total hip and knee arthroplasty
Conditions
Interventions
Group A:Receiving fondaparinux sodium for the thromboembolic prophylaxis after total hip and knee arthroplasty
Sponsors
The First Affiliated Hospital of Chongqing Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1) Male or female subjects, at least 18 years old; 2) Patients who plan to undergo elective primary total myelopathy or total knee arthroplasty meet the surgical indications; 3) There was no venous thrombotic disease before operation; 4) The subject or legal representative has been informed of the nature of the study, understands the provisions of the protocol, can ensure compliance, and signs the informed consent form.
Exclusion criteria
Exclusion criteria: 1) The creatinine clearance rate of patients with active bleeding or high-risk factors of bleeding, bleeding tendency, or the risk of massive bleeding after surgery according to the evaluation standard for risk factors of massive bleeding complications in surgical inpatients is less than 20ml / min; 2) Preoperative color Doppler ultrasound showed deep venous thrombosis of lower limbs 3) Those who had received anticoagulation therapy, antiplatelet therapy, fibrinolysis therapy within one week before operation; 4) Those who plan to undergo total hip and knee arthroplasty by stages and have a history of DVT (deep vein thrombosis); 5) Allergic to the study drug fondaparinux or similar drugs (heparin, other low molecular weight heparin drugs) or have a history of allergic diseases; 6) Patients who have severe coagulation dysfunction or active bleeding after operation and cannot receive postoperative prophylactic anticoagulation treatment according to this research process. (for example, patients with decreased blood pressure, weak pulse, wet and cold limbs, decreased urine and other circulatory system dysfunction or even shock and other highly suspected symptoms of active massive hemorrhage); 7) Patients with prothrombin activity <60%, platelet <100 x 109/l or hemoglobin <100 g/l, or unexplained thrombocytopenia after drug use or suspected hit (heparin induced thrombocytopenia) 8) Patients with major diseases such as bacterial endocarditis, hemorrhagic stroke and advanced tumor; 9) Have serious heart disease, liver and kidney dysfunction, lung disease. 10) Have participated in the study of other drugs / devices or during the follow-up of another drug / device study; 11) Patients may not comply with the study protocol (including the follow-up period), such as mental disorders, alcohol or drug abuse.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| VTE rate;Bleeding events;All-cause mortality; | — |
Secondary
| Measure | Time frame |
|---|---|
| Anti-Factor Xa activity (aFXa);Routine coagulation parameters(PT?PTR?INR?PTA?APTTTT);Routine fibrinolysis parameters (FDP?D-D);Thromboelastogram(TEG);Minor bleeding and wound complications (exudation, hematoma, infection);Intra-operative bleeding;Adverse Events;Gender;Age;Height;Weight;Surgical side;Surgery type;Major diagnosis;Hospitalization expenses;Length of stay; | — |
Countries
China
Contacts
Public ContactWei Huang
The First Affiliated Hospital of Chongqing Medical University
Outcome results
None listed