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Determining the Clinical Impact and Prevalence of Hemorrhagic Subtypes in Perimesencephalic Subarachnoid Hemorrhage (DECIPHER-pmSAH)

3 november 2026 uppdaterad av: Insel Gruppe AG, University Hospital Bern

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.

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.

Studieöversikt

Studietyp

Observationell

Inskrivning (Beräknad)

264

Kontakter och platser

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Studiekontakt

Studera Kontakt Backup

Studieorter

      • Bern, Schweiz, 3010
        • Rekrytering
        • Inselspital, University Hospital Bern
        • Huvudutredare:
          • Tomas Dobrocky, MD
        • Kontakt:
        • Kontakt:
        • Underutredare:
          • Luca Noti, MD
        • Underutredare:
          • Johann M Raabe, MD
        • Underutredare:
          • Bettina L Serrallach, MD

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Testmetod

Icke-sannolikhetsprov

Studera befolkning

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

Beskrivning

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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):
  • 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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Observationsmodeller: COHORT
  • Tidsperspektiv: PROSPECTIVE

Kohorter och interventioner

Grupp / Kohort
Intervention / Behandling
All patients included in the study

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 for all patients. All other analyzed data are collected as part of routine clinical care.

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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Tidsram
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
Tidsram: Within 7 days after pmSAH diagnosis
Within 7 days after pmSAH diagnosis

Sekundära resultatmått

Resultatmått
Tidsram
Rate of patients with excellent functional outcome (Modified Rankin Scale 0-1) at 3 months
Tidsram: 3 months after enrollment
3 months after enrollment
Rate of patients with favorable functional outcome (Modified Rankin Scale 0-2) at 3 months
Tidsram: 3 months after enrollment
3 months after enrollment
Patient-Reported Outcome (EQ-5D-5L questionnaire) at 3 months
Tidsram: 3 months after enrollment
3 months after enrollment
Modified Rankin Scale (mRS, range 0-6 with higher scores indicating worse functional status) at hospital discharge
Tidsram: 21 days after enrollment or hospital discharge (if discharged earlier)
21 days after enrollment or hospital discharge (if discharged earlier)
National Institutes of Health Stroke Scale (NIHSS, range 0-42 with higher scores indicating greater neurological impairement) at hospital discharge
Tidsram: 21 days after enrollment or hospital discharge (if discharged earlier)
21 days after enrollment or hospital discharge (if discharged earlier)
Rate of rebleeding
Tidsram: From enrollment to 3-month follow-up
From enrollment to 3-month follow-up
Rate of hydrocephalus requiring EVD or lumbar drain
Tidsram: From enrollment to 3-month follow-up
From enrollment to 3-month follow-up
Rate of symptomatic vasospasm
Tidsram: From enrollment to 3-month follow-up
From enrollment to 3-month follow-up
Rate of BAPAs in pmSAH overall (regardless of 3D-RA acquisition)
Tidsram: From enrollment to 3-month follow-up
From enrollment to 3-month follow-up

Samarbetspartners och utredare

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Publikationer och användbara länkar

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Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

1 januari 2026

Primärt slutförande (Beräknad)

31 mars 2029

Avslutad studie (Beräknad)

31 mars 2029

Studieregistreringsdatum

Först inskickad

12 oktober 2026

Först inskickad som uppfyllde QC-kriterierna

3 november 2026

Första postat (Faktisk)

6 november 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

6 november 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

3 november 2026

Senast verifierad

1 september 2026

Mer information

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