This study is to determine if a treatment target for a potential endovascular therapy exists in patients with an acute, spontaneous (non-traumatic) ICH.
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)
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
Single group
Diagnostic, cerebral Digital Subtraction Angiography (DSA)
Diagnostic testThe 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.
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: 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).
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University Hospital, Basel, Switzerland
Lead sponsor
Clinical Trial Unit, University Hospital Basel, Switzerland
Collaborator
