Subarachnoid Hemorrhage, Spontaneous
Conditions
Brief summary
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
None, observational study
Sponsors
UMC Utrecht
Dutch Heart Foundation
The Dutch Brain Foundation
Radboud University Medical Center
Erasmus Medical Center
Maastricht University Medical Center
Elisabeth-TweeSteden Ziekenhuis
Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC)
Isala
Medical Center Haaglanden
University Medical Center Groningen
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Modified Rankin Scale (mRS) | 6 months ± 30 days after SAH | The Modified Rankin Scale (mRS) is a scale ranging from 0 to 6, where 0 indicates no symptoms and 6 indicates death. Higher scores indicate a worse outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| modified Rankin Scale (mRS) | 18 months ± 30 days after SAH | The Modified Rankin Scale (mRS) is a scale ranging from 0 to 6, where 0 indicates no symptoms and 6 indicates death. Higher scores indicate a worse outcome. |
| Complications related to treatment of the ruptured aneurysm | Periprocedural | — |
| Complications related to SAH | During registry period (up to 18 months after SAH) | — |
| Degree of aneurysm occlusion | Up to 18 months after SAH | For endovascular treatment assessed by the modified Raymond Roy Classification |
| Newly found aneurysm or other vascular malformation at additional imaging in patients with non-perimesencephalic primary angiogram negative SAH | Up to 18 months after SAH | — |
| Patient reported outcomes (PROMS): SOS-SAH | Up to 18 months ± 30 days after SAH | The Questionnaire for the Screening of Symptoms in aneurysmal Subarachnoid Hemorrhage (SOS-SAH) is a disease-specific patient-reported outcome measure developed to screen for symptoms in patients after aSAH. It consists of 14 domains: cognitive abilities, hypersensitivity to stimuli, anxiety, depression, fatigue, social roles, personality change, language, vision, taste, smell, hearing, headache, and sexual function. It also includes a proxy measurement for use by family members to assess cognitive functioning and personality changes. External validation of the SOS-SAH is one of the objectives of this registry. |
| Patient reported outcomes (PROMS): Stroke Specific Quality of Life scale (SSQoL) | Up to 18 months ± 30 days after SAH | The Stroke Specific Quality of Life scale (SSQoL) assesses health-related quality of life, comprising 49 items across 12 domains. Items are rated on a 5-point Likert scale ranging from "total help needed" to "no help needed." Higher scores indicate better functioning. |
| Patient reported outcomes (PROMS): EuroQol 5-Dimension 5-Level (EQ-5D-5L) | Up to 18 months ± 30 days after SAH | The EuroQol 5-Dimension 5-Level (EQ-5D-5L) assesses general health status across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, each rated on a 5-level severity scale. Three scoring methods are used: (1) the EQ-VAS, a Visual Analogue Scale ranging from 0 to 100 where higher scores indicate better self-rated health; (2) the EQ-5D-5L health state, coded as a 5-digit number ranging from 11111 (full health) to 55555 (worst health); and (3) the EQ-5D-5L index value, calculated using the Dutch tariff, where higher scores indicate better health-related quality of life. |
| Patient reported outcomes (PROMS): Hospital Anxiety and Depression Scale (HADS) | Up to 18 months ± 30 days after SAH | The Hospital Anxiety and Depression Scale (HADS) is a 14-item instrument comprising two subscales: one for anxiety and one for depression. Each subscale ranges from 0 to 21. Higher scores indicate greater symptom severity. |
| Patient reported outcomes (PROMS): The Cognition scale of the CheckList for Cognitive and Emotional consequences following stroke (CLCE-C) | Up to 18 months ± 30 days after SAH | The Cognition scale of the CheckList for Cognitive and Emotional consequences following stroke (CLCE-C) is an instrument for identifying cognitive problems after stroke. It consists of 13 items addressing cognitive complaints, for each of which the respondent indicates whether the complaint is present or absent. The total score ranges from 0 to 13, where higher scores indicate more cognitive and emotional complaints. |
| Patient reported outcomes (PROMS): iMTA Medical Consumption Questionnaire (iMCQ) | Up to 18 months ± 30 days after SAH | The iMTA Medical Consumption Questionnaire (iMCQ) is a generic instrument that measures medical consumption, including hospitalization days, contacts with health care providers, and medication use. |
| Patient reported outcomes (PROMS): iMTA Productivity Cost Questionnaire (iPCQ) | Up to 18 months ± 30 days after SAH | The iMTA Productivity Cost Questionnaire (iPCQ) is a generic instrument designed to measure health-related productivity losses in paid and unpaid work. |
| Amsterdam Cognition Scan (ACS) | Up to 18 months ± 30 days after SAH | The Amsterdam Cognition Scan is a web-based digital cognitive test battery of approximately 60 minutes, consisting of 7 tasks assessing attention, memory, processing speed, executive functioning, and psychomotor speed. |
Countries
Netherlands
Contacts
CONTACTP.B. van Wijngaarden, MD
Outcome results
None listed