none, observational study
OtherNone, observational study
NCT Number: NCT07482124
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.
Interested in participating?
Request InfoAll sexes
Observational
Radboud University Medical Center, Nijmegen, Gelderland, Netherlands
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
None, observational study
Time frame: 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.
Time frame: 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.
Time frame: Periprocedural
Time frame: During registry period (up to 18 months after SAH)
Time frame: Up to 18 months after SAH
For endovascular treatment assessed by the modified Raymond Roy Classification
Time frame: Up to 18 months after SAH
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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 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.
Time frame: 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.
Contact information is provided by the study sponsor or research team.
UMC Utrecht
Other
Acronym: MEASURE
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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