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Role of Intraoperative Thymoglobulin in Decreasing Ischemia-Reperfusion Injury in Pediatric Heart Transplant Recipients

Information source: University of California, Los Angeles
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Ischemia Reperfusion Injury; Heart Transplantation

Intervention: Anti-Thymocyte Globulin (Drug); Normal Saline (Drug)

Phase: N/A

Status: Withdrawn

Sponsored by: University of California, Los Angeles

Official(s) and/or principal investigator(s):
Juan C Alejos, MD, Principal Investigator, Affiliation: Department of Pediatrics, University of California Los Angeles

Summary

The restoration of normal blood flow following a period of ischemia may result in ischemia / reperfusion injury (I/RI), which is characterized by inflammation and oxidative damage to tissues. Varying degrees of I/RI occur upon reperfusion of a donor heart after cold storage. Medications containing antibodies against immune cells have been used for many years as powerful immunosuppressants. These medications, called polyclonal antibody preparations, are generally only used immediately following transplantation and/or to treat rejection. At our institution, one such antibody preparation (Thymoglobulin) is used in most pediatric heart transplant recipients for 3-5 days immediately after transplantation. Because standard immunosuppressive medications (called calcineurin inhibitors) are toxic to the kidneys, the use of Thymoglobulin allows us to delay the initiation of calcineurin inhibitors until the kidneys of completely recovered from the shock of the transplant surgery. We hypothesize that Thymoglobulin may be beneficial in reducing the damage caused by I/RI. Thus, the present study seeks to evaluate the effectiveness of an intra-operative dose of Thymoglobulin (in addition to the standard doses post-operatively) at reducing the effects of I/RI. The study will be a double-bind placebo-controlled trial involving 20 subjects. Biologic markers for I/RI will be assessed at periodic intervals for six months post-transplantation. Subjects receiving intra-operative doses of Thymoglobulin will be compared to the controls in order to assess the effectiveness of intra-operative Thymoglobulin in ameliorating the effects of I/RI.

Clinical Details

Official title: Role of Intraoperative Thymoglobulin in Decreasing Ischemia-Reperfusion Injury in Pediatric Heart Transplant Recipients

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Eligibility

Minimum age: N/A. Maximum age: 21 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Pediatric population (ages 0-21 years)

- End-stage cardiac disease requiring heart transplantation

- Approval for listing by the UCLA Heart Transplant Committee

Exclusion Criteria:

- Prior documented Thymoglobulin allergy/adverse reaction

- History of or current diagnosis of lymphoma

- Documented lymphopenia

- Documented Thrombocytopenia

- Pregnancy

Locations and Contacts

Mattel Children's Hospital at UCLA, Los Angeles, California 90095, United States
Additional Information

Starting date: July 2008
Last updated: June 17, 2013

Page last updated: August 23, 2015

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