Prothrombin Complex Concentrate vs Fresh Frozen Plasma in Goal-directed Bleeding Management in Cardiac Surgery

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age20-75
SponsorKonkuk University Medical Center

About this trial

The primary endpoint of this study is the completion time of hemostasis treatment when administered Fresh frozen plasma (FFP) and frozen powder coagulation factor concentrate (PCC) in goal-directed bleeding management for cardiac surgery.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

patients undergoing cardiac surgery

Disqualifiers

thrombocytopenia

oral anti-coagulant

anti platelet agents

Trial design

Design model

Parallel

Treatments tested in this trial

  • fresh frozen plasma

    Biological/Vaccine

    transfusion of fresh frozen plasma

  • prothrombin complex concentrate

    Biological/Vaccine

    prothrombin complex concentrate administration

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: fresh frozen plasmaActive comparator 1 intervention
Group B: prothrombin complex concentrateExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

treatment time

duration from the time of diagnosing CT-EXTEM prolongation (ordering PCC or FFP) to the time achieving bleeding control (completing administration of PCC or FFP)

Time frame
1 min

Secondary outcomes

1

Red Blood Cell amount

Red Blood Cell transfusion amount during surgery

Time frame
I hour
2

FFP amount

Red Blood Cell transfusion amount during surgery

Time frame
1 hour
3

Platelet amount

Platelet transfusion amount during surgery

Time frame
1 hour
4

cryoprecipiate amount

amount of cryoprecipitate transfusion

Time frame
1 hour

Other outcomes

1

Thromboembolism complication

myocardial infarction, stroke, cerebral infarction, bowel ischemia

Time frame
24 hour

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Konkuk University Medical Center

Lead sponsor

Asan Medical Center

Collaborator

Soonchunhyang University Hospital

Collaborator