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Fibrinogen concentrate in severe trauma resuscitation (FiiRST)
NCT02203968Phase 2
Key facts
- Status
- Completed
- Start
- Oct 2014
- Primary completion
- Dec 2015
- Countries
- 1
- Sponsor
- Sunnybrook Health Sciences Centre
- Modality
- Recombinant Proteins and Enzymes
- Drugs
- Fibrinogen human
- Conditions
- Bleedingcoagulopathy
01
Overview
Phase 2, randomised, double-blind trial of Fibrinogen human in Bleeding and coagulopathy, sponsored by Sunnybrook Health Sciences Centre. Primary endpoint: Feasibility of rapid preparation and administration at 1 year. Started Oct 2014; status: completed.
02
Design
- Study design
- RandomizedDouble-blind
03
Who it enrols
Adult trauma patients with SBP ≤ 100mmHg and requiring RBC transfusion, excluding those with non-hemorrhagic shock, severe head/spinal injury, or pre-existing coagulopathy.
04
Endpoints
Primary
Feasibility of rapid preparation and administration
Secondary
Physiologic endpoints
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