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NCT Number: NCT03608423

Dutch Intracerebral Hemorrhage Surgery Trial Pilot Study

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).

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Key information

Conditions

Intracerebral Hemorrhage Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebral Hemorrhage Cerebrovascular Disorders Hemorrhage Intracranial Hemorrhages Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Surgical Procedures, Minimally Invasive Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Radboud University Medical Center, Nijmegen, Gelderland, Netherlands

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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).

Treatment and study plan

Minimally-invasive endoscopy-guided surgery

Device

Surgery started within 8 hours of onset of spontaneous intracerebral hemorrhage.

Other names: Minimally-invasive endoscopy-guided hematoma aspiration

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Radboud University Medical Center

Other

Collaborators

  • Dutch Heart Foundation
  • Penumbra Inc.

Registry information

Official study title

The Dutch Intracerebral Hemorrhage Surgery Trial Pilot Study; Minimally-invasive Endoscopy-guided Surgery for Spontaneous Intracerebral Hemorrhage

Acronym: DIST pilot

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Aug 1, 2018
Registry last updated
Oct 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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