Intracerebral HaemorrhageEMINENT-ICHNCT05681988
Early Minimally Invasive Image Guided Endoscopic Evacuation of Intracerebral Haemorrhage (EMINENT-ICH)
A study testing Early minimally invasive image guided endoscopic hematoma evacuation and Best medical treatment (BMT) in people with Intracerebral Haemorrhage, run by University Hospital, Basel, Switzerland at 10 sites in Switzerland.
Trial summary
This is an open-labelled, single centre randomised controlled trial evaluating the efficacy of early minimally invasive image-guided hematoma evacuation in combination with the current best medical treatment compared to best medical treatment alone in improving functional outcome rates at 6 months after initial… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Intracerebral Haemorrhage
- What is being tested?
- Early minimally invasive image guided endoscopic hematoma evacuation and Best medical treatment (BMT)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 10 sitesSwitzerland
- Study dates
- 1 Jan 2024to Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Spontaneous supratentorial intracerebral hemorrhage (SSICH), defined as the sudden occurrence of bleeding into the lobar parenchyma and/or into the basal ganglia and/or thalamus that may extend into the ventricles confirmed by imaging
- SSICH volume ≥20 mL <100 mL
- A focal neurological deficit consisting of either
- clinically relevant hemiparesis (≥4 motor points on the NIHSS for facial palsy, motoric upper and lower extremities combined)
- clinically relevant motor or sensory aphasia (≥2 points on the NIHSS)
- clinically relevant hemi-inattention (formerly neglect, 2 points on the NIHSS)
Show all 10Show fewer
- decreased level of consciousness (Glasgow Coma Scale (GCS)≤13)
- Presenting GCS 5 - 15 (in intubated patients GCS assessment will be performed after Rutledge et al. or if impossible, the last pre-intubation GCS will be used)
- Endoscopic hematoma evacuation can be initiated within 24 hours after the patient was last seen well/symptom onset
- Informed consent of patient or appropriate surrogate (for patients without competence)
Who cannot join
- SSICH due to known or suspected structural abnormality in the brain (e.g. vascular malformation, aneurysm, arteriovenous malformation (AVM), brain tumor) and/or brain trauma and/or hemorrhagic conversion of an ischemic infarction
- Multiple simultaneous intracranial hemorrhages (ICH) (e.g. multifocal ICH, chronic subdural hematoma (cSDH), acute subdural hematoma (aSDH), SAH)
- Infratentorial hemorrhage or midbrain extension/involvement of the hemorrhage
- Coagulation disorder (including anticoagulation) with an international normalized ratio (INR) of >1.5 which cannot be pharmacologically reverted until the planned time of evacuation
- Pregnancy
- Relevant disability prior to SSICH (mRS >2)
- Any comorbid disease or condition expected to compromise survival or ability to complete follow-up assessments through 180 days (e.g. bilateral fixed dilated pupils)
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
Switzerland10 sites, 10 recruiting
- Recruiting
Department of Neurosurgery, University Hospital Basel
Basel, 4031
Jehuda Soleman, Prof. Dr. med., jehuda.soleman@usb.ch
Tim Hallenberger, Dr., tim.hallenberger@usb.ch
- Recruiting
University Hospital Bern
Bern
Andreas Raabe, Prof. Dr. med., +41 31 632 24 09, andreas.raabe@insel.ch
Andreas Raabe, Prof. Dr. med.
- Recruiting
Hopitaux Universitare Geneve
Geneva
Philippe Bijlenga, Prof. Dr. med., +41 22 372 82 01, philippe.bijlenga@hcuge.ch
Philippe Bijlenga, Prof. Dr. med.
- Recruiting
Centre Hopitalier Universitaire Vaudoise
Lausanne
Mahmoud Messerer, PD Dr., +41 21 314 12 93, Mahmoud.Messerer@chuv.ch
Mahmoud Messerer, PD Dr.
- Recruiting
Luzerner Kantonsspital
Lucerne
Ulf C. Schneider, Prof. Dr. med., +41 41 205 45 04, neurochirurgie@luks.ch
Ulf C. Schneider, Prof. Dr. med.
