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| Name | Class |
|---|---|
| Clinical Trial Unit, University Hospital Basel, Switzerland | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Intervention: DSA | Experimental | additional diagnostic cerebral DSA |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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:
| one time assessment at baseline (duration of the DSA will be 15 to 20 minutes) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| 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 |
| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Neuroradiology, University Hospital Basel | Recruiting | Basel | 4031 | Switzerland |
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Explorative, one-arm, open label trial
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A person blinded to all clinical data will assess the primary endpoint.
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|
| ID | Term |
|---|---|
| D002543 | Cerebral Hemorrhage |
| D000083302 | Hemorrhagic Stroke |
| ID | Term |
|---|---|
| D020300 | Intracranial Hemorrhages |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020521 | Stroke |
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| ID | Term |
|---|---|
| D003933 | Diagnosis |
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