NCT02745041 - Fibrinogen Early In Severe Trauma studY | Biotech Hunter

Enrollment

100

Participants

Timeline

Start Date

December 31, 2016

Primary Completion Date

January 20, 2018

Study Completion Date

February 20, 2018

Conditions

TraumaHaemorrhageCoagulopathy

Interventions

DRUG

Fibrinogen Concentrate

"Fibrinogen Replacement using Fibrinogen Concentrate as per ROTEM guided treatment algorithm \[FIBTEM ≤ A5 10mm\]~FIBTEM A5 0mm (Flat Line) = 6g FC FIBTEM A5 1 - 4mm = 5g FC FIBTEM A5 5 - 6mm = 4g FC FIBTEM A5 7 - 8mm = 3g FC FIBTEM A5 9 - 10mm = 2g FC"

OTHER

Cryoprecipitate

"Fibrinogen replacement using Cryoprecipitate as per ROTEM guided treatment algorithm \[FIBTEM A5 ≤ 10mm\]~FIBTEM A5 0mm (Flat Line) = 20 Units Cryo FIBTEM A5 1- 4mm = 16 Units Cryo FIBTEM A5 5 - 6mm = 14 Units Cryo FIBTEM A5 7 - 8mm = 10 Units Cryo FIBTEM A5 9 - 10mm = 8 Units Cryo"

Trial Locations (4)

4029

Royal Brisbane and Women's Hospital, Brisbane

4102

Princess Alexandra Hospital, Brisbane

4215

Gold Coast University Hospital, Gold Coast

4814

Townsville Hospital, Townsville