- Recruiting
Ospedale Regionale di Lugano
Lugano
Andrea Cardia, Dr. med., +41 91 811 69 27, andrea.cardia@eoc.ch
Andrea Cardia, Dr. med.
- Recruiting
Kantonsspital St. Gallen
Sankt Gallen
lsabel Hostettler, PD Dr. Dr., +41 71 494 11 99, neurochirurgie@kssg.ch
lsabel Hostettler, PD Dr. Dr.
- Recruiting
Centre Hopitalier Universitaire du Valais Romand
Sion
Jean-Yves Fournier, PD Dr. Dr., +41 27 603 45 30, chvr.consult.neurochirurgie@hopitalvs.ch
Jean-Yves Fournier, PD Dr. Dr.
- Recruiting
Kantonsspital Winterthur
Winterthur
Alex Alfieri, Prof. Dr., +41 52 266 29 72, neurochirurgie@ksw.ch
Alex Alfieri, Prof. Dr.
- Not yet recruiting
Universitätsspital Zürich
Zurich
Kevin Akeret, Dr. Dr., +41 44 255 26 86, kevin.akeret@usz.ch
Kevin Akeret, Dr. Dr.
About this study
Official title: Early Minimally Invasive Image Guided Endoscopic Evacuation of Intracerebral Haemorrhage (EMINENT-ICH): a Randomized Controlled Trial
This is an open-labelled, single centre randomised controlled trial evaluating the efficacy of early minimally invasive image-guided hematoma evacuation in combination with the current best medical treatment compared to best medical treatment alone in improving functional outcome rates at 6 months after initial treatment in patients with spontaneous supratentorial intracerebral haemorrhage.
Read the detailed description
Spontaneous supratentorial intracerebral haemorrhage (SSICH) is the second most common form of stroke and accounts for approximately 2500 cases in Switzerland annually. The prognosis is very poor with nearly half of the patients dying within one year after haemorrhage. Treatment options for SSICH consist of either the current gold standard, best medical treatment (BMT), or surgical hematoma evacuation. Neither the best medical treatment nor the established surgical mainstay (conventional craniotomy) have shown relevant improvement of survival or functional outcome rates. A minimal invasive approach with early image-guided endoscopic surgery conducted within 24 hours after bleeding onset is therefore proposed. Endoscopic surgery was shown to be safe and effective, however large trials analyzing the benefits of endoscopic surgery are lacking. An earlier, more complete and more rapid hematoma evacuation could improve the functional outcome and mortality rates in affected patients. The primary objective of this two-armed, open-labelled, single centre randomised controlled trial is to show superiority of early minimally invasive image-guided hematoma evacuation additionally to BMT compared to BMT alone in improving functional outcome rates at 6 months in patients with SSICH. The study procedures include 6 visits in total, 4 of them during hospital stay, 2 of them as follow-up visits within the clinical routine. Each visit consists of assessing Glasgow Coma Scale (GCS), modified Rankin Scale (mRS) and National Institute of Health Stroke Scale (NIHSS), three visits include CT scans (before intervention, directly postoperative and during follow up) and blood sampling (before intervention, postoperative and during follow up). Three visits include assessing patient satisfaction and cognition, and two visits include patient quality of life assessments. This study was designed in collaboration with Patient and Public representatives.
- Conditions
- Intracerebral Haemorrhage
- Being tested
- Early minimally invasive image guided endoscopic hematoma evacuation, Best medical treatment (BMT)
- Keywords
- spontaneous supratentorial intracerebral haemorrhage (SSICH), best medical treatment (BMT), surgical hematoma evacuation, conventional craniotomy (CC), early image-guided endoscopic surgery, endoscopic surgery (ES), minimally invasive surgery (MIS), minimally invasive puncture surgery (MIPS), stereotactic aspiration (SA)
- Medical subject headings
- Cerebral Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early minimally invasive image guided endoscopic hematoma evacuationProcedure or surgery
The intervention group will first receive BMT (as defined below) upon admission and early minimally invasive image guided endoscopic hematoma evacuation as an add-on therapy to BMT. Surgery will be performed within 6-24 hours after SSICH symptom onset. Surgery will be performed in an emergency operating theatre or a hybrid operation theatre equipped with intraoperative CT (in hybrid OR), neuronavigation, and neuro-endoscopy.The position and progress of the trocar towards the hematoma cavity will be monitored with neuro-navigation. The endoscope (LOTTA® system, Karl Storz Endoscopes, Germany; Minop®, BBraun, Tuttlingen, Germany or equivalent) will be inserted into the trocar and tracked using neuro-navigation. Using the pre-planned trajectory, the hematoma will be entered. Using continuous suction and irrigation, the hematoma will be aspirated and/or washed out.
