Ignite Creation Date:
2025-12-24 @ 5:21 PM
Ignite Modification Date:
2025-12-27 @ 11:08 PM
Study NCT ID:
NCT01041950
Status:
COMPLETED
Last Update Posted:
2016-10-27
First Post:
2010-01-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Randomised Controlled Trial of Lumbar Drainage to Treat Communicating Hydrocephalus After Severe Intraventricular Hemorrhage
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002543', 'term': 'Cerebral Hemorrhage'}, {'id': 'D006849', 'term': 'Hydrocephalus'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-25', 'studyFirstSubmitDate': '2010-01-04', 'studyFirstSubmitQcDate': '2010-01-04', 'lastUpdatePostDateStruct': {'date': '2016-10-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-01-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Requirement of permanent VP-shunt', 'timeFrame': '14 days', 'description': 'if three attempts to clamp the EVD (control group) or LD (treatment group) fail, or overall extra-corporal drainage time exceeds 14 days, a VP-shunt is placed.'}], 'secondaryOutcomes': [{'measure': 'Safety aspects', 'timeFrame': 'during hospital stay', 'description': '(i) catheter-associated infections (ii) fibrinolysis- and catheter-associated bleedings (iii)overdrainage and herniation'}, {'measure': 'mortality and outcome', 'timeFrame': '3 and 6 months', 'description': 'modified Rankin Scale 3 and 6 months after treatment, as well as in-hospital mortality.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['intracerebral hemorrhage', 'intraventricular hemorrhage', 'hydrocephalus', 'Intracerebral hemorrhage with severe ventricular involvement and obstructive hydrocephalus'], 'conditions': ['Intracerebral Hemorrhage', 'Obstructive Hydrocephalus']}, 'referencesModule': {'references': [{'pmid': '27888608', 'type': 'DERIVED', 'citation': 'Staykov D, Kuramatsu JB, Bardutzky J, Volbers B, Gerner ST, Kloska SP, Doerfler A, Schwab S, Huttner HB. Efficacy and safety of combined intraventricular fibrinolysis with lumbar drainage for prevention of permanent shunt dependency after intracerebral hemorrhage with severe ventricular involvement: A randomized trial and individual patient data meta-analysis. Ann Neurol. 2017 Jan;81(1):93-103. doi: 10.1002/ana.24834.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if usage of early lumbar drainage leads to less shunt surgery and less catheter associated complications in patients with communicating hydrocephalus after intracerebral hemorrhage with severe ventricular involvement.', 'detailedDescription': 'All patients requiring external ventricular drain (EVD) for treatment of acute obstructive hydrocephalus receive intraventricular fibrinolysis with rt-PA via the ventricular catheter. Lumbar drainage (LD) is inserted at a timepoint, when communication between the internal and the external CSF-spaces is recognizable on CT ("opening" of third and fourth ventricle and aqueduct).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* supratentorial intracerebral hemorrhage \\<60ml\n* intraventricular hemorrhage with casting of the third and fourth ventricles\n* obstructive hydrocephalus with need of external ventricular drainage\n* GCS \\<9 on admission or within 48h of symptom onset\n* admission within 48h of symptom onset\n* preceding modified Rankin scale ≤3\n* age 18-85 years\n\nExclusion Criteria:\n\n* ICH related to oral anticoagulation, trauma, tumor, arteriovenous malformation, aneurysm, systemic thrombolysis or sinus thrombosis\n* infratentorial hemorrhage\n* pregnancy\n* admission 48h after symptom onset\n* preceding modified Rankin scale \\>3'}, 'identificationModule': {'nctId': 'NCT01041950', 'acronym': 'LUCAS-IVH', 'briefTitle': 'A Randomised Controlled Trial of Lumbar Drainage to Treat Communicating Hydrocephalus After Severe Intraventricular Hemorrhage', 'organization': {'class': 'OTHER', 'fullName': 'University of Erlangen-Nürnberg Medical School'}, 'officialTitle': 'Lumbar Drainage for Communicating Hydrocephalus After Intraventricular Hemorrhage: a Randomised, Controlled Trial(LUCAS-IVH: LUmbar CAtheter for Severe IntraVentricular Hemorrhage)', 'orgStudyIdInfo': {'id': 'LUCAS-IVH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lumbar drainage', 'interventionNames': ['Procedure: Lumbar drainage']}, {'type': 'NO_INTERVENTION', 'label': 'Control'}], 'interventions': [{'name': 'Lumbar drainage', 'type': 'PROCEDURE', 'description': 'Lumbar CSF drainage is started after communication between the internal and external CSF-spaces is seen on CT.', 'armGroupLabels': ['Lumbar drainage']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91054', 'city': 'Erlangen', 'country': 'Germany', 'facility': 'Neurology Department, University of Erlangen-Nuremberg', 'geoPoint': {'lat': 49.59099, 'lon': 11.00783}}], 'overallOfficials': [{'name': 'Hagen Huttner, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Neurology Department, University of Erlangen-Nuremberg'}, {'name': 'Dimitre Staykov, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Neurology Department, University of Erlangen-Nuremberg'}, {'name': 'Jürgen Bardutzky, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Freiburg'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Erlangen-Nürnberg Medical School', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Freiburg', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Priv.-Doz. Dr. med.', 'investigatorFullName': 'Dimitre Staykov', 'investigatorAffiliation': 'University of Erlangen-Nürnberg Medical School'}}}}