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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

130 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-12-01

Study Completion Date

2020-12-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Platelet Function Tests Thrombin Generation Tests Perioperative Coagulopathy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Thrombin generation and Platelet Function Testing

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

Intervention Type DEVICE

Eligibility Criteria

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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

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No