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| Name | Class |
|---|---|
| Genentech, Inc. | INDUSTRY |
| Scott and White Hospital & Clinic | OTHER |
| Scott, Sherwood and Brindley Foundation | OTHER |
| Texas A&M University |
The purpose of this study is to assess the benefit to patients with empyema or complicated parapneumonic effusion (CPE) using a daily versus twice daily Alteplase regimen of two different dose strategies compared with saline placebo.
This is a randomized, double-blind, placebo-controlled pilot study. Patients with empyema and complicated parapneumonic effusion who are felt to require fibrinolytic therapy will be considered for study enrollment. Enrolled patients will be randomized to one of five potential treatment arms (saline placebo, 4 mg once daily, 4 mg twice daily, 10 mg once daily, or 10 mg twice daily) in a double-blinded manner.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alteplase | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Need for surgical intervention via thoracostomy or open decortication as a result of conservative therapy. |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality | ||
| Hospital length of stay | ||
| Daily chest tube drainage |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Delores Gautier, RN, MSN | Contact | 254-724-1769 | lgautier@swmail.sw.org |
| Name | Affiliation | Role |
|---|---|---|
| Jeana D O'Brien, MD, FACP, FCCP | Scott and White Memorial Hospital and Scott, Sherwood and Brindley Foundation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Scott and White Memorial Hospital & Clinic | Recruiting | Temple | Texas | 76508 | United States |
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| ID | Term |
|---|---|
| D004653 | Empyema |
| D010996 | Pleural Effusion |
| ID | Term |
|---|---|
| D013492 | Suppuration |
| D007239 | Infections |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D010959 | Tissue Plasminogen Activator |
| ID | Term |
|---|---|
| D012697 | Serine Endopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
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| OTHER |
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| Radiographic improvement |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D010995 | Pleural Diseases |
| D012140 | Respiratory Tract Diseases |
| D004798 |
| Enzymes |
| D045762 | Enzymes and Coenzymes |
| D057057 | Serine Proteases |
| D010960 | Plasminogen Activators |
| D001779 | Blood Coagulation Factors |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001685 | Biological Factors |