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

3 novembre 2026 mis à jour par: 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.

Aperçu de l'étude

Type d'étude

Observationnel

Inscription (Estimé)

264

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Sauvegarde des contacts de l'étude

Lieux d'étude

      • Bern, Suisse, 3010
        • Recrutement
        • Inselspital, University Hospital Bern
        • Chercheur principal:
          • Tomas Dobrocky, MD
        • Contact:
        • Contact:
        • Sous-enquêteur:
          • Luca Noti, MD
        • Sous-enquêteur:
          • Johann M Raabe, MD
        • Sous-enquêteur:
          • Bettina L Serrallach, MD

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

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

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Modèles d'observation: COHORT
  • Perspectives temporelles: PROSPECTIVE

Cohortes et interventions

Groupe / Cohorte
Intervention / Traitement
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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Délai
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
Délai: Within 7 days after pmSAH diagnosis
Within 7 days after pmSAH diagnosis

Mesures de résultats secondaires

Mesure des résultats
Délai
Rate of patients with excellent functional outcome (Modified Rankin Scale 0-1) at 3 months
Délai: 3 months after enrollment
3 months after enrollment
Rate of patients with favorable functional outcome (Modified Rankin Scale 0-2) at 3 months
Délai: 3 months after enrollment
3 months after enrollment
Patient-Reported Outcome (EQ-5D-5L questionnaire) at 3 months
Délai: 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
Délai: 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
Délai: 21 days after enrollment or hospital discharge (if discharged earlier)
21 days after enrollment or hospital discharge (if discharged earlier)
Rate of rebleeding
Délai: From enrollment to 3-month follow-up
From enrollment to 3-month follow-up
Rate of hydrocephalus requiring EVD or lumbar drain
Délai: From enrollment to 3-month follow-up
From enrollment to 3-month follow-up
Rate of symptomatic vasospasm
Délai: 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)
Délai: From enrollment to 3-month follow-up
From enrollment to 3-month follow-up

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

1 janvier 2026

Achèvement primaire (Estimé)

31 mars 2029

Achèvement de l'étude (Estimé)

31 mars 2029

Dates d'inscription aux études

Première soumission

12 octobre 2026

Première soumission répondant aux critères de contrôle qualité

3 novembre 2026

Première publication (Réel)

6 novembre 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

6 novembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

3 novembre 2026

Dernière vérification

1 septembre 2026

Plus d'information

Termes liés à cette étude

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