Ignite Creation Date:
2025-12-25 @ 4:14 AM
Ignite Modification Date:
2025-12-26 @ 3:14 AM
Study NCT ID:
NCT05132920
Status:
RECRUITING
Last Update Posted:
2023-05-10
First Post:
2021-11-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Fight INflammation to Improve Outcome After Aneurysmal Subarachnoid HEmorRhage
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': 'D003907', 'term': 'Dexamethasone'}], 'ancestors': [{'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 334}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-12-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-05-08', 'studyFirstSubmitDate': '2021-11-02', 'studyFirstSubmitQcDate': '2021-11-12', 'lastUpdatePostDateStruct': {'date': '2023-05-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'modified Rankin Scale (mRS) at 6 months after SAH', 'timeFrame': '6 months', 'description': 'Dichotomized modified Rankin Scale (mRS) 6 months after subarachnoid haemorrhage. The dichotomization will be done in the classes "favourable" (mRS 0-3) versus "unfavourable " (mRS 4-6) outcome.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Aneurysmal Subarachnoid Hemorrhage']}, 'referencesModule': {'references': [{'pmid': '35361026', 'type': 'DERIVED', 'citation': 'Guresir E, Lampmann T, Bele S, Czabanka M, Czorlich P, Gempt J, Goldbrunner R, Hurth H, Hermann E, Jabbarli R, Krauthausen M, Konig R, Lindner D, Malinova V, Meixensberger J, Mielke D, Nemeth R, Darkwah Oppong M, Pala A, Prinz V, Rashidi A, Roder C, Sandalcioglu IE, Sauvigny T, Schebesch KM, Timmer M, Vajkoczy P, Wessels L, Wild F, Wilhelm C, Wostrack M, Vatter H, Coch C. Fight INflammation to Improve outcome after aneurysmal Subarachnoid HEmorRhage (FINISHER) trial: Study protocol for a randomized controlled trial. Int J Stroke. 2023 Feb;18(2):242-247. doi: 10.1177/17474930221093501. Epub 2022 May 3.'}]}, 'descriptionModule': {'briefSummary': 'Aneurysmal subarachnoid hemorrhage (SAH) is a fatal disease with high morbidity and mortality. While the primary injury results from the initial bleeding and cannot be influenced, secondary injury through vasospasms and delayed cerebral ischemia (DCI) during the course of the disease might be a target for intervention in order to improve outcome. To date, beside the aneurysm treatment to prevent re-bleeding and the administration of oral nimodipine, there is no causal therapy available, so that novel treatment concepts are desperately needed. There are strong indications that inflammation contributes to DCI and therefore poor outcome and plays a major role in SAH. Some studies suggest a beneficial effect of anti-inflammatory drugs like glucocorticoids (GC) in SAH patient, but there are no data from randomized controlled trials proving or disproving the beneficial effect of GC, so that current guidelines do not recommend the use of GC in SAH so far.\n\nThis multi-center trial aims to generate the first confirmatory data in a controlled randomized fashion that dexamethasone (DEX) improves the outcome in a clinically relevant endpoint in SAH patients. Moreover, this trial will generate first data in a secondary analysis, whether the initial inflammatory state of SAH patients defines a subgroup that particularly responds to a treatment with DEX.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Male or female subjects, equal or older than 18 years old\n2. Written consent to participate in the study by the patient or his legal representative (emergency inclusion by next of kin or consultant physician under the responsibility of the principal investigator is possible)\n3. Confirmed diagnosis of aneurysmal SAH and onset within 48 hours before inclusion.\n\nExclusion Criteria:\n\n1. SAH due to any other cause than aneurysm rupture (e.g. traumatic, arteriovenous malformation (AVM), fistula, dissection)\n2. Any condition that, in the judgement of the Investigator, could impose hazards to the patient if study therapy is initiated or affects the participation of the patient in the study\n3. Patients with obvious evidence of irreparable brainstem or thalamic injury\n4. Patients with foreseeable difficulties to attend follow-ups adequately\n5. Subjects with a physical or psychiatric condition which at the investigator's discretion may put the subject at risk, may confound the trial results, or may interfere with the subject's participation in this clinical trial\n6. Current positive pregnancy test (e.g. β-HCG test in serum)\n7. Known history of hypersensitivity to the investigational drug or to drugs with a similar chemical structure\n8. Severe infectious diseases\n9. Known angle-closure or open angle glaucoma\n10. Known ulceration in the gastro-intestinal tract\n11. History of gastro-intestinal bleeding\n12. Long-term treatment with corticosteroids prior SAH"}, 'identificationModule': {'nctId': 'NCT05132920', 'acronym': 'FINISHER', 'briefTitle': 'Fight INflammation to Improve Outcome After Aneurysmal Subarachnoid HEmorRhage', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Bonn'}, 'officialTitle': 'Fight INflammation to Improve Outcome After Aneurysmal Subarachnoid HEmorRhage', 'orgStudyIdInfo': {'id': 'NCH-201803'}, 'secondaryIdInfos': [{'id': '2021-000732-54', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental arm', 'description': '3 x 8 mg (2 ml) dexamethasone daily for days 1-7 and 1 x 8 mg (2 ml) dexamethasone daily for days 8-21 in addition to aneurysm treatment and best medical intensive care of SAH patients', 'interventionNames': ['Drug: Dexamethasone']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control arm', 'description': '3 x 2 ml Placebo daily for days 1-7 and 1 x 2 ml Placebo daily for days 8-21 in addition to aneurysm treatment and best medical intensive care of SAH patients', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Dexamethasone', 'type': 'DRUG', 'description': '3 x 8 mg dexamethasone daily for days 1-7 and 1 x 8 mg dexamethasone daily for days 8-21', 'armGroupLabels': ['Experimental arm']}, {'name': 'Placebo', 'type': 'DRUG', 'description': '3 x 2 ml Placebo daily for days 1-7 and 1 x 2 ml Placebo daily for days 8-21', 'armGroupLabels': ['Control arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72076', 'city': 'Tübingen', 'state': 'Baden-Wurttemberg', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Constantin Roder, Prof. Dr.', 'role': 'CONTACT'}, {'name': 'Helene Hürth, Dr.', 'role': 'CONTACT'}], 'facility': 'Eberhard Karls University of Tübingen', 'geoPoint': {'lat': 48.52266, 'lon': 9.05222}}, {'zip': '89312', 'city': 'Günzburg', 'state': 'Bavaria', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Ralph König, Prof. Dr.', 'role': 'CONTACT'}, {'name': 'Andrej Pala, PD Dr.', 'role': 'CONTACT'}], 'facility': 'University of Ulm/BKH Günzburg', 'geoPoint': {'lat': 48.45599, 'lon': 10.27695}}, {'zip': '81675', 'city': 'München', 'state': 'Bavaria', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Maria Wostrack, PD Dr.', 'role': 'CONTACT'}, {'name': 'Jens Gempt, Prof. Dr.', 'role': 'CONTACT'}], 'facility': 'Klinikum rechts der Isar, School of Medicine, Technical University of Munich', 'geoPoint': {'lat': 48.69668, 'lon': 13.46314}}, {'zip': '93053', 'city': 'Regensburg', 'state': 'Bavaria', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Karl-Michael Schebesch, Prof. Dr.', 'role': 'CONTACT'}, {'name': 'Sylvia Bele, Dr.', 'role': 'CONTACT'}], 'facility': 'University Medical Center Regensburg', 'geoPoint': {'lat': 49.01513, 'lon': 12.10161}}, {'zip': '60529', 'city': 'Frankfurt am Main', 'state': 'Hesse', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Marcus Czabanka, Prof. Dr.', 'role': 'CONTACT'}, {'name': 'Vincent Prinz, PD Dr.', 'role': 'CONTACT'}], 'facility': 'Johann Wolfgang Goethe-Universität Frankfurt am Main', 'geoPoint': {'lat': 50.11552, 'lon': 8.68417}}, {'zip': '30625', 'city': 'Hanover', 'state': 'Lower Saxony', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Florian Wild, Dr.', 'role': 'CONTACT'}, {'name': 'Elvis Hermann, PD Dr.', 'role': 'CONTACT'}], 'facility': 'Hannover Medical School', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}, {'zip': '53127', 'city': 'Bonn', 'state': 'North Rhine-Westphalia', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Hartmut Vatter, Prof. Dr.', 'role': 'CONTACT'}, {'name': 'Tim Lampmann', 'role': 'CONTACT'}], 'facility': 'University Hospital Bonn', 'geoPoint': {'lat': 50.73438, 'lon': 7.09549}}, {'zip': '50937', 'city': 'Cologne', 'state': 'North Rhine-Westphalia', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Roland Goldbrunner, Prof. Dr.', 'role': 'CONTACT'}, {'name': 'Marco Timmer, Dr.', 'role': 'CONTACT'}], 'facility': 'University of Cologne', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}, {'zip': '45147', 'city': 'Essen', 'state': 'North Rhine-Westphalia', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Ramazan Jabbarli, PD Dr.', 'role': 'CONTACT'}, {'name': 'Marvin Darkhwah Oppong, PD Dr.', 'role': 'CONTACT'}], 'facility': 'University Hospital of Essen', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}, {'zip': '04103', 'city': 'Leipzig', 'state': 'Saxony', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Erdem Güresir, Prof. Dr.', 'role': 'CONTACT'}, {'name': 'Dirk Lindner, PD Dr.', 'role': 'CONTACT'}], 'facility': 'University Hospital Leipzig', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}, {'zip': '39120', 'city': 'Magdeburg', 'state': 'Saxony-Anhalt', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Erol Sandalcioglu, Prof. Dr.', 'role': 'CONTACT'}, {'name': 'Ali Rashidi, Dr.', 'role': 'CONTACT'}], 'facility': 'Otto von Guericke University Magdeburg', 'geoPoint': {'lat': 52.13129, 'lon': 11.63189}}, {'zip': '10117', 'city': 'Berlin', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Nils Hecht, PD Dr.', 'role': 'CONTACT'}, {'name': 'Lars Wessels, Dr.', 'role': 'CONTACT'}], 'facility': 'Charité-Universitätsmedizin Berlin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '20246', 'city': 'Hamburg', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Patrick Czorlich, PD Dr.', 'role': 'CONTACT'}, {'name': 'Thomas Sauvigny, Dr.', 'role': 'CONTACT'}], 'facility': 'University Medical Center Hamburg-Eppendorf', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}], 'centralContacts': [{'name': 'Erdem Güresir, Prof. Dr.', 'role': 'CONTACT', 'email': 'Erdem.Gueresir@medizin.uni-leipzig.de', 'phone': '0049 - 341 97 17500'}], 'overallOfficials': [{'name': 'Erdem Güresir, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Neurosurgery, University Hospital Leipzig'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Bonn', 'class': 'OTHER'}, 'collaborators': [{'name': 'German Federal Ministry of Education and Research', 'class': 'OTHER_GOV'}, {'name': 'Pharmacy of the University Hospital Leipzig- AöR', 'class': 'UNKNOWN'}, {'name': 'nextevidence GmbH', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr. Erdem Güresir', 'investigatorFullName': 'Erdem Güresir, MD', 'investigatorAffiliation': 'University of Leipzig'}}}}