Intraoperative Versus Postoperative Thymoglobulin in Lung Transplantation

NCT ID: NCT00592306

Last Updated: 2020-09-10

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-01-31
• Study Completion Date: 2010-09-30

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.

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.

Conditions

Lung Transplant

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

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)

Group Type: ACTIVE_COMPARATOR

thymoglobulin (intraoperative)

Intervention Type: DRUG

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.

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)

Group Type: PLACEBO_COMPARATOR

thymoglobulin (postoperative)

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

thymoglobulin; thymoglobulin

Eligibility 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.).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genzyme, a Sanofi Company

INDUSTRY

Sponsor Role: collaborator

University of California, Los Angeles

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rajan Saggar, MD

Role: PRINCIPAL_INVESTIGATOR

Pulmonology & Critical Care at UCLA

Locations

Departments of Pulmonary and Critical Care, Cardiothoracic Surgery and Infectious Diseases at David Geffen School of Medicine at UCLA

Los Angeles, California, United States

Countries

United States

Other Identifiers

ATG in Lung Transplantation

Identifier Type: -

Identifier Source: org_study_id