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

3 de noviembre de 2026 actualizado por: 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.

Descripción general del estudio

Tipo de estudio

De observación

Inscripción (Estimado)

264

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Copia de seguridad de contactos de estudio

  • Nombre: Luca Noti, MD
  • Número de teléfono: +41 31 632 70 00
  • Correo electrónico: luca.noti@insel.ch

Ubicaciones de estudio

      • Bern, Suiza, 3010
        • Reclutamiento
        • Inselspital, University Hospital Bern
        • Investigador principal:
          • Tomas Dobrocky, MD
        • Contacto:
        • Contacto:
          • Luca Noti, MD
          • Número de teléfono: +41 31 632 70 00
          • Correo electrónico: luca.noti@insel.ch
        • Sub-Investigador:
          • Luca Noti, MD
        • Sub-Investigador:
          • Johann M Raabe, MD
        • Sub-Investigador:
          • Bettina L Serrallach, MD

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Método de muestreo

Muestra no probabilística

Población de estudio

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

Descripción

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 de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Modelos observacionales: COHORT
  • Perspectivas temporales: PROSPECTIVE

Cohortes e Intervenciones

Grupo / Cohorte
Intervención / Tratamiento
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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Periodo de tiempo
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
Periodo de tiempo: Within 7 days after pmSAH diagnosis
Within 7 days after pmSAH diagnosis

Medidas de resultado secundarias

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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

1 de enero de 2026

Finalización primaria (Estimado)

31 de marzo de 2029

Finalización del estudio (Estimado)

31 de marzo de 2029

Fechas de registro del estudio

Enviado por primera vez

12 de octubre de 2026

Primero enviado que cumplió con los criterios de control de calidad

3 de noviembre de 2026

Publicado por primera vez (Actual)

6 de noviembre de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

6 de noviembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

3 de noviembre de 2026

Última verificación

1 de septiembre de 2026

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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