Dutch Intracerebral Hemorrhage Surgery Trial Pilot Study

NCT03608423 | Completed DMC FDA Device

• 1 other identifier: NL6310007817
• Study Type: interventional
• Target: 169
• Locations: 1 country
• Sites: 10

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).

Conditions

Intracerebral Hemorrhage; Surgical Procedures, Minimally Invasive

Keywords

Intracerebral Hemorrhage; Surgical Procedures, Minimally Invasive; Surgical Procedures, Endoscopic

Outcome Measures

Primary Outcomes (3)

• Death within 24 hours

  Death within 24 hours after baseline.

  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,

  24 hours

• Proportion of volume reduction

  The proportion of volume reduction, based on baseline CT and CT at 24 hours (in the intervention group).

  Baseline and 24 hours (based on the comparison baseline CT and CT at 24 hours).

Secondary Outcomes (10)

• Procedure related complications

  7 days

• Mortality at 7 days

  7 days

• Mortality at 30 days

  30 days

• Percentage of patients with clot volume reduction ≥60%

  Baseline and 24 hours CT (the difference is measured)

• Percentage of patients with clot volume reduction ≥ 80%

  Baseline and 24 hours CT (the difference is measured)

Study Arms (2)

Surgical treatment

EXPERIMENTAL

Minimally-invasive endoscopy-guided surgery or hematoma aspiration, additional to standard medical treatment.

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)

Interventions

Minimally-invasive endoscopy-guided surgery DEVICE

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

Also known as: Minimally-invasive endoscopy-guided hematoma aspiration

Surgical treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Radboud University Medical Center: lead
• Dutch Heart Foundation: collaborator
• Penumbra Inc.: collaborator

Study Sites (10)

Radboud University Medical Center

Nijmegen, Gelderland, 6525 GC, Netherlands

Location

Academic Medical Center

Amsterdam, Netherlands

Location

Medisch Spectrum Twente

Enschede, Netherlands

Location

Leiden University Medical Center

Leiden, 2333 ZA, Netherlands

Location

Maastricht University Medical Center

Maastricht, Netherlands

Location

Erasmus Medical Center

Rotterdam, 3015 CE, Netherlands

Location

Haaglanden Medical Center

The Hague, Netherlands

Location

Elisabeth Tweesteden Ziekenhuis

Tilburg, Netherlands

Location

University Medical Center Utrecht

Utrecht, Netherlands

Location

Isala

Zwolle, Netherlands

Location

Related Publications (2)

• 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.

  PMID: 37103585 DERIVED

• 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.

  PMID: 31915166 DERIVED

Related Links

• Website of the Dutch ICH Surgery Trial pilot study

MeSH Terms

Conditions

Cerebral Hemorrhage

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ruben Dammers, Dr.

  Erasmus Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: April 30, 2018
• First Posted: August 1, 2018
• Study Start: December 3, 2018
• Primary Completion: April 7, 2022
• Study Completion: April 7, 2022
• Last Updated: October 13, 2022

Record last verified: 2022-08

Locations

NL (10)