Congenital Heart Disease
Conditions
Brief summary
This is an observational, prospective study to evaluate the role of tranexamic acid in reducing blood transfusion in neonates undergoing cardiopulmonary bypass.
Interventions
DRUGTranexamic Acid
100mg/kg prior to incision, 100mg/kg on CPB and 100mg/kg after reversal of heparin with protamine.
PROCEDUREAcute 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)
Sponsors
Aymen N Naguib
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 28 Days
Healthy volunteers
No
Inclusion criteria
* All neonates undergoing arterial switch or aortic arch procedure utilizing cardiopulmonary bypass (CPB).
Exclusion criteria
* Jehovah's witness patients.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Level of postoperative hemostasis | 24 hours | Evaluating the body's ability to stop or decrease postoperative bleeding. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Volume of blood transfusions | 24 hours | Assessing the need for and amount of blood transfusions during the 1st 24 hours post-op. |
Countries
United States
Outcome results
None listed