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Search / Trial NCT01212289

Use of ROTEM® in Pediatric Cardiac Surgical Patients

Launched by WEILL MEDICAL COLLEGE OF CORNELL UNIVERSITY · Sep 28, 2010

Trial Information

Current as of June 16, 2025

Completed

Keywords

ClinConnect Summary

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 abnormalities.
2. Compare ROTEM® coagulation profiles between subjects having primary surgery and those undergoing reoperation.

In order to test the study hypothesis, pediatric subjects scheduled to undergo cardiac surgery involving CPB will be recruited for two study groups: a) primary surgery; b) reoperation. For each group, a small amount of blood will be obtained for ROTEM® analysis after in...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Patients with congenital heart disease undergoing cardiac surgery needing cardiopulmonary bypass.
  • Males and females
  • Age 1 year to 6 years
  • Informed consent obtained
  • Exclusion Criteria:
  • 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.

About Weill Medical College Of Cornell University

Weill Medical College of Cornell University is a leading academic institution dedicated to advancing medical research and education. As a prominent sponsor of clinical trials, it focuses on innovative healthcare solutions and the development of new therapies across various medical disciplines. The institution is committed to fostering collaborative research efforts that enhance patient care and improve health outcomes. With a robust infrastructure and a team of experienced researchers and clinicians, Weill Cornell aims to translate scientific discoveries into practical applications, ensuring a strong emphasis on ethical standards and regulatory compliance throughout the clinical trial process.

Locations

New York, New York, United States

Patients applied

0 patients applied

Trial Officials

Aarti Sharma, M.D.

Principal Investigator

Weill Medical College of Cornell University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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