Intracerebral Hemorrhage (ICH)NCT04805177
Early Minimally Invasive Image Guided Endoscopic Evacuation of Intracerebral Haemorrhage
A study testing hematoma evacuation in people with Intracerebral Hemorrhage (ICH), run by University Hospital, Basel, Switzerland at 2 sites in Switzerland.
Trial summary
The aim of this pilot study is to provide an assessment of safety and feasibility of early minimally invasive image guided endoscopic hematoma evacuation (within 24 hours of symptom onset) in patients suffering from intracerebral haemorrhage (ICH). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Intracerebral Hemorrhage (ICH)
- What is being tested?
- hematoma evacuation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 2 sitesSwitzerland
- Study dates
- 8 Aug 2021to 31 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- No relevant disability prior to ICH (mRS 0-1 prior to ICH)
- Primary supratentorial deep or superficial intraparenchymal ICH of volume ≥ 20 mL < 100 mL (measured using formula) demonstrated on CT or MRI, with or without a 2 component of intraventricular haemorrhage
- CT/MRI demonstrates ICH stability (< 5 mL growth) at 6 hours after the admission scan if surgery is performed >6 hours after admission CT
- NIHSS ≥ 8 OR if a patient with a NIHSS<8 presents with at least one of the following deficits:
- a severe hemiparesis (4 motor points on the NIHSS for facial palsy, motoric upper and lower extremities combined); OR
- a severe motor or sensory aphasia (2 points on the NIHSS); OR
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- a profound hemi-inattention (formerly neglect, 2 points on the NIHSS); OR
- a decreased level of consciousness (GCS<13)
- Presenting GCS 5 - 15
- Endoscopic haematoma evacuation can be initiated within 24 hours of symptom onset
- Systolic blood pressure can be controlled at <160 mmHg
Who cannot join
- Imaging:
- "Spot sign" identified on CT angiography (CTA)
- Structural vascular or brain lesion as suspected cause of ICH, such as a vascular malformation (cavernous malformation, arteriovenous malformation (AVM) etc), aneurysm, neoplasm
- Haemorrhagic conversion of an underlying ischemic stroke
- Infratentorial haemorrhage
- Large associated intra-ventricular haemorrhage requiring treatment for related mass effect or shift due to trapped ventricle (extraventricular drainage (EVD) for intracranial pressure (ICP) management is allowed)
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- Midbrain extension/involvement
- Coagulation Issues:
- Oral or parenteral therapeutic anticoagulation which cannot be pharmacologically reverted until the planned time of evacuation
- Known hereditary or acquired haemorrhagic diathesis, coagulation factor deficiency
- Platelet count < 100 x 103 cells/mm3 or known platelet dysfunction
- international normalized ratio (INR) > 1.5 for any reason, elevated prothrombin time or activated partial thromboplastin time (aPTT), which cannot be corrected or otherwise accounted for (i.e., lupus anti-coagulant)
- Presenting GCS 3 or 4
- Requirement for emergent surgical decompression or uncontrolled ICP after EVD
- Unable to obtain consent from patient or appropriate surrogate (for patients without competence)
- Pregnancy, breast-feeding, or positive pregnancy test [either serum or urine] (woman of child-bearing potential must have a negative history of current pregnancy prior to the study procedure)
- Evidence of active infection (indicated by fever ≥38°C) at the time of study inclusion
- Any comorbid disease or condition expected to compromise survival or ability to complete follow-up assessments through 180 days
- Based on physician's judgment, patient does not have the necessary mental capacity to participate or is unwilling or unable to comply with protocol follow up appointment schedule
- Active drug or alcohol use or dependence
Trial locations and contacts
2 sites in 1 country.
Switzerland2 sites
Department of Neurology, University Hospital Basel
Basel, 4031
Department of Neurosurgery, University Hospital Basel
Basel, 4031
About this study
Official title: Early Minimally Invasive Image Guided Endoscopic Evacuation of Intracerebral Haemorrhage: a Prospective Pilot Study
The aim of this pilot study is to provide an assessment of safety and feasibility of early minimally invasive image guided endoscopic hematoma evacuation (within 24 hours of symptom onset) in patients suffering from intracerebral haemorrhage (ICH).
