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
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.
- Pediatric population (ages 0-21 years)
- End-stage cardiac disease requiring heart transplantation
- Approval for listing by the UCLA Heart Transplant Committee
- Prior documented Thymoglobulin allergy/adverse reaction
- History of or current diagnosis of lymphoma
- Documented lymphopenia
- Documented Thrombocytopenia
Juan C Alejos, MD
Department of Pediatrics, University of California Los Angeles