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Dutch Intracerebral Hemorrhage Surgery Trial; Minimally-invasive endoscopy-guided surgery for intracerebral hemorrhage: Analysis of Budget-impact and Cost-effectiveness (DIST- ABC) - a CONTRAST study.

Projectomschrijving

Elk jaar krijgen meer dan 6000 Nederlanders een hersenbloeding. Een hersenbloeding is de meest ernstige vorm van een beroerte: Vier op de tien patiënten overlijdt binnen een maand en van degenen die overleven blijft een groot deel afhankelijk van zorg. Er zijn op dit moment weinig effectieve behandelingen. Operatief verwijderen van de hersenbloeding waarbij de schedel wordt gelicht vergroot de kans op goed herstel niet.
De laatste jaren is een minimaal-invasieve endoscopie-geleide operatie ontwikkeld voor patiënten met een hersenbloeding. Hierbij wordt de hersenbloeding verwijderd met een kijkoperatie via een klein gaatje in de schedel. Recent onderzoek toont aan dat deze ingreep veilig is en dat het lukt om gemiddeld bijna 80% van de hersenbloeding weg te halen.
Samen met neurologen en neurochirurgen uit heel Nederland onderzoeken wij of de nieuwe operatie ook leidt tot beter herstel, vergeleken met de standaardbehandeling. Daarnaast onderzoeken wij of deze behandeling betaalbaar is voor de maatschappij.

Meer informatie

Bekijk informatie over dit project op de website van Zorginstituut Nederland en de bijbehorende richtlijn in de FMS Richtlijnendatabase

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Samenvatting van de aanvraag

RESEARCH QUESTION Intracerebral hemorrhage (ICH) is the deadliest stroke subtype with a 30-day case fatality of 40%. Of patients surviving, only few gain independence. Besides the effect of stroke unit care and early control of elevated blood pressure that may be beneficial, there are no medical or surgical treatments with proven benefit. ICH volume is an important predictor of functional outcome, but previous randomized clinical trials could not demonstrate that diminishing this volume by surgery improves functional outcome. In a recent years, evidence has accumulated that minimally-invasive surgery may improve functional outcome after supratentorial ICH. In a systematic review and meta-analysis, we showed that this treatment might be effective in particular when performed early after symptom onset. We propose a new surgical treatment with a minimally-invasive endoscopy-guided technique applied within 8 hours after symptom onset. We have recently completed a pilot study demonstrating that this treatment is feasible, safe, and effective in reducing the hematoma volume. Our next step is to fill the knowledge gap of whether this promising treatment improves functional outcome and is cost-effective. We will perform a randomized controlled trial with blinded outcome assessment in adult patients with spontaneous ICH, to investigate whether minimally-invasive endoscopy-guided surgery within 8 hours of symptom onset, in addition to standard medical management, improves functional outcome after 6 months when compared to standard medical management alone. In addition, we will assess cost-effectiveness and perform a budget-impact analysis. The results of this study will provide guideline changing evidence and will, when positive, provide for the first time an effective treatment opportunity for adult patients with this severe stroke type. HYPOTHESIS We hypothesize that minimally-invasive endoscopy-guided surgery for supratentorial ICH improves functional outcome, adds QALYs, and saves costs compared with standard medical management alone. STUDY POPULATION 600 adult patients with non-traumatic supratentorial ICH, with a volume of >=10mL, NIHSS >=2 and ICH-GS of 5-10. Patients with a vascular malformation, cerebral venous sinus thrombosis or known tumor as cause of their ICH will be excluded. 44 hospitals in the Netherlands will participate, with surgery performed in 11 hospitals with neurosurgical expertise and patient referrals from 33 additional participating centres. INTERVENTION Patients will be randomized (1:1) to minimally-invasive endoscopy-guided surgery performed within 8 hours of symptom onset in addition to standard medical management, or standard medical management alone. COMPARISON Standard medical management alone. OUTCOMES Primary outcome measure: The modified Rankin scale (mRS) score at 180 days. Treatment effect will be estimated with ordinal logistic regression analysis as common odds ratio, adjusted for prespecified prognostic factors. Secondary outcome measures include: - The ordinal shift on the mRS at 90 days - Favourable outcome defined as mRS at 180 days of 0-2, of 0-3, and of 0-4 - Favourable outcome at 90 days (mRS 0-2, 0-3, and 0-4) - Death at 90 days, at 180 days, and at 1 year - Generic quality of life measured with the EuroQol 5 Dimensions 5 level version (EQ-5D-5L) at 90 and 180 days and 1 year - Performance in activities of daily living measured with the Barthel index at 90 and 180 days and 1 year - Stroke-specific quality of life measured with, the Stroke-specific quality of life scale (SSQoL) at 90 and 180 days and 1 year - Resource use measured with the iMTA Medical Consumption Questionnaire (iMCQ) en iMTA Productivity Cost Questionnaire at 90 and 180 days and 1 year - Burden for the caregiver measured with the iMTA Valuation of Informal Care Questionnaire (iVICQ) at 90 and 180 days and 1 year FOLLOW-UP TIME 12 months. STUDY DESIGN Multicenter, prospective, randomized, open, blinded end-point clinical trial and cost-effectiveness and budget impact study. SAMPLE SIZE & DATA ANALYSIS Based on an estimated effect that minimally-invasive endoscopy-guided surgery will result in a favorable treatment effect with a common odds ratio of 1.49 over all mRS categories, we will need a sample size of 800, providing a 90% power with two-sided alpha=0.05. Covariate adjustment will reduce the sample size with 25%. Therefore we aim to include 600 patients (300 in each arm). COST-EFFECTIVENESS ANALYSIS / BUDGET IMPACT ANALYSIS For the cost-effectiveness analysis we will measure incremental cost-effectiveness ratios by dividing estimated differences in costs on a 1 year horizon by differences in quality-adjusted life years (QALY), based on the EQ-5D-5L questionnaire. Hospital costs will be recorded using case record forms and other resource use will be estimated by iMCQ and iPCQ questionnaires. Budget impact analysis will be performed according to ISPOR and ZonMw guidelines, adopting at least a hospital and societal perspective.

Kenmerken

Projectnummer:
2021038368
Looptijd: 35%
Looptijd: 35 %
2022
2027
Onderdeel van programma:
Gerelateerde subsidieronde:
Projectleider en penvoerder:
CJM Klijn
Verantwoordelijke organisatie:
Radboud Universitair Medisch Centrum