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Dutch Intracerebral Hemorrhage Surgery Trial Pilot Study (DIST pilot)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03608423
Recruitment Status : Completed
First Posted : August 1, 2018
Last Update Posted : August 24, 2022
Sponsor:
Collaborators:
Dutch Heart Foundation
Penumbra Inc.
Information provided by (Responsible Party):
Radboud University Medical Center

Tracking Information
First Submitted Date  ICMJE April 30, 2018
First Posted Date  ICMJE August 1, 2018
Last Update Posted Date August 24, 2022
Actual Study Start Date  ICMJE December 3, 2018
Actual Primary Completion Date April 7, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 6, 2018)
  • 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).
Original Primary Outcome Measures  ICMJE
 (submitted: July 23, 2018)
  • 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 indicatesthe 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).
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 6, 2018)
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: July 23, 2018)
  • Procedure related complications [ Time Frame: 7 days ]
    The proportion of patients with procedure related complications at 7 days, inlcuding: 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 indicatesthe level of impairment. The total score varies between 0 (no symptoms at all) and 42.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Dutch Intracerebral Hemorrhage Surgery Trial Pilot Study
Official Title  ICMJE The Dutch Intracerebral Hemorrhage Surgery Trial Pilot Study; Minimally-invasive Endoscopy-guided Surgery for Spontaneous Intracerebral Hemorrhage
Brief 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. 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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Intracerebral Hemorrhage
  • Surgical Procedures, Minimally Invasive
Intervention  ICMJE 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
Study Arms  ICMJE
  • Experimental: Surgical treatment
    Minimally-invasive endoscopy-guided surgery or hematoma aspiration, additional to standard medical treatment.
    Intervention: Device: Minimally-invasive endoscopy-guided surgery
  • 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)
Publications * Lahr 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 23, 2022)
169
Original Estimated Enrollment  ICMJE
 (submitted: July 23, 2018)
400
Actual Study Completion Date  ICMJE April 7, 2022
Actual Primary Completion Date April 7, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Age ≥ 18
  2. NIHSS ≥ 2
  3. 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]).
  4. Minimal lesion size 10 mL
  5. Intervention can be started within 8 hours from symptoms onset; or for controls presentation within 8 hours of symptom onset.
  6. Patient's or legal representative's written informed consent

Exclusion Criteria:

  1. Pre-stroke disability, which interferes with the assessment of functional outcome at 90 days, i.e. mRS > 2
  2. Causative vascular lesion (e.g. aneurysm, AVM, DAVF, CVST) on CT-angiography or other known underlying cause (e.g. tumor, cavernoma)
  3. 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.
  4. Current known severe infection for which antibiotic treatment at time of ICH symptom onset
  5. Patient moribund (e.g. coning, bilateral dilated unresponsive pupils)
  6. Pregnancy (note: most patients will be beyond child bearing age; if not a pregnancy test is mandatory).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03608423
Other Study ID Numbers  ICMJE NL6310007817
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Current Responsible Party Radboud University Medical Center
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Radboud University Medical Center
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • Dutch Heart Foundation
  • Penumbra Inc.
Investigators  ICMJE
Principal Investigator: Ruben Dammers, Dr. Erasmus Medical Center
PRS Account Radboud University Medical Center
Verification Date August 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP