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

Boston Children's Hospital

Overview

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.

Study Type

OBSERVATIONAL

Conditions

Congenital Heart Disease

Interventions

Perioperative blood samples collectionOTHER

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

Eligibility

Sex: ALLMax age: 12 Months

Medical Language ↔ Plain English

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))

Locations (1)

Boston Children's Hospital

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

Evidence of CPB-induced coagulopathy confirmed by coagulation assays

Time frame: Over 6 months

Data from ClinicalTrials.gov

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