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
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Not yet recruiting |
NCT06035991 -
First Clinical Evaluation of Heart Transplantation With Grafts Preserved Using an Ex-vivo Extended Perfusion System
|
N/A | |
| Recruiting |
NCT01927614 -
Advanced Cardiac Imaging in Cardiac Allograft Vasculopathy
|
N/A | |
| Recruiting |
NCT01705015 -
Organ Transplantation Rehabilitation: Effect of Bedside Exercise Device and Activity Reinforcement
|
N/A | |
| Completed |
NCT01655563 -
Pharmacogenetic Trial of Tacrolimus After Pediatric Transplantation
|
Phase 2 | |
| Completed |
NCT01028599 -
Effect of Physical Training on Oxygen Uptake and Endothelial Function in Heart Transplant Recipients
|
N/A | |
| Completed |
NCT00531921 -
Effects of Donor and Recipient Genetic Expression on Heart, Lung, Liver, or Kidney Transplant Survival
|
N/A | |
| Terminated |
NCT00420537 -
Shift to Everolimus (RAD) Kidney Sparing Study
|
Phase 4 | |
| Enrolling by invitation |
NCT03292861 -
The Effect and Safety Profile of Thymoglobulin® in Primary Cardiac Transplant Recipients
|
Phase 2 | |
| Recruiting |
NCT04924491 -
Cell Therapy With Treg Cells Obtained From Thymic Tissue (thyTreg) to Prevent Rejection in Heart Transplant Children
|
Phase 1/Phase 2 | |
| Recruiting |
NCT05270902 -
Haemoadsorption During Heart Transplantation
|
N/A | |
| Completed |
NCT05289180 -
Brachial Right Ventricle - Endomyocardial Biopsy
|
||
| Recruiting |
NCT03687723 -
Observational Study of the Clinical Use of the OCS™ Heart
|
||
| Completed |
NCT01091194 -
Effect of Exercise After Heart Transplantation
|
Phase 2 | |
| Completed |
NCT01182571 -
Exploration of Fatigue, Uncertainty, Depression and Quality of Life in Heart Transplantation Recipients
|
N/A | |
| Withdrawn |
NCT00780637 -
Brachial Artery t-PA Release in Heart Transplant Recipients
|
N/A | |
| Terminated |
NCT00678002 -
Quality of Life in Pediatric Transplant Patients
|
||
| Withdrawn |
NCT00780377 -
Intracoronary Bradykinin Mediated t-PA Release in Heart Transplant Recipients
|
N/A | |
| Terminated |
NCT00121784 -
Heart Spare the Nephron (STN) Study - A Study of CellCept (Mycophenolate Mofetil) and Rapamune (Sirolimus) in Heart Transplant Recipients
|
Phase 4 | |
| Withdrawn |
NCT00572286 -
Non-invasive Evaluation of Heart Transplant Rejection- Pilot Study
|
N/A | |
| Completed |
NCT00123331 -
Rapamycin Use in Calcineurin Inhibitor (CNI)-Free Immunosuppression for Stabilization/Improvement of Renal Function After Heart Transplantation
|
Phase 4 |