Low‐Molecular‐Weight Heparin for Adult Intensive Care Unit (ICU) Patients Who Require Thromboprophylaxis: Protocol for the Intensive Care Platform Trial (INCEPT) ‐Thromboprophylaxis Platform Trial Domain
Study context
- Population
- Adult acutely admitted ICU patients with an indication for thromboprophylaxisplanned max 10,000
- Planned comparison
- Fixed low dose vs Fixed intermediate dose vs Weight-adjusted dose
- Primary endpoint
- Days alive out of hospital
- Follow-up
- 30 days
Methodological detailsINCEPT platform trial, investigator-initiated, open-label, integrated feasibility phase, international, pragmatic, parallel-group, embedded, multifactorial, adaptive, Bayesian, response-adaptive randomisation, Feasibility assessed after 300 participants; adaptive analyses after 1500 participants and every additional 500 to a max of 10,000, Adaptive stopping for superiority/inferiority and practical equivalence (MD in primary outcome < 1 day); adaptive arm-dropping, Equal allocation initially, then response-adaptive randomisation with minimum 25% allocation per arm, Expected sample sizes 2265 to 4892, ≈100% probabilities of conclusiveness, Primary analysis in ITT population, Bayesian models with neutral, weakly informative priors
- INCEPT platform trial
- Investigator-initiated
- Open-label
- Integrated feasibility phase
- International
- Pragmatic
- Parallel-group
- Embedded
- Multifactorial
- Adaptive
- Bayesian
- Response-adaptive randomisation
- Feasibility assessed after 300 participants; adaptive analyses after 1500 participants and every additional 500 to a max of 10,000
- Adaptive stopping for superiority/inferiority and practical equivalence (MD in primary outcome < 1 day); adaptive arm-dropping
- Equal allocation initially, then response-adaptive randomisation with minimum 25% allocation per arm
- Expected sample sizes 2265 to 4892, ≈100% probabilities of conclusiveness
- Primary analysis in ITT population, Bayesian models with neutral, weakly informative priors
No results yet. This paper sets out the design of a trial; its results are to come.
Original publication
Low‐Molecular‐Weight Heparin for Adult ICU Patients Who Require Thromboprophylaxis: Protocol for the INCEPT ‐Thromboprophylaxis Platform Trial Domain. Acta Anaesthesiol Scand. Published 30 January 2026. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →