|- candidate number||27591|
|- NTR Number||NTR6599|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||27-jul-2017|
|- Secondary IDs||80-84300-98-81015 ZonMw|
|- Public Title||Kosteneffectiviteit bepalen bij behandeling met mini-hart/longmachine bij kritisch zieke patiŽnten|
|- Scientific Title||Cost-effectiveness of Extracorporeal Life Support (ECLS) Treatment|
|- hypothesis||ECLS is a cost-effective treatment|
|- Healt Condition(s) or Problem(s) studied||Heart failure, Lungfailure, Intensive care, Heart-lung machine|
|- Inclusion criteria||All consecutive adult patients who receive ECLS in one of the participating centers|
|- Exclusion criteria||< 18 years |
not able to give informed consent
|- mec approval received||yes|
|- multicenter trial||yes|
|- planned startdate ||1-dec-2017|
|- planned closingdate||1-dec-2020|
|- Target number of participants||210|
|- Interventions||ECLS as considered appropriate|
|- Primary outcome||Health related quality of life assessed with EQ-5D-5L questionnaire 12 months after initiation of ECLS treatment|
|- Secondary outcome||Secondary outcome is survival. Additional measurements are EQ-5D-VAS score and societal costs.|
|- Timepoints||EQ-5D-5L + VAS at -1, +6, +12 months |
iPCQ and iMTA at +6 and +12 months
|- Trial web site|
|- CONTACT FOR PUBLIC QUERIES|| A. Oude Lansink|
|- CONTACT for SCIENTIFIC QUERIES|| A. Oude Lansink|
|- Sponsor/Initiator ||University Medical Center Groningen (UMCG)|
(Source(s) of Monetary or Material Support)
|- Brief summary||OBJECTIVE(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)|
|- RECORD||27-jul-2017 - 13-aug-2017|