Not Yet RecruitingPhase 3ACTRN12606000057583

Improving blood coagulation function and reducing blood loss in infants after open heart surgery

Effect of nitric oxide gas and prostacyclin infusion on platelet function, coagulation activity and postoperative blood loss in paediatric cardiopulmonary bypass


Sponsor

Royal Childrens Hospital and Murdoch Children's Research Institute

Enrollment

80 participants

Start Date

Apr 3, 2006

Study Type

Interventional

Conditions


Eligibility

Sex: Both males and femalesMin Age: 0 YearssMax Age: 1 Years

Inclusion Criteria1

  • 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 Criteria1

  • 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.

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Interventions

This study will compare 4 anticoagulation treatments in infants during cardiac surgery with cardiopulmonary bypass: 2) anticoagulation with intravenous heparin 3 mg/kg plus 20 ppm nitric oxide (NO)

This study will compare 4 anticoagulation treatments in infants during cardiac surgery with cardiopulmonary bypass: 2) anticoagulation with intravenous heparin 3 mg/kg plus 20 ppm nitric oxide (NO) gas added to the oxygenator 3) anticoagulation with intravenous heparin 3 mg/kg plus intravenous infusion of prostacyclin 2 ng/kg/min 4) anticoagulation with intravenous heparin 3 mg/kg plus combination of 20 ppm NO gas added to oxygenator and intravenous infusion of prostacyclin 2 ng/kg/min


Locations(1)

Australia

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ACTRN12606000057583