Detection of an Endovascular Treatment Target in Patients With an Acute, Spontaneous Intracerebral Hemorrhage (HemEXPLO)

University Hospital Basel

Status

Enrolling

Conditions

Intracerebral Hemorrhage

Nontraumatic Intracerebral Hemorrhage

Treatments

Diagnostic Test: Diagnostic, cerebral Digital Subtraction Angiography (DSA)

Study type

Interventional

Funder types

Other

Identifiers

NCT05504941

2022-01435 th22Psychogios2;

Details and patient eligibility

About

This study is to determine if a treatment target for a potential endovascular therapy exists in patients with an acute, spontaneous (non-traumatic) ICH.

Full 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.

Enrollment

15 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)