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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Intracerebral Hemorrhage, Nontraumatic Intracerebral Hemorrhage

Intervention / Treatment
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* Diagnostic Test: Diagnostic, cerebral Digital Subtraction Angiography (DSA)


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Interventional Model Description: Explorative, one-arm, open label trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study Intervention: DSA<br>additional diagnostic cerebral DSA | Diagnostic Test: Diagnostic, cerebral Digital Subtraction Angiography (DSA)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Digital Subtraction Angiography (DSA), Hemorrhagic stroke, Hematoma expansion, Cerebral DSA