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Trial record 82 of 642 for:    test AND point-of-care

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

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ClinicalTrials.gov Identifier: NCT02833025
Recruitment Status : Not yet recruiting
First Posted : July 14, 2016
Last Update Posted : May 9, 2018
Sponsor:
Collaborator:
Synapse B.V. Research Institute, University of Maastricht
Information provided by (Responsible Party):
James O'Leary, 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.

Condition or disease Intervention/treatment
Platelet Function Tests Thrombin Generation Tests Perioperative Coagulopathy Device: Thrombin generation and Platelet Function Testing

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Study Type : Observational
Estimated Enrollment : 130 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Point-of-care Assessment of Thrombin Generation and Platelet Function in Children Undergoing Cardiac Surgery With Cardiopulmonary Bypass
Estimated Study Start Date : December 1, 2018
Estimated Primary Completion Date : December 1, 2020
Estimated Study Completion Date : December 1, 2020

Resource links provided by the National Library of Medicine



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


Primary Outcome Measures :
  1. Postoperative chest tube blood loss [ Time Frame: 24hr ]

Secondary Outcome Measures :
  1. Postoperative chest tube blood loss [ Time Frame: 6hr ]
  2. Postoperative chest tube blood loss [ Time Frame: 12hr ]
  3. Transfusion of blood products [ Time Frame: 24hr ]
  4. All-cause mortality [ Time Frame: within 30 days ]
  5. Length of hospital stay [ Time Frame: through study completion, an average of less than one month ]
  6. Length of ICU stay [ Time Frame: within 30 days ]
  7. Duration of mechanical ventilation [ Time Frame: within 30 days ]
  8. Inotropes [ Time Frame: within 30 days ]
    Duration of inotropic support

  9. Kidney injury [ Time Frame: within 30 days ]
    Acute kidney injury


Biospecimen Retention:   Samples Without DNA
Whole blood


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Ages Eligible for Study:   up to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Children aged ≤5 years undergoing cardiac surgery with cardiopulmonary bypass
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02833025


Contacts
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Contact: James D O'Leary 416-813-7654 ext 228845 james.oleary@sickkids.ca

Locations
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Canada, Ontario
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G1X8
Sponsors and Collaborators
The Hospital for Sick Children
Synapse B.V. Research Institute, University of Maastricht
Investigators
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Principal Investigator: James D O'Leary, MBBCh, MM, MD The Hospital for Sick Children

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Responsible Party: James O'Leary, Staff Anesthesiologist, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT02833025     History of Changes
Other Study ID Numbers: 1000053849
First Posted: July 14, 2016    Key Record Dates
Last Update Posted: May 9, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Blood Coagulation Disorders
Hemostatic Disorders
Hematologic Diseases
Vascular Diseases
Cardiovascular Diseases
Hemorrhagic Disorders
Thrombin
Hemostatics
Coagulants