After total knee arthroplasty (TKA) surgery, patients are at risk to develop venous thromboembolism (VTE). Two novel agents, dabigatran and rivaroxaban, recently gained market authorisation for prevention of venous thromboembolism after knee arthroplasty. Our aim is to compare the long term use of dabigatran and rivaroxaban versus nadroparin on safety after total knee arthroplasty (TKA)
Conditions
Interventions
Trade Name: Pradaxa
Product Name: dabigatran etexilate
Pharmaceutical Form: Capsule
INN or Proposed INN: DABIGATRAN ETEXILATE
CAS Number: 211915-06-9
Current Sponsor code: pradaxa
Other descriptive na
Sponsors
Martini Hospital Groningen
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients > 18 years and weighing more than 40 kg who are scheduled for primary elective total knee arthroplasty according to the ‘joint care program’ and want to provided signed informed consent are eligible for the study. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 75 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 75
Exclusion criteria
Exclusion criteria: Patients will be excluded if they meet one of the following exclusion criteria. -a known inherited or acquired clinically significant active high risk of bleeding or bleeding disorder; -major surgery, trauma, uncontrolled severe arterial hypertension, or myocardial infarction within the last 3 months; -history of acute intracranial disease or hemorrhagic stroke; -gastrointestinal or urogenital bleeding or ulcer disease within the last 6 months; -cirrhotic patients with moderate hepatic impairment (aspartate or alanine aminotransferase (AST, ALT) levels higher than 2x the upper limit of the normal range (ULN) within the last month); -severe renal insufficiency (creatinine clearance < 30 mL/min); -treatment with anticoagulants during study drug treatment; -active malignant disease; -pregnancy or breastfeeding; -and unable to give informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to compare the clinical safety with long term use of the oral once daily unmonitored thrombin inhibitors dabigatran and rivaroxaban versus subcutaneously administered nadroparin by observing the incidence of major bleeding and clinically relevant non-major bleeding in patients after knee arthroplasty surgery.;Secondary Objective: The secondary objectives of this study are effectivity of the agents, time till bleeding event, compliance, hospital stay, re-hospitalisation, outpatient clinic visits and interventions following complications. Additionally, coagulation monitoring, knee flexion range of motion, Knee injury and Osteoarthritis Outcome Score (KOOS), Knee Society Score (KSS) and relationship between health statuses and surgery parameters will be evaluated.;Primary end point(s): The primary endpoint of this study is the clinical safety with long term use of the oral once daily unmonitored thrombin inhibitors dabigatran and rivaroxaban versus subcutaneously administered nadroparin by observing the incidence of major bleeding and clinically relevant non major bleeding in patients after knee arthroplasty surgery.;Timepoint(s) of evaluation of this end point: After closure of the clinical trial a blinded committee will score bleeding events independently by defining the observed bleeding by the orthopaedic surgeon and the patient information. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary endpoints of this study are effectivity of the agents (occurrence of PE or DVT), time till bleeding event, compliance, hospital stay, re-hospitalisation, outpatient clinic visits and interventions following complications. ;Timepoint(s) of evaluation of this end point: After closure of the clinical trial a blinded committee will score bleeding events independently by defining the observed bleeding by the orthopaedic surgeon and the patient information. | — |
Countries
Netherlands
Contacts
Public ContactLucia van der Veen
Martini Hospital Groningn
Outcome results
None listed