Best medical treatment (BMT)Procedure or surgery
The control group will receive the current gold standard treatment for SSICH according to the guidelines (BMT). This involves strict blood pressure control (SBP<140mmHg), if needed with intravenous or intraarterial blood pressure lowering agents, reversal of anticoagulation if applicable, intensive care surveillance and nursing on a ICU or stroke unit, control of seizures as well as glucose levels as needed and neurointensive monitoring if deemed necessary
| Study group | Role | What they receive |
|---|---|---|
| Study Intervention | Experimental | Early minimally invasive image guided endoscopic hematoma evacuation as an add-on therapy to BMT performed within 24 hours after SSICH symptom onset. Receives: Procedure: Early minimally invasive image guided endoscopic hematoma evacuation; Procedure: Best medical treatment (BMT) |
| Control Intervention | Active comparator | Best medical treatment i.e. active blood pressure control, seizure prophylaxis and care as according to the current guidelines. Receives: Procedure: Best medical treatment (BMT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Good functional outcome, measured by the modified Rankin Scale (mRS)
Good functional outcome is defined as a mRS of ≤3 points and will be assessed as binary outcome (yes/no, final value). In this context, a mRS score of 3 points reflects the ability to walk unassisted and care for one's own bodily needs despite being moderately dependent on assistance, while a mRS score of 4 points describes a patient who is not able to walk anymore and needs assistance with all daily activities and thus marks a severe loss of patient autonomy.
Measured: At 6 months after treatment
Secondary outcomes (10)
Mortality rate
Mortality rate as measured by death of a participant (binary outcome (yes/no)
Measured: At 6 and 12 months after intervention
Change in Quality of Life, assessed by Patient-Reported Outcomes Measurement Information System (PROMIS®) questionnaire
The PROMIS® questionnaire scores can be categorized as: within normal limits, mild, moderate and severe.
Measured: At 3 and 6 months after intervention
Change in Patient cognitive outcome as assessed by the Montreal-Cognitive-Assessment-Test (MOCA® )
The MOCA assesses: Short term memory. Visuospatial abilities. Executive functions. Attention, concentration and working memory. Language.18-25 = mild cognitive impairment, 10-17= moderate cognitive impairment and less than 10= severe cognitive impairment. MoCA scores range between 0 and 30. A score of 26 or over is considered to be normal.
Measured: At 3 and 6 months after intervention
Morbidity rate
The morbidity rate, meaning occurrence of: Ischemic stroke, Recurrent SSICH (defined as any radiologically confirmed increase in hematoma volume postoperative/follow-up that is either asymptomatic or associated with a worsening of the focal-neurological deficit by ≥4 points on the NIHSS and/or a decrease in consciousness by ≥2 points on the GCS), Epileptic seizure, Surgical site infection (intervention group only), Any need for open neurosurgical procedures, Infections (i.e. pneumonia, urinary tract infection), Any other not defined complication that prolongs the hospital stay and/or leads to further treatment not envisaged in the original treatment plan.
Measured: At 6 and 12 months after intervention
Change of focal neurological deficit measured by the National Institute of Health Stroke Scale (NIHSS)
The NIHSS is composed of 11 items. The score for each ability is a number between 0 and 4, 0 being normal functioning and 4 being completely impaired.
Measured: From baseline to 6 months after intervention
Time to intervention
Time to intervention, defined as the period from symptom onset/last seen well to start of surgery (start surgical measures, i.e. positioning of patient) or start of medical treatment (admission of first treatment of BMT) (continuous variable, time to event).
