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

NCT05681988 | Recruiting DMC

• 1 other identifier: 2022-02216; ko22Guzman
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 10

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.

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); stereotactic aspiration (SA)

Outcome Measures

Primary Outcomes (1)

• 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.

  At 6 months after treatment

Secondary Outcomes (10)

• Mortality rate

  At 6 and 12 months after intervention

• Change in Quality of Life, assessed by Patient-Reported Outcomes Measurement Information System (PROMIS®) questionnaire

  At 3 and 6 months after intervention

• Change in Patient cognitive outcome as assessed by the Montreal-Cognitive-Assessment-Test (MOCA® )

  At 3 and 6 months after intervention

• Morbidity rate

  At 6 and 12 months after intervention

• Change of focal neurological deficit measured by the National Institute of Health Stroke Scale (NIHSS)

  From baseline to 6 months after intervention

Study Arms (2)

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.

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.

Procedure: Best medical treatment (BMT)

Interventions

Early minimally invasive image guided endoscopic hematoma evacuation 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.

Study Intervention

Best medical treatment (BMT) 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; Study Intervention

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead
• Swiss National Science Foundation: collaborator
• University Hospital, Geneva: collaborator
• Cantonal Hospital of St. Gallen: collaborator
• Ospedale Regionale di Lugano: collaborator
• Centre Hospitalier Universitaire Vaudois: collaborator
• Hôpital du Valais: collaborator
• University Hospital, Zürich: collaborator
• Kantonsspital Winterthur KSW: collaborator
• Insel Gruppe AG, University Hospital Bern: collaborator
• Luzerner Kantonsspital: collaborator

Study Sites (10)

Department of Neurosurgery, University Hospital Basel

Basel, 4031, Switzerland

RECRUITING

University Hospital Bern

Bern, Switzerland

RECRUITING

Hopitaux Universitare Geneve

Geneva, Switzerland

RECRUITING

Centre Hopitalier Universitaire Vaudoise

Lausanne, Switzerland

RECRUITING

Luzerner Kantonsspital

Lucerne, Switzerland

RECRUITING

Ospedale Regionale di Lugano

Lugano, Switzerland

RECRUITING

Kantonsspital St. Gallen

Sankt Gallen, Switzerland

RECRUITING

Centre Hopitalier Universitaire du Valais Romand

Sion, Switzerland

RECRUITING

Kantonsspital Winterthur

Winterthur, Switzerland

RECRUITING

Universitätsspital Zürich

Zurich, Switzerland

NOT YET RECRUITING

Related Publications (3)

• 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.

  PMID: 35930078 BACKGROUND

• 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.

  PMID: 39628893 DERIVED

• 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.

  PMID: 39425219 DERIVED

Related Links

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

MeSH Terms

Conditions

Cerebral Hemorrhage

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jehuda Soleman, Prof. Dr. med.

  Department of Neurosurgery, University Hospital Basel

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Raphael Guzman, Prof. Dr. med.

CONTACT

+41 61 265 33 68; raphael.guzman@usb.ch

Tim Hallenberger, Dr.

CONTACT

+41 61 556 55 01; tim.hallenberger@usb.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 20, 2022
• First Posted: January 12, 2023
• Study Start: January 1, 2024
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2029
• Last Updated: July 22, 2024

Record last verified: 2024-07

Locations

CH (10)