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

NCT02833025 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 130

Last updated 2018-05-09

No results posted yet for this study

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

DEVICE

Thrombin generation and Platelet Function Testing

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

Sponsors & Collaborators

  • Synapse B.V. Research Institute, University of Maastricht

    collaborator UNKNOWN

  • The Hospital for Sick Children

    lead OTHER

Principal Investigators

  • James D O'Leary, MBBCh, MM, MD · The Hospital for Sick Children

Eligibility

Max Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-01
Primary Completion
2020-12-01
Completion
2020-12-01

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02833025 on ClinicalTrials.gov