Detection of an Endovascular Treatment Target in Patients With an Acute, Spontaneous Intracerebral Hemorrhage (HemEXPLO)
Detection of an Endovascular Treatment Target in Patients With an Acute, Spontaneous Intracerebral Hemorrhage - an EXPLOrative Pilot Study (HemEXPLO)
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Marios-Nikos Psychogios, Prof Dr
- Phone Number: +41 61 328 59 36
- Email: marios.psychogios@usb.ch
Study Contact Backup
- Name: Alex Brehm, PhD
- Phone Number: +41 61 328 79 48
- Email: alex.brehm@usb.ch
Study Locations
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-
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Basel, Switzerland, 4031
- Recruiting
- Department of Neuroradiology, University Hospital Basel
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Principal Investigator:
- Marios-Nikos Psychogios, Prof Dr
-
Contact:
- Alex Brehm, PhD
- Email: alex.brehm@usb.ch
-
Principal Investigator:
- Urs Fischer, Prof Dr
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Study Intervention: DSA
additional diagnostic cerebral 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Presence of a treatment target for a potential endovascular therapy (binary endpoint: yes/no)
Time Frame: one time assessment at baseline (duration of the DSA will be 15 to 20 minutes)
|
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)
|
Collaborators and Investigators
Investigators
- Study Director: Marios-Nikos Psychogios, Prof Dr, Department of Neuroradiology, University Hospital Basel
- Study Chair: Urs Fischer, Prof Dr, Department of Neurology, University Hospital Basel
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2022-01435; th22Psychogios2
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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