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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

December 28, 2007
June 4, 2008
January 2006
September 2008   (final data collection date for primary outcome measure)
Primary Graft Dysfunction [ Time Frame: paO2/FiO2 ratio at post transplant, 24 hr, and 48 hr time points ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00592306 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Intraoperative Versus Postoperative Thymoglobulin in Lung Transplantation
A Prospective Single Center Randomized Trial of Intraoperative Versus Postoperative Thymoglobulin in Lung Transplantation.

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Lung Transplant
  • 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
  • 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.

  • 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)
    Intervention: Drug: rabbit antithymocyte globulin + placebo
  • Experimental: II
    We plan to blindly randomize these 25 lung transplant patients to 3 postoperative doses of thymoglobulin (the intraoperative dose will be placebo)
    Intervention: Drug: placebo + rabbit antithymocyte globulin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
120
September 2009
September 2008   (final data collection date for primary outcome measure)

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.).
Both
18 Years to 65 Years
No
Contact: Rajan Saggar, M.D. 310-825-5635 rsaggar@mednet.ucla.edu
Contact: Michaela Dyke 310-825-5635 mdyke@mednet.ucla.edu
United States
 
NCT00592306
ATG in Lung Transplantation
Yes
Rajan Saggar, David Geffen School of Medicine, UCLA
University of California, Los Angeles
Genzyme, a Sanofi Company
Principal Investigator: Rajan Saggar, MD Department of Pulmonology and Critical Care at David Geffen School of Medicine at UCLA
University of California, Los Angeles
June 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP