The Role of Tranexamic Acid in Reducing Blood Transfusion Requirements After Cardiopulmonary Bypass in Neonates
1 other identifier
observational
N/A
1 country
1
Brief Summary
This is an observational, prospective study to evaluate the role of tranexamic acid in reducing blood transfusion in neonates undergoing cardiopulmonary bypass.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jul 2013
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2013
CompletedFirst Submitted
Initial submission to the registry
July 31, 2013
CompletedFirst Posted
Study publicly available on registry
August 2, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2014
CompletedFebruary 1, 2017
January 1, 2017
11 months
July 31, 2013
January 31, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Level of postoperative hemostasis
Evaluating the body's ability to stop or decrease postoperative bleeding.
24 hours
Secondary Outcomes (1)
Volume of blood transfusions
24 hours
Study Arms (2)
Acute Normovolemic Hemodilution
Patients that receive acute normovolemic hemodilution prior to surgery.
Tranexamic Acid
Patients that receive tranexamic acid during surgery.
Interventions
100mg/kg prior to incision, 100mg/kg on CPB and 100mg/kg after reversal of heparin with protamine.
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)
Eligibility Criteria
Patients from the cardiothoracic surgery population at Nationwide Children's Hospital.
You may qualify if:
- All neonates undergoing arterial switch or aortic arch procedure utilizing cardiopulmonary bypass (CPB).
You may not qualify if:
- Jehovah's witness patients.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Aymen N Naguiblead
Study Sites (1)
Nationwide Children's Hospital
Columbus, Ohio, 43205, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Director of Pediatric Cardiothoracic Anesthesia
Study Record Dates
First Submitted
July 31, 2013
First Posted
August 2, 2013
Study Start
July 1, 2013
Primary Completion
June 1, 2014
Study Completion
June 1, 2014
Last Updated
February 1, 2017
Record last verified: 2017-01