- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07482124
Multicenter Registry of Patients With Subarachnoid Hemorrhage (MEASURE)
March 15, 2026 updated by: Mervyn Vergouwen, UMC Utrecht
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
1000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: P.B. van Wijngaarden, MD
- Phone Number: +88 755 5555
- Email: measure@umcutrecht.nl
Study Locations
-
-
Gelderland
-
Nijmegen, Gelderland, Netherlands, 6525 GA
- Recruiting
- Radboud University Medical Center
-
Contact:
- H.D. Boogaarts, MD, PhD
- Phone Number: +31243611111
- Email: jeroen.boogaarts@radboudumc.nl
-
-
Limburg
-
Maastricht, Limburg, Netherlands, 6229 HX
- Recruiting
- Maastricht University Medical Center+
-
Contact:
- R.H.L. Haeren, MD, PhD
- Phone Number: +31433876543
- Email: roel.haeren@mumc.nl
-
-
North Brabant
-
Tilburg, North Brabant, Netherlands, 5022GC
- Recruiting
- Elisabeth-Tweesteden Hospital
-
Contact:
- P.J.P. Nachtergaele, MD, PhD
- Phone Number: +31132210000
- Email: p.nachtergaele@etz.nl
-
-
North Holland
-
Amsterdam, North Holland, Netherlands, 1105AZ
- Recruiting
- Amsterdam University Medical Center
-
Contact:
- D. Verbaan, PhD
- Phone Number: +31205669111
- Email: d.verbaan@amsterdamumc.nl
-
-
Overijssel
-
Zwolle, Overijssel, Netherlands, 8025 AB
- Recruiting
- Isala
-
Contact:
- M. Podlogar, MD, PhD
- Phone Number: +31886245000
- Email: m.podlogar@isala.nl
-
-
Provincie Groningen
-
Groningen, Provincie Groningen, Netherlands, 9713 GZ
- Recruiting
- University Medical Center Groningen
-
Contact:
- J.M.C. van Dijk, MD, PhD
- Phone Number: +31503616161
- Email: j.m.c.van.dijk@umcg.nl
-
-
South Holland
-
Rotterdam, South Holland, Netherlands, 3015 GD
- Recruiting
- Erasmus University Medical Center
-
Contact:
- V. Volovici, MD, PhD
- Phone Number: +31107040704
- Email: v.volovici@erasmusmc.nl
-
The Hague, South Holland, Netherlands, 2512 VA
- Recruiting
- Haaglanden Medical Center
-
Contact:
- W.A. Moojen, MD, PhD
- Phone Number: +31889797900
- Email: w.moojen@haaglandenmc.nl
-
-
Utrecht
-
Utrecht, Utrecht, Netherlands, 3584 CX
- Recruiting
- Utrecht University Medical Center
-
Contact:
- M.D.I. Vergouwen, MD, PhD
- Phone Number: +3188755555
- Email: m.d.i.vergouwen@umcutrecht.nl
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Patients with spontaneous subarachnoid hemorrhage
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Spontaneous Subarachnoid Hemorrhage
|
None, observational study
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Modified Rankin Scale (mRS)
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.
|
6 months ± 30 days after SAH
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
modified Rankin Scale (mRS)
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.
|
18 months ± 30 days after SAH
|
|
Complications related to treatment of the ruptured aneurysm
Time Frame: Periprocedural
|
Periprocedural
|
|
|
Complications related to SAH
Time Frame: During registry period (up to 18 months after SAH)
|
During registry period (up to 18 months after SAH)
|
|
|
Degree of aneurysm occlusion
Time Frame: Up to 18 months after SAH
|
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
Time Frame: Up to 18 months after SAH
|
Up to 18 months after SAH
|
|
|
Patient reported outcomes (PROMS): SOS-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.
|
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
|
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)
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.
|
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
|
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)
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.
|
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
|
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)
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.
|
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
|
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)
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.
|
Up to 18 months ± 30 days after SAH
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 12, 2024
Primary Completion (Estimated)
August 1, 2026
Study Completion (Estimated)
February 1, 2028
Study Registration Dates
First Submitted
March 9, 2026
First Submitted That Met QC Criteria
March 15, 2026
First Posted (Actual)
March 19, 2026
Study Record Updates
Last Update Posted (Actual)
March 19, 2026
Last Update Submitted That Met QC Criteria
March 15, 2026
Last Verified
March 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Vascular Diseases
- Cardiovascular Diseases
- Pathologic Processes
- Hemorrhage
- Intracranial Hemorrhages
- Pathological Conditions, Signs and Symptoms
- Subarachnoid Hemorrhage
- Investigative Techniques
- Methods
- Observation
Other Study ID Numbers
- 23U-0340
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
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.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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