Overview

Intraoperative Versus Postoperative Thymoglobulin in Lung Transplantation

Status:
Withdrawn
Trial end date:
2010-09-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to take a population of lung transplant recipients who meet UCLA criteria for induction chemotherapy with thymoglobulin and prospectively study weather giving the first dose intraoperatively versus postoperatively makes a difference with how patients do during and after lung transplantation.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of California, Los Angeles
Collaborator:
Genzyme, a Sanofi Company
Treatments:
Antilymphocyte Serum
Thymoglobulin
Criteria
Inclusion Criteria:

- On a voluntary basis, all patients eligible for bilateral lung transplantation between
the ages of 18-65 years (inclusive)

Exclusion Criteria:

- Have any known allergy to horse or rabbit antithymocyte polyclonal agents

- Have a preoperative platelet count less then 100,000/mm3

- Are recipients of multiple organ transplants (either simultaneous or sequential)

- Are recipients of a single lung transplantation

- Have a contraindication to rabbit antithymocyte globulin based on judgement of the
investigators (i.e. bleeding diathesis or overwhelming risk of intense
immunosuppression) including the following patients: greater than 65 years of age,
prior diagnosis of malignancy (with the exception skin malignancies), underlying
suppurative lung disease (i.e. bronchiectasis, cystic fibrosis, etc.).