Measured: At baseline
Total time spent on the intensive care unit (ICU)/stroke unit
The total time spent on the intensive care unit (ICU)/stroke unit as a continuous variable from the first admission to the ICU/stroke unit to discharge from ICU/stroke unit
Measured: At 7 days/discharge after intervention
Total time spent in intubation measured in minutes
The total time spent in intubation measured in minutes from the start of intubation to extubation as specified in the anesthesiology report
Measured: At 7 days/discharge after intervention
Proportion of hematoma volume reduction rate (in the intervention group only)
The hematoma volume will be measured on serial cranial computer tomography (cCT) and the difference between the volume of the cCT used for surgery and the cCT directly after surgery will be calculated.
Measured: Directly after intervention
Change in Patient Satisfaction Questionnaire
Patient Satisfaction as assessed by a 5- item survey on a scale of 1-5 (Score (1=worst, 5=best)
Measured: At 3 and 6 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2023
- Study start1 Jan 2024
- Primary completionDec 2028 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Intracerebral HaemorrhageStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- National multi-centre, two-arm, open labelled randomised controlled trial within the stroke units and stroke centres of the swiss stroke registry in a superiority fashion.
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- Swiss National Science Foundation, University Hospital, Geneva, Cantonal Hospital of St. Gallen, Ospedale Regionale di Lugano, Centre Hospitalier Universitaire Vaudois, Hôpital du Valais, University Hospital, Zürich, Kantonsspital Winterthur KSW, Insel Gruppe AG, University Hospital Bern, Luzerner Kantonsspital
- Responsible party
- Sponsor
- Investigators
- Jehuda Soleman, Prof. Dr. med., Principal investigator, Department of Neurosurgery, University Hospital Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05681988
- Sponsor's protocol ID
- 2022-02216; ko22Guzman
- Acronym
- EMINENT-ICH
- Status last verified
- Jul 2024
- First submitted
- 20 Dec 2022
- Last updated
- 22 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- 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 35930078Hallenberger TJ, Fischer U, Ghosh N, Kuhle J, Guzman R, Bonati LH, Soleman J. Early minimally invasive image-guided eNdoscopic evacuation of iNTracerebral hemorrhage: a phase II pilot trial. Front Neurol. 2024 Nov 19;15:1484255. doi: 10.3389/fneur.2024.1484255. eCollection 2024.
PubMed 39628893Hallenberger TJ, Fischer U, Bonati LH, Dutilh G, Mucklow R, Vogt AS, Boeni-Eckstein C, Cardia A, Schubert GA, Bijlenga P, Messerer M, Raabe A, Akeret K, Zweifel C, Kuhle J, Alfieri A, Fournier JY, Fandino J, Hostettler IC, Schneider UC, Guzman R, Soleman J. Early minimally invasive image-guided endoscopic evacuation of intracerebral hemorrhage (EMINENT-ICH): a randomized controlled trial. Trials. 2024 Oct 18;25(1):692. doi: 10.1186/s13063-024-08534-7.
PubMed 39425219
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 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 (EMINENT-ICH): a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05681988
- Acronym / sponsor ID
- EMINENT-ICH / 2022-02216; ko22Guzman
- Conditions
- Intracerebral Haemorrhage
- Keywords
- spontaneous supratentorial intracerebral haemorrhage (SSICH), best medical treatment (BMT), surgical hematoma evacuation, conventional craniotomy (CC), early image-guided endoscopic surgery, endoscopic surgery (ES), minimally invasive surgery (MIS), minimally invasive puncture surgery (MIPS)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Collaborators
- Swiss National Science Foundation, University Hospital, Geneva, Cantonal Hospital of St. Gallen, Ospedale Regionale di Lugano, Centre Hospitalier Universitaire Vaudois, Hôpital du Valais, University Hospital, Zürich, Kantonsspital Winterthur KSW, Insel Gruppe AG, University Hospital Bern, Luzerner Kantonsspital
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 12 Jan 2023 (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.
This is an open-labelled, single centre randomised controlled trial evaluating the efficacy of early minimally invasive image-guided hematoma evacuation in combination with the current best medical treatment compared to best medical treatment alone in improving functional outcome rates at 6 months after initial treatment in patients with spontaneous supratentorial intracerebral haemorrhage.
