Ignite Creation Date:
2025-12-25 @ 12:04 AM
Ignite Modification Date:
2026-02-20 @ 7:33 PM
Study NCT ID:
NCT00650858
Status:
COMPLETED
Last Update Posted:
2017-12-11
First Post:
2007-12-26
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Clinical Trial on Treatment of Intraventricular Hemorrhage
Sponsor:
Organization:
Raw JSON
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Hanley, MD', 'organization': 'Johns Hopkins University'}, 'certainAgreement': {'otherDetails': 'The PI shall provide the sponsor with a copy of any proposed publication for review and comment thirty (30) days prior to submission. JHU may request a delay in publication, not to exceed 90 days if it is necessary to protect any intellectual property.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': '0.3 mg Rt-PA q12h', 'description': 'Stage 1 (Dose Finding)', 'otherNumAtRisk': 8, 'otherNumAffected': 7, 'seriousNumAtRisk': 8, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': '1.0 mg Rt-PA q12h', 'description': 'Stage 1 (Dose Finding)', 'otherNumAtRisk': 8, 'otherNumAffected': 8, 'seriousNumAtRisk': 8, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': '1.0 mg Rt-PA q8h', 'description': 'Stage 2 (Dose Optimization)', 'otherNumAtRisk': 36, 'otherNumAffected': 32, 'seriousNumAtRisk': 36, 'seriousNumAffected': 11}], 'otherEvents': [{'term': 'Acute Renal Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders'}, {'term': 'Adult Respiratory Distress Syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'Aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Atelectasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Atrial Fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders'}, {'term': 'Bacteremia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders'}, {'term': 'Brain Edema / Swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders'}, {'term': 'CSF Leak', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders'}, {'term': 'Cerebral Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Nervous system disorders'}, {'term': 'Cerebral infarction, extension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders'}, {'term': 'Congestive Heart Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders'}, {'term': 'Decreased Level of counciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 12, 'numAffected': 7}], 'organSystem': 'Nervous system disorders'}, {'term': 'Decubitus ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Renal and urinary disorders'}, {'term': 'Edema (metabolic causes)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}, {'term': 'Fever of unknown origin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'General disorders'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Nervous system disorders'}, {'term': 'Hemorrhage enl, cath tract >5mm w/o mass, asym', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders'}, {'term': 'Hemorrhage enlargement, catheter tract > 5 mm with mass effect, asymptomatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders'}, {'term': 'Hemorrhage, new catheter tract <= 5 mm, asymptomatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders'}, {'term': 'Hemorrhage, new catheter tract > 5 mm with mass effect, asymptomatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders'}, {'term': 'Hemorrhage, new catheter tract > 5 mm with mass effect, symptomatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}, {'term': 'Herniation, Brain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 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'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Pneumonia, aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Pulmonary edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, 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'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Ventriculitis, bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 4, 'numAffected': 2}], 'organSystem': 'Nervous system disorders'}, {'term': 'Ventriculitis, non-bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 9, 'numAffected': 8}], 'organSystem': 'Nervous system disorders'}], 'seriousEvents': [{'term': 'Accidental Extubation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Cardiac Arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Cardiac disorders'}, {'term': 'Cerebral Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}, {'term': 'Hemorrhage new catheter tract >5 mm with mass effect, symptomatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}, {'term': 'Hydrocephalus, Communicating', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}, {'term': 'ICH Hemorrhage, new symptomatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}, {'term': 'IVH Hemorrhage enlargement - asymptomatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}, {'term': 'IVH Hemorrhage enlargement - symptomatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}, {'term': 'IVH hemorrhage, new symptomatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}, {'term': 'Myocardial Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders'}, {'term': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders'}, {'term': 'Suspected cardiac or pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Tracheal stricture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Ventilatory failure, mechanical', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Ventriculitis, Bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}, {'term': 'Ventriculitis, non-bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 36, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': '30-day Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '0.3 mg Rt-PA q12h', 'description': 'Stage 1 (Dose Finding)'}, {'id': 'OG001', 'title': '1.0 mg Rt-PA q12h', 'description': 'Stage 1 (Dose Finding)'}, {'id': 'OG002', 'title': '1.0 mg Rt-PA q8h', 'description': 'Stage 2 (Dose Optimization)'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 days', 'description': 'The number of subjects who died at or before the 30-day follow-up visit were determined as a measure of safety. If more than 50% of the subjects died at or before the 30-day follow-up visit, the study would have been stopped for full DSMB review.', 'unitOfMeasure': 'Number of participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Incidence of Bacterial Ventriculitis, Meningitis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '0.3 mg Rt-PA q12h', 'description': 'Stage 1 (Dose Finding)'}, {'id': 'OG001', 'title': '1.0 mg Rt-PA q12h', 'description': 'Stage 1 (Dose Finding)'}, {'id': 'OG002', 'title': '1.0 mg Rt-PA q8h', 'description': 'Stage 2 (Dose Optimization)'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 days', 'description': 'The incidence of bacterial ventriculitis/meningitis was recorded to determine the safety of intraventricular administration of rt-PA. If 30% or more subjects experienced this event, the study would have been stopped for full DSMB review.', 'unitOfMeasure': 'Number of participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Rate of Symptomatic Bleeding Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '0.3 mg Rt-PA q12h', 'description': 'Stage 1 (Dose Finding)'}, {'id': 'OG001', 'title': '1.0 mg Rt-PA q12h', 'description': 'Stage 1 (Dose Finding)'}, {'id': 'OG002', 'title': '1.0 mg Rt-PA q8h', 'description': 'Stage 2 (Dose Optimization)'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30-days', 'description': 'The rate of symptomatic brain bleeding events were recorded to determine the safety of intraventricular administrations of rt-PA. If 35% or more subjects experienced a symptomatic bleeding event prior to the 30-day follow-up visit, the study would have been stopped for a full DSMB review.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Average Daily Percentage Clot Size Resolution Over the First 3 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '0.3 mg Rt-PA q12h', 'description': 'Stage 1 (Dose Finding)'}, {'id': 'OG001', 'title': '1.0 mg Rt-PA q12h', 'description': 'Stage 1 (Dose Finding)'}, {'id': 'OG002', 'title': '1.0 mg Rt-PA q8h', 'description': 'Stage 2 (Dose Optimization)'}], 'classes': [{'categories': [{'measurements': [{'value': '22.19', 'groupId': 'OG000', 'lowerLimit': '8', 'upperLimit': '66'}, {'value': '24.20', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '72'}, {'value': '19.99', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '60'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 