Intraoperative Versus Postoperative Thymoglobulin in Lung Transplantation

Sponsor

University of California, Los Angeles (Other)

Overall Status

Withdrawn

CT.gov ID

NCT00592306

Collaborator

Genzyme, a Sanofi Company (Industry)

Enrollment

Location

Arms

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 Design

Study Type:

Interventional

Actual Enrollment :

0 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 :

Jan 1, 2006

Actual Primary Completion Date :

Sep 1, 2009

Actual Study Completion Date :

Sep 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Active 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 Names: 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 Names: thymoglobulin

Arm

Intervention/Treatment

Active 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 Names:

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 Names:

thymoglobulin

Outcome Measures

Primary Outcome Measures

Primary Graft Dysfunction [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	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