Detailed description
Spontaneous supratentorial intracerebral haemorrhage (SSICH) is the second most common form of stroke and accounts for approximately 2500 cases in Switzerland annually. The prognosis is very poor with nearly half of the patients dying within one year after haemorrhage. Treatment options for SSICH consist of either the current gold standard, best medical treatment (BMT), or surgical hematoma evacuation. Neither the best medical treatment nor the established surgical mainstay (conventional craniotomy) have shown relevant improvement of survival or functional outcome rates. A minimal invasive approach with early image-guided endoscopic surgery conducted within 24 hours after bleeding onset is therefore proposed. Endoscopic surgery was shown to be safe and effective, however large trials analyzing the benefits of endoscopic surgery are lacking. An earlier, more complete and more rapid hematoma evacuation could improve the functional outcome and mortality rates in affected patients. The primary objective of this two-armed, open-labelled, single centre randomised controlled trial is to show superiority of early minimally invasive image-guided hematoma evacuation additionally to BMT compared to BMT alone in improving functional outcome rates at 6 months in patients with SSICH. The study procedures include 6 visits in total, 4 of them during hospital stay, 2 of them as follow-up visits within the clinical routine. Each visit consists of assessing Glasgow Coma Scale (GCS), modified Rankin Scale (mRS) and National Institute of Health Stroke Scale (NIHSS), three visits include CT scans (before intervention, directly postoperative and during follow up) and blood sampling (before intervention, postoperative and during follow up). Three visits include assessing patient satisfaction and cognition, and two visits include patient quality of life assessments. This study was designed in collaboration with Patient and Public representatives.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- National multi-centre, two-arm, open labelled randomised controlled trial within the stroke units and stroke centres of the swiss stroke registry in a superiority fashion.
| Arm | Type | Receives |
|---|---|---|
| Study Intervention | Experimental | Procedure: Early minimally invasive image guided endoscopic hematoma evacuation, Procedure: Best medical treatment (BMT)Early minimally invasive image guided endoscopic hematoma evacuation as an add-on therapy to BMT performed within 24 hours after SSICH symptom onset. |
| Control Intervention | Active comparator | Procedure: Best medical treatment (BMT)Best medical treatment i.e. active blood pressure control, seizure prophylaxis and care as according to the current guidelines. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Spontaneous supratentorial intracerebral hemorrhage (SSICH), defined as the sudden occurrence of bleeding into the lobar parenchyma and/or into the basal ganglia and/or thalamus that may extend into the ventricles confirmed by imaging
- SSICH volume ≥20 mL <100 mL
- A focal neurological deficit consisting of either
- Presenting GCS 5 - 15 (in intubated patients GCS assessment will be performed after Rutledge et al. or if impossible, the last pre-intubation GCS will be used)
- Endoscopic hematoma evacuation can be initiated within 24 hours after the patient was last seen well/symptom onset
Key exclusion criteria (7 listed)
- SSICH due to known or suspected structural abnormality in the brain (e.g. vascular malformation, aneurysm, arteriovenous malformation (AVM), brain tumor) and/or brain trauma and/or hemorrhagic conversion of an ischemic infarction
- Multiple simultaneous intracranial hemorrhages (ICH) (e.g. multifocal ICH, chronic subdural hematoma (cSDH), acute subdural hematoma (aSDH), SAH)
- Infratentorial hemorrhage or midbrain extension/involvement of the hemorrhage
- Coagulation disorder (including anticoagulation) with an international normalized ratio (INR) of >1.5 which cannot be pharmacologically reverted until the planned time of evacuation
- Pregnancy
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 |
|---|---|---|
| Early minimally invasive image guided endoscopic hematoma evacuationThe intervention group will first receive BMT (as defined below) upon admission and early minimally invasive image guided endoscopic hematoma evacuation as an add-on therapy to BMT. Surgery will be performed within 6-24 hours after SSICH symptom onset. Surgery will be performed in an emergency operating theatre or a hybrid operation theatre equipped with intraoperative CT (in hybrid OR), neuronavigation, and neuro-endoscopy.The position and progress of the trocar towards the hematoma cavity will be monitored with neuro-navigation. The endoscope (LOTTA® system, Karl Storz Endoscopes, Germany; Minop®, BBraun, Tuttlingen, Germany or equivalent) will be inserted into the trocar and tracked using neuro-navigation. Using the pre-planned trajectory, the hematoma will be entered. Using continuous suction and irrigation, the hematoma will be aspirated and/or washed out. | Procedure or surgery | Study Intervention |
| Best medical treatment (BMT)The control group will receive the current gold standard treatment for SSICH according to the guidelines (BMT). This involves strict blood pressure control (SBP<140mmHg), if needed with intravenous or intraarterial blood pressure lowering agents, reversal of anticoagulation if applicable, intensive care surveillance and nursing on a ICU or stroke unit, control of seizures as well as glucose levels as needed and neurointensive monitoring if deemed necessary | Procedure or surgery | Control Intervention, Study Intervention |
Primary outcome
Good functional outcome, measured by the modified Rankin Scale (mRS)
Time frame: At 6 months after treatment
Good functional outcome is defined as a mRS of ≤3 points and will be assessed as binary outcome (yes/no, final value). In this context, a mRS score of 3 points reflects the ability to walk unassisted and care for one's own bodily needs despite being moderately dependent on assistance, while a mRS score of 4 points describes a patient who is not able to walk anymore and needs assistance with all daily activities and thus marks a severe loss of patient autonomy.
