Venous Thromboembolism Clinical Trial
— DARINAOfficial title:
A Randomized Pilot Study Comparing the Safety of DAbigatran and RIvaroxaban Versus NAdroparin in the Prevention of Venous Thromboembolism After Knee Arthroplasty Surgery
NCT number | NCT01431456 |
Other study ID # | DARINA |
Secondary ID | |
Status | Completed |
Phase | Phase 3 |
First received | |
Last updated | |
Start date | September 2013 |
Est. completion date | October 2014 |
Verified date | June 2018 |
Source | Martini Hospital Groningen |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 148 |
Est. completion date | October 2014 |
Est. primary completion date | October 2014 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 110 Years |
Eligibility |
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. 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. |
Country | Name | City | State |
---|---|---|---|
Netherlands | Martini Ziekenhuis | Groningen |
Lead Sponsor | Collaborator |
---|---|
Martini Hospital Groningen |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Major and clinically relevant non-major bleeding | 135 days |
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