Clinical trial NCT00709293: Role of Intraoperative Thymoglobulin in Decreasing Ischemia-Reperfusion Injury in Pediatric Heart Transplant Recipients
Official title: Role of Intraoperative Thymoglobulin in Decreasing Ischemia-Reperfusion Injury in Pediatric Heart Transplant Recipients
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Ischemia Reperfusion Injury
Heart Transplantation
Keywords: Ischemia Reperfusion Injury
Pediatric Heart Transplant
ATG
Induction Therapy
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: Genzyme, a Sanofi Company
First posted: 2008-07-03
Enrollment: 0
Sex: ALL
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Mattel Children's Hospital at UCLA
state: California
Study officials:
affiliation: Department of Pediatrics, University of California Los Angeles
name: Juan C Alejos, MD
role: PRINCIPAL_INVESTIGATOR
References: