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

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12606000057583

Acronym

NOPCPB

Enrollment

Registered

2006-02-08

Start date

2006-04-03

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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) 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

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

0 to 1 Years

Healthy volunteers

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.

Outcome results