Point-of-care Assessment of Thrombin Generation and Platelet Function in Children Requiring Cardiopulmonary Bypass

The Hospital for Sick Children

Status: Unknown

Conditions: Perioperative Coagulopathy; Thrombin Generation Tests; Platelet Function Tests

Treatments: Device: Thrombin generation and Platelet Function Testing

Study type: Observational

Funder types: Other

Identifiers

NCT02833025

1000053849

Details and patient eligibility

About

Coagulopathy after cardiopulmonary bypass (CPB) is associated with increased morbidity and mortality. Clot formation and clot stability are important factors in coagulation and hemostasis. As such platelet dysfunction and impaired thrombin generation play a central role in bleeding after cardiac surgery. The primary objective of this study is to evaluate the relationship between point-of-care determined platelet function and thrombin generation and postoperative bleeding in infants and young children undergoing cardiac surgery with cardiopulmonary bypass adjusting for clinically important confounding factors.

Enrollment: 130 estimated patients

Sex: All

Ages: Under 5 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age ≤5 years
2. Undergoing cardiac surgery with cardiopulmonary bypass

Exclusion criteria

1. Non-english speaking parents/care-givers
2. Refusal to consent
3. Extracorporeal membrane oxygenation (ECMO) or ventricular assist device prior to surgery
4. Therapeutic heparin use (unfractionated or low molecular weight) in the immediate preoperative period (<12 hr)
5. Weight <3 kg