NCT02833025

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

Point-of-care Assessment of Thrombin Generation and Platelet Function in Children Undergoing Cardiac Surgery With Cardiopulmonary Bypass

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 130 (estimated)
• Sponsor: The Hospital for Sick Children · Academic / Other
• Sex: All
• Age: 5 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Platelet Function Tests
• Thrombin Generation Tests
• Perioperative Coagulopathy

Interventions

Type	Name	Description
DEVICE	Thrombin generation and Platelet Function Testing	Point-of-care testing of thrombin generation, platelet function, and rotational thromboelastometry

Timeline

• Start date: 2018-12-01
• Primary completion: 2020-12-01
• Completion: 2020-12-01
• First posted: 2016-07-14
• Last updated: 2018-05-09

Locations

1 site across 1 country: Canada