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

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

Interventions

PROCEDURE

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.

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

Sponsors & Collaborators

• Swiss National Science Foundation

  collaborator OTHER

• University Hospital, Geneva

  collaborator OTHER

• Cantonal Hospital of St. Gallen

  collaborator OTHER

• Ospedale Regionale di Lugano

  collaborator OTHER

• Centre Hospitalier Universitaire Vaudois

  collaborator OTHER

• Hôpital du Valais

  collaborator OTHER

• University Hospital, Zürich

  collaborator OTHER

• Kantonsspital Winterthur KSW

  collaborator OTHER

• Insel Gruppe AG, University Hospital Bern

  collaborator OTHER

• Luzerner Kantonsspital

  collaborator OTHER

• University Hospital, Basel, Switzerland

  lead OTHER

Principal Investigators

• Jehuda Soleman, Prof. Dr. med. · Department of Neurosurgery, University Hospital Basel

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-01-01

Primary Completion

2028-12-31

Completion

2029-12-31

Countries

• Switzerland

Study Locations