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Clinical Trials/NCT02352662
NCT02352662
Withdrawn
Not Applicable

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

Boston Children's Hospital1 site in 1 countryApril 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Congenital Heart Disease
Sponsor
Boston Children's Hospital
Locations
1
Primary Endpoint
Evidence of CPB-induced coagulopathy confirmed by coagulation assays
Status
Withdrawn
Last Updated
9 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
April 2015
End Date
April 2017
Last Updated
9 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

David Faraoni

Cardiac Anesthesiologist

Boston Children's Hospital

Eligibility Criteria

Inclusion Criteria

  • Neonates weighing greater than 2.5 kg
  • Patients equal to or less than 12 months of age
  • Undergoing elective cardiac surgery with cardiopulmonary bypass

Exclusion Criteria

  • Emergent procedure
  • The patient is deemed to be in a moribund condition (American Society of Anesthesiology (ASA 5))

Outcomes

Primary Outcomes

Evidence of CPB-induced coagulopathy confirmed by coagulation assays

Time Frame: Over 6 months

Study Sites (1)

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