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

Boston Children's Hospital

Status: Withdrawn

Conditions: Congenital Heart Disease

Treatments: Other: Perioperative blood samples collection

Study type: Observational

Funder types: Other

Identifiers

NCT02352662

IRB-P00016002

Details and patient eligibility

About

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.

Sex: All

Ages: Under 12 months old

Volunteers: No Healthy Volunteers

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))

Trial design

0 participants in 1 patient group

Study Group

Description:

Three blood samples will be collected intra-operatively from each subject enrolled

Treatment:

Other: Perioperative blood samples collection