10,078
Participants
Start Date
November 11, 2024
Primary Completion Date
May 1, 2030
Study Completion Date
February 1, 2031
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)."
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)."
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.
RECRUITING
Gelre Ziekenhuizen, Apeldoorn
RECRUITING
Zuyderland, Geleen
RECRUITING
Anna Ziekenhuis, Geldrop
NOT_YET_RECRUITING
Bravis ziekenhuis, Roosendaal
RECRUITING
Elisabeth-TweeSteden Ziekenhuis, Tilburg
RECRUITING
OLVG, Amsterdam
RECRUITING
Bergman Clinics, Naarden
RECRUITING
Isala ziekenhuis, Zwolle
RECRUITING
Alrijne, Leiderdorp
RECRUITING
Reinier Haga Orthopedisch Centrum, Zoetermeer
Leiden University Medical Center
OTHER