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Dutch Intracerebral Hemorrhage Surgery Trial (DIST)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03608423
Recruitment Status : Recruiting
First Posted : August 1, 2018
Last Update Posted : June 25, 2019
Sponsor:
Collaborators:
Penumbra Inc.
Netherlands Heart Foundation
Information provided by (Responsible Party):
Radboud University

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).


Condition or disease Intervention/treatment Phase
Intracerebral Hemorrhage Surgical Procedures, Minimally Invasive Device: Minimally-invasive endoscopy-guided surgery Not Applicable

Detailed Description:
The full protocol is available at https://dutch-ich.nl/trial-protocol-and-trial-documents.html

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : February 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding Endoscopy

Arm Intervention/treatment
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)



Primary Outcome Measures :
  1. Death within 24 hours [ Time Frame: 24 hours ]
    Death within 24 hours after baseline.

  2. 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,

  3. 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).


Secondary Outcome Measures :
  1. 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)

  2. Mortality at 7 days [ Time Frame: 7 days ]
    Proportion of patients that died within 7 days after baseline

  3. Mortality at 30 days [ Time Frame: 30 days ]
    Proportion of patients that died within 30 days after baseline

  4. 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)

  5. 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)

  6. 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)

  7. 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)

  8. 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.


  9. 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.


  10. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).

Information from the National Library of Medicine

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


Contacts
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Contact: Catharina JM Klijn, Prof. dr. +31 24 361 33 94 karin.klijn@radboudumc.nl
Contact: Lotte Sondag, MD +31 24 36166 00 lotte.sondag@radboudumc.nl

Locations
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Netherlands
Radboud University Medical Center Recruiting
Nijmegen, Gelderland, Netherlands, 6525 GC
Contact: Lotte Sondag, MD    +31 24 36166 00    lotte.sondag@radboudumc.nl   
Contact: Catharina JM Klijn, Prof. Dr.    +31 24 361 33 94    karin.klijn@radboudumc.nl   
Sub-Investigator: Floris HBM Schreuder, MD         
Academic Medical Center Recruiting
Amsterdam, Netherlands
Contact: W P Vandertop, Prof. Dr.         
Haaglanden Medical Center Recruiting
Den Haag, Netherlands
Contact: Jelis Boiten, Dr.         
Medisch Spectrum Twente Recruiting
Enschede, Netherlands
Contact: M H Den Hertog, Dr.         
Leiden University Medical Center Recruiting
Leiden, Netherlands, 2333 ZA
Contact: Marieke JM Wermer, Dr.         
Maastricht University Medical Center Recruiting
Maastricht, Netherlands
Contact: Inger De Ridder, Dr.         
Erasmus Medical Center Recruiting
Rotterdam, Netherlands, 3015 CE
Contact: Ruben Dammers, Dr.    +31 10 704 0704    r.dammers@erasmusmc.nl   
Contact: Paula M Janssen, MD.    +31 10 704 0704    p.m.janssen@erasmusmc.nl   
Elisabeth Tweesteden Ziekenhuis Recruiting
Tilburg, Netherlands
Contact: Paul LM De Kort, Dr.         
University Medical Center Utrecht Recruiting
Utrecht, Netherlands
Contact: A. Van der Zwan, Prof. Dr.         
Isala Recruiting
Zwolle, Netherlands
Contact: Heleen den Hertog, PHD         
Sponsors and Collaborators
Radboud University
Penumbra Inc.
Netherlands Heart Foundation
Investigators
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Principal Investigator: Ruben Dammers, Dr. Erasmus Medical Center
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Radboud University
ClinicalTrials.gov Identifier: NCT03608423    
Other Study ID Numbers: NL6310007817
First Posted: August 1, 2018    Key Record Dates
Last Update Posted: June 25, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Keywords provided by Radboud University:
Intracerebral Hemorrhage
Surgical Procedures, Minimally Invasive
Surgical Procedures, Endoscopic
Additional relevant MeSH terms:
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Cerebral Hemorrhage
Hemorrhage
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases