Early Minimally Invasive Image Guided Endoscopic Evacuation of Intracerebral Haemorrhage (EMINENT-ICH)

NCT ID: NCT05681988

Last Updated: 2024-07-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-01
• Study Completion Date: 2029-12-31

Brief 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 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.

Conditions

Intracerebral Haemorrhage

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Study Intervention

Early minimally invasive image guided endoscopic hematoma evacuation as an add-on therapy to BMT performed within 24 hours after SSICH symptom onset.

Group Type: EXPERIMENTAL

Early minimally invasive image guided endoscopic hematoma evacuation

Intervention Type: PROCEDURE

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)

Intervention Type: PROCEDURE

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

Control Intervention

Best medical treatment i.e. active blood pressure control, seizure prophylaxis and care as according to the current guidelines.

Group Type: ACTIVE_COMPARATOR

Best medical treatment (BMT)

Intervention Type: PROCEDURE

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

Interventions

Early minimally invasive image guided endoscopic hematoma evacuation

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.

Intervention Type: PROCEDURE

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

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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)
• 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)

Exclusion Criteria

• 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Swiss National Science Foundation

OTHER

Sponsor Role: collaborator

University Hospital, Geneva

OTHER

Sponsor Role: collaborator

Cantonal Hospital of St. Gallen

OTHER

Sponsor Role: collaborator

Ospedale Regionale di Lugano

OTHER

Sponsor Role: collaborator

Centre Hospitalier Universitaire Vaudois

OTHER

Sponsor Role: collaborator

Hôpital du Valais

OTHER

Sponsor Role: collaborator

University Hospital, Zürich

OTHER

Sponsor Role: collaborator

Kantonsspital Winterthur KSW

OTHER

Sponsor Role: collaborator

Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role: collaborator

Luzerner Kantonsspital

OTHER

Sponsor Role: collaborator

University Hospital, Basel, Switzerland

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jehuda Soleman, Prof. Dr. med.

Role: PRINCIPAL_INVESTIGATOR

Department of Neurosurgery, University Hospital Basel

Locations

Department of Neurosurgery, University Hospital Basel

Basel, , Switzerland

Site Status: RECRUITING

University Hospital Bern

Bern, , Switzerland

Site Status: RECRUITING

Hopitaux Universitare Geneve

Geneva, , Switzerland

Site Status: RECRUITING

Centre Hopitalier Universitaire Vaudoise

Lausanne, , Switzerland

Site Status: RECRUITING

Luzerner Kantonsspital

Lucerne, , Switzerland

Site Status: RECRUITING

Ospedale Regionale di Lugano

Lugano, , Switzerland

Site Status: RECRUITING

Kantonsspital St. Gallen

Sankt Gallen, , Switzerland

Site Status: RECRUITING

Centre Hopitalier Universitaire du Valais Romand

Sion, , Switzerland

Site Status: RECRUITING

Kantonsspital Winterthur

Winterthur, , Switzerland

Site Status: RECRUITING

Universitätsspital Zürich

Zurich, , Switzerland

Site Status: NOT_YET_RECRUITING

Countries

Switzerland

Central Contacts

Raphael Guzman, Prof. Dr. med.

Role: CONTACT

raphael.guzman@usb.ch

+41 61 265 33 68

Tim Hallenberger, Dr.

Role: CONTACT

tim.hallenberger@usb.ch

+41 61 556 55 01

Facility Contacts

Jehuda Soleman, Prof. Dr. med.

Role: primary

jehuda.soleman@usb.ch

Tim Hallenberger, Dr.

Role: backup

tim.hallenberger@usb.ch

Andreas Raabe, Prof. Dr. med.

Role: primary

andreas.raabe@insel.ch

+41 31 632 24 09

Philippe Bijlenga, Prof. Dr. med.

Role: primary

philippe.bijlenga@hcuge.ch

+41 22 372 82 01

Mahmoud Messerer, PD Dr.

Role: primary

Mahmoud.Messerer@chuv.ch

+41 21 314 12 93

Ulf C. Schneider, Prof. Dr. med.

Role: primary

neurochirurgie@luks.ch

+41 41 205 45 04

Andrea Cardia, Dr. med.

Role: primary

andrea.cardia@eoc.ch

+41 91 811 69 27

lsabel Hostettler, PD Dr. Dr.

Role: primary

neurochirurgie@kssg.ch

+41 71 494 11 99

Jean-Yves Fournier, PD Dr. Dr.

Role: primary

chvr.consult.neurochirurgie@hopitalvs.ch

+41 27 603 45 30

Alex Alfieri, Prof. Dr.

Role: primary

neurochirurgie@ksw.ch

+41 52 266 29 72

Kevin Akeret, Dr. Dr.

Role: primary

kevin.akeret@usz.ch

+41 44 255 26 86

References

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.

Reference Type: BACKGROUND

PMID: 35930078 (View on PubMed)

Hallenberger 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.

Reference Type: DERIVED

PMID: 39628893 (View on PubMed)

Hallenberger 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.

Reference Type: DERIVED

PMID: 39425219 (View on PubMed)

Related Links

https://link.springer.com/article/10.1007/s00701-022-05326-3

Publication with PMID35930078: "Minimally invasive image-guided endoscopic evacuation of intracerebral haemorrhage: How I Do it"

Other Identifiers

2022-02216; ko22Guzman

Identifier Type: -

Identifier Source: org_study_id