10 secondary outcomes
Mortality rate
Time frame: At 6 and 12 months after intervention
Change in Quality of Life, assessed by Patient-Reported Outcomes Measurement Information System (PROMIS®) questionnaire
Time frame: At 3 and 6 months after intervention
Change in Patient cognitive outcome as assessed by the Montreal-Cognitive-Assessment-Test (MOCA® )
Time frame: At 3 and 6 months after intervention
Morbidity rate
Time frame: At 6 and 12 months after intervention
Change of focal neurological deficit measured by the National Institute of Health Stroke Scale (NIHSS)
Time frame: From baseline to 6 months after intervention
Time to intervention
Time frame: At baseline
Total time spent on the intensive care unit (ICU)/stroke unit
Time frame: At 7 days/discharge after intervention
Total time spent in intubation measured in minutes
Time frame: At 7 days/discharge after intervention
Proportion of hematoma volume reduction rate (in the intervention group only)
Time frame: Directly after intervention
Change in Patient Satisfaction Questionnaire
Time frame: At 3 and 6 months after intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2024.
- Background: 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.
- Derived from this study: PubMed 39628893Hallenberger TJ, Fischer U, Ghosh N, Kuhle J, Guzman R, Bonati LH, Soleman J. Early minimally invasive image-guided eNdoscopic evacuation of iNTracerebral hemorrhage: a phase II pilot trial. Front Neurol. 2024 Nov 19;15:1484255. doi: 10.3389/fneur.2024.1484255. eCollection 2024.
- Derived from this study: PubMed 39425219Hallenberger TJ, Fischer U, Bonati LH, Dutilh G, Mucklow R, Vogt AS, Boeni-Eckstein C, Cardia A, Schubert GA, Bijlenga P, Messerer M, Raabe A, Akeret K, Zweifel C, Kuhle J, Alfieri A, Fournier JY, Fandino J, Hostettler IC, Schneider UC, Guzman R, Soleman J. Early minimally invasive image-guided endoscopic evacuation of intracerebral hemorrhage (EMINENT-ICH): a randomized controlled trial. Trials. 2024 Oct 18;25(1):692. doi: 10.1186/s13063-024-08534-7.
- Publication with PMID35930078: "Minimally invasive image-guided endoscopic evacuation of intracerebral haemorrhage: How I Do it"Link provided by the sponsor.
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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.
Jehuda Soleman, Prof. Dr. med. principal investigator
Department of Neurosurgery, University Hospital Basel
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early minimally invasive image guided endoscopic hematoma evacuation and Best medical treatment (BMT) in people with Intracerebral Haemorrhage, run by University Hospital, Basel, Switzerland at 10 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 10 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 22 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Raphael Guzman, Prof. Dr. med. (+41 61 265 33 68, raphael.guzman@usb.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Good functional outcome, measured by the modified Rankin Scale (mRS) (time frame: At 6 months after treatment). 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 NCT05681988, which also lists 3 linked publications.
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 22 Jul 2024.