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Subarachnoid Hemorrhage, SpontaneousDECIPHER-pmSAHNCT07923084

Determining the Clinical Impact and Prevalence of Hemorrhagic Subtypes in Perimesencephalic Subarachnoid Hemorrhage

An observational study of Subarachnoid Hemorrhage, Spontaneous and Subarachnoid Hemorrhage, Aneurysmal, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Background: Perimesencephalic subarachnoid hemorrhage (pmSAH) is a distinct subtype of traumatic subarachnoid hemorrhage (SAH) characterized by a localized bleeding pattern around the midbrain not resulting from a ruptured aneurysm of a posterior circulation main artery. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Completion of a patient-reported outcome measure (PROM) in the form of a EQ-5D questionnaire
How many people
264 participants
Where
1 siteSwitzerland
Study dates
1 Jan 2026to 31 Mar 2029
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients from participating centers, diagnosed with a perimesencephalic subarachnoid hemorrhage (pmSAH) not resulting from a mechanical trauma or from a ruptured aneurysm of the main arteries of the posterior circulation (V4, Basilar trunk, basilar tip, AICA, PICA, PCA). Taking into account further exclusion criteria (see above), this leaves 2 possible etiologies for pmSAH: 1) basilar artery perforator aneurysms (BAPA); 2) "sine materia" = no vascular lesion could be identified as the source of the pmSAH

Who may be able to join

  • Patients aged ≥18 years with a non-traumatic pmSAH or limited additional blood in adjacent cisterns (pmSAH "plus")
  • Cross-sectional imaging at baseline (CT or MRI)
  • Written informed consent for study participation was obtained.

Who cannot join

  • Presence of documented written or verbal refusal
  • pmSAH patients with a presumed traumatic source
  • Saccular/fusiform aneurysm of the main arteries of the posterior circulation (e.g. V4, AICA, PICA, basilar trunk, basilar tip)
  • pmSAH patients with a shunting lesion in the vertebrobasilar territory (i.e. brain AVM, brain/spine AVF)
  • pmSAH patients with a cavernous malformation in the posterior fossa
  • Basilar artery perforator aneurysm group (BAPA group):
Show all 11Show fewer
  • Aneurysm arising from the basilar artery trunk adjacent to a perforating branch but not involving a perforating artery (Satti Type 1)
  • Flow-related BAPA (i.e. AVM, AVF)
  • Severely impaired renal function defined as KDIGO grade 4 (GFR <30 mL/min/1.73 m2)
  • Pregnancy or suspected pregnancy
  • Known adverse events to iodinated contrast media

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Switzerland1 site, 1 recruiting
  • Inselspital, University Hospital Bern

    Bern, 3010

    Tomas Dobrocky, MD, +41 31 632 13 77, tomas.dobrocky@insel.ch

    Luca Noti, MD, +41 31 632 70 00, luca.noti@insel.ch

    Recruiting

Other trials in Switzerland

About this study

Official title: Determining the Clinical Impact and Prevalence of Hemorrhagic Subtypes in Perimesencephalic Subarachnoid Hemorrhage - A Prospective Observational Study

Background:

Perimesencephalic subarachnoid hemorrhage (pmSAH) is a distinct subtype of traumatic subarachnoid hemorrhage (SAH) characterized by a localized bleeding pattern around the midbrain not resulting from a ruptured aneurysm of a posterior circulation main artery. Traditionally considered benign with generally good prognosis, pmSAH has been attributed to a presumed venous etiology. However, recent advances in imaging technology have led to the identification of previously occult vascular lesions, most notably basilar artery perforator aneurysms (BAPAs) that may present a potential cause in a subset of patients with pmSAH. Preliminary data from the international PERFAN registry which retrospectively included 148 patients with ruptured BAPAs, challenge the benign perception of pmSAH as a whole. Interestingly, in this biggest case collection so far, patients diagnosed with BAPAs experienced significantly higher rates of complications and worse functional outcomes compared to cases of non-aneurysmal pmSAH (NA-pmSAH). To date, prospective data on prevalence, presentation and outcome of BAPA-associated pmSAH (BAPA-pmSAH) is missing, thus complicating decisions on management of this increasingly diagnosed entity.