days', 'description': 'Daily IVH clot volume resolution, as a percentage of stability CT IVH volume, averaged over the first 3 days, determined by CT scans', 'unitOfMeasure': 'Percent of stability CT volume resolved', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': '90 Day Follow-Up Modified Rankin Scale (mRS) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '0.3 mg Rt-PA q12h', 'description': 'Stage 1 (Dose Finding)'}, {'id': 'OG001', 'title': '1.0 mg Rt-PA q12h', 'description': 'Stage 1 (Dose Finding)'}, {'id': 'OG002', 'title': '1.0 mg Rt-PA q8h', 'description': 'Stage 2 (Dose Optimization)'}], 'classes': [{'categories': [{'measurements': [{'value': '4.3', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '6'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '90 days', 'description': '90 day follow-up visit mRS score. The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 to 6: 0. No Symptoms, 1. No Significant Disability, 2. Slight Disability, 3. Moderate Disability, 4. Moderately Severe Disability, 5. Severe Disability and 6. Dead.\n\n(Stage 1 patients only had 30 day scores, Stage 2 patients had 30 day, 90 day and 180 day scores collected)', 'unitOfMeasure': 'mRS score', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': '90 Day Follow-Up Glasgow Outcome Scale (GOS) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '0.3 mg Rt-PA q12h', 'description': 'Stage 1 (Dose Finding)'}, {'id': 'OG001', 'title': '1.0 mg Rt-PA q12h', 'description': 'Stage 1 (Dose Finding)'}, {'id': 'OG002', 'title': '1.0 mg Rt-PA q8h', 'description': 'Stage 2 (Dose Optimization)'}], 'classes': [{'categories': [{'measurements': [{'value': '2.3', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '4'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '90 days', 'description': '90 day follow-up visit GOS score. The GOS is a scale used to determine the degree of recovery from patients with brain injury. There are five categories: 1. Dead, 2. Vegetative State, 3. Severe Disability, 4. Moderate Disability and 5. Good Recovery.\n\n(Stage 1 patients only had 30 day scores, Stage 2 patients had 30 day, 90 day and 180 day scores collected)', 'unitOfMeasure': 'GOS score', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': '180 Day Follow-Up Modified Rankin Scale (mRS) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '0.3 mg Rt-PA q12h', 'description': 'Stage 1 (Dose Finding)'}, {'id': 'OG001', 'title': '1.0 mg Rt-PA q12h', 'description': 'Stage 1 (Dose Finding)'}, {'id': 'OG002', 'title': '1.0 mg Rt-PA q8h', 'description': 'Stage 2 (Dose Optimization)'}], 'classes': [{'categories': [{'measurements': [{'value': '4.0', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '6'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '180 days', 'description': '180 day follow-up visit mRS score. The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 to 6: 0. No Symptoms, 1. No Significant Disability, 2. Slight Disability, 3. Moderate Disability, 4. Moderately Severe Disability, 5. Severe Disability and 6. Dead.\n\n(Stage 1 patients only had 30 day scores, Stage 2 patients had 30 day, 90 day and 180 day scores collected)', 'unitOfMeasure': 'mRS score', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': '180 Day Follow-Up Glasgow Outcome Scale (GOS) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '0.3 mg Rt-PA q12h', 'description': 'Stage 1 (Dose Finding)'}, {'id': 'OG001', 'title': '1.0 mg Rt-PA q12h', 'description': 'Stage 1 (Dose Finding)'}, {'id': 'OG002', 'title': '1.0 mg Rt-PA q8h', 'description': 'Stage 2 (Dose Optimization)'}], 'classes': [{'categories': [{'measurements': [{'value': '2.3', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '4'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '180 days', 'description': '180 day follow-up visit GOS score. The GOS is a scale used to determine the degree of recovery from patients with brain injury. There are five categories: 1. Dead, 2. Vegetative State, 3. Severe Disability, 4. Moderate Disability and 5. Good Recovery.