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| Name | Class |
|---|---|
| Genzyme, a Sanofi Company | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| thymoglobulin (intraoperative) | Active Comparator | 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) |
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| thymoglobulin (postoperative dosing) | Placebo Comparator | We plan to blindly randomize these 25 lung transplant patients to 3 postoperative doses of thymoglobulin (the intraoperative dose will be placebo) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| thymoglobulin (intraoperative) | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Primary Graft Dysfunction | 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 | paO2/FiO2 ratio at post transplant, 24 hr, 48 hr, and 72 hr time points |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rajan Saggar, MD | Pulmonology & Critical Care at UCLA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Departments of Pulmonary and Critical Care, Cardiothoracic Surgery and Infectious Diseases at David Geffen School of Medicine at UCLA | Los Angeles | California | 90095-1690 | United States |
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| ID | Term |
|---|---|
| D055031 | Primary Graft Dysfunction |
| ID | Term |
|---|---|
| D015427 | Reperfusion Injury |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D011183 | Postoperative Complications |
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| ID | Term |
|---|---|
| C512542 | thymoglobulin |
| D011184 | Postoperative Period |
| ID | Term |
|---|---|
| D059035 | Perioperative Period |
| D013514 | Surgical Procedures, Operative |
| D005791 | Patient Care |
| D006296 | Health Services |
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| thymoglobulin (postoperative) | 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. |
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| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005159 |
| Health Care Facilities Workforce and Services |