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

This study has been withdrawn prior to enrollment.
(Insufficient funding)
Sponsor:
Collaborator:
Genzyme, a Sanofi Company
Information provided by (Responsible Party):
Juan Alejos, University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT00709293
First received: July 1, 2008
Last updated: June 17, 2013
Last verified: June 2013
  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:


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

Enrollment: 0
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

Locations
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
Investigators
Principal Investigator: Juan C Alejos, MD Department of Pediatrics, University of California Los Angeles
  More Information

No publications provided

Responsible Party: Juan Alejos, Clinical Professor, 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: June 17, 2013
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
Wounds and Injuries
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 April 15, 2014