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

Primary Purpose

Intracerebral Haemorrhage

Status

Not yet recruiting

Phase

Not Applicable

Locations

Switzerland

Study Type

Interventional

Intervention

Early minimally invasive image guided endoscopic hematoma evacuation

Best medical treatment (BMT)

About this trial

This is an interventional treatment trial for Intracerebral Haemorrhage focused on measuring 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)

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 Stable clot volume defined as absence of arterial spot sign (spot like/serpiginous appearance inside the hematoma and/or increase of >33% (as assessed using the formula (A * B * C)/2 of initial clot volume on follow-up imaging 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 Positive history of current pregnancy, breast-feeding, or positive pregnancy test [either serum or urine] in premenopausal women 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)

Sites / Locations

Department of Neurosurgery, University Hospital Basel

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Study Intervention

Control Intervention

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Mortality rate

Mortality rate as measured by death of a participant (binary outcome (yes/no)

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.

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.

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.

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.

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).

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

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

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.

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)

Full Information

NCT ID

NCT05681988

First Posted

December 20, 2022

Last Updated

January 13, 2023

Sponsor

University Hospital, Basel, Switzerland

1. Study Identification

Unique Protocol Identification Number

NCT05681988

Brief Title

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

Acronym

EMINENT-ICH

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Not yet recruiting

Study Start Date

September 2023 (Anticipated)

Primary Completion Date

September 2028 (Anticipated)

Study Completion Date

September 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Basel, Switzerland

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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)

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

National single-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)

Allocation

Randomized

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Study Intervention

Arm Type

Experimental

Arm Description

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

Arm Title

Control Intervention

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

Early minimally invasive image guided endoscopic hematoma evacuation

Intervention Description

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

Intervention Name(s)

Best medical treatment (BMT)

Intervention Description

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

Primary Outcome Measure Information:

Title

Good functional outcome, measured by the modified Rankin Scale (mRS)

Description

Time Frame

At 6 months after treatment

Secondary Outcome Measure Information:

Title

Mortality rate

Description

Mortality rate as measured by death of a participant (binary outcome (yes/no)

Time Frame

At 6 months after intervention

Title

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

Description

The PROMIS® questionnaire scores can be categorized as: within normal limits, mild, moderate and severe.

Time Frame

At 7 days, 3 and 6 months after intervention

Title

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

Description

Time Frame

At 7 days, 3 and 6 months after intervention

Title

Morbidity rate

Description

Time Frame

At 6 months after intervention

Title

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

Description

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.

Time Frame

From baseline to 6 months after intervention

Title

Time to intervention

Description

Time Frame

At baseline

Title

Total time spent on the intensive care unit (ICU)/stroke unit

Description

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

Time Frame

At 7 days/discharge after intervention

Title

Total time spent in intubation measured in minutes

Description

The total time spent in intubation measured in minutes from the start of intubation to extubation as specified in the anesthesiology report

Time Frame

At 7 days/discharge after intervention

Title

Proportion of hematoma volume reduction rate (in the intervention group only)

Description

Time Frame

Directly after intervention

Title

Change in Patient Satisfaction Questionnaire

Description

Patient Satisfaction as assessed by a 5- item survey on a scale of 1-5 (Score (1=worst, 5=best)

Time Frame

At 7 days, 3 and 6 months after intervention

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Raphael Guzman, Prof. Dr. med.

Phone

+41 (0)61 265 33 68

raphael.guzman@usb.ch

First Name & Middle Initial & Last Name or Official Title & Degree

Tim Hallenberger

Phone

+41 (0)61 556 55 01

tim.hallenberger@usb.ch

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Raphael Guzman, Prof. Dr. med.

Organizational Affiliation

Department of Neurosurgery, University Hospital Basel

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Neurosurgery, University Hospital Basel

City

Basel

ZIP/Postal Code

4031

Country

Switzerland

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jehuda Soleman, PD Dr. med.

jehuda.soleman@usb.ch

First Name & Middle Initial & Last Name & Degree

Tim Hallenberger

tim.hallenberger@usb.ch

First Name & Middle Initial & Last Name & Degree

Jehuda Soleman, PD Dr. med.

First Name & Middle Initial & Last Name & Degree

Urs Fischer, Prof. Dr. med.

First Name & Middle Initial & Last Name & Degree

Tim Hallenberger

12. IPD Sharing Statement

Learn more about this trial

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

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