Department of Neuroradiology, University Hospital Basel
Basel, 4031, Switzerland
Location status: Recruiting
Location contact
Alex Brehm, PhD
CONTACT
Marios-Nikos Psychogios, Prof Dr
PRINCIPAL_INVESTIGATOR
Urs Fischer, Prof Dr
PRINCIPAL_INVESTIGATOR
NCT Number: NCT05504941
This study is to determine if a treatment target for a potential endovascular therapy exists in patients with an acute, spontaneous (non-traumatic) ICH.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Basel, 4031, Switzerland
Location status: Recruiting
Alex Brehm, PhD
CONTACT
Marios-Nikos Psychogios, Prof Dr
PRINCIPAL_INVESTIGATOR
Urs Fischer, Prof Dr
PRINCIPAL_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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:
Contact information is provided by the study sponsor or research team.
Alex Brehm, PhD
CONTACT
Marios-Nikos Psychogios, Prof Dr
CONTACT
University Hospital, Basel, Switzerland
Other
Detection of an Endovascular Treatment Target in Patients With an Acute, Spontaneous Intracerebral Hemorrhage - an EXPLOrative Pilot Study (HemEXPLO)
Acronym: HemEXPLO
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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