inDividual, Targeted thrombosIS Prophylaxis Versus the Standard 'One Size Fits All' Approach in Patients Undergoing Total hIp or Total kNee replaCemenT

PHASE4RecruitingINTERVENTIONAL
Enrollment

10,078

Participants

Timeline

Start Date

November 11, 2024

Primary Completion Date

May 1, 2030

Study Completion Date

February 1, 2031

Conditions
Venous ThromboembolismVenous ThrombosesPulmonary EmbolismDeep Vein Thrombosis
Interventions
OTHER

Short duration prophylaxis

"Only during hospitalization: any type of LMWH or DOAC in a prophylactic dose as approved by the Dutch guideline Antitrombotisch beleid. First dose of LMWH within 6-24h following surgery. First dose of apixaban within 12-24h following surgery. First dose of rivaroxaban 6-10h following surgery. First dose of dabigatran within 1-4h following surgery. The applied type of anticoagulant is according to the local standard use (same type as used for control group)."

OTHER

Higher intensity and longer duration prophylaxis

"The use of any thrombocyte aggregation inhibitors should be discontinued 5 days prior to surgery. Day 0-2: any type of LMWH or DOAC in a prophylactic dose as approved by the Dutch guidelines. First dose of LMWH within 6-24h following surgery. First dose of apixaban within 12-24h following surgery. First dose of rivaroxaban 6-10h following surgery. First dose of dabigatran within 1-4h following surgery. The applied type of anticoagulant is according to the local standard use.~Day 3: Apixaban 5mg b.i.d., continued until 6 weeks after surgery, conditional on the fact that no active bleeding of the surgical wound can be observed. In case of active bleeding, the prophylactic dose of thrombosis prophylaxis is continued. Thereafter, in case no active bleeding has been observed for 24 hours, the 5mg b.i.d. apixaban treatment will be started.~The 5mg b.i.d. apixaban dose will be adjusted to 2.5mg b.i.d. in case of an impaired kidney function (defined as eGFR 10-30ml/min)."

OTHER

Control

4 weeks: any type of LMWH or DOAC in a prophylactic dose as approved by the Dutch guidelines. First dose of LMWH within 6-24h following surgery. First dose of apixaban within 12-24h following surgery. First dose of rivaroxaban 6-10h following surgery. First dose of dabigatran within 1-4h following surgery. The applied type of anticoagulant is according to the local standard use.

Trial Locations (10)

7334 DZ

RECRUITING

Gelre Ziekenhuizen, Apeldoorn

6162 BG

RECRUITING

Zuyderland, Geleen

5564EH

RECRUITING

Anna Ziekenhuis, Geldrop

4708 AE

NOT_YET_RECRUITING

Bravis ziekenhuis, Roosendaal

5022GC

RECRUITING

Elisabeth-TweeSteden Ziekenhuis, Tilburg

1091AC

RECRUITING

OLVG, Amsterdam

1411DE

RECRUITING

Bergman Clinics, Naarden

8025AB

RECRUITING

Isala ziekenhuis, Zwolle

2353 GA

RECRUITING

Alrijne, Leiderdorp

2725NA

RECRUITING

Reinier Haga Orthopedisch Centrum, Zoetermeer

All Listed Sponsors
lead

Leiden University Medical Center

OTHER