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

NCT02833025 | Unknown

• 1 other identifier: 1000053849
• Study Type: observational
• Target: 130
• Locations: 1 country
• Sites: 1

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.

Conditions

Platelet Function Tests; Thrombin Generation Tests; Perioperative Coagulopathy

Outcome Measures

Primary Outcomes (1)

• Postoperative chest tube blood loss

  24hr

Secondary Outcomes (9)

• 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

Interventions

Thrombin generation and Platelet Function Testing DEVICE

Point-of-care testing of thrombin generation, platelet function, and rotational thromboelastometry

Eligibility Criteria

• Age: Up to 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children aged ≤5 years undergoing cardiac surgery with cardiopulmonary bypass

You may qualify if:

• Age ≤5 years
• Undergoing cardiac surgery with cardiopulmonary bypass

You may not qualify if:

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

Sponsors & Collaborators

• The Hospital for Sick Children: lead
• Synapse B.V. Research Institute, University of Maastricht: collaborator

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5G1X8, Canada

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Whole blood

Study Officials

• James D O'Leary, MBBCh, MM, MD

  The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

Central Study Contacts

James D O'Leary

CONTACT

416-813-7654; james.oleary@sickkids.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Anesthesiologist

Study Record Dates

• First Submitted: July 5, 2016
• First Posted: July 14, 2016
• Study Start: December 1, 2018
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: May 9, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)