Detection of an Endovascular Treatment Target in Patients With an Acute, Spontaneous Intracerebral Hemorrhage

NCT05504941 | Recruiting

• 1 other identifier: 2022-01435; th22Psychogios2
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

This study is to determine if a treatment target for a potential endovascular therapy exists in patients with an acute, spontaneous (non-traumatic) ICH.

Conditions

Intracerebral Hemorrhage; Nontraumatic Intracerebral Hemorrhage

Keywords

Digital Subtraction Angiography (DSA); Hemorrhagic stroke; Hematoma expansion; Cerebral DSA

Outcome Measures

Primary Outcomes (1)

• Presence of a treatment target for a potential endovascular therapy (binary endpoint: yes/no)

  Presence of a treatment target for a potential endovascular therapy (binary endpoint: yes/no). It is defined by a ruptured artery which fulfills the following two criteria: 1. Extravasate of contrast media into the surrounding tissue, and 2. Potentially reachable by a (micro-)catheter which can be used for treatment (i.e., local infusion of a procoagulant medication or (temporary) occlusion of the ruptured artery).

  one time assessment at baseline (duration of the DSA will be 15 to 20 minutes)

Study Arms (1)

Study Intervention: DSA

EXPERIMENTAL

additional diagnostic cerebral DSA

Diagnostic Test: Diagnostic, cerebral Digital Subtraction Angiography (DSA)

Interventions

Diagnostic, cerebral Digital Subtraction Angiography (DSA) DIAGNOSTIC_TEST

The DSA is the goldstandard for the visualization of brain vessels. For performing a diagnostic cerebral DSA, the femoral artery of the patient will be punctured in the groin. Over this arterial access a catheter will be advanced under fluoroscopy guidance to the target vessel in the brain. After navigation to the targeted brain vessel, contrast media will be injected over the catheter into the vessel. The efflux of the contrast media will be monitored and visualized with fluoroscopy. The additional radiation to the patient due to the DSA will be approx. 1.1 mSv. The duration of the DSA will be 15 to 20 minutes.

Study Intervention: DSA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of an acute spontaneous ICH based on non-contrast CT
• Time from symptom onset to anticipated start of cerebral DSA of under 3 hours
• Agreement of the treating physician to perform DSA
• Informed consent documented by signature or fulfilling the criteria for emergency consent procedures (deferral of consent)

You may not qualify if:

• High probability that the etiology of the bleeding is a ruptured aneurysm, an arteriovenous malformation or an amyloid angiopathy as judged by the treating physician
• Any time critical surgical or minimal invasive intervention is planned
• Evidence of an ongoing pregnancy, a negative pregnancy test is mandatory in all persons of childbearing potential
• Contraindications against the use of iodine contrast media
• Known severe kidney insufficiency (Glomerular filtration rate \< 30 ml/min)

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead
• Clinical Trial Unit, University Hospital Basel, Switzerland: collaborator

Study Sites (1)

Department of Neuroradiology, University Hospital Basel

Basel, 4031, Switzerland

RECRUITING

MeSH Terms

Conditions

Cerebral Hemorrhage; Hemorrhagic Stroke

Interventions

Diagnosis

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Stroke

Study Officials

• Marios-Nikos Psychogios, Prof Dr

  Department of Neuroradiology, University Hospital Basel

  STUDY DIRECTOR

• Urs Fischer, Prof Dr

  Department of Neurology, University Hospital Basel

  STUDY CHAIR

Central Study Contacts

Alex Brehm, PhD

CONTACT

+41 61 328 79 48; alex.brehm@usb.ch

Marios-Nikos Psychogios, Prof Dr

CONTACT

+41 61 328 59 36; marios.psychogios@usb.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: A person blinded to all clinical data will assess the primary endpoint.
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Explorative, one-arm, open label trial

Study Record Dates

• First Submitted: August 15, 2022
• First Posted: August 17, 2022
• Study Start: October 25, 2022
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 11, 2025

Record last verified: 2025-04

Locations

CH (1)