DISTINCT: inDividual, targeted thrombosIS prophylaxis versus the standard ‘one size fits all’ approach in patients undergoing Total hIp or total kNee replaCemenT: a national, multicenter, randomized, multi-arm, open-label trial

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-510186-98-00

Enrollment

10078

Registered

2024-08-12

Start date

2024-10-23

Completion date

Unknown

Last updated

2025-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Venous thromboembolism

Brief summary

Number of VTEs in the first 3 months postoperative, Number of major bleeds in the first 3 months postoperative.

Detailed description

Clinically relevant non major bleeding, Impact of events on QALY’s, Healthcare costs, Prosthetic joint infections, Patient reported outcome measures, Myocardial infarction, Ischemic stroke, Death

Interventions

DRUGNADROPARIN CALCIUM

DRUGAPIXABAN

DRUGANDEXANET ALFA

DRUGDALTEPARIN SODIUM

DRUGCofact 500 IE poeder en oplosmiddel voor oplossing voor injectie.

DRUGDABIGATRAN

DRUGENOXAPARIN SODIUM

DRUGRIVAROXABAN

DRUGCofact 250 IE poeder en oplosmiddel voor oplossing voor injectie.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Number of VTEs in the first 3 months postoperative, Number of major bleeds in the first 3 months postoperative.	—

Secondary

Measure	Time frame
Clinically relevant non major bleeding, Impact of events on QALY’s, Healthcare costs, Prosthetic joint infections, Patient reported outcome measures, Myocardial infarction, Ischemic stroke, Death	—

Countries

Netherlands

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026