Improving blood coagulation function and reducing blood loss in infants after open heart surgery
Phase 3
- Conditions
- Haemostasis during and after paediatric cardiopulmonary bypassBlood - Other blood disordersSurgery - Other surgery
- Registration Number
- ACTRN12606000057583
- Lead Sponsor
- Royal Childrens Hospital and Murdoch Children's Research Institute
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 80
Inclusion Criteria
Infants of either sex and less than one year of age having open heart surgery with cardiopulmonary bypass and who have no pre-existing haemostatic abnormality or platelet dysfunction, will be eligible for the study.
Exclusion Criteria
Infants will be excluded if 1) cardiac output is greater than 1.5 litres/min; 2) body weight is less than 3 kg; 3) they have a known abnormality of platelet function or are on anti-platelet therapy; 4) they are receiving inhaled nitric oxide gas or any nitric oxide-donor therapy; 5) they have a known blood coagulation abnormality or are on anticoagulation therapy.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To determine if supplementation of standard heparin anticoagulation with NO gas and/or prostacyclin in infants reduces activation of platelets and the coagulation cascade[Measured at the end of cardiopulmonary bypass, and preserves platelet function, measured 6 and 24 hours after the end of bypass.]
- Secondary Outcome Measures
Name Time Method To determine if supplementation of standard heparin anticoagulation with NO gas and/or prostacyclin in infants during cardiopulmonary bypass reduces postoperative blood loss.[Measured 6 and 24 hours after the end of bypass, or requirement for blood or blood products in Intensive Care and in the period between the end of surgery and hospital discharge.]