venous thromboembolism
Conditions
Interventions
Control group A:In addition to routine VTE prophylaxis measures, GCS (graduated compression stockings) will be used postoperatively.
Control group B:In addition to routine VTE prophylaxis measures, IPC pump (manufacturer: Arjo, device model: Flowtron) will be used intraoperatively and postoperatively.
Experimental group C:In addition to routine VTE prophylaxis measures, intraoperative and postoperative NMES will be used.
Sponsors
Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: ? Participants aged 18 years or older. ? Patients scheduled for orthopedic major surgery, including total hip arthroplasty, total knee arthroplasty, and surgical fixation of hip fractures (intramedullary fixation for femoral neck, intertrochanteric, or subtrochanteric fractures). ? Preoperative Caprini risk assessment score of high risk or above (score = 3). ? Lower extremity deep veins are patent and free of thrombosis based on imaging examination. ? No use of mechanical prophylaxis measures (VFPs, IPC, or GCS) determined by the principal investigator within 10 days prior to enrollment. ? Estimated surgical duration of at least 2 hours. ? Voluntary participation in the study and signing of informed consent. In the case where the participant lacks capacity to read and sign the informed consent form, their legal guardian must go through the informed consent process and sign the form on their behalf. In the case where the participant lacks the ability to read the informed consent form (e.g., illiterate participants), a witness must be present to witness the informed consent process and sign the form.
Exclusion criteria
Exclusion criteria: ? History or signs of previous deep vein or superficial vein thrombosis/pulmonary embolism. ? Doppler ultrasound showing deep vein thrombosis (DVT). ? Peripheral arterial disease (ABPI 40 kg/m2). ? History of the following significant diseases: I. Cardiovascular: recent myocardial infarction (< 6 months); II. Percutaneous coronary intervention (PCI) with bare-metal stent (BMS) (< 3 months) or drug-eluting stent (DES) (< 12 months); III. Moderate to severe congestive heart failure, uncontrolled atrial fibrillation; IV. Neurological: stroke, hemiplegia/paraplegia, epilepsy; V. Severe skin diseases affecting the lower limbs, causing skin damage or inflammation, especially in the area where the device is installed; VI. Clinically significant blood disorders, such as coagulation disorders, sickle cell disease; VII. Mental illness. ? Use of anticoagulant therapy such as heparin or warfarin within one week prior to signing the informed consent form. ? Critically ill patients. ? Patients with mental disorders or impaired cognitive function who are unable to comply with the protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of DVT;Incidence of PE;Coagulation indicators; | — |
Secondary
| Measure | Time frame |
|---|---|
| Hemodynamics;Intraoperative blood loss and postoperative drainage volume; | — |
Countries
China
Contacts
Public ContactJingying Huang
Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
Outcome results
None listed