None listed
Conditions
Brief summary
Venous thromboembolism (VTE) (blood clotting) is a recognised risk after major surgery. Current methods to reduce this risk include chemical prophylaxis (low molecular weight heparin medication), graduated compression stockings, and intermittent pneumatic compression devices. Australian guidelines currently recommend the use of heparin along with stockings and/or compression devices after surgery, with most Australian surgeons routinely adopting all three methods. Compression devices introduce new clinical risks, increase care burden, are not well tolerated by patients, and are expensive, single-use, disposable plastic items. Further, they may prolong recovery as patients lie immobilised while wearing them. The potential to use just heparin and stockings without compression devices, as occurs in the UK, without impeding patient outcomes would therefore be more practicable and acceptable for patients and health services, as well as having added financial and environmental benefits. Our primary hypothesis: Treatment with heparin and stockings alone results in a proportion of patients with VTE by 30 days that is no greater than 2% higher than the patients randomised to receive heparin, stockings, and compression devices. This study is a clinical trial for patients undergoing major surgery at John Hunter Hospital, Calvary Mater Hospital, Gosford Hospital, Tamworth Hospital and Port Macquarie Hospital. Participants are randomly allocated using a computer to one of two groups: Group A: Participants are treated with low molecular weight heparin (LMWH) plus GCS for standard procedural timeframe plus intermittent pneumatic compression devices (IPCDs) for 5 days. Group B: Participants are treated with low molecular weight heparin (LMWH) as per standard clinical recommendations (dosing regimen depending on participant characteristics). These patients are also given below graduated compression stockings (GCS) to wear. The research nurse will contact each participant by telephone on days 30 and 90 post-surgery to collect outcome data. If participants report that they had symptoms, they will be followed up with GPs and get the ultrasound images and final diagnosis. Outcome data will be recorded for each participant, including the presence of DVT or PE (confirmed by ultrasound), clinical symptoms of DVT or PE, surgical complications, all-cause mortality at Day 30 and Day 90, length of stay in the hospital, days alive and out of the hospital, ED presentations, and any hospital readmissions due to VTE, patient-reported measures including compliance with interventions while an in-patient, sleep disturbance measures (PROMIS-SF), health professional service utilisation, QoL (EQ5D) and WHODAS-12. Removal of compression devices will have benefits for patients, staff and health services, including reduced nursing workload, early patient mobilisation, improved patient experience, reduced needless cost and reduced plastic waste.
Interventions
Group A: Participants are treated with low molecular weight heparin (LMWH) plus graduated compression stockings (GCS) for a standard procedural timeframe (see below) plus intermittent pneumatic compression devices (IPCDs) for 5 days.
Timing
Graduated compression stockings are applied by a nurse prior to surgery.
IPCDs are applied by the anaesthetic nurse in the theatre prior to surgery.
The anaesthetist gives the dose of clexane during or after surgery depending on the treating team.
Dose/Durat
Group A: Participants are treated with low molecular weight heparin (LMWH) plus graduated compression stockings (GCS) for a standard procedural timeframe (see below) plus intermittent pneumatic compression devices (IPCDs) for 5 days. Timing Graduated compression stockings are applied by a nurse prior to surgery. IPCDs are applied by the anaesthetic nurse in the theatre prior to surgery. The anaesthetist gives the dose of clexane during or after surgery depending on the treating team. Dose/Duration The dose of LMWH administration will be determined, in accordance with local hospital guidelines. This is 40mg given at night by the ward nurse and ordered by the treating team. The dose may vary due to the weight of the patient as per guidelines. The duration is dependent on the treating team. Some will be up until discharge from the hospital and some will have extended clexane prophylaxis. GCS and IPCDs are to be worn continuously every day unless bathing. For the IPCDs that are to be removed when walking. The duration of GCS is the hospital length of stay and then for 28 days. The IPCDs are to be worn up to and at day 5, unless discharged home. Strategies The administration of Clexane can be monitored through paper or digital medication charts. The research nurse at each site is responsible for checking patients twice daily for compliance. The patient is also given a simple diary that allows them to document how long they were removed. The research nurse will be responsible for checking the correct size of the GCS and the IPCDs.
Sponsors
University of Newcastle
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Investigator)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• Patient undergoing elective major surgery with major surgery defined as any operation deemed by the surgical team to be requiring admission to hospital beyond 24 hours • >18 years of age • Moderate or high risk of venous thromboembolism (VTE) based on NSW risk assessment form
Exclusion criteria
• Are unable to give written informed consent to take part in the study • are not expected to be ambulant within 24 hours • Have contraindications to LMWH • Have contraindications to GCS or IPCDs • Have had previous heparin-induced thrombocytopenia/thrombosis (HITT) • are undergoing lower leg surgery (orthopaedics) • Have active, clinically significant bleeding (Class 2 and above) i.e. volume loss of 15% to over 40% of total blood volume. • Have documented congenital or acquired bleeding tendency/disorders • Have had a recent intracranial haemorrhage or recent (less than 3 months prior to randomization) brain spinal, or ophthalmologic surgery • Have epidural or spinal anaesthesia planned • Have active peptic ulcer or treatment of same in the last three months • Have severe liver disease (Liver cirrhosis) • Have current thrombocytopenia e.g., platelets <70 • Have renal Impairment GFR <30 and or creatinine level above 2.0 mg/dL (180 µmol/L) in a well-hydrated participant • Are pregnant and/or breastfeeding women • Have evidence of leg ischemia caused by peripheral vascular disease (previously documented or on clinical assessment) • Have clinical signs of VTE and/or a history of VTE- Pulmonary embolism, Deep vein thrombosis • Have pre-existing indications for heparins (including LMWH). These are people at a high risk of getting clots, to reduce their chances of developing serious conditions such as strokes and heart attacks ie Atrial fibrillation, Pulmonary hypertension, Cardiomyopathy, Ischemic stroke, Certain congenital heart disorders, Artificial valve replacement
Outcome results
None listed