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

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

• Registration Number: NCT02833025
• Lead Sponsor: The Hospital for Sick Children

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-07-05
• Study First Submitted QC: 2016-07-11
• Study First Posted: 2016-07-14
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-08
• Last Update Posted: 2018-05-09
• Study Start: 2018-12-01
• Primary Completion: 2020-12-01
• Study Completion: 2020-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 130

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Postoperative chest tube blood loss	24hr

Secondary Outcome Measures

Name	Time	Method
Kidney injury	within 30 days	Acute kidney injury
Length of hospital stay	through study completion, an average of less than one month
Transfusion of blood products	24hr
Length of ICU stay	within 30 days
Inotropes	within 30 days	Duration of inotropic support
All-cause mortality	within 30 days
Postoperative chest tube blood loss	12hr
Duration of mechanical ventilation	within 30 days

Trial Locations

Locations (1)

The Hospital for Sick Children; 🇨🇦 Toronto, Ontario, Canada