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Trial record 68 of 199 for:    Protamine

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. Identifier: NCT01914211
Recruitment Status : Withdrawn
First Posted : August 2, 2013
Last Update Posted : February 1, 2017
Information provided by (Responsible Party):
Aymen N Naguib, Nationwide Children's Hospital

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

Condition or disease Intervention/treatment
Congenital Heart Disease Drug: Tranexamic Acid Procedure: Acute Normovolemic Hemodilution

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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : July 2013
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
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)

Tranexamic Acid
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.

Primary Outcome Measures :
  1. Level of postoperative hemostasis [ Time Frame: 24 hours ]
    Evaluating the body's ability to stop or decrease postoperative bleeding.

Secondary Outcome Measures :
  1. Volume of blood transfusions [ Time Frame: 24 hours ]
    Assessing the need for and amount of blood transfusions during the 1st 24 hours post-op.

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 28 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients from the cardiothoracic surgery population at Nationwide Children's Hospital.

Inclusion Criteria:

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

Exclusion Criteria:

  • Jehovah's witness patients.

Information from the National Library of Medicine

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 identifier (NCT number): NCT01914211

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United States, Ohio
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Sponsors and Collaborators
Aymen N Naguib

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Responsible Party: Aymen N Naguib, Director of Pediatric Cardiothoracic Anesthesia, Nationwide Children's Hospital Identifier: NCT01914211     History of Changes
Other Study ID Numbers: IRB13-00350
First Posted: August 2, 2013    Key Record Dates
Last Update Posted: February 1, 2017
Last Verified: January 2017
Additional relevant MeSH terms:
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Heart Diseases
Cardiovascular Diseases
Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action