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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

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Lung Transplant Drug: thymoglobulin (intraoperative) Drug: thymoglobulin (postoperative) Phase 3

Detailed Description:

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: A Prospective Single Center Randomized Trial of Intraoperative Versus Postoperative Thymoglobulin in Lung Transplantation.
Actual Study Start Date : January 2006
Actual Primary Completion Date : September 2009
Actual Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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)
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
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)
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



Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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.).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00592306


Locations
United States, California
Departments of Pulmonary and Critical Care, Cardiothoracic Surgery and Infectious Diseases at David Geffen School of Medicine at UCLA
Los Angeles, California, United States, 90095-1690
Sponsors and Collaborators
Rajan Saggar
Genzyme, a Sanofi Company
Investigators
Principal Investigator: Rajan Saggar, MD Department of Pulmonology and Critical Care at David Geffen School of Medicine at UCLA

Responsible Party: Rajan Saggar, Principal Investigator, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT00592306     History of Changes
Other Study ID Numbers: ATG in Lung Transplantation
First Posted: January 14, 2008    Key Record Dates
Last Update Posted: March 6, 2018
Last Verified: March 2018

Keywords provided by Rajan Saggar, University of California, Los Angeles:
ATG
rabbit thymoglobulin
reperfusion lung injury
primary graft dysfunction
lung transplantation

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