Dutch Intracerebral Hemorrhage Surgery Trial Pilot Study (DIST pilot)
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|ClinicalTrials.gov Identifier: NCT03608423|
Recruitment Status : Active, not recruiting
First Posted : August 1, 2018
Last Update Posted : November 10, 2021
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).
|Condition or disease||Intervention/treatment||Phase|
|Intracerebral Hemorrhage Surgical Procedures, Minimally Invasive||Device: Minimally-invasive endoscopy-guided surgery||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||400 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||The Dutch Intracerebral Hemorrhage Surgery Trial Pilot Study; Minimally-invasive Endoscopy-guided Surgery for Spontaneous Intracerebral Hemorrhage|
|Actual Study Start Date :||December 3, 2018|
|Actual Primary Completion Date :||November 1, 2021|
|Estimated Study Completion Date :||May 2022|
Experimental: Surgical treatment
Minimally-invasive endoscopy-guided surgery or hematoma aspiration, additional to standard medical treatment.
Device: Minimally-invasive endoscopy-guided surgery
Surgery started within 8 hours of onset of spontaneous intracerebral hemorrhage.
Other Name: Minimally-invasive endoscopy-guided hematoma aspiration
No Intervention: Standard medical management
Standard medical treatment (treatment of bloodpressure, admission to stroke unit and supportive care, surgical treatment if necessary in case of deterioration)
- 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).
- Procedure related complications [ Time Frame: 7 days ]The proportion of patients with procedure related complications at 7 days, including: rebleed, intracranial hemorrhage, epileptic seizures and intracranial infection. (in the intervention group)
- Mortality at 7 days [ Time Frame: 7 days ]Proportion of patients that died within 7 days after baseline
- Mortality at 30 days [ Time Frame: 30 days ]Proportion of patients that died within 30 days after baseline
- Percentage of patients with clot volume reduction ≥60% [ Time Frame: Baseline and 24 hours CT (the difference is measured) ]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)
- Percentage of patients with clot volume reduction ≥ 80% [ Time Frame: Baseline and 24 hours CT (the difference is measured) ]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)
- Percentage of patients with remaining clot volume of ≤ 15mL [ Time Frame: 24 hours CT ]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)
- Proportion of conversion to craniotomy [ Time Frame: 24 hours ]The proportion of patients in which a conversion to craniotomy was required and done. (in the intervention group)
- Functional outcome at 3 months [ Time Frame: 3 months (90 days) ]
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.
- Functional outcome at 6 months [ Time Frame: 6 months (180 days) ]
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.
- National Institute of Health Stroke Scale (NIHSS) at 7 days or discharge [ Time Frame: 7 days (or at discharge from the hospital if earlier) ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03608423
|Radboud University Medical Center|
|Nijmegen, Gelderland, Netherlands, 6525 GC|
|Academic Medical Center|
|Haaglanden Medical Center|
|Den Haag, Netherlands|
|Medisch Spectrum Twente|
|Leiden University Medical Center|
|Leiden, Netherlands, 2333 ZA|
|Maastricht University Medical Center|
|Erasmus Medical Center|
|Rotterdam, Netherlands, 3015 CE|
|Elisabeth Tweesteden Ziekenhuis|
|University Medical Center Utrecht|
|Principal Investigator:||Ruben Dammers, Dr.||Erasmus Medical Center|