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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

Non-surgical bleeding after cardiopulmonary bypass

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

Inclusion Criteria1

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

Exclusion Criteria5

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

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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