An observational study in Aneurysmal Subarachnoid Hemorrhage, sponsored by University Hospital, Essen. Not yet recruiting at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-14.
Sponsored by University Hospital, Essen · Observational
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.
Decompressive craniectomy is used in selected patients with aneurysmal subarachnoid hemorrhage (aSAH) to manage space-occupying hemorrhage, cerebral edema, infarction-related swelling, or refractory intracranial hypertension. Existing evidence is predominantly observational and heterogeneous and is strongly affected by confounding by indication, differences in baseline severity, treatment timing, technical characteristics, center-specific practice, and treatment-era effects.
DECIDE-SAH is an international, multicenter, retrospective, observational, non-interventional secondary-use patient-level cohort study using pre-existing routine-care data. There is no randomization, prospective treatment allocation, study-specific diagnostic or therapeutic procedure, investigational product, or study-related patient contact. Clinical management was determined independently by the treating teams. Only routine-care information documented on or before 15 September 2026 is eligible for the study dataset under the current protocol.
The study uses a hierarchical data architecture consisting of a Minimum Required Dataset (MRD), a Standard Dataset, and optional Extension Modules. The MRD is the minimum information required for scientifically interpretable cohort contribution and includes a technical center-specific study identifier without direct identifiers, an index time period for the qualifying aSAH episode, age, sex, initial clinical severity, 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 required for the registered primary endpoint analysis but is not required for participation in analyses that use other available outcomes.
DECIDE-SAH is availability-based and does not use a fixed prospective recruitment target derived from a power calculation. Each participating center is expected to contribute the largest reliably available consecutive eligible adult aSAH cohort from its authorized retrospective source-data period rather than selected decompressive-craniectomy cases only. There is no minimum center case count and no requirement for identical calendar periods across centers. Centers with low or no routine use of decompressive craniectomy remain eligible because between-center practice variation is an important component of the observational study framework.
The principal exposure is decompressive craniectomy during the index hospitalization. Exact or best-available ictus-to-DC timing and the clinical context at the treatment decision are prioritized where available. The contributing center/source classification of Primary DC versus Secondary DC is retained as a pragmatic exposure variable and is not defined by a fixed ictus-to-DC hour threshold. For Primary DC, the relevant clinical context is the baseline/admission or intraoperative status; for Secondary DC, pre-Secondary-DC neurological status is used where available. The documented indication and technical characteristics of DC, including type, extent or dimensions where available, duraplasty, and concomitant procedures, are also considered. Descriptive any-DC versus no-DC comparisons may be reported, but clinically comparable treatment-strategy analyses will be defined according to the available temporal and clinical granularity.
The primary endpoint is unfavorable functional outcome approximately 6 months after ictus, defined as modified Rankin Scale (mRS) 4-6. Routine-care assessments obtained within 3 to 9 months after ictus are eligible; when more than one assessment is available, the assessment closest to day 180 is selected, and if two assessments are equally close, the later assessment is used. Secondary outcomes include ordinal and alternative dichotomized mRS outcomes, discharge outcome, mortality, mRS at approximately 12 and 24 months where retrospectively available, cerebral infarction, delayed cerebral ischemia-related infarction, rebleeding before aneurysm treatment, intracranial-hypertension burden, hydrocephalus and ventriculoperitoneal shunt placement, endovascular rescue treatment for vasospasm or delayed cerebral ischemia, intensive-care and hospital length of stay, and decompressive-craniectomy-related complications. Therapy-requiring intracranial hypertension and total ICP-treatment days are cohort-wide measures that may be evaluated in patients with or without decompressive craniectomy.
Analyses will use multilevel models with center effects where feasible, propensity-score-based adjustment, weighting or matching, treatment-era adjustment, and timing-aware landmark, risk-set, or target-trial-emulation-oriented approaches when data granularity permits. These methods are intended to reduce confounding by indication, treatment-selection bias, center effects, calendar-time effects, timing bias, and immortal-time bias. Results will be interpreted as observational estimates and not as equivalent to randomized evidence.
Only patient-level data without direct identifiers are transferred to the coordinating center. Where legally and institutionally authorized, pseudonymized patient-level data may be transferred while any re-identification key remains exclusively under local control; where pseudonymized transfer is not permitted, an anonymous site export is required. Each participating center must meet the applicable local ethics, data-protection, institutional, contractual, and international-transfer requirements before patient-level data transfer. Central transfer of DICOM or other source imaging is not part of the main study dataset. Imaging/DICOM/computer-vision/AI analyses and cranioplasty-related follow-up are optional future substudies requiring separate data specifications and any additional approvals applicable at that time.
521 studies on the registry are indexed under Subarachnoid Hemorrhage; 126 are open to participants now.
This study's planned enrollment of 10,000 is above the median of 116 across 234 observational studies indexed under Subarachnoid Hemorrhage.
Browse Subarachnoid Hemorrhage studies →University Hospital, Essen is the lead sponsor of 116 studies on the registry; 33 are open to participants now.
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Adults with confirmed aneurysmal subarachnoid hemorrhage caused by rupture of a qualifying intracranial aneurysm and managed at participating neurovascular or neurosurgical centers. Eligible aneurysm morphologies include saccular, blister-like, dissecting, fusiform, and other non-excluded aneurysmal morphologies. Data are derived exclusively from pre-existing routine-care information documented within each center's authorized retrospective source-data period. Each participating center is expected to contribute the largest reliably available consecutive eligible adult aSAH cohort rather than selected decompressive-craniectomy cases only. No minimum center case count or identical calendar period across centers is required. Centers with low or no routine use of decompressive craniectomy remain eligible. Patients with treatment limitation are not excluded a priori from the descriptive cohort and are handled through prespecified analysis restrictions and sensitivity analyses.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Adults with aneurysmal subarachnoid hemorrhage who did not undergo decompressive craniectomy during the index hospitalization. This is an observational comparator group; treatment was determined by the treating clinical team and was not assigned by DECIDE-SAH.
Patients undergoing decompressive craniectomy classified as Primary DC according to the contributing center/source definition, generally as part of the initial treatment strategy based on baseline or intraoperative clinical and radiographic findings. Primary DC is not defined by a fixed ictus-to-DC time threshold. Exact or best-available ictus-to-DC timing remains a separate preferred exposure variable when available.
Procedure: Decompressive craniectomy
Patients undergoing decompressive craniectomy classified as Secondary DC according to the contributing center/source definition after documented clinical or radiographic deterioration or a secondary event. Relevant contexts may include refractory intracranial hypertension, infarction-related edema, delayed cerebral swelling, delayed-cerebral-ischemia-related infarction, or hemorrhagic complications. Secondary DC is not defined solely by an absolute ictus-to-DC time threshold.
Procedure: Decompressive craniectomy
Surgical decompression performed as part of routine clinical care. DECIDE-SAH does not assign or modify treatment. The exposure is characterized by exact or best-available ictus-to-DC timing, the neurological context at the treatment decision, the documented indication for decompression, and technical characteristics including DC type, extent or dimensions where available, and duraplasty. For Primary DC, the relevant clinical context is the baseline/admission or intraoperative status; for Secondary DC, pre-Secondary-DC neurological status is used where available.
Unfavorable functional outcome at approximately 6 months
Binary functional outcome derived from the modified Rankin Scale (mRS), which ranges from 0 (no symptoms) to 6 (death), with higher scores indicating greater disability. Unfavorable outcome is defined as mRS 4-6. If more than one mRS assessment is available within the 3-9-month window, the assessment closest to day 180 is selected. If two assessments are equally close to day 180, the later assessment is used.
Time frame: 3 to 9 months after ictus; assessment closest to day 180
Ordinal modified Rankin Scale at approximately 6 months
Exact ordinal modified Rankin Scale (mRS) score from 0 (no symptoms) to 6 (death), with higher scores indicating greater disability, using the same 3-9-month assessment-selection rule as the primary endpoint.
Time frame: 3 to 9 months after ictus; assessment closest to day 180
Severe disability or death at approximately 6 months
Binary outcome derived from the modified Rankin Scale (mRS 0-6); severe disability or death is defined as mRS 5-6.
Time frame: 3 to 9 months after ictus; assessment closest to day 180
Functional dependency or death at approximately 6 months
Binary outcome derived from the modified Rankin Scale (mRS 0-6); functional dependency or death is defined as mRS 3-6.
Time frame: 3 to 9 months after ictus; assessment closest to day 180
Modified Rankin Scale at hospital discharge
Exact modified Rankin Scale (mRS) score from 0 (no symptoms) to 6 (death), with higher scores indicating greater disability, recorded at discharge from the index hospitalization where available.
Time frame: At discharge from the index hospitalization, assessed up to 12 months after ictus
In-hospital mortality
Death occurring before discharge from the index hospitalization for aneurysmal subarachnoid hemorrhage.
Time frame: From ictus through discharge from the index hospitalization, up to 12 months after ictus
30-day mortality
Vital status 30 days after ictus, where available.
Time frame: 30 days after ictus
90-day mortality
Vital status 90 days after ictus, where available.
Time frame: 90 days after ictus
Mortality at approximately 6 months
Vital status at approximately 6 months after aneurysmal subarachnoid hemorrhage, where available.
Time frame: Approximately 6 months after ictus
12-month mortality
Vital status 12 months after ictus, where available.
Time frame: 12 months after ictus
Modified Rankin Scale at approximately 12 months
Exact modified Rankin Scale (mRS) score from 0 (no symptoms) to 6 (death), with higher scores indicating greater disability, where retrospectively documented.
Time frame: 12 months after ictus
Early cerebral infarction
Occurrence of cerebral infarction documented within 72 hours after aneurysmal subarachnoid hemorrhage, excluding imaging abnormalities attributable to intracerebral hemorrhage, ventricular-drain placement, or the surgical approach where these causes can be distinguished.
Time frame: Within 72 hours after ictus
Delayed cerebral ischemia-related cerebral infarction
Occurrence of cerebral infarction attributed to delayed cerebral ischemia using the source-center definition and, where reconstructable, the Vergouwen consensus framework: a new cerebral infarction on CT or MRI within 6 weeks after aSAH that was not present on imaging 24-48 hours after early aneurysm occlusion and is not attributable to another cause.
Time frame: Within 6 weeks after ictus
Rebleeding before aneurysm treatment
Documented recurrent hemorrhage after the qualifying aneurysmal subarachnoid hemorrhage and before definitive treatment of the ruptured aneurysm. In patients without definitive aneurysm treatment, ascertainment ends at discharge from the index hospitalization.
Time frame: From ictus until definitive aneurysm treatment or discharge from the index hospitalization, whichever occurs first, up to 12 months after ictus
Therapy-requiring intracranial hypertension
Occurrence of documented intracranial hypertension requiring active ICP-directed treatment, where reliably reconstructable. This cohort-wide measure may be present in patients with or without decompressive craniectomy.
Time frame: From ictus through discharge from the index hospitalization, up to 12 months after ictus
Total days with therapy-requiring intracranial hypertension
Total number of calendar days with active treatment for documented intracranial hypertension, where reliably reconstructable. This cohort-wide measure may be assessed in patients with or without decompressive craniectomy.
Time frame: From ictus through discharge from the index hospitalization, up to 12 months after ictus
Ventriculoperitoneal shunt placement
Placement of a ventriculoperitoneal shunt for hydrocephalus after aneurysmal subarachnoid hemorrhage.
Time frame: From ictus through 24 months after ictus
Endovascular rescue treatment for vasospasm or delayed cerebral ischemia
Occurrence of documented endovascular rescue treatment for vasospasm or delayed cerebral ischemia, including intra-arterial vasodilator treatment and/or balloon angioplasty, where available.
Time frame: Within 6 weeks after ictus
Intensive care unit length of stay
Number of days in the intensive care unit during the index hospitalization.
Time frame: From intensive care unit admission through intensive care unit discharge, up to 12 months after hospital admission
Hospital length of stay
Total number of days in the index hospital stay.
Time frame: From hospital admission through discharge from the index hospitalization, up to 12 months after admission
Decompressive craniectomy-related complications
Composite binary outcome defined as occurrence of one or more source-documented DC-related complications during the index hospitalization, including postoperative hemorrhage, wound-healing disorder, surgical-site infection, empyema or abscess, cerebrospinal-fluid fistula, hygroma, bone-flap-related complication, or need for surgical revision, where available.
Time frame: From first decompressive craniectomy through discharge from the index hospitalization, up to 12 months after ictus
Favorable functional outcome at approximately 6 months
Binary outcome derived from the modified Rankin Scale (mRS 0-6); favorable functional outcome is defined as mRS 0-3.
Time frame: 3 to 9 months after ictus; assessment closest to day 180
Glasgow Outcome Scale at approximately 6 months
Glasgow Outcome Scale (GOS) score from 1 to 5, where 1 indicates death and 5 indicates good recovery; higher scores indicate better functional outcome. This secondary measure is used where GOS is available and does not replace the registered primary mRS endpoint.
Time frame: 3 to 9 months after ictus; assessment closest to day 180
Modified Rankin Scale at approximately 24 months
Exact modified Rankin Scale (mRS) score from 0 (no symptoms) to 6 (death), with higher scores indicating greater disability, where retrospectively documented.
Time frame: 24 months after ictus
Glasgow Outcome Scale Extended at approximately 6 months
Glasgow Outcome Scale Extended (GOSE) score from 1 to 8, where 1 indicates death and 8 indicates upper good recovery; higher scores indicate better functional outcome. This secondary measure is used where GOSE is available and does not replace the registered primary mRS endpoint.
Time frame: 3 to 9 months after ictus; assessment closest to day 180
Plan to share: No — The pooled patient-level dataset will not be made publicly available because its use is governed by site-specific ethics approvals, data-protection requirements, institutional requirements, and applicable data-sharing or data-transfer agreements. No direct identifiers are accepted by the coordinating center. Where legally and institutionally authorized, pseudonymized patient-level data may be transferred while any re-identification key remains exclusively under local control at the contributing center. Where pseudonymized transfer is not permitted, only an anonymous site export may be transferred. Aggregate results, study metadata, data dictionaries, and analysis code may be shared where legally, ethically, and institutionally permissible.
Start is estimated for Nov 2026; primary completion for Dec 2031, 61 months later.
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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