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Recruiting NCT07482124

Multicenter Registry of Patients With Subarachnoid Hemorrhage

— Observational Subarachnoid Hemorrhage, Spontaneous

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: None, observational study.
Who it may be relevant to
Registry conditions: Subarachnoid Hemorrhage, Spontaneous. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Netherlands
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

The purpose of this registry is to collect detailed information on the characteristics, treatment, and outcomes of patients with a subarachnoid hemorrhage. This information will enable research aimed at improving the safety and effectiveness of current and future treatments. By studying these data, the investigators aim to identify which treatment strategies offer the best results and which factors are most important in the care of patients with a subarachnoid hemorrhage. The knowledge gained from this research will help improve patient care in the future.

Interventions

  • Other None, observational study
    None, observational study

Primary outcome measures

  • Modified Rankin Scale (mRS) [Time frame: 6 months ± 30 days after SAH]
Secondary outcome measures (12)
  • modified Rankin Scale (mRS) [Time frame: 18 months ± 30 days after SAH]
  • Complications related to treatment of the ruptured aneurysm [Time frame: Periprocedural]
  • Complications related to SAH [Time frame: During registry period (up to 18 months after SAH)]
  • Degree of aneurysm occlusion [Time frame: Up to 18 months after SAH]
  • Newly found aneurysm or other vascular malformation at additional imaging in patients with non-perimesencephalic primary angiogram negative SAH [Time frame: Up to 18 months after SAH]
  • Patient reported outcomes (PROMS): SOS-SAH [Time frame: Up to 18 months ± 30 days after SAH]
  • Patient reported outcomes (PROMS): Stroke Specific Quality of Life scale (SSQoL) [Time frame: Up to 18 months ± 30 days after SAH]
  • Patient reported outcomes (PROMS): EuroQol 5-Dimension 5-Level (EQ-5D-5L) [Time frame: Up to 18 months ± 30 days after SAH]
  • Patient reported outcomes (PROMS): Hospital Anxiety and Depression Scale (HADS) [Time frame: Up to 18 months ± 30 days after SAH]
  • Patient reported outcomes (PROMS): The Cognition scale of the CheckList for Cognitive and Emotional consequences following stroke (CLCE-C) [Time frame: Up to 18 months ± 30 days after SAH]
  • Patient reported outcomes (PROMS): iMTA Medical Consumption Questionnaire (iMCQ) [Time frame: Up to 18 months ± 30 days after SAH]
  • Patient reported outcomes (PROMS): iMTA Productivity Cost Questionnaire (iPCQ) [Time frame: Up to 18 months ± 30 days after SAH]

Eligibility criteria

Inclusion criteria

  • Age ≥ 18 years
  • Spontaneous subarachnoid hemorrhage with blood in the basal cisterns and/or major fissures on non-contrast head computed tomography (CT), or xanthochromia of cerebrospinal fluid confirmed by spectrophotometric analysis.
  • Eligible etiologies/patterns:
  • Aneurysmal SAH
  • SAH from other intracranial vascular malformation (e.g. AVM, dural AVF)
  • Perimesencephalic SAH
  • Non-perimesencephalic angiogram negative SAH
  • SAH from intracranial artery dissection

Exclusion criteria

  • Traumatic, neoplastic, infection related (except mycotic aneurysms), or iatrogenic SAH
  • Isolated convexity SAH

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Netherlands · 9 centers
  • Radboud University Medical Center — Nijmegen
  • Maastricht University Medical Center+ — Maastricht
  • Elisabeth-Tweesteden Hospital — Tilburg
  • Amsterdam University Medical Center — Amsterdam
  • Isala — Zwolle
  • University Medical Center Groningen — Groningen
  • Erasmus University Medical Center — Rotterdam
  • Haaglanden Medical Center — The Hague
  • … and 1 more center

Identifiers

NCT: NCT07482124 · 23U-0340

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