NCT02352662

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

• Status: Withdrawn
• Phase: —
• Study type: Observational
• Enrollment: 0 (actual)
• Sponsor: Boston Children's Hospital · Academic / Other
• Sex: All
• Age: 12 Months
• Healthy volunteers: Not accepted

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.

Conditions

• Congenital Heart Disease

Interventions

Type	Name	Description
OTHER	Perioperative blood samples collection	Collect blood samples at 3 different points intra-operatively. Each blood sample will be run using rotational thromboelastometry to assess intraoperative coagulation

Timeline

• Start date: 2015-04-01
• Primary completion: 2017-04-01
• Completion: 2017-04-01
• First posted: 2015-02-02
• Last updated: 2017-04-10

Locations

1 site across 1 country: United States