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

Withdrawn before enrolling

Conditions studied: Congenital Heart Disease

In brief

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.

Key facts

Study ID

NCT02352662

Run by

Boston Children's Hospital

People needed

0

Starts

2015-04-01

Expected to finish

2017-04-01

Last updated by the study team

2017-04-10

Who can join

Age: any, up to 1. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

• Boston Children's Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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