Read more

Aims:

The DECIPHER-pmSAH study aims to establish a prospective registry to:

  1. determine and compare the prevalence of BAPA-pmSAH and non-aneurysmal pmSAH
  2. compare short-term and mid-term functional outcomes between patients with BAPA-pmSAH and those with non-aneurysmal pmSAH
  3. evaluate the rate and nature of complications in both these pmSAH subgroups
  4. enhance the understanding of radiological features associated with pmSAH, with the aim of distinguishing between BAPA-pmSAH and non-aneurysmal pmSAH
  5. characterize observed treatment strategies and their outcomes, comparing conservative and active management approaches

Design:

The DECIPHER-pmSAH is a prospective, multicenter, observational study. For an adequately powered study, we are aiming at enrollment of at least 264 patients over the course of three years, starting on January 1st, 2026. For recruiting participating sites, we are aiming to build upon the previously established collaboration with multiple international centers contributing to the PERFAN registry, in which cases of perforator aneurysms were retrospectively collected.

Methods:

This study will include cases of atraumatic pmSAH where no aneurysm of main arteries of the posterior circulation was detected. Predefined diagnostic workup criteria must be met for patient enrollment, including cross-sectional imaging (CT or MRI) at baseline, whenever possible and clinically justified at least one digital subtraction angiography (DSA) with high-resolution three-dimensional rotational angiography (3D-RA) and collection of clinical data at index presentation, hospital discharge and 90 days follow-up. Anonymized imaging data will be centrally analyzed by trained neuroradiologists, blinded to clinical data in a core lab at the Inselspital, Bern. The primary endpoint to be examined is the prevalence of ruptured BAPA and non-aneurysmal hemorrhage in cases of pmSAH. Secondary and tertiary endpoints include clinical outcomes at 90 days after index presentations and specific radiological findings respectively.

Being tested
Completion of a patient-reported outcome measure (PROM) in the form of a EQ-5D questionnaire
Keywords
Perimesencephalic Subarachnoid Hemorrhage, Basilar Artery Perforator Aneurysm, pmSAH, BAPA, Basal Vein of Rosenthal, BVR
Medical subject headings
Subarachnoid Hemorrhage

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Completion of a patient-reported outcome measure (PROM) in the form of a EQ-5D questionnaireDiagnostic test

    The only study-specific intervention is the collection of a patient-reported outcome measure (PROM) in the form of the EQ-5D questionnaire at 3-month follow-up.

Study groups in NCT07923084
Study groupRoleWhat they receive
All patients included in the studyThe only study-specific intervention is the collection of a patient-reported outcome measure (PROM) in the form of the EQ-5D questionnaire at 3-month follow-up for all patients. All other analyzed data are collected as part of routine clinical care.
Receives: Diagnostic Test: Completion of a patient-reported outcome measure (PROM) in the form of a EQ-5D questionnaire

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of BAPAs in pmSAH where at least one high-resolution 3D-rotational angiography (3D-RA) of the dominant vertebral artery was performed within 7 days after the index presentation

    Measured: Within 7 days after pmSAH diagnosis

Secondary outcomes (9)
  1. Rate of patients with excellent functional outcome (Modified Rankin Scale 0-1) at 3 months

    Measured: 3 months after enrollment

  2. Rate of patients with favorable functional outcome (Modified Rankin Scale 0-2) at 3 months

    Measured: 3 months after enrollment

  3. Patient-Reported Outcome (EQ-5D-5L questionnaire) at 3 months

    Measured: 3 months after enrollment

  4. Modified Rankin Scale (mRS, range 0-6 with higher scores indicating worse functional status) at hospital discharge

    Measured: 21 days after enrollment or hospital discharge (if discharged earlier)

  5. National Institutes of Health Stroke Scale (NIHSS, range 0-42 with higher scores indicating greater neurological impairement) at hospital discharge

    Measured: 21 days after enrollment or hospital discharge (if discharged earlier)

