Ignite Creation Date:
2025-12-24 @ 1:33 PM
Ignite Modification Date:
2026-01-19 @ 11:40 AM
Study NCT ID:
NCT01447095
Status:
COMPLETED
Last Update Posted:
2014-07-21
First Post:
2011-10-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Prostacyclin Infusion on Cerebral Vessels and Metabolism in Patients With Subarachnoid Haemorrhage
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013345', 'term': 'Subarachnoid Hemorrhage'}], 'ancestors': [{'id': 'D020300', 'term': 'Intracranial Hemorrhages'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011464', 'term': 'Epoprostenol'}], 'ancestors': [{'id': 'D044062', 'term': 'Prostaglandins I'}, {'id': 'D011453', 'term': 'Prostaglandins'}, {'id': 'D015777', 'term': 'Eicosanoids'}, {'id': 'D005231', 'term': 'Fatty Acids, Unsaturated'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D012898', 'term': 'Autacoids'}, {'id': 'D018836', 'term': 'Inflammation Mediators'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-07', 'completionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-07-18', 'studyFirstSubmitDate': '2011-10-02', 'studyFirstSubmitQcDate': '2011-10-02', 'lastUpdatePostDateStruct': {'date': '2014-07-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-10-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Neuropeptide Y', 'timeFrame': 'May 2014', 'description': 'Neuropeptide Y will be measured in all patients Day 2-11. The concentration will be related to CBF, angiographic vasospasm and clinical outcome for all patients. The results will be reported in a separate puplication.'}], 'primaryOutcomes': [{'measure': 'Radiographic vasospasm measured by CT perfusion', 'timeFrame': 'Day 8 (+/- 1 day) after aneurysm treatment', 'description': 'Changes in regional cerebral blood flow from baseline in the arterial territories of the anterior cerebral artery, medial cerebral artery and the posterior cerebral artery'}], 'secondaryOutcomes': [{'measure': 'Cerebral metabolism measured by microdialysis', 'timeFrame': 'every 2. hour day 3-10 after aneurysm treatment', 'description': 'Cerebral metabolism measured by microdialysis. Lactate, pyruvate, glucose, glutamate and glycerol are measured.'}, {'measure': 'Glasgow outcome scale (GOS) at 3 months', 'timeFrame': '3 months efter SAH', 'description': 'Glasgow outcome scale (GOS) at 3 months obtained by telephone interview.'}, {'measure': 'Clinical vasospasm', 'timeFrame': 'day 5-10 after SAH', 'description': 'Clinical vasospasm defined as delayed neurological deficits (DIND).'}, {'measure': 'Brain tissue oxygen (PtiO2)', 'timeFrame': 'continuous measurement day 3-10 after SAH', 'description': 'Brain tissue oxygen (PtiO2) measured by Licox catheter.'}, {'measure': 'Mean arterial pressure (MAP)', 'timeFrame': 'Continuous day 1-10 after SAH', 'description': 'Mean arterial pressure (MAP) measured by arterial catheter.'}, {'measure': 'Radiographic vasospasm measured by CT angiography', 'timeFrame': 'Measured day 8 +/- 1 day', 'description': 'Qualitative assessment (none, mild/moderate, severe) of vasospasm.'}, {'measure': 'Level of brain damage biomarker', 'timeFrame': 'daily day 4-11 after SAH', 'description': 'Serum levels of S100b in peripheral blood'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Subarachnoid hemorrhage', 'vasospasm', 'prostacyclin'], 'conditions': ['Subarachnoid Hemorrhage']}, 'referencesModule': {'references': [{'pmid': '25414173', 'type': 'DERIVED', 'citation': 'Rasmussen R, Wetterslev J, Stavngaard T, Juhler M, Skjoth-Rasmussen J, Grande PO, Olsen NV. Effects of prostacyclin on cerebral blood flow and vasospasm after subarachnoid hemorrhage: randomized, pilot trial. Stroke. 2015 Jan;46(1):37-41. doi: 10.1161/STROKEAHA.114.007470. Epub 2014 Nov 20.'}, {'pmid': '24929796', 'type': 'DERIVED', 'citation': 'Rasmussen R, Juhler M, Wetterslev J. Effects of continuous prostacyclin infusion on regional blood flow and cerebral vasospasm following subarachnoid haemorrhage: statistical analysis plan for a randomized controlled trial. Trials. 2014 Jun 14;15:228. doi: 10.1186/1745-6215-15-228.'}, {'pmid': '22747768', 'type': 'DERIVED', 'citation': 'Rasmussen R, Wetterslev J, Stavngaard T, Skjoth-Rasmussen J, Grande PO, Olsen NV, Romner B. The effects of continuous prostacyclin infusion on regional blood flow and cerebral vasospasm following subarachnoid haemorrhage: study protocol for a randomised controlled trial. Trials. 2012 Jul 2;13:102. doi: 10.1186/1745-6215-13-102.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether prostacyclin is effective in prevention of cerebral vasospasm in patients with subarachnoidal hemorrhage (SAH).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* SAH verified by CT\n* Aneurysm identified and treated\n* Fisher grade 3 + 4\n* WFNS grade 1-4 (World Federation of Neurosurgical Societies )\n\nExclusion Criteria:\n\n* Pregnancy/lactation\n* Heard failure\n* Kidney failure\n* Liver failure\n* Hemorrhagic diathesis'}, 'identificationModule': {'nctId': 'NCT01447095', 'briefTitle': 'Effects of Prostacyclin Infusion on Cerebral Vessels and Metabolism in Patients With Subarachnoid Haemorrhage', 'organization': {'class': 'OTHER', 'fullName': 'Rigshospitalet, Denmark'}, 'officialTitle': 'Effect of Prostacyclin Infusion on Cerebral Vessels, Cerebral Bloodflow and Cerebral Metabolism in Patients With Subarachnoid Haemorrhage', 'orgStudyIdInfo': {'id': '2011-002798-50'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Low dose prostacyclin', 'interventionNames': ['Drug: Prostacyclin 1 ng/kg/min']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'High dose prostacyclin', 'interventionNames': ['Drug: Prostacyclin 2 ng/kg/min']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Prostacyclin 1 ng/kg/min', 'type': 'DRUG', 'otherNames': ['Flolan'], 'description': 'Continuous i.v. infusion of epoprostenol 1 ng/kg/min day 5-10 after SAH', 'armGroupLabels': ['Low dose prostacyclin']}, {'name': 'Prostacyclin 2 ng/kg/min', 'type': 'DRUG', 'otherNames': ['Flolan'], 'description': 'Continuous i.v. infusion of epoprostenol 2 ng/kg/min day 5-10 after SAH', 'armGroupLabels': ['High dose prostacyclin']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Continuous i.v. infusion with placebo day 5-10 after SAH', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2200', 'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Rigshospitalet, dep. of neurosurgery', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'overallOfficials': [{'name': 'Rune Rasmussen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rigshospitalet, Denmark'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rune Rasmussen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'MD, Sponsor-Investigator', 'investigatorFullName': 'Rune Rasmussen', 'investigatorAffiliation': 'Rigshospitalet, Denmark'}}}}