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

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.

Study Overview

• Status: Unknown
• Conditions: Platelet Function Tests; Thrombin Generation Tests; Perioperative Coagulopathy
• Intervention / Treatment: Device: Thrombin generation and Platelet Function Testing

• Study Type: Observational
• Enrollment (Anticipated): 130

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G1X8
      • The Hospital for Sick Children

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 5 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Children aged ≤5 years undergoing cardiac surgery with cardiopulmonary bypass

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Postoperative chest tube blood loss	24hr

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: The Hospital for Sick Children
• Collaborators: Synapse B.V. Research Institute, University of Maastricht
• Investigators: Principal Investigator: James D O'Leary, MBBCh, MM, MD, The Hospital for Sick Children

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2018
• Primary Completion (Anticipated): December 1, 2020
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: July 5, 2016
• First Submitted That Met QC Criteria: July 11, 2016
• First Posted (Estimate): July 14, 2016

Study Record Updates

• Last Update Posted (Actual): May 9, 2018
• Last Update Submitted That Met QC Criteria: May 8, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hematologic Diseases; Hemorrhagic Disorders; Hemostatic Disorders; Blood Coagulation Disorders; Hemostatics; Coagulants; Thrombin
• Other Study ID Numbers: 1000053849

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No