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Peri-operative Assessment of Coagulopathy in Neonates and Infants Undergoing Cardiac Surgery

NCT02352662 · Status: WITHDRAWN · Type: OBSERVATIONAL

Last updated 2017-04-10

No results posted yet for this study

Summary

This prospective study will aim to globally assess the coagulopathy induced during cardiac surgery with cardiopulmonary bypass (CPB) in a large pediatric population. The investigators primary objective will be the understanding of CPB-induced coagulopathy based on demographic and surgical characteristics, and coagulation assays. Secondary objective will aim at determining the relationship between coagulation assays, postoperative blood loss, and transfusion requirements. The ultimate goal will be to design an algorithm using point-of-care monitoring that could be used to guide hemostatic therapies in neonates and children undergoing cardiac surgery.To do this, investigators will examine the coagulation in the laboratory based setting.

Conditions

  • Congenital Heart Disease

Interventions

OTHER

Perioperative blood samples collection

Collect blood samples at 3 different points intra-operatively. Each blood sample will be run using rotational thromboelastometry to assess intraoperative coagulation

Sponsors & Collaborators

Principal Investigators

  • David Faraoni, MD · Boston Children's Hospital

Eligibility

Max Age
12 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2017-04-30
Completion
2017-04-30

Countries

  • United States

Study Locations

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Entities

Companies

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 NCT02352662 on ClinicalTrials.gov