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| Name | Class |
|---|---|
| Swiss National Science Foundation | OTHER |
| University Hospital, Geneva | OTHER |
| Cantonal Hospital of St. Gallen | OTHER |
| Ospedale Regionale di Lugano |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Control Intervention | Active Comparator | Best medical treatment i.e. active blood pressure control, seizure prophylaxis and care as according to the current guidelines. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality rate | Mortality rate as measured by death of a participant (binary outcome (yes/no) | At 6 and 12 months after intervention |
| Change in Quality of Life, assessed by Patient-Reported Outcomes Measurement Information System (PROMIS®) questionnaire |
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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
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| 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 |
| Name | Affiliation | Role |
|---|---|---|
| Jehuda Soleman, Prof. Dr. med. | Department of Neurosurgery, University Hospital Basel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Neurosurgery, University Hospital Basel | Recruiting | Basel | 4031 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35930078 | Background | 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. | |
| 39628893 | Derived | 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. |
| Label | URL |
|---|---|
| Publication with PMID35930078: "Minimally invasive image-guided endoscopic evacuation of intracerebral haemorrhage: How I Do it" | View source |
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| OTHER |
| Centre Hospitalier Universitaire Vaudois | OTHER |
| Hôpital du Valais | OTHER |
| University Hospital, Zürich | OTHER |
| Kantonsspital Winterthur KSW | OTHER |
| Insel Gruppe AG, University Hospital Bern | OTHER |
| Luzerner Kantonsspital | OTHER |
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.
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| 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 |
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The PROMIS® questionnaire scores can be categorized as: within normal limits, mild, moderate and severe. |
| At 3 and 6 months after intervention |
| 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. | At 3 and 6 months after intervention |
| 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. | At 6 and 12 months after intervention |
| 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. | From baseline to 6 months after intervention |
| 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). | At baseline |
| 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 | At 7 days/discharge after intervention |
| 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 | At 7 days/discharge after intervention |
| 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. | Directly after intervention |
| 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) | At 3 and 6 months after intervention |
| University Hospital Bern | Recruiting | Bern | Switzerland |
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| Hopitaux Universitare Geneve | Recruiting | Geneva | Switzerland |
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| Centre Hopitalier Universitaire Vaudoise | Recruiting | Lausanne | Switzerland |
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| Luzerner Kantonsspital | Recruiting | Lucerne | Switzerland |
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| Ospedale Regionale di Lugano | Recruiting | Lugano | Switzerland |
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| Kantonsspital St. Gallen | Recruiting | Sankt Gallen | Switzerland |
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| Centre Hopitalier Universitaire du Valais Romand | Recruiting | Sion | Switzerland |
|
| Kantonsspital Winterthur | Recruiting | Winterthur | Switzerland |
|
| Universitätsspital Zürich | Not yet recruiting | Zurich | Switzerland |
|
| 39425219 | 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. |
| ID | Term |
|---|---|
| D002543 | Cerebral Hemorrhage |
| ID | Term |
|---|---|
| D020300 | Intracranial Hemorrhages |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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