Acute critical illness requiring intensive care unit admission.
Conditions
Brief summary
Each domain in INCEPT will use one of the outcomes listed below under 'secondary end points' as the primary - the primary outcome will thus differ between domains, but always be one of the secondary outcomes (the core outcome set defined in the core protocol).
Detailed description
All-cause 30-day mortality, All-cause 90-day mortality, All-cause 180-day mortality, Days alive without life support at day 30, Days alive without life support at day 90, Days alive out of hospital at day 30, Days alive out of hospital at day 90, Days free of delirium at day 30, EQ-5D-5L index values (health-related quality of life) at day 180, EQ VAS (health-related quality of life) at day 180, Cognitive function at day 180 (Montreal Cognitive Assessment test 5-minute version, v2.1 [“Mini MoCA”]), One or more domain-specific safety outcomes
Interventions
DRUGFragmin
DRUGinjektionsvæske
DRUGopløsning i fyldt injektionssprøjte med nålebeskytter
DRUGinfusionsvæske
DRUGopløsning 20 %
DRUGInnohep
DRUGopløsning i fyldt injektionssprøjte 2.500 anti-Xa IE
DRUGFraxiparine 2.850 IE/ 0
DRUG3 ml oplossing voor injectie
DRUGEnoxaparin "Becat"
DRUGopløsning 5 %
Sponsors
Rigshospitalet
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Each domain in INCEPT will use one of the outcomes listed below under 'secondary end points' as the primary - the primary outcome will thus differ between domains, but always be one of the secondary outcomes (the core outcome set defined in the core protocol). | — |
Secondary
| Measure | Time frame |
|---|---|
| All-cause 30-day mortality, All-cause 90-day mortality, All-cause 180-day mortality, Days alive without life support at day 30, Days alive without life support at day 90, Days alive out of hospital at day 30, Days alive out of hospital at day 90, Days free of delirium at day 30, EQ-5D-5L index values (health-related quality of life) at day 180, EQ VAS (health-related quality of life) at day 180, Cognitive function at day 180 (Montreal Cognitive Assessment test 5-minute version, v2.1 [“Mini MoCA”]), One or more domain-specific safety outcomes | — |
Countries
Denmark
Outcome results
None listed