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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified June 2008 by University of California, Los Angeles.
Recruitment status was Not yet recruiting

Sponsor:

Collaborator:

Genzyme

Information provided by:

University of California, Los Angeles

ClinicalTrials.gov Identifier:

NCT00709293

First received: July 1, 2008

Last updated: July 2, 2008

Last verified: June 2008

History of Changes

Purpose

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.

Condition	Intervention
Ischemia Reperfusion Injury Heart Transplantation	Drug: Anti-Thymocyte Globulin Drug: Normal Saline

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention
Official Title:	Role of Intraoperative Thymoglobulin in Decreasing Ischemia-Reperfusion Injury in Pediatric Heart Transplant Recipients

Resource links provided by NLM:

MedlinePlus related topics: Heart Transplantation

Drug Information available for: Antilymphocyte Serum

U.S. FDA Resources

Further study details as provided by University of California, Los Angeles:

Estimated Enrollment:	20
Study Start Date:	July 2008
Estimated Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: 1	Drug: Normal Saline Normal saline will be utilized as a placebo comparator. It will be infused in the same fashion as the Thymoglobulin in the intervention arm.
Active Comparator: 2	Drug: Anti-Thymocyte Globulin Thymoglobulin (1.5 mg/kg body weight) will be infused through a peripheral intravenous line over a minimum of 6 hours. The infusion will be started at the time of donor visualization (once it is confirmed the transplant is proceeding). The peri-operative nurse or anesthesiologist will be responsible for drug infusion. Other Name: ATG

Eligibility

Ages Eligible for Study:	up to 21 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00709293

Contacts

Contact: Brent Gordon, MD

310-825-5296

BGordon@mednet.ucla.edu

Locations

United States, California
Mattel Children's Hospital at UCLA	Not yet recruiting
Los Angeles, California, United States, 90095
Principal Investigator: Juan C Alejos, MD
Sub-Investigator: Brent Gordon, MD

Sponsors and Collaborators

University of California, Los Angeles

Genzyme

Investigators

Principal Investigator:

Juan C Alejos, MD

Department of Pediatrics, University of California Los Angeles

More Information

No publications provided

Responsible Party:	Juan Alejos, MD - Principal Investigator, Department of Pediatrics, University of California Los Angeles
ClinicalTrials.gov Identifier:	NCT00709293 History of Changes
Other Study ID Numbers:	Thymoglobulin - Alejos
Study First Received:	July 1, 2008
Last Updated:	July 2, 2008
Health Authority:	United States: Institutional Review Board

Keywords provided by University of California, Los Angeles:

Ischemia Reperfusion Injury
Pediatric Heart Transplant
ATG
Induction Therapy

Additional relevant MeSH terms:

Ischemia
Reperfusion Injury
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases
Postoperative Complications

Antilymphocyte Serum
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013

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