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NCT Number: NCT05504941

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Neuroradiology, University Hospital Basel

Basel, 4031, Switzerland

Location status: Recruiting

Location contact

Alex Brehm, PhD

CONTACT

[email protected]

Marios-Nikos Psychogios, Prof Dr

PRINCIPAL_INVESTIGATOR

Urs Fischer, Prof Dr

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Diagnostic, cerebral Digital Subtraction Angiography (DSA)

Diagnostic Test

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.

Primary outcomes

  1. 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)

    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:

    • Extravasate of contrast media into the surrounding tissue, and
    • 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Alex Brehm, PhD

CONTACT

[email protected]

+41 61 328 79 48

Marios-Nikos Psychogios, Prof Dr

CONTACT

[email protected]

+41 61 328 59 36

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Collaborators

  • Clinical Trial Unit, University Hospital Basel, Switzerland

Registry information

Official study title

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

Acronym: HemEXPLO

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Aug 17, 2022
Registry last updated
Apr 11, 2025

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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