Dutch Intracerebral Hemorrhage Surgery Trial
DIST
Dutch ICH Surgery Trial; Minimally Invasive Endoscopy-guided Surgery for Spontaneous Supratentorial Intracerebral Hemorrhage
1 other identifier
interventional
600
1 country
11
Brief Summary
Background: Intracerebral hemorrhage (ICH) accounts for 16-19% of all strokes in Western Europe and contributes profoundly to mortality and disability. Thirty-day case fatality is 40% and of those surviving, only few gain independence. Except for stroke unit care and possibly early blood pressure lowering, there is currently no treatment of proven benefit. Surgical treatment has so far not been proven effective. In the largest trials STICH I and II, and MISTIE III, the median time to treatment was more than 24 hours, which may be an important explanation for the lack of a treatment effect. A recent meta-analysis of randomized controlled trials showed that surgical treatment may be beneficial, in particular with minimally invasive procedures and when performed early. In the Dutch ICH Surgery pilot study, we showed that early minimally invasive endoscopy-guided surgical treatment performed within 8 hours of symptom onset in patients with supratentorial ICH is safe and technically effective. We hypothesize that early minimally invasive endoscopy-guided surgery improves the outcome in patients with supratentorial spontaneous ICH. Objectives:
- 1.To study whether minimally invasive endoscopy-guided surgery, in addition to standard medical management, for the treatment of spontaneous supratentorial ICH performed within 8 hours of symptom onset, improves functional outcome in comparison with standard medical management alone;
- 2.Determine whether patients treated with minimally invasive surgery develop less perihematomal edema on non-contrast CT at day 6 (±1 day) than controls, and whether the CT perfusion permeability surface-area product around the ICH at baseline modifies this effect (DIST-INFLAME);
- 3.Compare immune profiles over time in peripheral venous blood between surgically treated patients and controls (DIST-INFLAME);
- 4.To assess the cost-effectiveness and budget-impact of minimally invasive endoscopy-guided surgery for the treatment of spontaneous supratentorial ICH performed within 8 hours of symptom onset.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2022
Longer than P75 for not_applicable
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 12, 2022
CompletedFirst Posted
Study publicly available on registry
July 15, 2022
CompletedStudy Start
First participant enrolled
November 3, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2028
November 21, 2024
November 1, 2024
4.7 years
July 12, 2022
November 18, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
modified Rankin Scale (mRS) at 180 days
Ordinal shift in functional outcome assessed with the mRS at 180 days, adjusted for prespecified prognostic factors. This is a six point scale in which a score of 0 means no symptoms at all, a higher score means more impairment, and a score of 6 means the participant is dead.
180 days (±14 days)
Secondary Outcomes (49)
mRS at 90 days
90 days (±14 days)
mRS at 365 days
365 days (±14 days)
Favorable outcome, defined as a mRS of 0-2 at 90 days
90 days (±14 days)
Favorable outcome, defined as a mRS of 0-2 at 180 days
180 days (±14 days)
Favorable outcome, defined as a mRS of 0-2 at 365 days
365 days (±14 days)
- +44 more secondary outcomes
Other Outcomes (3)
Perihematomal edema at 6 days (±1 day)
6 days (±1 day)
Immune and metabolomic profiles in venous blood at 3 days
3 days
Immune and metabolomic profiles in venous blood at 6 days (±1 day)
6 days (±1 day)
Study Arms (2)
Surgical treatment
EXPERIMENTALMinimally invasive endoscopy-guided surgery in addition to standard medical management for the treatment of spontaneous supratentorial intracerebral hemorrhage performed within 8 hours of symptom onset.
Standard medical management
NO INTERVENTIONStandard medical treatment for the treatment of spontaneous supratentorial intracerebral hemorrhage (treatment of blood pressure, admission to stroke unit and supportive care, surgical treatment if necessary in case of deterioration).
Interventions
The devices allowed into the trial, are minimally invasive neuronavigation integrated endoscopy-guided devices that are CE approved and admissible by the steering committee. Currently, only the Artemis Neuro Evacuation Device (Penumbra Inc, Alameda, California, USA) is available and CE approved.
Eligibility Criteria
You may qualify if:
- Age 18 years or older;
- NIHSS ≥ 2;
- Supratentorial non-traumatic ICH confirmed by non-contrast CT, without a CT-angiography confirmed causative vascular lesion (e.g. aneurysm, arteriovenous malformation \[AVM\], dural arteriovenous fistula \[DAVF\], cerebral venous sinus thrombosis \[CVST\]), or other known underlying lesion (e.g. tumor, cavernoma);
- Minimal hematoma volume of 10 mL;
- Intervention can be started within 8 hours of symptom onset;
- Written informed consent (deferred).
You may not qualify if:
- Considerable pre-stroke dependency in activities of daily living, defined as a pre-stroke mRS ≥3;
- ICH-GS score ≥11;
- Hemorrhage due to hemorrhagic transformation of an infarct;
- Untreated coagulation abnormalities, including INR \>1.3 (point of care measurement allowed), treatment with heparin and treatment with factor Xa inhibitors. Patients on vitamin K antagonist can be included after correction of the INR, and patients on dabigatran (direct thrombin inhibitor) can be included after reversal of dabigatran with idarucizumab;
- Moribund (e.g. coning, bilateral dilated unresponsive pupils), or progressively deteriorating clinical course with imminent death;
- Pregnancy (note: most patients will be beyond childbearing age);
- DIST-INFLAME sub-study: patients that use immunosuppressive or immune-modulating medication.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Radboud University Medical Centerlead
- ZonMw: The Netherlands Organisation for Health Research and Developmentcollaborator
- Dutch National Health Care Institutecollaborator
- Penumbra Inc.collaborator
Study Sites (11)
Amsterdam University Medical Center
Amsterdam, Netherlands
Medisch Spectrum Twente
Enschede, Netherlands
University Medical Center Groningen
Groningen, Netherlands
Leiden University Medical Center
Leiden, Netherlands
Maastricht University Medical Center
Maastricht, Netherlands
Radboud University Medical Center
Nijmegen, Netherlands
Erasmus University Medical Center
Rotterdam, Netherlands
Haaglanden Medical Center
The Hague, Netherlands
Elisabeth-TweeSteden Hospital
Tilburg, Netherlands
University Medical Center Utrecht
Utrecht, Netherlands
Isala
Zwolle, Netherlands
Related Publications (1)
Wilting FNH, Wolsink A, Colmer NHC, Schreuder FHBM, Brouwers HB, Boogaarts HD, Dippel DWJ, Hannink G, Jolink WMT, Verbaan D, Wermer MJH, Dammers R, Klijn CJM. The Dutch Intracerebral Haemorrhage Surgery Trial: study protocol for a randomised clinical trial of minimally invasive endoscopy-guided surgery in patients with spontaneous, supratentorial intracerebral haemorrhage. Eur Stroke J. 2026 Jan 1;11(1):aakaf008. doi: 10.1093/esj/aakaf008.
PMID: 41614502DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Catharina JM Klijn, MD PhD
Radboud University Medical Center
- PRINCIPAL INVESTIGATOR
Ruben Dammers, MD PhD
Erasmus Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 12, 2022
First Posted
July 15, 2022
Study Start
November 3, 2022
Primary Completion (Estimated)
July 1, 2027
Study Completion (Estimated)
July 1, 2028
Last Updated
November 21, 2024
Record last verified: 2024-11
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- at least 18 months after the publication of the main report.
- Access Criteria
- Written proposals will be assessed by DIST investigators for appropriateness of use, and a data sharing agreement in accordance with Dutch regulations will be put in place before data is shared.
De-identified data may be shared with other parties to maximize the usefulness of the collected research data. Data can be requested from the principal investigators with a detailed description of the objectives and methods of the study for which the data is intended. Data will be made available for this purpose at least 18 months after the publication of the main report. Data may also be shared with non-commercial parties for scientific purposes, including individual patient meta-analyses, and with the commercial parties involved in this study as manufacturers of minimally invasive neuronavigation integrated endoscopy-guided devices. For these purposes, specific consent will be asked from the participants. In addition, specific consent will be asked for sharing of de-identified data outside of the European Union.