Intraoperative Versus Postoperative Thymoglobulin in Lung Transplantation

Condition(s) targeted: Lung Transplant

Intervention: rabbit antithymocyte globulin + placebo (Drug); placebo + rabbit antithymocyte globulin (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: University of California, Los Angeles

Official(s) and/or principal investigator(s):
Rajan Saggar, MD, Principal Investigator, Affiliation: Department of Pulmonology and Critical Care at David Geffen School of Medicine at UCLA

Overall contact:
Rajan Saggar, M.D., Phone: 310-825-5635, Email: rsaggar@mednet.ucla.edu

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. In addition, these cohorts will be compared to patients who do not qualify for thymoglobulin and receive either an alternative agent or no agent. The primary endpoint is primary graft dysfunction. We will also evaluate several other early and late end points such as ventilator days, ICU/hospital days, acute/chronic rejection, infection, CT chest abnormalities, and survival.

We will also collect donor lung tissue and lavage fluid for measurement of various proteins and receptor expression at two time points: (1) prior to implementation and dosing of induction chemotherapy and (2) after transplantation (following a course of induction chemotherapy). This will allow us to possibly make a connection between the profiles of the various proteins and receptors and the clinical outcomes, depending on weather the patient has received induction chemotherapy, starting intraoperatively or postoperatively.

Official title: A Prospective Single Center Randomized Trial of Intraoperative Versus Postoperative Thymoglobulin in Lung Transplantation.

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Primary outcome: Primary Graft Dysfunction

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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.).

Rajan Saggar, M.D., Phone: 310-825-5635, Email: rsaggar@mednet.ucla.edu

Departments of Pulmonary and Critical Care, Cardiothoracic Surgery and Infectious Diseases at David Geffen School of Medicine at UCLA, Los Angeles, California 90095-1690, United States; Recruiting
Rajan Saggar, M.D., Phone: 310-825-5635, Email: rsaggar@mednet.ucla.edu
Michaela Dyke, Phone: 310-825-5635, Email: mdyke@mednet.ucla.edu
Rajan Saggar, M.D., Principal Investigator
David J Ross, M.D., Sub-Investigator
John Belperio, M.D., Sub-Investigator
Joseph P Lynch, III, M.D., Sub-Investigator
Abbas Ardehali, M.D., Sub-Investigator
Bernard Kubak, MD, Sub-Investigator
Rajeev Saggar, MD, Sub-Investigator
Sam Weigt, MD, Sub-Investigator
Aric Gregson, MD, Sub-Investigator

Starting date: January 2006
Last updated: June 4, 2008