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- Withdrawn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