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

NCT ID: NCT05504941

Last Updated: 2025-04-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-25
• Study Completion Date: 2026-12-31

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.

Detailed Description

Hemorrhagic stroke caused by an intracerebral hemorrhage (ICH) is a common (roughly 15% of all strokes) and devastating disease with high rates of mortality and morbidity. The most important potentially modifiable prognostic factor after acute diagnosis of an ICH is hematoma expansion.

The investigators hypothesize that in hyperacute ICH patients a treatment target can be detected with a diagnostic, cerebral DSA. The DSA is the goldstandard for the visualization of brain vessels. A treatment target would be a vessel from which contrast media extravasates as a sign of an active bleeding. If such a target could be identified, it could lay the rationale for future trials which would evaluate if stopping the bleeding directly at the origin improves patient outcomes. The only intervention in this study is an additional diagnostic cerebral DSA. 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Study Intervention: DSA

additional diagnostic cerebral DSA

Group Type: EXPERIMENTAL

Diagnostic, cerebral Digital Subtraction Angiography (DSA)

Intervention Type: 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.

Interventions

Diagnostic, cerebral Digital Subtraction Angiography (DSA)

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• 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)

Exclusion Criteria

• 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Clinical Trial Unit, University Hospital Basel, Switzerland

OTHER

Sponsor Role: collaborator

University Hospital, Basel, Switzerland

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marios-Nikos Psychogios, Prof Dr

Role: STUDY_DIRECTOR

Department of Neuroradiology, University Hospital Basel

Urs Fischer, Prof Dr

Role: STUDY_CHAIR

Department of Neurology, University Hospital Basel

Locations

Department of Neuroradiology, University Hospital Basel

Basel, , Switzerland

Site Status: RECRUITING

Countries

Switzerland

Central Contacts

Alex Brehm, PhD

Role: CONTACT

alex.brehm@usb.ch

+41 61 328 79 48

Marios-Nikos Psychogios, Prof Dr

Role: CONTACT

marios.psychogios@usb.ch

+41 61 328 59 36

Facility Contacts

Alex Brehm, PhD

Role: primary

alex.brehm@usb.ch

Other Identifiers

2022-01435; th22Psychogios2

Identifier Type: -

Identifier Source: org_study_id