Ignite Creation Date:
2025-12-24 @ 9:18 PM
Ignite Modification Date:
2026-04-05 @ 11:54 PM
Study NCT ID:
NCT00468104
Status:
COMPLETED
Last Update Posted:
2012-04-30
First Post:
2007-04-29
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy and Safety of Activase (Ateplase) vs Placebo in Complicated Pleural Effusions (CPE)/Empyemas
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004653', 'term': 'Empyema'}], 'ancestors': [{'id': 'D013492', 'term': 'Suppuration'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010959', 'term': 'Tissue Plasminogen Activator'}], 'ancestors': [{'id': 'D012697', 'term': 'Serine Endopeptidases'}, {'id': 'D010450', 'term': 'Endopeptidases'}, {'id': 'D010447', 'term': 'Peptide Hydrolases'}, {'id': 'D006867', 'term': 'Hydrolases'}, {'id': 'D004798', 'term': 'Enzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D057057', 'term': 'Serine Proteases'}, {'id': 'D010960', 'term': 'Plasminogen Activators'}, {'id': 'D001779', 'term': 'Blood Coagulation Factors'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'tommi4@cox.et', 'phone': '402 206 7372', 'title': 'George Thommi', 'organization': 'Midwest Pulmonary and critical care'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'The sample size for secondary outcomes in the Placebo group is small'}}, 'adverseEventsModule': {'timeFrame': 'soon after drug instillation and for the first 24 hours in the hospital and then followed up for six months', 'description': 'adverse events that occurred in patients after they received both Alteplase and Placebo were placed in a separate group as we were unable to determine which intervention ( Alteplase or Placebo) caused the problem', 'eventGroups': [{'id': 'EG000', 'title': 'Received Alteplase Only', 'description': 'These patients received only Alteplase and were not crossed over', 'otherNumAtRisk': 42, 'otherNumAffected': 10, 'seriousNumAtRisk': 42, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Received Placebo Only', 'description': 'These patients received Placebo only and were not crossed over', 'otherNumAtRisk': 8, 'otherNumAffected': 5, 'seriousNumAtRisk': 8, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Received Both Alteplase and Placebo', 'description': 'These patients were crossed over and received both Alteplase and Placebo', 'otherNumAtRisk': 40, 'otherNumAffected': 8, 'seriousNumAtRisk': 40, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'severe chest pain post drug instillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 40, 'numEvents': 12, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'mild to moderate chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 12, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 40, 'numEvents': 12, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'hypotension and worsening renal function', 'notes': 'congestive heart failure, cardiomyopathy and malignant pleural effusions patients had significant pleural fluid loss both with Alteplase and Placebo. These patients need careful fluid status and diuretics monitoring.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 40, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'hypotension'}, {'term': 'blood loss--pleural fluid', 'notes': 'Patients effusion were bloody to start with and decreasing hemoglobin was noted over 2-3 days post drug instillation needing blood transfusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 40, 'numEvents': 3, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'other'}, {'term': 'increasing shortness of breath', 'notes': 'increasing SOB secondary to increasing pleural fluid', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 40, 'numEvents': 2, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'other'}, {'term': 'worsening sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 40, 'numEvents': 2, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'serious bleeding at the chest tube site', 'notes': 'bleeding occurred soon after Alteplase instillation at the chest tube site--patient needed transfusion and was taken off the trial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Shortness of breath, worsening sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'No Surgical Intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alteplase', 'description': '25mg of Alteplase in 100 cc of normal saline given intrapleurally daily for 3 days either in the first or second arm'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo in 100 cc of normal saline given daily intrapleurally for 3 days either in the first or second arm'}], 'classes': [{'categories': [{'measurements': [{'value': '66', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'A univariate analysis was done to identify possible predictors of successful resolution of symptoms. The chi-square analysis was used to compare the percent successful.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'patients were followed six weeks per protocol. Most patients treated with Alteplase were also followed for up to six months', 'description': 'CT scans of the chest and Chest X rays (CXR) were used to determine resolution of Pleural effusions/empyema/ pneumonia after 3 days of Alteplase/ Placebo therapy. If no response was noted with the first intervention patients were offered surgery --Decortiation/ Video Assisted Thoracic Surgery (VATS) or to receive the second intervention. Patients that failed the second intervention were offered surgery.