NCT02203968View on ClinicalTrials.gov

Fibrinogen in the Initial Resuscitation of Severe Trauma (FiiRST)

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

October 31, 2014

Primary Completion Date

December 31, 2015

Study Completion Date

December 31, 2015

Conditions
TraumaInjuryBleedingHaemorrhageCoagulopathy
Interventions
DRUG

Fibrinogen concentrate

Six grams of fibrinogen concentrate (RiaSTAP™) will be administered intravenously as a single 300ml rapid infusion (less than 3min) via level I automated pressure pump within one hour of hospital admission.

DRUG

Placebo Comparator

Placebo Comparator: Normal saline Placebo (normal saline) will be administered intravenously as a single 300ml rapid infusion (less than 3min) via level I automated pressure pump within one hour of hospital admission.

Trial Locations (1)

M4N3M5

Sunnybrook Health Sciences Centre, Toronto

All Listed Sponsors
lead

Sunnybrook Health Sciences Centre

OTHER

NCT02203968 - Fibrinogen in the Initial Resuscitation of Severe Trauma (FiiRST) | Biotech Hunter | Biotech Hunter