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Intraoperative Versus Postoperative Thymoglobulin in Lung Transplantation

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ClinicalTrials.gov Identifier: NCT00592306
Recruitment Status : Completed
First Posted : January 14, 2008
Last Update Posted : March 6, 2018
Sponsor:
Collaborator:
Genzyme, a Sanofi Company
Information provided by (Responsible Party):
Rajan Saggar, University of California, Los Angeles

December 28, 2007
January 14, 2008
March 6, 2018
January 2006
September 2009   (Final data collection date for primary outcome measure)
Primary Graft Dysfunction [ Time Frame: paO2/FiO2 ratio at post transplant, 24 hr, 48 hr, and 72 hr time points ]
the definition for primary graft dysfunction is established and will be used to determine the grade of primary graft dysfunction at 4 time points after lung transplantation
Primary Graft Dysfunction [ Time Frame: paO2/FiO2 ratio at post transplant, 24 hr, and 48 hr time points ]
Complete list of historical versions of study NCT00592306 on ClinicalTrials.gov Archive Site
Not Provided
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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.

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.

Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Lung Transplant
  • Drug: thymoglobulin (intraoperative)

    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: thymoglobulin (postoperative)

    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.

    Other Name: thymoglobulin
  • Placebo Comparator: thymoglobulin (intraoperative)
    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: thymoglobulin (intraoperative)
  • Placebo Comparator: thymoglobulin (postoperative dosing)
    We plan to blindly randomize these 25 lung transplant patients to 3 postoperative doses of thymoglobulin (the intraoperative dose will be placebo)
    Intervention: Drug: thymoglobulin (postoperative)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
120
September 2010
September 2009   (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.).
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00592306
ATG in Lung Transplantation
Yes
Not Provided
Not Provided
Rajan Saggar, University of California, Los Angeles
Rajan Saggar
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
March 2018

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