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

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: NCT00709293
Recruitment Status : Withdrawn (Insufficient funding)
First Posted : July 3, 2008
Last Update Posted : June 18, 2013
Genzyme, a Sanofi Company
Information provided by (Responsible Party):
Juan Alejos, University of California, Los Angeles

Brief 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.

Condition or disease Intervention/treatment Phase
Ischemia Reperfusion Injury Heart Transplantation Drug: Anti-Thymocyte Globulin Drug: Normal Saline Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Role of Intraoperative Thymoglobulin in Decreasing Ischemia-Reperfusion Injury in Pediatric Heart Transplant Recipients
Study Start Date : July 2008
Estimated Primary Completion Date : May 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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): NCT00709293

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United States, California
Mattel Children's Hospital at UCLA
Los Angeles, California, United States, 90095
Sponsors and Collaborators
University of California, Los Angeles
Genzyme, a Sanofi Company
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Principal Investigator: Juan C Alejos, MD Department of Pediatrics, University of California Los Angeles
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Responsible Party: Juan Alejos, Clinical Professor, University of California, Los Angeles Identifier: NCT00709293    
Other Study ID Numbers: Thymoglobulin - Alejos
First Posted: July 3, 2008    Key Record Dates
Last Update Posted: June 18, 2013
Last Verified: June 2013
Keywords provided by Juan Alejos, University of California, Los Angeles:
Ischemia Reperfusion Injury
Pediatric Heart Transplant
Induction Therapy
Additional relevant MeSH terms:
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Reperfusion Injury
Wounds and Injuries
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases
Postoperative Complications
Antilymphocyte Serum
Immunologic Factors
Physiological Effects of Drugs
Immunosuppressive Agents