The Role of Tranexamic Acid in Reducing Blood Transfusion Requirements After Cardiopulmonary Bypass in Neonates
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01914211|
Recruitment Status : Withdrawn
First Posted : August 2, 2013
Last Update Posted : February 1, 2017
|Condition or disease||Intervention/treatment|
|Congenital Heart Disease||Drug: Tranexamic Acid Procedure: Acute Normovolemic Hemodilution|
|Study Type :||Observational|
|Actual Enrollment :||0 participants|
|Study Start Date :||July 2013|
|Actual Primary Completion Date :||June 2014|
|Actual Study Completion Date :||June 2014|
Acute Normovolemic Hemodilution
Patients that receive acute normovolemic hemodilution prior to surgery.
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)
Patients that receive tranexamic acid during surgery.
Drug: Tranexamic Acid
100mg/kg prior to incision, 100mg/kg on CPB and 100mg/kg after reversal of heparin with protamine.
- Level of postoperative hemostasis [ Time Frame: 24 hours ]Evaluating the body's ability to stop or decrease postoperative bleeding.
- Volume of blood transfusions [ Time Frame: 24 hours ]Assessing the need for and amount of blood transfusions during the 1st 24 hours post-op.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01914211
|United States, Ohio|
|Nationwide Children's Hospital|
|Columbus, Ohio, United States, 43205|