NCT07872774Not yet recruiting
Decompressive Craniectomy After Aneurysmal Subarachnoid Hemorrhage (DECIDE-SAH)
Decompressive Craniectomy After Aneurysmal Subarachnoid Hemorrhage: An International Multicenter Retrospective Patient-Level Cohort Study
Source: ClinicalTrials.gov · Last updated 14 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 10000 (estimated)
- First submitted
- 2 Oct 2026
- Start date
- Nov 2026
- Primary completion date
- Dec 2031
- Lead sponsor
- University Hospital, Essen
- Diseases
- Stroke, High blood pressure
- NCT number
- NCT07872774
What you commit to
- Study type: Observational
- Planned participants: 10000
- From Nov 2026 to the primary completion date, Dec 2031
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Non-aneurysmal subarachnoid hemorrhage, including subarachnoid hemorrhage caused primarily by another vascular lesion without a qualifying ruptured intracranial aneurysm.
- Traumatic subarachnoid hemorrhage.
Age
- Age below 18 years.
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Neurosurgery and Spine Surgery, University Hospital Essen Coordinator of this site? Confirm its status | Essen | Germany | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.