Clinical trial NCT05504941: Detection of an Endovascular Treatment Target in Patients With an Acute, Spontaneous Intracerebral Hemorrhage
Official title: Detection of an Endovascular Treatment Target in Patients With an Acute, Spontaneous Intracerebral Hemorrhage - an EXPLOrative Pilot Study (HemEXPLO)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Intracerebral Hemorrhage
Nontraumatic Intracerebral Hemorrhage
Keywords: Digital Subtraction Angiography (DSA)
Hemorrhagic stroke
Hematoma expansion
Cerebral DSA
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
Collaborators: name: Clinical Trial Unit, University Hospital Basel, Switzerland
First posted: 2022-08-17
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Explorative, one-arm, open label trial
Primary purpose: BASIC_SCIENCE

Brief 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.

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.

Eligibility 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)

Primary outcomes:
measure: Presence of a treatment target for a potential endovascular therapy (binary endpoint: yes/no)
timeFrame: one time assessment at baseline (duration of the DSA will be 15 to 20 minutes)
Secondary outcomes:
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Department of Neuroradiology, University Hospital Basel
Study officials:
affiliation: Department of Neuroradiology, University Hospital Basel
name: Marios-Nikos Psychogios, Prof Dr
role: STUDY_DIRECTOR
affiliation: Department of Neurology, University Hospital Basel
name: Urs Fischer, Prof Dr
role: STUDY_CHAIR
References: