Prothrombinex or Fresh Frozen Plasma for Cardio Pulmonary Bypass Associated Bleeding (POPCAB)

For patients who experience bleeding after cardiopulmonary bypass, will treatment with Prothrombinex VF as compared to treatment with Fresh Frozen Plasma, decrease the rate of red cell and platelet transfusions?

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12613001279718

Acronym

POPCAB

Enrollment

122

Registered

2013-11-20

Start date

2016-02-02

Completion date

Unknown

Last updated

2021-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

A multi centre, randomised, active control, trial of 200 patients comparing Prothrombinex VF with Fresh Frozen Plasma (FFP) as first line treatment for non surgical bleeding after cardiopulmonary bypass.

Interventions

Human 3 Factor Prothrombin complex concentrate (Prothrombinex VF) 25IU/kg IV bolus for the first line treatment of non surgical bleeding post cardiopulmonary bypass.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Eligibility

Sex/Gender

All

Age

18 Years to 100 Years

Healthy volunteers

Inclusion criteria

Patients undergoing cardiac surgery requiring cardiopulmonary bypass and determined to have non surgical bleeding post heparin reversal.

Exclusion criteria

The following patient groups will be excluded: 1.Patients with pre-existing bleeding diatheses 2.Patients receiving Prothrombinex or FFP less than 5 days before CPB 3.Patients receiving heart or lung transplant 4.Patients having implantation of ventricular assist devices (VAD’s)

Outcome results