The Role of Tranexamic Acid in Reducing Blood Transfusion Requirements After Cardiopulmonary Bypass in Neonates

Withdrawn

• Conditions: Congenital Heart Disease
• Interventions: Procedure: Acute Normovolemic Hemodilution; Drug: Tranexamic Acid

• Registration Number: NCT01914211
• Lead Sponsor: Aymen N Naguib

Brief Summary

This is an observational, prospective study to evaluate the role of tranexamic acid in reducing blood transfusion in neonates undergoing cardiopulmonary bypass.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-07
• Study First Submitted: 2013-07-31
• Study First Submitted QC: 2013-07-31
• Study First Posted: 2013-08-02
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-31
• Last Update Posted: 2017-02-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• All neonates undergoing arterial switch or aortic arch procedure utilizing cardiopulmonary bypass (CPB).

Exclusion Criteria

• Jehovah's witness patients.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Acute Normovolemic Hemodilution	Acute Normovolemic Hemodilution	Patients that receive acute normovolemic hemodilution prior to surgery.
Tranexamic Acid	Tranexamic Acid	Patients that receive tranexamic acid during surgery.

Primary Outcome Measures

Name	Time	Method
Level of postoperative hemostasis	24 hours	Evaluating the body's ability to stop or decrease postoperative bleeding.

Secondary Outcome Measures

Name	Time	Method
Volume of blood transfusions	24 hours	Assessing the need for and amount of blood transfusions during the 1st 24 hours post-op.

Trial Locations

Locations (1)

Nationwide Children's Hospital; 🇺🇸 Columbus, Ohio, United States