Read the detailed description
Spontaneous supratentorial intracerebral haemorrhage (SSICH) is the is the second most common form of stroke. The aim of this single centre, single arm pilot study is to provide an assessment of safety and feasibility of early minimally invasive image guided endoscopic hematoma evacuation (within 24 hours of symptom onset) in patients suffering from intracerebral haemorrhage (ICH).
Furthermore this study contributes to the understanding of secondary neuronal damage involved in ICH through the measurement of biomarkers for neuronal damage and their response to early hematoma evacuation.
- Conditions
- Intracerebral Hemorrhage (ICH)
- Being tested
- hematoma evacuation
- Keywords
- endoscopic evacuation, pilot study, spontaneous supratentorial Intracerebral Hemorrhage (SSICH), minimally invasive image guided endoscopic surgery, early hematoma evacuation
- Medical subject headings
- Cerebral Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hematoma evacuationProcedure or surgery
early minimally invasive image guided hematoma evacuation in patients suffering from ICH
| Study group | Role | What they receive |
|---|---|---|
| hematoma evacuation | Experimental | Early minimally invasive image guided hematoma evacuation Receives: Procedure: hematoma evacuation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of disability
level of disability 6 months after treatment, measured by the modified Rankin Scale (mRS). Good functional outcome is defined by a score on the mRS of ≤3.
Measured: 6 month after treatment onset
Change in hematoma volume to ≤15 mL
Change in hematoma volume to ≤15 mL
Measured: from baseline to 24 hours after treatment
number of specific adverse events (AE)
number of specific adverse events (AE) (death, ischemic stroke, recurrent ICH (defined as any increase in hematoma volume at follow-up that is associated with a worsening of the focal-neurological deficit by ≥4 points on the National Institute of Health Stroke Scale (NIHSS) and/or a decrease in consciousness by ≥2 points on the Glasgow Coma Scale (GCS), epileptic seizure, infection, any need for open neurosurgical procedures)
Measured: 6 month after treatment onset
Secondary outcomes (5)
Change in relative (percentage) hematoma volume
Change in relative (percentage) hematoma volume
Measured: from baseline to 24 hours after treatment
Change of focal neurological deficit measured by the NIHSS
Change of focal neurological deficit measured by the NIHSS. The NIHSS is composed of 11 items, each of which scores a specific ability between a 0 and 4. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment.
Measured: from baseline to 6 months
Change of serum biomarkers of brain injury
Change of serum biomarkers of brain injury (light-chain neurofilament subunit (NfL), the Glial Fibrillary Acidic Protein (GFAP) and the S100 calcium-binding protein B (S100B))
Measured: from baseline to 6 months
Total time spent on the intensive care unit
Total time spent on the intensive care unit
Measured: from baseline to hospital discharge (approx. 1 month)
Total time spent in intubation
Total time spent in intubation
Measured: from baseline to hospital discharge (approx. 1 month)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2021
- Study start8 Aug 2021
- Primary completion31 Dec 2023
- Study completion31 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intracerebral Hemorrhage (ICH)Studies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- single arm pilot study
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- Swiss Heart Foundation
- Responsible party
- Sponsor
- Investigators
- Jehuda Soleman, PD Dr. med., Principal investigator, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04805177
- Sponsor's protocol ID
- 2021-00161, ko21Bonati
- Status last verified
- Aug 2024
- First submitted
- 16 Mar 2021
- Last updated
- 15 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hallenberger TJ, Guzman R, Soleman J. Minimally invasive image-guided endoscopic evacuation of intracerebral haemorrhage: How I Do it. Acta Neurochir (Wien). 2023 Jun;165(6):1597-1602. doi: 10.1007/s00701-022-05326-3. Epub 2022 Aug 5.
