Decompressive Craniectomy After Aneurysmal Subarachnoid Hemorrhage (DECIDE-SAH)
A legfontosabb adatok
- Hol
- Essen (Németország)A helyszín megnézése
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A vizsgálat olyan felnőtteket keres, akiknek repedt agyi értágulat (aneurizma) miatt vérzett az agya. Meglévő kórházi adatokat használ annak vizsgálatára, hogy a koponyatető-eltávolító műtét (dekompresszív kraniektómia) hogyan függ össze a gyógyulással kb. 6 hónap után.
- Életkor
- 18 éves vagy idősebb
- Nem
- Minden nem
- A betegség stádiuma
- Igazolt subarachnoidealis vérzés (az agy körüli vérzés), amelyet repedt agyi aneurizma okozott.
A részvétel fő kizáró okai
- 18 évesnél fiatalabb
- Nem aneurizma okozta vérzés
- Sérülés okozta (traumás) vérzés
- Fertőzéses, sérüléses vagy műtéti eredetű aneurizma, illetve AVM-hez vagy AVF-hez kapcsolódó aneurizma repedése
- Az iratokban nincs elég adat a diagnózis igazolásához vagy a minimális adatkészlethez
Gépi kiolvasás: 2026. november 12.
Helyszínek itt: Németország
- Department of Neurosurgery and Spine Surgery, University Hospital EssenEssen, NémetországContact: Ramazan Jabbarli, MDNo longer taking part
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Contact the study team: see the registry record → Contacts and Locations
Oldal nyomtatása az orvosomnakA vizsgálat adatai
- Ki végzi
- University Hospital, Essen
- Azonosító
- NCT07872774
- A regiszteradat frissítve
- 2026. október 14.
- Eredeti leírás
DECIDE-SAH is an international, multicenter, retrospective, observational, non-interventional secondary-use cohort study of adults with aneurysmal subarachnoid hemorrhage (aSAH). The study combines pre-existing routine-care patient-level data from consecutive retrospective aSAH cohorts. Its primary objective is to evaluate the association between decompressive craniectomy (DC) strategies and unfavorable functional outcome approximately 6 months after aSAH, with particular emphasis on exact or best-available ictus-to-DC timing, the neurological context at the treatment decision, the indication for decompression, and technical characteristics of DC. The primary endpoint is modified Rankin Scale (mRS) 4-6 approximately 6 months after ictus. No prospective patient recruitment, study-specific treatment, additional diagnostic procedure, treatment allocation, or patient contact is planned.A teljes eredeti leírásKevesebb
Decompressive Craniectomy After Aneurysmal Subarachnoid Hemorrhage: An International Multicenter Retrospective Patient-Level Cohort Study
DECIDE-SAH is an international, multicenter, retrospective, observational, non-interventional secondary-use cohort study of adults with aneurysmal subarachnoid hemorrhage (aSAH). The study combines pre-existing routine-care patient-level data from consecutive retrospective aSAH cohorts. Its primary objective is to evaluate the association between decompressive craniectomy (DC) strategies and unfavorable functional outcome approximately 6 months after aSAH, with particular emphasis on exact or best-available ictus-to-DC timing, the neurological context at the treatment decision, the indication for decompression, and technical characteristics of DC. The primary endpoint is modified Rankin Scale (mRS) 4-6 approximately 6 months after ictus. No prospective patient recruitment, study-specific treatment, additional diagnostic procedure, treatment allocation, or patient contact is planned.
Bevonási feltételek: Age 18 years or older at ictus or hospital admission; Confirmed aneurysmal subarachnoid hemorrhage caused by rupture of a qualifying intracranial aneurysm; Eligible qualifying aneurysm morphologies include saccular, blister-like, dissecting, fusiform, and other non-excluded aneurysmal morphologies; Treatment or clinical management at a participating center during its documented consecutive retrospective cohort period; Availability of the Minimum Required Dataset (MRD) for scientific cohort contribution. The MRD requires a technical center-specific study identifier without direct identifiers, an index time period for the qualifying aSAH episode, age, sex, initial clinical severity represented by an accepted grading scale or valid Good Grade/Poor Grade classification, aneurysm-treatment status and modality, decompressive-craniectomy status, and at least one interpretable discharge clinical outcome; Complete Standard Dataset or Extension Module information is not required for cohort eligibility. Six-month mRS is not required for participation in analyses that do not use the registered primary endpoint.
Kizáró feltételek: Non-aneurysmal subarachnoid hemorrhage, including subarachnoid hemorrhage caused primarily by another vascular lesion without a qualifying ruptured intracranial aneurysm; Traumatic subarachnoid hemorrhage; Age below 18 years; Rupture of an infectious/mycotic intracranial aneurysm; Rupture of a traumatic pseudoaneurysm; Rupture of an iatrogenic pseudoaneurysm; Rupture of an AVM-/AVF-associated flow-related aneurysm; Source information insufficient to establish the qualifying aSAH diagnosis or to meet the Minimum Required Dataset threshold; Pregnancy, acute lack of decision-making capacity during the original aSAH episode, and non-German language are not exclusion criteria for this retrospective secondary use of pre-existing routine-care data.