Lung Transplant
Conditions
Keywords
ATG, rabbit thymoglobulin, reperfusion lung injury, primary graft dysfunction, lung transplantation
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.
Interventions
DRUGthymoglobulin (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.
DRUGthymoglobulin (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.
Sponsors
Genzyme, a Sanofi Company
University of California, Los Angeles
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed