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

Primary Purpose

Intracerebral Hemorrhage, Nontraumatic Intracerebral Hemorrhage

Status

Recruiting

Phase

Not Applicable

Locations

Switzerland

Study Type

Interventional

Intervention

Diagnostic, cerebral Digital Subtraction Angiography (DSA)

About this trial

This is an interventional basic science trial for Intracerebral Hemorrhage focused on measuring Digital Subtraction Angiography (DSA), Hemorrhagic stroke, Hematoma expansion, Cerebral DSA

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

Department of Neuroradiology, University Hospital BaselRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Study Intervention: DSA

Arm Description

additional diagnostic cerebral DSA

Outcomes

Primary Outcome Measures

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: 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).

Secondary Outcome Measures

Full Information

NCT ID

NCT05504941

First Posted

August 15, 2022

Last Updated

October 25, 2022

Sponsor

University Hospital, Basel, Switzerland

Collaborators

Clinical Trial Unit, University Hospital Basel, Switzerland

1. Study Identification

Unique Protocol Identification Number

NCT05504941

Brief Title

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

Acronym

HemEXPLO

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Recruiting

Study Start Date

October 25, 2022 (Actual)

Primary Completion Date

November 1, 2023 (Anticipated)

Study Completion Date

December 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Basel, Switzerland

Collaborators

Clinical Trial Unit, University Hospital Basel, Switzerland

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Intracerebral Hemorrhage, Nontraumatic Intracerebral Hemorrhage

Keywords

Digital Subtraction Angiography (DSA), Hemorrhagic stroke, Hematoma expansion, Cerebral DSA

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

Explorative, one-arm, open label trial

Masking

None (Open Label)

Masking Description

A person blinded to all clinical data will assess the primary endpoint.

Allocation

N/A

Enrollment

15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Study Intervention: DSA

Arm Type

Experimental

Arm Description

additional diagnostic cerebral DSA

Intervention Type

Diagnostic Test

Intervention Name(s)

Diagnostic, cerebral Digital Subtraction Angiography (DSA)

Intervention Description

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 Outcome Measure Information:

Title

Presence of a treatment target for a potential endovascular therapy (binary endpoint: yes/no)

Description

Time Frame

one time assessment at baseline (duration of the DSA will be 15 to 20 minutes)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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)

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Alex Brehm, PhD

Phone

+41 61 328 79 48

alex.brehm@usb.ch

First Name & Middle Initial & Last Name or Official Title & Degree

Marios-Nikos Psychogios, Prof Dr

Phone

+41 61 328 59 36

marios.psychogios@usb.ch

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Marios-Nikos Psychogios, Prof Dr

Organizational Affiliation

Department of Neuroradiology, University Hospital Basel

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Urs Fischer, Prof Dr

Organizational Affiliation

Department of Neurology, University Hospital Basel

Official's Role

Study Chair

Facility Information:

Facility Name

Department of Neuroradiology, University Hospital Basel

City

Basel

ZIP/Postal Code

4031

Country

Switzerland

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Alex Brehm, PhD

alex.brehm@usb.ch

First Name & Middle Initial & Last Name & Degree

Marios-Nikos Psychogios, Prof Dr

First Name & Middle Initial & Last Name & Degree

Urs Fischer, Prof Dr

12. IPD Sharing Statement

Learn more about this trial

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

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