Intraoperative Versus Postoperative Thymoglobulin in Lung Transplantation - Full Text View

Purpose

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.

Condition	Intervention	Phase
Lung Transplant	Drug: rabbit antithymocyte globulin + placebo Drug: placebo + rabbit antithymocyte globulin	Phase III

MedlinePlus related topics:

Lung Transplantation

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

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

Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:

Primary Graft Dysfunction [ Time Frame: paO2/FiO2 ratio at post transplant, 24 hr, and 48 hr time points ] [ Designated as safety issue: No ]

Estimated Enrollment:	120
Study Start Date:	January 2006
Estimated Study Completion Date:	September 2009
Estimated Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
I: Active Comparator We plan to blindly randomize these 25 lung transplant patients to intraoperative dosing of thymoglobulin followed by 3 additional postoperative doses (the first of these 3 postoperative doses will be placebo)	Drug: rabbit antithymocyte globulin + placebo All patients (Arm I and Arm II) will receive 3 doses of thymoglobulin at 1.5mg/kg IV over 6 hours; only the timing of the medication is being altered. Each arm will also receive a single placebo dose. Arm I will receive thymoglobulin intraoperatively followed by a postoperative placebo dose and two subsequent thymoglobulin doses.
II: Experimental We plan to blindly randomize these 25 lung transplant patients to 3 postoperative doses of thymoglobulin (the intraoperative dose will be placebo)	Drug: placebo + rabbit antithymocyte globulin All patients (Arm I and Arm II) will receive 3 doses of thymoglobulin at 1.5mg/kg IV over 6 hours; only the timing of the medication is being altered. Each arm will also receive a single placebo dose. Arm II will receive placebo intraoperatively followed by 3 postoperative doses of thymoglobulin.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00592306

Contacts


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

Contact: Michaela Dyke	310-825-5635	mdyke@mednet.ucla.edu

Locations


United States, California
	Departments of Pulmonary and Critical Care, Cardiothoracic Surgery and Infectious Diseases at David Geffen School of Medicine at UCLA	Recruiting
	Los Angeles, California, United States, 90095-1690
	Contact: Rajan Saggar, M.D. 310-825-5635 rsaggar@mednet.ucla.edu
	Contact: Michaela Dyke 310-825-5635 mdyke@mednet.ucla.edu
	Principal Investigator: Rajan Saggar, M.D.
	Sub-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: Bernard Kubak, MD
	Sub-Investigator: Aric Gregson, MD

Sponsors and Collaborators

University of California, Los Angeles

Genzyme

Investigators


Principal Investigator:	Rajan Saggar, MD	Department of Pulmonology and Critical Care at David Geffen School of Medicine at UCLA

More Information

Responsible Party:	David Geffen School of Medicine, UCLA ( Rajan Saggar )
Study ID Numbers:	ATG in Lung Transplantation
First Received:	December 28, 2007
Last Updated:	June 4, 2008
ClinicalTrials.gov Identifier:	NCT00592306
Health Authority:	United States: Food and Drug Administration

Keywords provided by University of California, Los Angeles:

ATG

rabbit thymoglobulin

reperfusion lung injury

primary graft dysfunction

lung transplantation

Study placed in the following topic categories:

Antilymphocyte Serum

Additional relevant MeSH terms:

Immunologic Factors

Physiological Effects of Drugs

Immunosuppressive Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on August 21, 2008

Sponsors and Collaborators:	University of California, Los Angeles Genzyme
Information provided by:	University of California, Los Angeles
ClinicalTrials.gov Identifier:	NCT00592306