Heart Transplantation Clinical Trial
Official title:
Role of Intraoperative Thymoglobulin in Decreasing Ischemia-Reperfusion Injury in Pediatric Heart Transplant Recipients
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.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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