Multicenter Registry of Patients With Subarachnoid Hemorrhage (MEASURE)
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Contacts and Locations
Study Contact
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
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-
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
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Zwolle, Overijssel, Netherlands, 8025 AB
- Recruiting
- Isala
-
Contact:
- M. Podlogar, MD, PhD
- Phone Number: +31886245000
- Email: m.podlogar@isala.nl
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-
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
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
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
How is the study designed?
Design Details
Number of groups / cohorts
Cohorts and Interventions
Group / CohortGroup / Cohort |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Spontaneous Subarachnoid Hemorrhage
|
None, observational study
|
What is the study measuring?
Primary Outcome Measures
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
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
Sponsor
Sponsor
Collaborators
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
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
Other Study ID Numbers
- 23U-0340
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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