Status:
COMPLETED
Use of ROTEM® in Pediatric Cardiac Surgical Patients
Lead Sponsor:
Weill Medical College of Cornell University
Conditions:
Congenital Heart Defect
Eligibility:
All Genders
1-6 years
Brief Summary
Cardiac surgery requiring use of a heart-lung machine, also known as cardiopulmonary bypass (CPB) can induce abnormalities in blood coagulation (clotting) that lead to excessive blood loss during and ...
Detailed Description
Specific aims of the proposed pilot studies are to: 1. Use bedside blood analysis with ROTEM® in pediatric cardiac surgical patients to provide preliminary information on the nature of coagulation ab...
Eligibility Criteria
Inclusion
- Patients with congenital heart disease undergoing cardiac surgery needing cardiopulmonary bypass.
- Males and females
- Age 1 year to 6 years
- Informed consent obtained
Exclusion
- Known pre-existing haemostatic abnormalities
- Emergency surgery
- Pre-operative treatment with prostaglandin infusion or any other medication known to interfere with platelet function or cause coagulation abnormalities .
- Inclusion in another clinical research study
- Refusal or inability of patient's parent to sign the Informed Consent Form in English.
Key Trial Info
Start Date :
September 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 1 2014
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT01212289
Start Date
September 1 2010
End Date
February 1 2014
Last Update
February 18 2016
Active Locations (1)
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1
New York Presbyterian Hospital/ Weill Cornell Medical College
New York, New York, United States, 10021