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'intention to treat'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Pneumonia That Responded to Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alteplase', 'description': '25mg of Alteplase in 100 cc of normal saline instilled intrapleurally'}, {'id': 'OG001', 'title': 'Placebo', 'description': '100 cc of normal saline instilled intrapleurally'}], 'paramType': 'NUMBER', 'timeFrame': '6 weeks', 'description': 'patients were followed for 6 weeks and CXR and CT scan were done to document resolution of pneumonia', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'protocol design prevented assigning symptom resolution to a specific intervention therefore secondary outcome measures in 6 weeks were not analyzed'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Pleural Effusion/Empyema That Responded to Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alteplase', 'description': '25mg of Alteplase in 100 cc of normal saline instilled intrapleurally'}, {'id': 'OG001', 'title': 'Placebo', 'description': '100 cc of normal saline instilled intrapleurally'}], 'paramType': 'NUMBER', 'timeFrame': '6 weeks', 'description': 'patients were followed for 6 weeks and CXR and CT scan were done to document resolution of pleural effusion/empyema', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'protocol design prevented assigning symptom resolution to a specific intervention therefore secondary outcome measures in 6 weeks were not analyzed'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Shortness of Breath That Responded to Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alteplase', 'description': '25mg of Alteplase in 100 cc of normal saline instilled intrapleurally'}, {'id': 'OG001', 'title': 'Placebo', 'description': '100 cc of normal saline instilled intrapleurally'}], 'paramType': 'NUMBER', 'timeFrame': '6 weeks', 'description': 'patients were followed for 6 weeks and clinical symptoms of resolution of shortness of breath were documented', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'protocol design prevented assigning symptom resolution to a specific intervention therefore secondary outcome measures in 6 weeks were not analyzed'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Clinical Symptoms of Sepsis That Responded to Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Alteplase', 'description': '25mg of Alteplase in 100 cc of normal saline instilled intrapleurally'}, {'id': 'OG001', 'title': 'Placebo', 'description': '100 cc of normal saline instilled intrapleurally'}], 'paramType': 'NUMBER', 'timeFrame': '6 weeks', 'description': 'patients were followed for 6 weeks and resolution of sepsis was documented', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'protocol design prevented assigning symptom resolution to a specific intervention therefore secondary outcome measures in 6 weeks were not analyzed'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Alteplase Then Placebo', 'description': '25 mg of Alteplase in 100 cc of normal saline was instilled intrapleurally daily for three days. Chest CT scans were performed on the fourth day . If less than a 50% reduction in the pleural effusion was determined, the patient was given the option to go to surgery or to the second intervention of the trial (with Placebo)'}, {'id': 'FG001', 'title': 'Placebo Then Alteplase', 'description': 'Placebo in 100 cc of normal saline was instilled intrapleurally daily for three days. Chest CT scans were performed on the fourth day . If less than a 50% reduction in the pleural effusion was determined, the patient was given the option to go to surgery or to the second intervention of the trial (with Alteplase)'}], 'periods': [{'title': 'First Intervention', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '54'}, {'groupId': 'FG001', 'numSubjects': '46'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '45'}, {'groupId': 'FG001', 'numSubjects': '45'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'bleeding at chest tube site--first dose', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'died within 3 weeks', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'malposition/blocked chest tube tube', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'large lung mass with minimal effusion', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'associated prolonged pneumothorax', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'trapped lung', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Second Intervention', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': '37 responded to Alteplase and did not go to the second intervention', 'groupId': 'FG000', 'numSubjects': '8'}, {'comment': '4 patients responded to Placebo and did not go to the second intervention', 'groupId': 'FG001', 'numSubjects': '41'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '37'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'discarded for malposition of chest tube', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'Patients with loculated pleural effusions that failed to respond to chest tube placement and standard medical treatment and were considered for surgery were given the option to enter into a double blind cross over trial', 'preAssignmentDetails': '108 patients were evaluated but only 100 entered the trial. 2 patients refused, 2 patients admitting physicians opted out of the trial, 3 patients chest tube removed inadvertently, 1 patient for coagulopathy'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Alteplase; Placebo', 'description': '25mg of Alteplase in 100 cc of normal saline instilled intrapleurally; 100 cc of normal saline instilled intrapleurally'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '39', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '61', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '67', 'spread': '15', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '36', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '64', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '100', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-04', 'completionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-04-25', 'studyFirstSubmitDate': '2007-04-29', 'resultsFirstSubmitDate': '2011-12-18', 'studyFirstSubmitQcDate': '2007-05-01', 'lastUpdatePostDateStruct': {'date': '2012-04-30', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-04-07', 'studyFirstPostDateStruct': {'date': '2007-05-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-04-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'No Surgical Intervention', 'timeFrame': 'patients were followed six weeks per protocol. Most patients treated with Alteplase were also followed for up to six months', 'description': 'CT scans of the chest and Chest X rays (CXR) were used to determine resolution of Pleural effusions/empyema/ pneumonia after 3 days of Alteplase/ Placebo therapy. If no response was noted with the first intervention patients were offered surgery --Decortiation/ Video Assisted Thoracic Surgery (VATS) or to receive the second intervention. Patients that failed the second intervention were offered surgery.