This clinical study aims to evaluate the efficacy and safety of the anticoagulant Dimolegin® compared to low molecular weight heparin (Clexane®) for the prevention of venous thromboembolic events (VTE) in patients undergoing major joint (hip or knee) replacement surgery. The study will assess the incidence of VTE, VTE-related mortality, and all-cause mortality during different follow-up periods in both treatment groups. Additionally, the study will evaluate the frequency of bleeding events and the incidence, number, and characteristics of all adverse events associated with Dimolegin® and Clexane® therapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
215
Subgroup 2A (Hip Arthroplasty): Patients undergoing total hip arthroplasty will receive Clexane® subcutaneously administered 12±1 hours before surgery starting 6-10 hours after surgery everyday for 35±2 days. Subgroup 2B (Knee Arthroplasty): Patients undergoing total knee arthroplasty will receive Clexane® subcutaneously administered 12±1 hours before surgery everyday for 14±1 days.
Subgroup 1A (Hip Arthroplasty): Patients undergoing total hip arthroplasty will receive Dimolegin® starting 6-10 hours after surgery everyday for 35±2 days. Subgroup 1B (Knee Arthroplasty): Patients undergoing total knee arthroplasty will receive Dimolegin® starting 6-10 hours after surgery everyday for 14±1 days.
Subgroup 2A (Hip Arthroplasty): Patients undergoing total hip arthroplasty will receive placebo Dimolegin® starting 6-10 hours after surgery everyday for 35±2 days. Subgroup 2B (Knee Arthroplasty): Patients undergoing total knee arthroplasty will receive placebo Dimolegin® starting 6-10 hours after surgery everyday for 14±1 days.
Subgroup 1A (Hip Arthroplasty): Patients undergoing total hip arthroplasty will receive palcebo Clexane® subcutaneously administered 12±1 hours before surgery starting 6-10 hours after surgery everyday for 35±2 days. Subgroup 2B (Knee Arthroplasty): Patients undergoing total knee arthroplasty will receive placebo Clexane® subcutaneously administered 12±1 hours before surgery everyday for 14±1 days.
Bryansk City Hospital No. 1
Bryansk, Russia
I.M. Sechenov First Moscow State Medical University (Sechenov University)
Moscow, Russia
Privolzhsky Research Medical University
Nizhny Novgorod, Russia
Rostov State Medical University
Rostov-on-Don, Russia
Ryazan State Medical University named after academician I.P. Pavlov
Ryazan, Russia
Samara Regional Clinical Hospital named after V.D. Seredavin
Samara, Russia
National Research Ogarev Mordovia State University
Saransk, Russia
Saratov State Medical University named after V. I. Razumovsky
Saratov, Russia
Composite endpoint i.e.: confirmed symptomatic DVT, asymptomatic DVT, non fatal PE, death of all causes
Time frame: up to the follow-up visit (28±2 days after the end of therapy)
Composite endpoint i.e.: confirmed symptomatic DVT, asymptomatic DVT, non fatal PE, death due to thrombosis
Time frame: up to the follow-up visit (28±2 days after the end of therapy)
Switching to other anticoagulant therapy
Time frame: up to the follow-up visit (28±2 days after the end of therapy)
Incidence of DVT (proximal, distal)
Time frame: up to the follow-up visit (28±2 days after the end of therapy)
Incidence of non fatal PE
Time frame: up to the follow-up visit (28±2 days after the end of therapy)
Incidence of symptomatic VTE
Time frame: up to the follow-up visit (28±2 days after the end of therapy)
Death due to VTE
Time frame: up to the follow-up visit (28±2 days after the end of therapy)
Death of all causes
Time frame: up to the end of therapy (for subgroup A - up to 14±1 days, for subgroup B - up to 35±2 days)
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