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NCT01914211 Clinical Trial

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

Congenital Heart Disease Clinical Trial

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT01914211
Other study ID # IRB13-00350
Secondary ID
Status Withdrawn
Phase N/A
First received July 31, 2013
Last updated January 31, 2017
Start date July 2013
Est. completion date June 2014

Study information
Verified date January 2017
Source Nationwide Children's Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date June 2014
Est. primary completion date June 2014
Accepts healthy volunteers No
Gender All
Age group N/A to 28 Days
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

- Jehovah's witness patients.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Tranexamic Acid
100mg/kg prior to incision, 100mg/kg on CPB and 100mg/kg after reversal of heparin with protamine.
Procedure:
• Acute Normovolemic Hemodilution
Draw 20 mL/kg (up to 5Kg) of blood from patient and replace with washed PRBCs at 10-20mL/kg. (If > 5Kg draw 20% of circulating blood volume without PRBC replacement)

Locations
Country Name City State
United States Nationwide Children's Hospital Columbus Ohio

Sponsors (1)
Lead Sponsor Collaborator
Aymen N Naguib

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Level of postoperative hemostasis Evaluating the body's ability to stop or decrease postoperative bleeding. 24 hours
Secondary Volume of blood transfusions Assessing the need for and amount of blood transfusions during the 1st 24 hours post-op. 24 hours
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