Trial Outcomes & Findings for Fibrinogen Concentrate vs Cryoprecipitate (NCT NCT03014700)

Results Overview

For our study, 1 donor exposure = 1 unit of blood product transfusion. A blood product includes red blood cells, fresh frozen plasma, cryoprecipitate, and platelets.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

60 participants

Primary outcome timeframe

From administration of the drug during surgery to ICU arrival postoperatively (up to 24 hours)

Results posted on

2019-05-07

Participant Flow

Participant milestones

Participant milestones
Measure	Cryoprecipitate Arm Subject will be administered Cryoprecipitate to control bleeding after open heart surgery when randomized to Cryoprecipitate group Cryoprecipitate: Subject will be administered Cryoprecipitate to control bleeding after open heart surgery when randomized to Cryoprecipitate group	Fibrinogen Concentrate Arm Subject will be administered Fibrinogen Concentrate to control bleeding after open heart surgery when randomized to Fibrinogen Concentrate group Fibrinogen Concentrate: Subject will be administered Fibrinogen Concentrate to control bleeding after open heart surgery when randomized to Fibrinogen Concentrate group
Overall Study STARTED	30	30
Overall Study COMPLETED	25	29
Overall Study NOT COMPLETED	5	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Fibrinogen Concentrate vs Cryoprecipitate

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cryoprecipitate Arm n=30 Participants Subject will be administered Cryoprecipitate to control bleeding after open heart surgery when randomized to Cryoprecipitate group Cryoprecipitate: Subject will be administered Cryoprecipitate to control bleeding after open heart surgery when randomized to Cryoprecipitate group	Fibrinogen Concentrate Arm n=30 Participants Subject will be administered Fibrinogen Concentrate to control bleeding after open heart surgery when randomized to Fibrinogen Concentrate group Fibrinogen Concentrate: Subject will be administered Fibrinogen Concentrate to control bleeding after open heart surgery when randomized to Fibrinogen Concentrate group	Total n=60 Participants Total of all reporting groups
Age, Continuous	4 months n=39 Participants	4 months n=41 Participants	4 months n=35 Participants
Sex: Female, Male Female	16 Participants n=39 Participants	9 Participants n=41 Participants	25 Participants n=35 Participants
Sex: Female, Male Male	14 Participants n=39 Participants	21 Participants n=41 Participants	35 Participants n=35 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants
Race (NIH/OMB) Asian	1 Participants n=39 Participants	3 Participants n=41 Participants	4 Participants n=35 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants
Race (NIH/OMB) Black or African American	3 Participants n=39 Participants	5 Participants n=41 Participants	8 Participants n=35 Participants
Race (NIH/OMB) White	22 Participants n=39 Participants	18 Participants n=41 Participants	40 Participants n=35 Participants
Race (NIH/OMB) More than one race	0 Participants n=39 Participants	1 Participants n=41 Participants	1 Participants n=35 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=39 Participants	3 Participants n=41 Participants	7 Participants n=35 Participants

PRIMARY outcome

Timeframe: From administration of the drug during surgery to ICU arrival postoperatively (up to 24 hours)

For our study, 1 donor exposure = 1 unit of blood product transfusion. A blood product includes red blood cells, fresh frozen plasma, cryoprecipitate, and platelets.