\n\n(Stage 1 patients only had 30 day scores, Stage 2 patients had 30 day, 90 day and 180 day scores collected)', 'unitOfMeasure': 'GOS score', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '0.3 mg Rt-PA q12h', 'description': 'Stage 1 (Dose Finding)'}, {'id': 'FG001', 'title': '1.0 mg Rt-PA q12h', 'description': 'Stage 1 (Dose Finding)'}, {'id': 'FG002', 'title': '1.0 mg Rt-PA q8h', 'description': 'Stage 2 (Dose Optimization)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '36'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '36'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Recruitment began for protocol stage 1 in August 2005 and ended for protocol stage 2 on February 6, 2008. Subjects were screened by clinical stroke service personnel in the Emergency Department or by direct transfer from an outside hospital.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}, {'value': '52', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': '0.3 mg Rt-PA q12h', 'description': 'Stage 1 (Dose Finding)'}, {'id': 'BG001', 'title': '1.0 mg Rt-PA q12h', 'description': 'Stage 1 (Dose Finding)'}, {'id': 'BG002', 'title': '1.0 mg Rt-PA q8h', 'description': 'Stage 2 (Dose Optimization)'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '39', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '47.6', 'spread': '9.8', 'groupId': 'BG000'}, {'value': '57.3', 'spread': '8.3', 'groupId': 'BG001'}, {'value': '57.0', 'spread': '10.2', 'groupId': 'BG002'}, {'value': '55.6', 'spread': '10.3', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '34', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}, {'value': '47', 'groupId': 'BG003'}]}]}, {'title': 'Canada', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}]}, {'title': 'Germany', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}, {'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-11-08', 'studyFirstSubmitDate': '2007-12-26', 'resultsFirstSubmitDate': '2009-03-12', 'studyFirstSubmitQcDate': '2008-04-01', 'lastUpdatePostDateStruct': {'date': '2017-12-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2012-06-13', 'studyFirstPostDateStruct': {'date': '2008-04-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-07-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '30-day Mortality', 'timeFrame': '30 days', 'description': 'The number of subjects who died at or before the 30-day follow-up visit were determined as a measure of safety. If more than 50% of the subjects died at or before the 30-day follow-up visit, the study would have been stopped for full DSMB review.'}, {'measure': 'Incidence of Bacterial Ventriculitis, Meningitis', 'timeFrame': '30 days', 'description': 'The incidence of bacterial ventriculitis/meningitis was recorded to determine the safety of intraventricular administration of rt-PA. If 30% or more subjects experienced this event, the study would have been stopped for full DSMB review.'}, {'measure': 'Rate of Symptomatic Bleeding Events', 'timeFrame': '30-days', 'description': 'The rate of symptomatic brain bleeding events were recorded to determine the safety of intraventricular administrations of rt-PA. If 35% or more subjects experienced a symptomatic bleeding event prior to the 30-day follow-up visit, the study would have been stopped for a full DSMB review.'}], 'secondaryOutcomes': [{'measure': 'Average Daily Percentage Clot Size Resolution Over the First 3 Days', 'timeFrame': '3 days', 'description': 'Daily IVH clot volume resolution, as a percentage of stability CT IVH volume, averaged over the first 3 days, determined by CT scans'}, {'measure': '90 Day Follow-Up Modified Rankin Scale (mRS) Score', 'timeFrame': '90 days', 'description': '90 day follow-up visit mRS score. The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 to 6: 0. No Symptoms, 1. No Significant Disability, 2. Slight Disability, 3. Moderate Disability, 4. Moderately Severe Disability, 5. Severe Disability and 6. Dead.\n\n(Stage 1 patients only had 30 day scores, Stage 2 patients had 30 day, 90 day and 180 day scores collected)'}, {'measure': '90 Day Follow-Up Glasgow Outcome Scale (GOS) Score', 'timeFrame': '90 days', 'description': '90 day follow-up visit GOS score. The GOS is a scale used to determine the degree of recovery from patients with brain injury. There are five categories: 1. Dead, 2. Vegetative State, 3. Severe Disability, 4. Moderate Disability and 5. Good Recovery.\n\n(Stage 1 patients only had 30 day scores, Stage 2 patients had 30 day, 90 day and 180 day scores collected)'}, {'measure': '180 Day Follow-Up Modified Rankin Scale (mRS) Score', 'timeFrame': '180 days', 'description': '180 day follow-up visit mRS score. The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 to 6: 0. No Symptoms, 1. No Significant Disability, 2. Slight Disability, 3. Moderate Disability, 4. Moderately Severe Disability, 5. Severe Disability and 6. Dead.\n\n(Stage 1 patients only had 30 day scores, Stage 2 patients had 30 day, 90 day and 180 day scores collected)'}, {'measure': '180 Day Follow-Up Glasgow Outcome Scale (GOS) Score', 'timeFrame': '180 days', 'description': '180 day follow-up visit GOS score. The GOS is a scale used to determine the degree of recovery from patients with brain injury. There are five categories: 1. Dead, 2. Vegetative State, 3. Severe Disability, 4. Moderate Disability and 5. Good Recovery.\n\n(Stage 1 patients only had 30 day scores, Stage 2 patients had 30 day, 90 day and 180 day scores collected)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Intraventricular hemorrhage (IVH)', 'rt-PA'], 'conditions': ['Intraventricular Hemorrhage']}, 'referencesModule': {'references': [{'pmid': '26228884', 'type': 'DERIVED', 'citation': 'Kornbluth J, Nekoovaght-Tak S, Ullman N, Carhuapoma JR, Hanley DF, Ziai W. Early Quantification of Hematoma Hounsfield Units on Noncontrast CT in Acute Intraventricular Hemorrhage Predicts Ventricular Clearance after Intraventricular Thrombolysis. AJNR Am J Neuroradiol. 2015 Sep;36(9):1609-15. doi: 10.3174/ajnr.A4393. Epub 2015 Jul 30.'}, {'pmid': '23463422', 'type': 'DERIVED', 'citation': 'Ziai W, Moullaali T, Nekoovaght-Tak S, Ullman N, Brooks JS, Morgan TC, Hanley DF. No exacerbation of perihematomal edema with intraventricular tissue plasminogen activator in patients with spontaneous intraventricular hemorrhage. Neurocrit Care. 2013 Jun;18(3):354-61. doi: 10.1007/s12028-013-9826-1.'}, {'pmid': '23370203', 'type': 'DERIVED', 'citation': 'Morgan TC, Dawson J, Spengler D, Lees KR, Aldrich C, Mishra NK, Lane K, Quinn TJ, Diener-West M, Weir CJ, Higgins P, Rafferty M, Kinsley K, Ziai W, Awad I, Walters MR, Hanley D; CLEAR and VISTA Investigators. The Modified Graeb Score: an enhanced tool for intraventricular hemorrhage measurement and prediction of functional outcome. Stroke. 2013 Mar;44(3):635-41. doi: 10.1161/STROKEAHA.112.670653. Epub 2013 Jan 31.'}, {'pmid': '22474059', 'type': 'DERIVED', 'citation': 'Webb AJ, Ullman NL, Mann S, Muschelli J, Awad IA, Hanley DF. Resolution of intraventricular hemorrhage varies by ventricular region and dose of intraventricular thrombolytic: the Clot Lysis: Evaluating Accelerated Resolution of IVH (CLEAR IVH) program. Stroke. 2012 Jun;43(6):1666-8. doi: 10.1161/STROKEAHA.112.650523. Epub 2012 Apr 3.'}, {'pmid': '22382155', 'type': 'DERIVED', 'citation': 'Ziai WC, Muschelli J, Thompson CB, Keyl PM, Lane K, Shao S, Hanley DF. Factors affecting clot lysis rates in patients with spontaneous intraventricular hemorrhage. Stroke. 2012 May;43(5):1234-9. doi: 10.1161/STROKEAHA.111.641050. Epub 2012 Mar 1.'}, {'pmid': '21940973', 'type': 'DERIVED', 'citation': 'Herrick DB, Ziai WC, Thompson CB, Lane K, McBee NA, Hanley DF. Systemic hematologic status following intraventricular recombinant tissue-type plasminogen activator for intraventricular hemorrhage: the CLEAR IVH Study Group. Stroke. 2011 Dec;42(12):3631-3. doi: 10.1161/STROKEAHA.111.625749. Epub 2011 Sep 22.'}]}, 'descriptionModule': {'briefSummary': "The specific objective of this trial is to determine the lowest dose and dose frequency possible with the best pharmacokinetic and safety profile and it's ability to remove a blood clot from the ventricular system.", 'detailedDescription': 'The purpose of this trial is to determine the efficacy and pharmacokinetics of intraventricular injections of multiple low doses of rt-PA. Sixteen subjects were already randomized to receive intraventricular injections of with 0.3 mg or 1.0 mg of rt-PA every 12 hours for up to 8 doses. Results of this stage (n=16) were then analyzed and the most effective dose of 1.0 mg was chosen to be used in the second stage (n=36) to determine the optimal frequency of dosing. We propose to test if this intervention facilitates more rapid clot resolution, complete recovery function and decreased mortality from this condition.