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

NCT00709293 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2013-06-18

No results posted yet for this study

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.

Conditions

  • Ischemia Reperfusion Injury
  • Heart Transplantation

Interventions

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.

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.

Sponsors & Collaborators

Principal Investigators

  • Juan C Alejos, MD · Department of Pediatrics, University of California Los Angeles

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-07-31
Primary Completion
2009-05-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00709293 on ClinicalTrials.gov