Identifying treatment targets for bleeding in patients with spontaneous brain hemorrhage
Detection of an Endovascular Treatment Target in Patients With an Acute, Spontaneous Intracerebral Hemorrhage - an EXPLOrative Pilot Study (HemEXPLO)
This study is testing if a special imaging technique can help find the source of bleeding in patients with sudden brain hemorrhages to improve their treatment options.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Basel, Switzerland Academic / other |
| Locations | 1 site (Basel) |
| Trial ID | NCT05504941 on ClinicalTrials.gov |
What this trial studies
This study aims to determine if a specific treatment target can be identified in patients suffering from acute, spontaneous intracerebral hemorrhage (ICH) using diagnostic cerebral Digital Subtraction Angiography (DSA). The researchers hypothesize that DSA can reveal a vessel from which contrast media leaks, indicating active bleeding. If such a target is found, it could support future trials aimed at directly addressing the bleeding to improve patient outcomes. The only intervention in this study is the additional DSA procedure performed on eligible patients.
Who should consider this trial
Good fit: Ideal candidates include individuals diagnosed with acute spontaneous ICH within three hours of symptom onset.
Not a fit: Patients with a high likelihood of bleeding due to a ruptured aneurysm or other specific conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies for patients experiencing acute spontaneous intracerebral hemorrhage.
How similar studies have performed: While the approach of using DSA for identifying treatment targets in ICH is promising, it remains largely untested in this specific context.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Basel
- Department of Neuroradiology, University Hospital Basel — Basel, Switzerland (Recruiting)
Study contacts
- Study coordinator: Alex Brehm, PhD
- Email: alex.brehm@usb.ch
- Phone: +41 61 328 79 48
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.