  6. Rate of rebleeding

    Measured: From enrollment to 3-month follow-up

  7. Rate of hydrocephalus requiring EVD or lumbar drain

    Measured: From enrollment to 3-month follow-up

  8. Rate of symptomatic vasospasm

    Measured: From enrollment to 3-month follow-up

  9. Rate of BAPAs in pmSAH overall (regardless of 3D-RA acquisition)

    Measured: From enrollment to 3-month follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Nov 2026
  2. Study start1 Jan 2026
  3. Primary completion31 Mar 2029 (estimated)
  4. Study completion31 Mar 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
264 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07923084
Sponsor's protocol ID
CH-2025-01117
Acronym
DECIPHER-pmSAH
Status last verified
Sep 2026
First submitted
12 Oct 2026
Last updated
6 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • Lu GD, Zhao LB, Jia ZY, Liu S. Micro-guidewire electrocoagulation for the treatment of intracranial aneurysms that are inaccessible by microcatheterization: a case series and review of the literature. J Neurointerv Surg. 2023 Dec;15(12):1229-1233. doi: 10.1136/jnis-2022-019355. Epub 2022 Oct 25.

    PubMed 36283807
  • Elsheikh S, Mohlenbruch M, Seker F, Berlis A, Maurer C, Kocer N, Jamous A, Behme D, Taschner C, Urbach H, Meckel S. Flow Diverter Treatment of Ruptured Basilar Artery Perforator Aneurysms : A Multicenter Experience. Clin Neuroradiol. 2022 Sep;32(3):783-789. doi: 10.1007/s00062-021-01133-y. Epub 2022 Jan 20.

    PubMed 35059755
  • Shlobin NA, Cantrell DR, Ansari SA, Hurley MC, Shaibani A, Jahromi BS, Potts MB. Conservative Management and Natural History of Ruptured Basilar Perforator Artery Aneurysms: Two Cases and Literature Review. World Neurosurg. 2020 Jun;138:218-222. doi: 10.1016/j.wneu.2020.03.042. Epub 2020 Mar 16.

    PubMed 32194275
  • Rajbhandari S, Serrallach BL, Raabe JM, Piechowiak EI, Goldberg J, Seiffge DJ, Rentzos A, Zhu F, Scarcia L, Narata A, Amans MR, Premat K, Demerath T, Moehlenbruch M, Kumar R, Limbucci N, Piano M, Burel J, Bellanger G, Dorn F, Hennersdorf F, Stracke P, Milonia L, Cirillo L, Wasselius J, Lenthall R, Flynn L, Keston P, Raz E, Barvulsky E, Giubbolini F, Leonard-Lorant I, Smajda S, Klisch J, Kaiser DPO, Rizzuti M, Tanaka M, Kizilkilic O, Booth TC, Linfante I, Leber SL, Hassan F, Dumas V, Forestier G, Li Y, Alexandre A, Padilla-Palomo FJ, Karwacki GM, Saleem N, Abdalkader M, Herial NA, Pulli B, Tran CC, Raabe A, Gralla J, Bervini D, Z'Graggen WJ, Kaesmacher J, Dobrocky T; PERFAN registry (PERforator ANeurysm registry) collaborators. Differentiating aetiologies in perimesencephalic SAH: clinical insights into basilar artery perforator aneurysms. J Neurol Neurosurg Psychiatry. 2026 Jul 14:jnnp-2026-338621. doi: 10.1136/jnnp-2026-338621. Online ahead of print.

    PubMed 42448461
  • Kumagawa T, Otani N, Kakei Y, Negishi H, Suma T, Yoshino A. Ruptured Basilar Artery Perforator Aneurysm Definitely Diagnosed with Intraoperative Microsurgical Findings: Case Report and Literature Review. NMC Case Rep J. 2023 Jan 16;10:1-7. doi: 10.2176/jns-nmc.2022-0184. eCollection 2023.

    PubMed 36778213
  • Granja MF, Monteiro A, Agnoletto GJ, Jamal S, Sauvageau E, Aghaebrahim A, Hanel R. A systematic review of non-trunk basilar perforator aneurysms: is it worth chasing the small fish? J Neurointerv Surg. 2020 Apr;12(4):412-416. doi: 10.1136/neurintsurg-2019-015311. Epub 2019 Oct 9.

