Prothrombinex or Fresh Frozen Plasma for Cardio Pulmonary Bypass Associated Bleeding (POPCAB)
Phase 2
Recruiting
- Conditions
- on-surgical bleeding after cardiopulmonary bypassNon-surgical bleeding after cardiopulmonary bypassBlood - Clotting disorders
- Registration Number
- ACTRN12613001279718
- Lead Sponsor
- Dr Warren Pavey
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 200
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)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The composite end point of those patients receiving either allogeneic red blood cells or platelets after 15ml/kg FFP or Prothrombinex 25IU/kg[Up to 24 hours post operation];The total cost of treatment following randomisation, which will include, drugs, procedures, imaging, length of stay in ICU and hospital. We will also include best estimation of blood product costs.[During hospital stay]
- Secondary Outcome Measures
Name Time Method Incidence of thrombotic complications defined by CHADx groups:<br>5.2 (pulmonary embolism) and 5.8 Venous thrombosis/embolism(not progressing to PE) <br>Assessment will be clinical and based on discharge coding.[At hospital discharge];Respiratory indices (P:F ratios)[at 6 and 12 hrs post op];Overall mortality[at 30 days];Length of stay in ICU and Hospital[At discharge from hospital];Chest drain output[6 and 24 hours];ICU arrival haemoglobin[On ICU arrival];Total surgical red cell loss (Mercuriali formula)[Post operative day 5]