RecruitingPhase 2ACTRN12613001279718

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?


Sponsor

Dr Warren Pavey

Enrollment

200 participants

Start Date

Feb 2, 2016

Study Type

Interventional

Conditions

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.


Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 100 Yearss

Plain Language Summary

Simplified for easier understanding

This study compares two blood products — Prothrombinex VF and Fresh Frozen Plasma (FFP) — for stopping non-surgical bleeding that sometimes occurs after heart surgery involving a heart-lung bypass machine (cardiopulmonary bypass). Researchers want to find out which product works better as the first treatment option in this situation. You may be eligible if: - You are 18 years of age or older (up to 100 years) - You are undergoing heart surgery that requires a cardiopulmonary bypass machine - Bleeding occurs after the blood-thinning drug heparin is reversed, and the bleeding is not from a surgical cause You may NOT be eligible if: - You have a pre-existing bleeding disorder - You received Prothrombinex or FFP within 5 days before the bypass procedure - You are having a heart or lung transplant - You are having a ventricular assist device (VAD) implanted Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.

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


Locations(2)

Mount Hospital - Perth

WA, Australia

Fiona Stanley Hospital - Murdoch

WA, Australia

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ACTRN12613001279718