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NCT07872774
Decompressive Craniectomy After Aneurysmal Subarachnoid Hemorrhage (DECIDE-SAH)
Conditions: Aneurysmal Subarachnoid Hemorrhage
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 10000
Sponsor: University Hospital, Essen
Location: Department of Neurosurgery and Spine Surgery, University Hospital Essen Essen North Rhine-Westphalia
Summary
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.
Eligibility Criteria
Inclusion Criteria:
* 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.
Exclusion Criteria:
* Age below 18 years.
* Non-aneurysmal subarachnoid hemorrhage, including subarachnoid hemorrhage caused primarily by another vascular lesion without a qualifying ruptured intracranial aneurysm.
* Traumatic subarachnoid hemorrhage.
* 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.
Source: ClinicalTrials.gov (NCT07872774). StuddyBuddy aggregates publicly available trial information.