Venous Thromboembolism Clinical Trial
Official title:
A Randomized Pilot Study Comparing the Safety of DAbigatran and RIvaroxaban Versus NAdroparin in the Prevention of Venous Thromboembolism After Knee Arthroplasty Surgery
Rationale:
After total knee arthroplasty (TKA) surgery, patients are at risk to develop venous
thromboembolism (VTE) or deep venous thrombosis (DVT) potentially resulting in a fatal
pulmonary embolism (PE). Two novel agents, dabigatran and rivaroxaban, recently gained market
authorisation for prevention of venous thromboembolism after knee arthroplasty.
However, there are no clinical trials with dabigatran and/or rivaroxaban and the comparator
nadroparin.
Nadroparin is used in the most Dutch departments of orthopaedic surgery after total knee
arthroplasty. Also safety of the new oral agents with long term use of 42 days is not
available for total knee arthroplasty.
Our aim is to compare the long term use of dabigatran and rivaroxaban versus nadroparin on
safety after total knee arthroplasty (TKA) in a clinical explorative pilot study by observing
the incidence of major bleeding and clinical relevant non-major bleeding using a standardized
model of bleeding definitions.
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
subcutaneous administered nadroparin by observing the incidence of major bleeding and
clinical relevant non-major bleeding in patients after knee arthroplasty surgery.
The secondary objectives of this study are effectivity of the agents, 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.
Study design:
The study is designed as non-inferiority randomized open label controlled pilot study. A
total of 150 patients will be included, 50 patients in each treatment group (dabigatran,
rivaroxaban and nadroparin).
Study population:
Patients ≥ 18 years and weighing more than 40 kg, participate in the 'joint care program' for
primary elective total knee arthroplasty and want to provide signed informed consent are
eligible for the study.
Intervention:
Patients receive subcutaneously nadroparin or oral rivaroxaban or oral dabigatran after knee
replacement surgery.
Main study parameters/endpoints:
The primary safety outcome is the incidence of bleeding events occurring during the study
period of 135 days (including follow-up). Major bleeding events and clinically relevant
non-major bleeding events were defined according to accepted guidelines.
n/a
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