    PubMed 31597686
  • Rouchaud A, Lehman VT, Murad MH, Burrows A, Cloft HJ, Lindell EP, Kallmes DF, Brinjikji W. Nonaneurysmal Perimesencephalic Hemorrhage Is Associated with Deep Cerebral Venous Drainage Anomalies: A Systematic Literature Review and Meta-Analysis. AJNR Am J Neuroradiol. 2016 Sep;37(9):1657-63. doi: 10.3174/ajnr.A4806. Epub 2016 May 12.

    PubMed 27173362
  • Hou K, Yu J. Current status of perimesencephalic non-aneurysmal subarachnoid hemorrhage. Front Neurol. 2022 Sep 1;13:960702. doi: 10.3389/fneur.2022.960702. eCollection 2022.

    PubMed 36119687
  • Rass V, Altmann K, Zamarian L, Lindner A, Kofler M, Gaasch M, Ianosi BA, Putnina L, Kindl P, Delazer M, Schiefecker AJ, Beer R, Pfausler B, Helbok R. Cognitive, Mental Health, Functional, and Quality of Life Outcomes 1 Year After Spontaneous Subarachnoid Hemorrhage: A Prospective Observational Study. Neurocrit Care. 2024 Aug;41(1):70-79. doi: 10.1007/s12028-023-01895-y. Epub 2023 Dec 21.

    PubMed 38129710
  • Jung JY, Kim YB, Lee JW, Huh SK, Lee KC. Spontaneous subarachnoid haemorrhage with negative initial angiography: a review of 143 cases. J Clin Neurosci. 2006 Dec;13(10):1011-7. doi: 10.1016/j.jocn.2005.09.007. Epub 2006 Aug 23.

    PubMed 16931020
  • Rinkel GJ, Wijdicks EF, Hasan D, Kienstra GE, Franke CL, Hageman LM, Vermeulen M, van Gijn J. Outcome in patients with subarachnoid haemorrhage and negative angiography according to pattern of haemorrhage on computed tomography. Lancet. 1991 Oct 19;338(8773):964-8. doi: 10.1016/0140-6736(91)91836-j.

    PubMed 1681340
  • Mensing LA, Vergouwen MDI, Laban KG, Ruigrok YM, Velthuis BK, Algra A, Rinkel GJE. Perimesencephalic Hemorrhage: A Review of Epidemiology, Risk Factors, Presumed Cause, Clinical Course, and Outcome. Stroke. 2018 Jun;49(6):1363-1370. doi: 10.1161/STROKEAHA.117.019843. Epub 2018 Apr 25.

    PubMed 29695465
  • Wallace AN, Vyhmeister R, Dines JN, Chatterjee AR, Kansagra AP, Viets R, Whisenant JT, Moran CJ, Cross DT 3rd, Derdeyn CP. Evaluation of an anatomic definition of non-aneurysmal perimesencephalic subarachnhoid hemorrhage. J Neurointerv Surg. 2016 Apr;8(4):378-85. doi: 10.1136/neurintsurg-2015-011680. Epub 2015 Mar 23.

    PubMed 25801775
  • Rinkel GJ, Wijdicks EF, Vermeulen M, Ramos LM, Tanghe HL, Hasan D, Meiners LC, van Gijn J. Nonaneurysmal perimesencephalic subarachnoid hemorrhage: CT and MR patterns that differ from aneurysmal rupture. AJNR Am J Neuroradiol. 1991 Sep-Oct;12(5):829-34.

    PubMed 1950905

Questions about this trial

What is this clinical trial studying?

An observational study of Subarachnoid Hemorrhage, Spontaneous and Subarachnoid Hemorrhage, Aneurysmal, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Tomas Dobrocky, MD (+41 31 632 13 77, tomas.dobrocky@insel.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of BAPAs in pmSAH where at least one high-resolution 3D-rotational angiography (3D-RA) of the dominant vertebral artery was performed within 7 days after the index presentation (time frame: Within 7 days after pmSAH diagnosis). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07923084, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.

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