Peri-operative Assessment of Coagulopathy in Neonates and Infants Undergoing Cardiac Surgery
- Conditions
- Congenital Heart Disease
- Interventions
- Other: Perioperative blood samples collection
- Registration Number
- NCT02352662
- Lead Sponsor
- Boston Children's Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- Neonates weighing greater than 2.5 kg
- Patients equal to or less than 12 months of age
- Undergoing elective cardiac surgery with cardiopulmonary bypass
- Emergent procedure
- The patient is deemed to be in a moribund condition (American Society of Anesthesiology (ASA 5))
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Study Group Perioperative blood samples collection Three blood samples will be collected intra-operatively from each subject enrolled
- Primary Outcome Measures
Name Time Method Evidence of CPB-induced coagulopathy confirmed by coagulation assays Over 6 months
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Boston Children's Hospital
🇺🇸Boston, Massachusetts, United States