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Kosteneffectiviteit bepalen bij behandeling met mini-hart/longmachine bij kritisch zieke patiŽnten


- candidate number27591
- NTR NumberNTR6599
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR27-jul-2017
- Secondary IDs80-84300-98-81015 ZonMw
- Public TitleKosteneffectiviteit bepalen bij behandeling met mini-hart/longmachine bij kritisch zieke patiŽnten
- Scientific TitleCost-effectiveness of Extracorporeal Life Support (ECLS) Treatment
- ACRONYM
- hypothesisECLS is a cost-effective treatment
- Healt Condition(s) or Problem(s) studiedHeart failure, Lungfailure, Intensive care, Heart-lung machine
- Inclusion criteriaAll consecutive adult patients who receive ECLS in one of the participating centers
- Exclusion criteria< 18 years
not able to give informed consent
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- group[default]
- Type[default]
- Studytypeobservational
- planned startdate 1-dec-2017
- planned closingdate1-dec-2020
- Target number of participants210
- InterventionsECLS as considered appropriate
- Primary outcomeHealth related quality of life assessed with EQ-5D-5L questionnaire 12 months after initiation of ECLS treatment
- Secondary outcomeSecondary outcome is survival. Additional measurements are EQ-5D-VAS score and societal costs.
- TimepointsEQ-5D-5L + VAS at -1, +6, +12 months
iPCQ and iMTA at +6 and +12 months
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIES A. Oude Lansink
- CONTACT for SCIENTIFIC QUERIES A. Oude Lansink
- Sponsor/Initiator University Medical Center Groningen (UMCG)
- Funding
(Source(s) of Monetary or Material Support)
ZonMw
- Publications
- Brief summaryOBJECTIVE(S)/RESEARCH QUESTION(S): Extracorporeal life support (ECLS) seems an efficient therapy in terms of survival benefit, but no undisputed evidence is delivered yet. Our objective is to study whether patients actually benefit from ECLS and at what costs. HYPOTHESIS: ECLS is cost-effective.
STUDY DESIGN: Prospective cohort study.
STUDY POPULATION: All Dutch patients in the participating centers who receive ECLS in 18 mth.
INTERVENTION: ECLS as considered appropriate.
USUAL CARE /COMPARISON : Predicted mortality for every patient based on validated scoring systems at the initiation of ECLS will be compared with the actual outcome, so every patient is his own control.
PRIMARY OUTCOME MEASURES: 1) HR-QoL assessed with the EQ-5D-5L and EQ-VAS at 1 year; 2) 1 yr. survival; 3) Healthcare and societal costs.
COST-EFFECTIVENESS ANALYSIS/ BIA: The aim will be to estimate societal costs and gain of ECLS utilization. Monetary gains will be measured in terms of resumed productivity. Health gains will be measured in terms of QALYs based on EQ-5D-5L defined utilities. All medical cost items expected to be affected by the ECLS therapy will be measured and valued according to the Dutch standard guidelines for economic evaluations. The BIA will be performed from a healthcare perspective to inform decision-makers about the financial consequences of ECLS diffusion in Dutch healthcare. The model will take changes in the availability and adoption of the use of ECLS into account by calculating the financial consequences of five scenarios with a time horizon of 5-10 years.
TIME SCHEDULE: 3 years
- Main changes (audit trail)
- RECORD27-jul-2017 - 13-aug-2017


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