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| Name | Class |
|---|---|
| Dutch Heart Foundation | OTHER |
| The Dutch Brain Foundation | OTHER |
| Radboud University Medical Center | OTHER |
| Erasmus Medical Center |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Spontaneous Subarachnoid Hemorrhage |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| None, observational study | Other | None, observational study |
|
| Measure | Description | Time Frame |
|---|---|---|
| Modified Rankin Scale (mRS) | 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. | 6 months ± 30 days after SAH |
| Measure | Description | Time Frame |
|---|---|---|
| modified Rankin Scale (mRS) | 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. | 18 months ± 30 days after SAH |
| Complications related to treatment of the ruptured aneurysm |
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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:
Exclusion Criteria:
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Patients with spontaneous subarachnoid hemorrhage
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| P.B. van Wijngaarden, MD | Contact | +88 755 5555 | measure@umcutrecht.nl |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Radboud University Medical Center | Recruiting | Nijmegen | Gelderland | 6525 GA | Netherlands |
Upon reasonable request: For each study using the data of this registry, analyses will be performed according to a predefined analysis plan with clearly defined statistical methods. These plans will be prepared prior to data analysis and in accordance with relevant reporting standards, such as the STROBE guideline. All data requests and accompanying statistical analysis plans will be reviewed by an independent research committee affiliated with CONTRAST-2 (the Data Access and Writing Committee) to ensure appropriate use of the registry data.
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| ID | Term |
|---|---|
| D013345 | Subarachnoid Hemorrhage |
| ID | Term |
|---|---|
| D020300 | Intracranial Hemorrhages |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D019370 | Observation |
| ID | Term |
|---|---|
| D008722 | Methods |
| D008919 | Investigative Techniques |
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| OTHER |
| Maastricht University Medical Center | OTHER |
| Elisabeth-TweeSteden Ziekenhuis | OTHER |
| Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC) | OTHER |
| Isala | OTHER |
| Medical Center Haaglanden | OTHER |
| University Medical Center Groningen | OTHER |
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| Periprocedural |
| Complications related to SAH | During registry period (up to 18 months after SAH) |
| Degree of aneurysm occlusion | For endovascular treatment assessed by the modified Raymond Roy Classification | 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 | Up to 18 months after SAH |
| Patient reported outcomes (PROMS): SOS-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. | Up to 18 months ± 30 days after SAH |
| Patient reported outcomes (PROMS): Stroke Specific Quality of Life scale (SSQoL) | 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. | Up to 18 months ± 30 days after SAH |
| Patient reported outcomes (PROMS): EuroQol 5-Dimension 5-Level (EQ-5D-5L) | 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. | Up to 18 months ± 30 days after SAH |
| Patient reported outcomes (PROMS): Hospital Anxiety and Depression Scale (HADS) | 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. | 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) | 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. | Up to 18 months ± 30 days after SAH |
| Patient reported outcomes (PROMS): iMTA Medical Consumption Questionnaire (iMCQ) | 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. | Up to 18 months ± 30 days after SAH |
| Patient reported outcomes (PROMS): iMTA Productivity Cost Questionnaire (iPCQ) | The iMTA Productivity Cost Questionnaire (iPCQ) is a generic instrument designed to measure health-related productivity losses in paid and unpaid work. | 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) | 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 15 items addressing cognitive and emotional complaints, for each of which the respondent indicates whether the complaint is present or absent. The total score ranges from 0 to 15, where higher scores indicate more cognitive complaints. | Up to 18 months ± 30 days after SAH |
| Amsterdam Cognition Scan (ACS) | 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. | Up to 18 months ± 30 days after SAH |
| Maastricht University Medical Center+ | Recruiting | Maastricht | Limburg | 6229 HX | Netherlands |
|
| Elisabeth-Tweesteden Hospital | Recruiting | Tilburg | North Brabant | 5022GC | Netherlands |
|
| Amsterdam University Medical Center | Recruiting | Amsterdam | North Holland | 1105AZ | Netherlands |
|
| Isala | Recruiting | Zwolle | Overijssel | 8025 AB | Netherlands |
|
| University Medical Center Groningen | Recruiting | Groningen | Provincie Groningen | 9713 GZ | Netherlands |
|
| Erasmus University Medical Center | Recruiting | Rotterdam | South Holland | 3015 GD | Netherlands |
|
| Haaglanden Medical Center | Recruiting | The Hague | South Holland | 2512 VA | Netherlands |
|
| Utrecht University Medical Center | Recruiting | Utrecht | Utrecht | 3584 CX | Netherlands |
|
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |