Intracerebral HemorrhageDIST pilotNCT03608423
Dutch Intracerebral Hemorrhage Surgery Trial Pilot Study
A study testing Minimally-invasive endoscopy-guided surgery in people with Intracerebral Hemorrhage and Surgical Procedures, Minimally Invasive, run by Radboud University Medical Center at 10 sites in Netherlands.
Trial summary
Background: Intracerebral hemorrhage (ICH) accounts for 15-20% 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intracerebral Hemorrhage, Surgical Procedures, Minimally Invasive
- What is being tested?
- Minimally-invasive endoscopy-guided surgery
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 169 participants
- Where
- 10 sitesNetherlands
- Study dates
- 3 Dec 2018to 7 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18
- NIHSS ≥ 2
- Supratentorial ICH confirmed by CT, without a CT-angiography confirmed causative vascular lesion (e.g. aneurysma, arteriovenous malformation [AVM], dural arteriovenous fistula [DAVF], cerebral venous sinus thrombosis [CVST]).
- Minimal lesion size 10 mL
- Intervention can be started within 8 hours from symptoms onset; or for controls presentation within 8 hours of symptom onset.
- Patient's or legal representative's written informed consent
Who cannot join
- Pre-stroke disability, which interferes with the assessment of functional outcome at 90 days, i.e. mRS > 2
- Causative vascular lesion (e.g. aneurysm, AVM, DAVF, CVST) on CT-angiography or other known underlying cause (e.g. tumor, cavernoma)
- Untreated coagulation abnormalities, including INR > 1.3 (point of care measurement allowed) and treatment with oral thrombin or factor X antagonists; patients on vitamin K antagonist can be included after correction of the INR.
- Current known severe infection for which antibiotic treatment at time of ICH symptom onset
- Patient moribund (e.g. coning, bilateral dilated unresponsive pupils)
- Pregnancy (note: most patients will be beyond child bearing age; if not a pregnancy test is mandatory).
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Netherlands10 sites
Academic Medical Center
Amsterdam
Medisch Spectrum Twente
Enschede
Leiden University Medical Center
Leiden, 2333 ZA
Maastricht University Medical Center
Maastricht
Radboud University Medical Center
Nijmegen, Gelderland, 6525 GC
Erasmus Medical Center
Rotterdam, 3015 CE
Haaglanden Medical Center
The Hague
Elisabeth Tweesteden Ziekenhuis
Tilburg
University Medical Center Utrecht
Utrecht
Isala
Zwolle
About this study
Official title: The Dutch Intracerebral Hemorrhage Surgery Trial Pilot Study; Minimally-invasive Endoscopy-guided Surgery for Spontaneous Intracerebral Hemorrhage
Background:
Intracerebral hemorrhage (ICH) accounts for 15-20% 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 early blood pressure lowering there is currently no treatment of proven benefit. Important predictors of poor outcome are increasing age, decreasing Glasgow Coma Scale score, increasing ICH volume, presence of intraventricular hemorrhage and deep or infratentorial location. In addition, secondary injury due to development of edema and inflammatory response, contribute to disability and death. Surgical treatment, mostly comprising craniotomy, has so far not been proven effective. In the largest trials STICH and STICH II, the median time to treatment was more than 24 hours, which may be an important explanation for the lack of treatment effect.
Read more
The investigators hypothesize that early, minimally-invasive, endoscopy-guided surgery improves outcome in patients with spontaneous supratentorial ICH.
Objective: to study safety, feasibility and technical effectiveness of minimally-invasive endoscopy guided surgery for treatment of spontaneous supratentorial ICH and to estimate the potential effect on outcome.
Study design: a multicenter, prospective intervention study (phase II) with a telephonic follow up interview at 90 and 180 days.The pilot study serves as a prelude to a randomized phase III trial in which the investigators aim to assess whether this intervention improves functional outcome at 90 and 180 days.
Study population: patients with spontaneous supratentorial ICH of 18 years and older. Forty patients in three participating centers (Radboudumc, Erasmus MC and AMC) will undergo minimally-invasive endoscopy-guided surgery. Three-hundred-and-sixty patients undergoing standard medical treatment in one of 7 other participating centers, will be included as a control group.
Intervention: minimally-invasive endoscopy-guided surgery within 8 hours of symptom onset, in addition to standard medical management.
Primary study outcomes: safety (death within 24 hours, 7-day procedure related complications, 7-day mortality, 30-day mortality) and technical effectiveness (proportional volume reduction, proportion of participants with volume reduction > 60 and >80%, and proportion with remaining clot volume <15mL).
Secondary outcomes: modified Rankin Scale score at 90 and 180 days after ICH (functional outcome).
Read the detailed description
The full protocol is available at https://dutch-ich.nl/trial-protocol-and-trial-documents.html
- Being tested
- Minimally-invasive endoscopy-guided surgery
- Keywords
- Intracerebral Hemorrhage, Surgical Procedures, Minimally Invasive, Surgical Procedures, Endoscopic
- Medical subject headings
- Cerebral Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minimally-invasive endoscopy-guided surgeryDevice
Also called Minimally-invasive endoscopy-guided hematoma aspiration
Surgery started within 8 hours of onset of spontaneous intracerebral hemorrhage.
| Study group | Role | What they receive |
|---|---|---|
| Surgical treatment | Experimental | Minimally-invasive endoscopy-guided surgery or hematoma aspiration, additional to standard medical treatment. Receives: Device: Minimally-invasive endoscopy-guided surgery |
| Standard medical management | No intervention | Standard medical treatment (treatment of bloodpressure, admission to stroke unit and supportive care, surgical treatment if necessary in case of deterioration) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Death within 24 hours
Death within 24 hours after baseline.
Measured: 24 hours
Neurological deterioration within 24 hours
Neurological deterioration, defined as an increase of ≥4 points on the sumscore of the NIHSS or >2 National Institutes of Health Stroke Scale (NIHSS)is a sum score, composed of 11 items, each of which scores a specific ability between 0 and 4. For each item, a score of 0 typically indicates normal function in that ability, while a higher score indicates the level of impairment. The total score varies between 0 (no symptoms at all) and 42. points on one item of NIHSS,
Measured: 24 hours
Proportion of volume reduction
The proportion of volume reduction, based on baseline CT and CT at 24 hours (in the intervention group).
Measured: Baseline and 24 hours (based on the comparison baseline CT and CT at 24 hours).
Secondary outcomes (10)
Procedure related complications
The proportion of patients with procedure related complications at 7 days, including: rebleed, intracranial hemorrhage, epileptic seizures and intracranial infection. (in the intervention group)
Measured: 7 days
Mortality at 7 days
Proportion of patients that died within 7 days after baseline
Measured: 7 days
Mortality at 30 days
Proportion of patients that died within 30 days after baseline
Measured: 30 days
Percentage of patients with clot volume reduction ≥60%
The proportion of patients in which the clot volume could be reduced with 60% or more, based on the comparison baseline CT and CT at 24 hours. (in the intervention group)
Measured: Baseline and 24 hours CT (the difference is measured)
Percentage of patients with clot volume reduction ≥ 80%
The proportion of patients in which the clot volume could be reduced with 80% or more, based on the comparison baseline CT and CT at 24 hours. (in the intervention group)
Measured: Baseline and 24 hours CT (the difference is measured)
Percentage of patients with remaining clot volume of ≤ 15mL
The proportion of patients in which due to clot removal a remaining clot volume of ≤ 15mL was established at 24 hours. (in the intervention group)
Measured: 24 hours CT
Proportion of conversion to craniotomy
The proportion of patients in which a conversion to craniotomy was required and done. (in the intervention group)
Measured: 24 hours
Functional outcome at 3 months
Ordinal shift in functional outcome (comparing the intervention group to the controls), assessed with the modified Rankin Scale (mRS) at 3 months. 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.
A favorable outcome is defined as mRS 0-3 and mRS 0-2.
Measured: 3 months (90 days)
Functional outcome at 6 months
Ordinal shift in functional outcome (comparing the intervention group to the controls), , assessed with the modified Rankin Scale (mRS) at 6 months. 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.
A favorable outcome is defined as mRS 0-3 and mRS 0-2.
Measured: 6 months (180 days)
National Institute of Health Stroke Scale (NIHSS) at 7 days or discharge
National Institutes of Health Stroke Scale (NIHSS)is a sum score, composed of 11 items, each of which scores a specific ability between 0 and 4. For each item, a score of 0 typically indicates normal function in that ability, while a higher score indicates the level of impairment. The total score varies between 0 (no symptoms at all) and 42.
Measured: 7 days (or at discharge from the hospital if earlier)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2018
- Study start3 Dec 2018
- Primary completion7 Apr 2022
- Study completion7 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Intracerebral HemorrhageStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- We will include 40 patients in the surgical arm (inclusion in three hospitals) and aim for 120 matched controls in the other arm (in 7 other hospitals).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 169 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Dutch Heart Foundation, Penumbra Inc.
- Responsible party
- Sponsor
- Investigators
- Ruben Dammers, Dr., Principal investigator, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03608423
- Sponsor's protocol ID
- NL6310007817
- Acronym
- DIST pilot
- Status last verified
- Aug 2022
- First submitted
- 30 Apr 2018
- Last updated
- 13 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
Sondag L, Schreuder FHBM, Pegge SAH, Coutinho JM, Dippel DWJ, Janssen PM, Vandertop WP, Boogaarts HD, Dammers R, Klijn CJM; Dutch ICH Surgery Trial Study Group, part of the CONTRAST consortium. Safety and technical efficacy of early minimally invasive endoscopy-guided surgery for intracerebral haemorrhage: the Dutch Intracerebral haemorrhage Surgery Trial pilot study. Acta Neurochir (Wien). 2023 Jun;165(6):1585-1596. doi: 10.1007/s00701-023-05599-2. Epub 2023 Apr 27.
PubMed 37103585Lahr MMH, Maas WJ, van der Zee DJ, Uyttenboogaart M, Buskens E. Rationale and design for studying organisation of care for intra-arterial thrombectomy in the Netherlands: simulation modelling study. BMJ Open. 2020 Jan 7;10(1):e032754. doi: 10.1136/bmjopen-2019-032754.
PubMed 31915166
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Dutch Intracerebral Hemorrhage Surgery Trial Pilot Study; Minimally-invasive Endoscopy-guided Surgery for Spontaneous Intracerebral Hemorrhage
- ClinicalTrials.gov ID
- NCT03608423
- Acronym / sponsor ID
- DIST pilot / NL6310007817
- Keywords
- Intracerebral Hemorrhage, Surgical Procedures, Minimally Invasive, Surgical Procedures, Endoscopic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 169 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- Dutch Heart Foundation, Penumbra Inc.
- Study start
- 3 Dec 2018 (actual)
- Primary completion
- 7 Apr 2022 (actual)
- Study completion
- 7 Apr 2022 (actual)
- First posted
- 1 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background:
Intracerebral hemorrhage (ICH) accounts for 15-20% 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 early blood pressure lowering there is currently no treatment of proven benefit. Important predictors of poor outcome are increasing age, decreasing Glasgow Coma Scale score, increasing ICH volume, presence of intraventricular hemorrhage and deep or infratentorial location. In addition, secondary injury due to development of edema and inflammatory response, contribute to disability and death. Surgical treatment, mostly comprising craniotomy, has so far not been proven effective. In the largest trials STICH and STICH II, the median time to treatment was more than 24 hours, which may be an important explanation for the lack of treatment effect.
The investigators hypothesize that early, minimally-invasive, endoscopy-guided surgery improves outcome in patients with spontaneous supratentorial ICH.
Objective: to study safety, feasibility and technical effectiveness of minimally-invasive endoscopy guided surgery for treatment of spontaneous supratentorial ICH and to estimate the potential effect on outcome.
Study design: a multicenter, prospective intervention study (phase II) with a telephonic follow up interview at 90 and 180 days.The pilot study serves as a prelude to a randomized phase III trial in which the investigators aim to assess whether this intervention improves functional outcome at 90 and 180 days.
Study population: patients with spontaneous supratentorial ICH of 18 years and older. Forty patients in three participating centers (Radboudumc, Erasmus MC and AMC) will undergo minimally-invasive endoscopy-guided surgery. Three-hundred-and-sixty patients undergoing standard medical treatment in one of 7 other participating centers, will be included as a control group.
Intervention: minimally-invasive endoscopy-guided surgery within 8 hours of symptom onset, in addition to standard medical management.
Primary study outcomes: safety (death within 24 hours, 7-day procedure related complications, 7-day mortality, 30-day mortality) and technical effectiveness (proportional volume reduction, proportion of participants with volume reduction > 60 and >80%, and proportion with remaining clot volume <15mL).
Secondary outcomes: modified Rankin Scale score at 90 and 180 days after ICH (functional outcome).
Detailed description
The full protocol is available at https://dutch-ich.nl/trial-protocol-and-trial-documents.html
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- We will include 40 patients in the surgical arm (inclusion in three hospitals) and aim for 120 matched controls in the other arm (in 7 other hospitals).
| Arm | Type | Receives |
|---|---|---|
| Surgical treatment | Experimental | Device: Minimally-invasive endoscopy-guided surgeryMinimally-invasive endoscopy-guided surgery or hematoma aspiration, additional to standard medical treatment. |
| Standard medical management | No intervention | –Standard medical treatment (treatment of bloodpressure, admission to stroke unit and supportive care, surgical treatment if necessary in case of deterioration) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 18
- NIHSS ≥ 2
- Supratentorial ICH confirmed by CT, without a CT-angiography confirmed causative vascular lesion (e.g. aneurysma, arteriovenous malformation [AVM], dural arteriovenous fistula [DAVF], cerebral venous sinus thrombosis [CVST]).
- Minimal lesion size 10 mL
- Intervention can be started within 8 hours from symptoms onset; or for controls presentation within 8 hours of symptom onset.
Key exclusion criteria (6 listed)
- Pre-stroke disability, which interferes with the assessment of functional outcome at 90 days, i.e. mRS > 2
- Causative vascular lesion (e.g. aneurysm, AVM, DAVF, CVST) on CT-angiography or other known underlying cause (e.g. tumor, cavernoma)
- Untreated coagulation abnormalities, including INR > 1.3 (point of care measurement allowed) and treatment with oral thrombin or factor X antagonists; patients on vitamin K antagonist can be included after correction of the INR.
- Current known severe infection for which antibiotic treatment at time of ICH symptom onset
- Patient moribund (e.g. coning, bilateral dilated unresponsive pupils)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Minimally-invasive endoscopy-guided surgeryAlso: Minimally-invasive endoscopy-guided hematoma aspirationSurgery started within 8 hours of onset of spontaneous intracerebral hemorrhage. | Device | Surgical treatment |
Primary outcome
Death within 24 hours
Time frame: 24 hours
Death within 24 hours after baseline.
Neurological deterioration within 24 hours
Time frame: 24 hours
Neurological deterioration, defined as an increase of ≥4 points on the sumscore of the NIHSS or >2 National Institutes of Health Stroke Scale (NIHSS)is a sum score, composed of 11 items, each of which scores a specific ability between 0 and 4. For each item, a score of 0 typically indicates normal function in that ability, while a higher score indicates the level of impairment. The total score varies between 0 (no symptoms at all) and 42. points on one item of NIHSS,
Proportion of volume reduction
Time frame: Baseline and 24 hours (based on the comparison baseline CT and CT at 24 hours).
The proportion of volume reduction, based on baseline CT and CT at 24 hours (in the intervention group).
10 secondary outcomes
Procedure related complications
Time frame: 7 days
Mortality at 7 days
Time frame: 7 days
Mortality at 30 days
Time frame: 30 days
Percentage of patients with clot volume reduction ≥60%
Time frame: Baseline and 24 hours CT (the difference is measured)
Percentage of patients with clot volume reduction ≥ 80%
Time frame: Baseline and 24 hours CT (the difference is measured)
Percentage of patients with remaining clot volume of ≤ 15mL
Time frame: 24 hours CT
Proportion of conversion to craniotomy
Time frame: 24 hours
Functional outcome at 3 months
Time frame: 3 months (90 days)
Functional outcome at 6 months
Time frame: 6 months (180 days)
National Institute of Health Stroke Scale (NIHSS) at 7 days or discharge
Time frame: 7 days (or at discharge from the hospital if earlier)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2022.
- Derived from this study: PubMed 37103585Sondag L, Schreuder FHBM, Pegge SAH, Coutinho JM, Dippel DWJ, Janssen PM, Vandertop WP, Boogaarts HD, Dammers R, Klijn CJM; Dutch ICH Surgery Trial Study Group, part of the CONTRAST consortium. Safety and technical efficacy of early minimally invasive endoscopy-guided surgery for intracerebral haemorrhage: the Dutch Intracerebral haemorrhage Surgery Trial pilot study. Acta Neurochir (Wien). 2023 Jun;165(6):1585-1596. doi: 10.1007/s00701-023-05599-2. Epub 2023 Apr 27.
- Derived from this study: PubMed 31915166Lahr MMH, Maas WJ, van der Zee DJ, Uyttenboogaart M, Buskens E. Rationale and design for studying organisation of care for intra-arterial thrombectomy in the Netherlands: simulation modelling study. BMJ Open. 2020 Jan 7;10(1):e032754. doi: 10.1136/bmjopen-2019-032754.
- Website of the Dutch ICH Surgery Trial pilot studyLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ruben Dammers, Dr. principal investigator
Erasmus Medical Center
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Minimally-invasive endoscopy-guided surgery in people with Intracerebral Hemorrhage and Surgical Procedures, Minimally Invasive, run by Radboud University Medical Center at 10 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Death within 24 hours (time frame: 24 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03608423, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2022.