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)

Overview

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.

Interventions

• Diagnostic test 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 additi

Primary outcome measures

• 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)]

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Basic science

Study locations

Switzerland · 1 center

• Department of Neuroradiology, University Hospital Basel — Basel

Identifiers

NCT: NCT05504941 · 2022-01435; th22Psychogios2

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