Ignite Creation Date:
2025-12-25 @ 3:31 AM
Ignite Modification Date:
2026-01-12 @ 8:24 AM
Study NCT ID:
NCT02540005
Status:
COMPLETED
Last Update Posted:
2016-06-28
First Post:
2015-09-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Coagulation Disorders After Aneurysmatic Subarachnoid Haemorrhage
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'lastUpdateSubmitDate': '2016-06-27', 'studyFirstSubmitDate': '2015-09-01', 'studyFirstSubmitQcDate': '2015-09-02', 'lastUpdatePostDateStruct': {'date': '2016-06-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-09-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ROTEM analysis: MCF (mm) by EXTEM activators', 'timeFrame': '12 hours'}]}, 'conditionsModule': {'conditions': ['Aneurysmatic Subarachnoid Haemorrhage']}, 'descriptionModule': {'briefSummary': 'The main purpose of this study is to analyse the on-going coagulation process after aSAH. For investigation the investigators use the rotational thromboelastometry (ROTEM) which is a point-of-care test using a variety of activators to provide a targeted and a dynamic analysis of coagulation cascade. This is a prospective, observational clinical study done in 16 aSAH patients treated in Tampere University Hospital intensive care unit and 16 control patients (elective craniotomy due to non-ruptured intracranial aneurysm.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Acute aneurysmal subarachnoid haemorrhage patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years\n* Acute subarachnoid haemorrhage (confirmed by computed tomography, CT, or cerebrospinal fluid erythrocyte count over 1000 x 106/l) AND confirmed origin either with computed angiography (CTA) or digital subtraction angiography (DSA)\n* Onset of symptoms ≤ 12 hours\n* Expected to stay 72 hours in the ICU\n\nExclusion Criteria:\n\n* Pregnancy\n* Any long-term anticoagulant medication, except for low-dose aspirin (\\<150 mg/day)\n* Known active cancer'}, 'identificationModule': {'nctId': 'NCT02540005', 'briefTitle': 'Coagulation Disorders After Aneurysmatic Subarachnoid Haemorrhage', 'organization': {'class': 'OTHER', 'fullName': 'Tampere University Hospital'}, 'officialTitle': 'Coagulation Disorders After Aneurysmatic Subarachnoid Haemorrhage', 'orgStudyIdInfo': {'id': '230215-1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Aneurysmatic subarachnoid haemorrhage', 'description': 'Acute subarachnoid haemorrhage (confirmed by computed tomography, CT, or cerebrospinal fluid erythrocyte count over 1000 x 106/l) AND confirmed origin either with computed angiography (CTA) or digital subtraction angiography (DSA)', 'interventionNames': ['Other: ROTEM analysis']}, {'label': 'Control patients', 'description': 'Elective craniotomy due to non-ruptured intracranial aneurysm', 'interventionNames': ['Other: ROTEM analysis']}], 'interventions': [{'name': 'ROTEM analysis', 'type': 'OTHER', 'armGroupLabels': ['Aneurysmatic subarachnoid haemorrhage', 'Control patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33521', 'city': 'Tampere', 'state': 'Pirkanmaa', 'country': 'Finland', 'facility': 'Tampere University Hospital', 'geoPoint': {'lat': 61.49911, 'lon': 23.78712}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tampere University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'CSL Behring', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Annukka Vahtera', 'investigatorAffiliation': 'Tampere University Hospital'}}}}