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age 18-75\n2. IVC placed as standard of care using less than or equal to 2 complete passes.\n3. Spontaneous ICH less than or equal to 30 cc.\n4. Able to receive first dose within 48 hours of CT scan diagnosing IVH (providing the time of symptom onset to diagnostic CT does not exceed 12 hours).\n5. Clot size measured on CT scan done 6 hours after IVC placement must be equal to the presentation clot size plus or minus 5 cc (as determined by the AxBxC)/2 method).\n6. ON stability CT scan either the 3rd or 4th ventricles are occluded with blood (no evidence of CSF flow on CT).\n7. SBP \\< 200 mmHg sustained for 6 hours.\n8. Historical Rankin of 0 or 1.\n\nExclusion Criteria:\n\n1. Suspected or untreated aneurysm or AVM (unless ruled out by angiogram or MRA/MRI).\n2. Clotting disorders.\n3. Patients with platelet count \\< 100,000, INR \\> 1.7, PT \\> 15s, or an elevated APTT.\n4. Pregnancy (positive pregnancy test).\n5. Infratentorial hemorrhage (i.e., parenchymal/posterior fossa hematoma; all cerebellar hematomas excluded).\n6. SAH (An angiogram should be obtained when the diagnostic CT scan demonstrates subarachnoid hemorrhage or any hematoma location or appearance not strongly associated with hypertension. If the angiogram does not demonstrate a bleeding source that accounts for the hemorrhage, the patient is eligible for the study).\n7. ICH enlargement during the 6-hour stabilization period (6 hour after IVC placement).\n8. Internal bleeding, involving retroperitoneal sites, or the gastrointestinal, genitourinary, or respiratory tracts.\n9. Superficial or surface bleeding, observed mainly at vascular puncture and access sites (e.g., venous cutdowns, arterial punctures) or site of recent surgical intervention.\n10. Known risk for embolization, including history of left heart thrombus, mitral stenosis with atrial fibrillation, acute pericarditis, and subacute bacterial endocarditis.\n11. Prior enrollment in the study.\n12. Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated.\n13. Participation in another simultaneous medical investigation or trial.'}, 'identificationModule': {'nctId': 'NCT00650858', 'acronym': 'CLEAR IVH', 'briefTitle': 'Clinical Trial on Treatment of Intraventricular Hemorrhage', 'organization': {'class': 'OTHER', 'fullName': 'Johns Hopkins University'}, 'officialTitle': 'Clot Lysis: Evaluating Accelerated Resolution of Intraventricular Hemorrhage (IVH)', 'orgStudyIdInfo': {'id': 'IVH05'}, 'secondaryIdInfos': [{'id': 'ISRCTN47341677', 'type': 'REGISTRY', 'domain': 'ISRCTN registry'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '0.3 mg rt-PA', 'description': 'In stage 1 of the protocol, dose finding, subjects were randomized to either this 0.3 mg dose arm or the 1.0 mg dose arm. Subjects in this arm (0.3 mg) received up to 8 doses of 0.3 mg rt-PA every 12 hours through the intraventricular catheter to treat intraventricular hemorrhage.', 'interventionNames': ['Drug: tissue plasminogen activator, rt-PA (thrombolytic) (Cathflo)']}, {'type': 'ACTIVE_COMPARATOR', 'label': '1.0 mg rt-PA', 'description': 'In stage 1 of the protocol, dose finding, subjects were randomized to either this 1.0 mg dose arm or the 0.3 mg dose arm. Subjects in this arm (1.0 mg) received up to 8 doses of 1.0 mg rt-PA every 12 hours through the intraventricular catheter to treat intraventricular hemorrhage.', 'interventionNames': ['Drug: tissue plasminogen activator, rt-PA (thrombolytic) (Cathflo)']}, {'type': 'EXPERIMENTAL', 'label': '1.0 mg Rt-PA q8h', 'description': 'In stage 2 of the protocol, dose frequency, subjects received up to 8 doses of 1.0 mg of rt-PA (Cathflo) every 8 hours through the intraventricular catheter to treat intraventricular hemorrhage.', 'interventionNames': ['Drug: tissue plasminogen activator, rt-PA (thrombolytic) (Cathflo)']}], 'interventions': [{'name': 'tissue plasminogen activator, rt-PA (thrombolytic) (Cathflo)', 'type': 'DRUG', 'otherNames': ['rt-PA', 'Cathflo', 'Activase'], 'description': '0.3 mg and 1.0 mg of rt-PA (Cathflo) were administered every 12 hours (dose finding) and every 8 hours (dose frequency) via the intraventricular catheter to treat intraventricular hemorrhage.', 'armGroupLabels': ['0.3 mg rt-PA', '1.0 mg Rt-PA q8h', '1.0 mg rt-PA']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '90059', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'CR Drew Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94394', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': 'Standford Medical Center', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'zip': '06102', 'city': 'Hartford', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Hartford Hospital', 'geoPoint': {'lat': 41.76371, 'lon': -72.68509}}, {'zip': '60153', 'city': 'Maywood', 'state': 'Illinois', 'country': 'United States', 'facility': 'Loyola University Medical Center', 'geoPoint': {'lat': 41.8792, 'lon': -87.84312}}, {'zip': '67214', 'city': 'Wichita', 'state': 'Kansas', 'country': 'United States', 'facility': 'Via Christi Regional Medical Center', 'geoPoint': {'lat': 37.69224, 'lon': -97.33754}}, {'zip': '21202', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'University of Maryland Medical Systems', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins University', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '48201', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Wayne State University', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '48202', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Henry Ford Hospital', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'St. Louis University', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '12208', 'city': 'Albany', 'state': 'New York', 'country': 'United States', 'facility': 'Albany Medical Center', 'geoPoint': {'lat': 42.65258, 'lon': -73.75623}}, {'zip': '10029', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Mt. Sinai Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '45267', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'University of Cincinnati', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '19140', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Temple University', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '29425', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Medical University of South Carolina', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Baylor College of Medicine', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas HSC, San Antonio', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '22908', 'city': 'Charlottesville', 'state': 'Virginia', 'country': 'United States', 'facility': 'University of Virginia, Charlottesville', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}, {'zip': '22042', 'city': 'Fairfax', 'state': 'Virginia', 'country': 'United States', 'facility': 'INOVA Fairfax Medical Center', 'geoPoint': {'lat': 38.84622, 'lon': -77.30637}}, {'zip': '23298', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'Virginia Commonwealth University', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}, {'zip': '53226', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Medical College of Wisconsin', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}, {'zip': 'T2N 2T9', 'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Foothills Medical Centre', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'zip': '69120', 'city': 'Heidelberg', 'country': 'Germany', 'facility': 'University of Heidelberg', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}, {'zip': 'NE4 6BE', 'city': 'Newcastle upon Tyne', 'country': 'United Kingdom', 'facility': 'Newcastle General Hospital', 'geoPoint': {'lat': 54.97328, 'lon': -1.61396}}], 'overallOfficials': [{'name': 'Daniel F Hanley, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Johns Hopkins University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johns Hopkins University', 'class': 'OTHER'}, 'collaborators': [{'name': 'FDA Office of Orphan Products Development', 'class': 'FED'}, {'name': 'Genentech, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}