Intraoperative Versus Postoperative Thymoglobulin in Lung Transplantation

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2008 by University of California, Los Angeles.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Genzyme, a Sanofi Company
Information provided by:
University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT00592306
First received: December 28, 2007
Last updated: June 4, 2008
Last verified: June 2008
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: A Prospective Single Center Randomized Trial of Intraoperative Versus Postoperative Thymoglobulin in Lung Transplantation.

Resource links provided by NLM:


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
Active Comparator: I
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.

Other Name: thymoglobulin
Experimental: II
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: Aric Gregson, MD         
Sponsors and Collaborators
University of California, Los Angeles
Genzyme, a Sanofi Company
Investigators
Principal Investigator: Rajan Saggar, MD Department of Pulmonology and Critical Care at David Geffen School of Medicine at UCLA
  More Information

No publications provided

Responsible Party: Rajan Saggar, David Geffen School of Medicine, UCLA
ClinicalTrials.gov Identifier: NCT00592306     History of Changes
Other Study ID Numbers: ATG in Lung Transplantation
Study First Received: December 28, 2007
Last Updated: June 4, 2008
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

Additional relevant MeSH terms:
Antilymphocyte Serum
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Immunosuppressive Agents

ClinicalTrials.gov processed this record on October 01, 2014