); or iv) they had evidence of having a catastrophic head injury (such as transcranial gunshot wound, open skull fracture with exposure/loss of brain tissue, or expert opinion by either the trauma team leader or neurosurgical consultant based on initial clinical or initial CT findings); or v) they had evidence that their shock state was unrelated to hemorrhage (ie cardiogenic, septic, anaphylactic, acute adrenal insufficiency, neurogenic, or obstructive (cardiac tamponade, tension pneumothorax and massive pulmonary emboli); or vi) they had a known hereditary or acquired coagulopathy unrelated to the trauma resuscitation (for example: hemophilia, hepatic insufficiency, or anti-coagulant medications); or vii) they were moribund with evidence of unsalvageable injuries.
Exclusion
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2011
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT00945542
Start Date
July 1 2009
End Date
December 1 2011
Last Update
December 2 2011
Active Locations (1)
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1
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5