NCT02565836View on ClinicalTrials.gov

Fixed-dose Activated Versus Variable-dose Inactivated Prothrombin Complex Concentrate for Warfarin-associated Major Bleed

CompletedOBSERVATIONAL
Enrollment

342

Participants

Timeline

Start Date

October 31, 2015

Primary Completion Date

September 30, 2016

Study Completion Date

September 30, 2016

Conditions
Hemorrhage
Interventions
DRUG

fixed-dose activated prothrombin complex concentrate

"FEIBA VH 500 units IV one time for INR less than 5. FEIBA VH 1000 units IV one time for INR greater than 5.~Check INR after infusion and may repeat dose if INR still elevated"

DRUG

variable-dose inactivated prothrombin complex concentrate

"Kcentra 25 units/kg IV one time for INR less than 4. Kcentra 35 units/kg IV one-time for INR 4 to 6. Kcentra 50 units/kg IV one-time for INR greater than 6.~Check INR after infusion and may repeat dose if INR still elevated."

All Listed Sponsors
collaborator

Wake Forest University Health Sciences

OTHER

lead

Rush University Medical Center

OTHER

NCT02565836 - Fixed-dose Activated Versus Variable-dose Inactivated Prothrombin Complex Concentrate for Warfarin-associated Major Bleed | Biotech Hunter | Biotech Hunter