Intracerebral HemorrhageHemEXPLONCT05504941
Detection of an Endovascular Treatment Target in Patients With an Acute, Spontaneous Intracerebral Hemorrhage
A study testing Diagnostic, cerebral Digital Subtraction Angiography (DSA) in people with Intracerebral Hemorrhage and Nontraumatic Intracerebral Hemorrhage, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intracerebral Hemorrhage, Nontraumatic Intracerebral Hemorrhage
- What is being tested?
- Diagnostic, cerebral Digital Subtraction Angiography (DSA)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteSwitzerland
- Study dates
- 25 Oct 2022to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
Department of Neuroradiology, University Hospital Basel
Basel, 4031
Alex Brehm, PhD, alex.brehm@usb.ch
Marios-Nikos Psychogios, Prof Dr
About this study
Official title: Detection of an Endovascular Treatment Target in Patients With an Acute, Spontaneous Intracerebral Hemorrhage - an EXPLOrative Pilot Study (HemEXPLO)
This study is to determine if a treatment target for a potential endovascular therapy exists in patients with an acute, spontaneous (non-traumatic) ICH.
Read the 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.
- Being tested
- Diagnostic, cerebral Digital Subtraction Angiography (DSA)
- Keywords
- Digital Subtraction Angiography (DSA), Hemorrhagic stroke, Hematoma expansion, Cerebral DSA
- Medical subject headings
- Cerebral Hemorrhage, Hemorrhagic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Study Intervention: DSA | Experimental | additional diagnostic cerebral DSA Receives: Diagnostic Test: Diagnostic, cerebral Digital Subtraction Angiography (DSA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: one time assessment at baseline (duration of the DSA will be 15 to 20 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2022
- Study start25 Oct 2022
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracerebral HemorrhageStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Explorative, one-arm, open label trial
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- Clinical Trial Unit, University Hospital Basel, Switzerland
- Responsible party
- Sponsor
- Investigators
- Marios-Nikos Psychogios, Prof Dr, Study director, Department of Neuroradiology, University Hospital BaselUrs Fischer, Prof Dr, Study chair, Department of Neurology, University Hospital Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05504941
- Sponsor's protocol ID
- 2022-01435; th22Psychogios2
- Acronym
- HemEXPLO
- Status last verified
- Apr 2025
- First submitted
- 15 Aug 2022
- Last updated
- 11 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of an Endovascular Treatment Target in Patients With an Acute, Spontaneous Intracerebral Hemorrhage - an EXPLOrative Pilot Study (HemEXPLO)
- ClinicalTrials.gov ID
- NCT05504941
- Acronym / sponsor ID
- HemEXPLO / 2022-01435; th22Psychogios2
- Keywords
- Digital Subtraction Angiography (DSA), Hemorrhagic stroke, Hematoma expansion, Cerebral DSA
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Collaborators
- Clinical Trial Unit, University Hospital Basel, Switzerland
- Study start
- 25 Oct 2022 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 17 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Explorative, one-arm, open label trial
| Arm | Type | Receives |
|---|---|---|
| Study Intervention: DSA | Experimental | Diagnostic Test: Diagnostic, cerebral Digital Subtraction Angiography (DSA)additional diagnostic cerebral DSA |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Diagnostic test | Study Intervention: DSA |
Primary outcome
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: 1. Extravasate of contrast media into the surrounding tissue, and 2. 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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marios-Nikos Psychogios, Prof Dr study director
Department of Neuroradiology, University Hospital Basel
Urs Fischer, Prof Dr study chair
Department of Neurology, University Hospital Basel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diagnostic, cerebral Digital Subtraction Angiography (DSA) in people with Intracerebral Hemorrhage and Nontraumatic Intracerebral Hemorrhage, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alex Brehm, PhD (+41 61 328 79 48, alex.brehm@usb.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2025.