PubMed 35930078
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Minimally Invasive Image Guided Endoscopic Evacuation of Intracerebral Haemorrhage: a Prospective Pilot Study
- ClinicalTrials.gov ID
- NCT04805177
- Acronym / sponsor ID
- 2021-00161, ko21Bonati
- Conditions
- Intracerebral Hemorrhage (ICH)
- Keywords
- endoscopic evacuation, pilot study, spontaneous supratentorial Intracerebral Hemorrhage (SSICH), minimally invasive image guided endoscopic surgery, early hematoma evacuation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Collaborators
- Swiss Heart Foundation
- Study start
- 8 Aug 2021 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 18 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this pilot study is to provide an assessment of safety and feasibility of early minimally invasive image guided endoscopic hematoma evacuation (within 24 hours of symptom onset) in patients suffering from intracerebral haemorrhage (ICH).
Detailed description
Spontaneous supratentorial intracerebral haemorrhage (SSICH) is the is the second most common form of stroke. The aim of this single centre, single arm pilot study is to provide an assessment of safety and feasibility of early minimally invasive image guided endoscopic hematoma evacuation (within 24 hours of symptom onset) in patients suffering from intracerebral haemorrhage (ICH).
Furthermore this study contributes to the understanding of secondary neuronal damage involved in ICH through the measurement of biomarkers for neuronal damage and their response to early hematoma evacuation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- single arm pilot study
| Arm | Type | Receives |
|---|---|---|
| hematoma evacuation | Experimental | Procedure: hematoma evacuationEarly minimally invasive image guided hematoma evacuation |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- No relevant disability prior to ICH (mRS 0-1 prior to ICH)
- Primary supratentorial deep or superficial intraparenchymal ICH of volume ≥ 20 mL < 100 mL (measured using formula) demonstrated on CT or MRI, with or without a 2 component of intraventricular haemorrhage
- CT/MRI demonstrates ICH stability (< 5 mL growth) at 6 hours after the admission scan if surgery is performed >6 hours after admission CT
- NIHSS ≥ 8 OR if a patient with a NIHSS<8 presents with at least one of the following deficits:
- Presenting GCS 5 - 15
Key exclusion criteria (20 listed)
- Imaging:
- Coagulation Issues:
- Presenting GCS 3 or 4
- Requirement for emergent surgical decompression or uncontrolled ICP after EVD
- Unable to obtain consent from patient or appropriate surrogate (for patients without competence)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hematoma evacuationearly minimally invasive image guided hematoma evacuation in patients suffering from ICH | Procedure or surgery | hematoma evacuation |
Primary outcome
Level of disability
Time frame: 6 month after treatment onset
level of disability 6 months after treatment, measured by the modified Rankin Scale (mRS). Good functional outcome is defined by a score on the mRS of ≤3.
Change in hematoma volume to ≤15 mL
Time frame: from baseline to 24 hours after treatment
Change in hematoma volume to ≤15 mL
number of specific adverse events (AE)
Time frame: 6 month after treatment onset
number of specific adverse events (AE) (death, ischemic stroke, recurrent ICH (defined as any increase in hematoma volume at follow-up that is associated with a worsening of the focal-neurological deficit by ≥4 points on the National Institute of Health Stroke Scale (NIHSS) and/or a decrease in consciousness by ≥2 points on the Glasgow Coma Scale (GCS), epileptic seizure, infection, any need for open neurosurgical procedures)
5 secondary outcomes
Change in relative (percentage) hematoma volume
Time frame: from baseline to 24 hours after treatment
Change of focal neurological deficit measured by the NIHSS
Time frame: from baseline to 6 months
Change of serum biomarkers of brain injury
Time frame: from baseline to 6 months
Total time spent on the intensive care unit
Time frame: from baseline to hospital discharge (approx. 1 month)
Total time spent in intubation
Time frame: from baseline to hospital discharge (approx. 1 month)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2024.
- Derived from this study: PubMed 35930078Hallenberger TJ, Guzman R, Soleman J. Minimally invasive image-guided endoscopic evacuation of intracerebral haemorrhage: How I Do it. Acta Neurochir (Wien). 2023 Jun;165(6):1597-1602. doi: 10.1007/s00701-022-05326-3. Epub 2022 Aug 5.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jehuda Soleman, PD Dr. med. principal investigator
University Hospital, Basel, Switzerland
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hematoma evacuation in people with Intracerebral Hemorrhage (ICH), run by University Hospital, Basel, Switzerland at 2 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of disability (time frame: 6 month after treatment onset). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04805177, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2024.