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

Platelet Function Tests Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02833025
• Other study ID #: 1000053849
• Status: Not yet recruiting
• Start date: December 1, 2018
• Est. completion date: December 1, 2020

Study information

• Verified date: May 2018
• Source: The Hospital for Sick Children
• Contact: James D O'Leary
• Phone: 416-813-7654
• Email: james.oleary[@]sickkids.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 130
• Est. completion date: December 1, 2020
• Est. primary completion date: December 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 5 Years

Eligibility

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

Related Conditions & MeSH terms

• Blood Coagulation Disorders
• Hemostatic Disorders
• Perioperative Coagulopathy
• Platelet Function Tests
• Thrombin Generation Tests

Intervention

Device:
• Thrombin generation and Platelet Function Testing
Point-of-care testing of thrombin generation, platelet function, and rotational thromboelastometry

Locations

Country	Name	City	State
Canada	The Hospital for Sick Children	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
The Hospital for Sick Children	Synapse B.V. Research Institute, University of Maastricht

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative chest tube blood loss		24hr
Secondary	Postoperative chest tube blood loss		6hr
Secondary	Postoperative chest tube blood loss		12hr
Secondary	Transfusion of blood products		24hr
Secondary	All-cause mortality		within 30 days
Secondary	Length of hospital stay		through study completion, an average of less than one month
Secondary	Length of ICU stay		within 30 days
Secondary	Duration of mechanical ventilation		within 30 days
Secondary	Inotropes	Duration of inotropic support	within 30 days
Secondary	Kidney injury	Acute kidney injury	within 30 days