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RECRUITING
NCT05681988
NA

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

Sponsor: University Hospital, Basel, Switzerland

View on ClinicalTrials.gov

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.

Official title: Early Minimally Invasive Image Guided Endoscopic Evacuation of Intracerebral Haemorrhage (EMINENT-ICH): a Randomized Controlled Trial

Key Details

Gender

All

Age Range

18 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

200

Start Date

2024-01-01

Completion Date

2029-12

Last Updated

2024-07-22

Healthy Volunteers

No

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

Locations (10)

Department of Neurosurgery, University Hospital Basel

Basel, Switzerland

University Hospital Bern

Bern, Switzerland

Hopitaux Universitare Geneve

Geneva, Switzerland

Centre Hopitalier Universitaire Vaudoise

Lausanne, Switzerland

Luzerner Kantonsspital

Lucerne, Switzerland

Ospedale Regionale di Lugano

Lugano, Switzerland

Kantonsspital St. Gallen

Sankt Gallen, Switzerland

Centre Hopitalier Universitaire du Valais Romand

Sion, Switzerland

Kantonsspital Winterthur

Winterthur, Switzerland

Universitätsspital Zürich

Zurich, Switzerland