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Pneumonia That Responded to Therapy', 'timeFrame': '6 weeks', 'description': 'patients were followed for 6 weeks and CXR and CT scan were done to document resolution of pneumonia'}, {'measure': 'Number of Participants With Pleural Effusion/Empyema That Responded to Therapy', 'timeFrame': '6 weeks', 'description': 'patients were followed for 6 weeks and CXR and CT scan were done to document resolution of pleural effusion/empyema'}, {'measure': 'Number of Participants With Shortness of Breath That Responded to Therapy', 'timeFrame': '6 weeks', 'description': 'patients were followed for 6 weeks and clinical symptoms of resolution of shortness of breath were documented'}, {'measure': 'Number of Participants With Clinical Symptoms of Sepsis That Responded to Therapy', 'timeFrame': '6 weeks', 'description': 'patients were followed for 6 weeks and resolution of sepsis was documented'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['parapneumonic pleural effusion', 'empyema', 'TPA (Activase, Alteplase)'], 'conditions': ['Pleural Effusion Associated With Pulmonary Infection', 'Bacterial Pleural Effusion Other Than Tuberculosis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to document the efficacy and safety of intrapleural instillation of Activase vs Placebo in the management of complicated pleural effusions and empyemas', 'detailedDescription': 'The current treatments available for complicated pleural effusions (CPE) include chest tube placement for drainage and IV antibiotics. If this fails and CPE occurs then in most patients thoracotomy is performed. Patients that are not surgical candidates have image guided catheter placement performed, sometimes multiple times. The American College of Chest Physicians (ACCP) formed a CPE panel and published guidelines for treating CPE. Percutaneous image-guided drainage is the most common approach for CPE. The panel recognizes the cumulative data that supports the use of fibrinolytics, VATS, and thoracotomy. The CPE panel acknowledged the lack of randomized clinical trials to determine efficacy and safety of these modalities in CPE and strongly encourages the research to take place.\n\nFibrinolytic therapy is a relatively noninvasive, easy to use, and is relatively inexpensive. If successful, it will prevent sepsis and septic shock, decrease hospital stay, morbidity and mortality and prevent any surgical procedures. Multiple doses of fibrinolytics have been used in CPE with no evidence of systemic anti-fibrinolytic activity. Complications with these medications are also very uncommon and only isolated instances are reported. The benefit from successful pleural drainage using these agents will decrease morbidity, mortality, surgical procedures, and hospital stay.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosed with complicated pleural effusions\n* Ability to provide written informed consent and comply with study assessments for the full duration of the study.\n* Age \\> 18 years\n\nExclusion Criteria\n\n* Current use of oral anticoagulants (e.g., warfarin sodium) with an International Normalized Ratio (INR) \\>5- Activated partial thromboplastin time (aPPT) \\> 80, Platelet count \\< 100,000/mm3;\n* Severe uncontrolled hypertension\n* Recognized hypersensitivity to Activase; or any component of its formulation; Traumatic pleural effusion\n* Pregnancy (positive pregnancy test)\n* In another study for this condition\n* Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated\n* Participation in another simultaneous medical investigation\n* Recent stroke\n* Intracranial hemorrhage\n* arteriovenous malformation or aneurysm\n* Intracranial neoplasm\n* Acute myocardial infarction\n* Acute pulmonary embolus'}, 'identificationModule': {'nctId': 'NCT00468104', 'acronym': 'CPE', 'briefTitle': 'Efficacy and Safety of Activase (Ateplase) vs Placebo in Complicated Pleural Effusions (CPE)/Empyemas', 'organization': {'class': 'OTHER', 'fullName': 'Midwest Pulmonary and Critical Care'}, 'officialTitle': 'Response to Instillation of Activase in the Pleural Cavity vs Placebo in the Management of Complicated Pleural Effusion/Empyema', 'orgStudyIdInfo': {'id': '11415'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Alteplase, Placebo- intapleural instillation', 'description': 'Either 25 mg of Alteplase or Placebo instilled daily. Response to therapy after three days. cross over to the other drug if no response was noted.', 'interventionNames': ['Drug: Alteplase', 'Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Placebo, Alteplase -2nd arm', 'description': 'If the first arm fails then the 2nd arm ( cross over to either Placebo or Alteplase not used in the first arm) instilled intrapleurally daily for three days', 'interventionNames': ['Drug: Alteplase', 'Drug: Placebo']}], 'interventions': [{'name': 'Alteplase', 'type': 'DRUG', 'description': '25 Mg of Alteplase in 100 cc of normal saline was instilled intrapeurally for daily for three days', 'armGroupLabels': ['Alteplase, Placebo- intapleural instillation', 'Placebo, Alteplase -2nd arm']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['TPA, Activase'], 'description': 'Placebo in 100 cc of normal saline was instilled intrapleurally daily for three days', 'armGroupLabels': ['Alteplase, Placebo- intapleural instillation', 'Placebo, Alteplase -2nd arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '68114', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Nebraska Methodist Hospital', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}], 'overallOfficials': [{'name': 'George Thommi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Midwest Pulmonary and Critical Care, PC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Midwest Pulmonary and Critical Care', 'class': 'OTHER'}, 'collaborators': [{'name': 'Genentech, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'GEORGE THOMMI', 'investigatorAffiliation': 'Midwest Pulmonary and Critical Care'}}}}