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

Intracerebral Hemorrhage Clinical Trial

— HemEXPLO  

Official title:

Detection of an Endovascular Treatment Target in Patients With an Acute, Spontaneous Intracerebral Hemorrhage - an EXPLOrative Pilot Study (HemEXPLO)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05504941
• Other study ID #: 2022-01435; th22Psychogios2
• Status: Recruiting
• Phase: N/A
• Start date: October 25, 2022
• Est. completion date: January 2025

Study information

• Verified date: May 2024
• Source: University Hospital, Basel, Switzerland
• Contact: Alex Brehm, PhD
• Phone: +41 61 328 79 48
• Email: alex.brehm[@]usb.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: January 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Cerebral Hemorrhage
• Hemorrhage
• Intracerebral Hemorrhage

Intervention

Diagnostic Test:
• 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.

Locations

Country	Name	City	State
Switzerland	Department of Neuroradiology, University Hospital Basel	Basel

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland	Clinical Trial Unit, University Hospital Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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: Extravasate of contrast media into the surrounding tissue, and; 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)