None listed
Conditions
Brief summary
One of the risks of having surgery is the formation of a blood clot in a vein in the body. These may form in the deep veins in the legs especially, this kind of clot is called a “thrombus” and if it moves to another part of the body it is then called an “embolus”. Developing a blood clot is a major complication of surgery and at its worst may be life-threatening, and at its best in some cases you may not even know you have a clot as there are no signs and symptoms. Part of the usual care of a person having a surgical procedure is to try and stop these clots forming by using 3 treatments or a combination of these 3 treatments: • Compression stockings (commonly known as TED stockings) • Intermittent pneumatic compression devices (IPCDs). These are disposable and inflatable “sleeves” and are applied to your legs at the time of operation by wrapping around your lower legs and are connected to a pump to inflate and deflate continuously to help move blood from your lower legs back to your heart. • Injection of an anti-blood clotting drug called Clexane® under the skin daily, up to 28 days from surgery (extended Clexane® injections is not for all patients). For this “pilot” the research team are wanting to know if they are able to get sufficient patients to a 30 day ultrasound of both legs.
Interventions
Prior to surgery the patient will be randomised to either the intervention or control group. When in the operating theatre the intervention group will have compressions stockings plus low molecular weight heparin plus intermittent pneumatic compression devices placed on their legs and device commenced. The control group will have only have the compression stockings and standard dose of Low molecular weight heparin. After surgery both groups will follow standard treatment. IPCDs are a therapeutic technique used in medical devices that include an air pump and inflatable auxiliary sleeves in a system designed to improve venous circulation in the limbs of patients who suffer edema or the risk of deep vein thrombosis (DVT) or pulmonary embolism (PE). The intervention group will have the intermittent pneumatic devices still on legs and only taken off for walking and showering. The standard dose of low molecular weight heparin (LMWH) is 40mg by subcutaneous injection once a day for the length of hospital stay. IPCDs are a therapeutic technique used in medical devices that include an air pump and inflatable auxiliary sleeves in a system designed to improve venous circulation in the limbs of patients who suffer edema or the risk of deep vein thrombosis (DVT) or pulmonary embolism (PE). Compression stockings are elastic garments worn around the leg, compressing the limb. This reduces the diameter of distended veins and increases venous blood flow velocity and valve effectiveness. Knee-high compression stockings are used not only to help increase circulation, but also to help prevent the formation of blood clots in the lower legs. The GCS in both groups are to be worn at all times except when showering or if soiled. The IPCDs are to be removed if walking, showering or soiled and in this case need to be replaced. The group wearing the IPCDs will not have to them after discharge. Both groups will be advised to continue wearing the GCS for four weeks post discharge. Prior to discharge both groups will have follow-up bilateral ultrasounds of lower legs at a vascular lab at day 30. A letter to the GP will be sent to explain the patient is in this study if they present with signs of a deep vein thrombosis or pulmonary embolism. One week prior to the ultrasound a research team member will ring the patient to remind them of appointment and organise transport if needed. Following the ultrasound 2 vascular surgeons will be reporting on the scans and will immediately ring the research team. If at any time the patient is symptomatic they will be advised to wither go to the closet emergency department or their GP to organise a scan.
Sponsors
Study design
Eligibility
Inclusion criteria
All patients 40 years and over undergoing elective major abdominal surgery with an anticipated length of stay greater than 24 hours and able to attend a 30-day follow-up bilateral lower leg venous ultrasound.
Exclusion criteria
Patients from the above group will be excluded if they have: • Unable to give written informed consent to take part in the study, • Active, clinically significant bleeding • Documented congenital or acquired bleeding tendency/disorders • Recent intracranial hemorrhage or recent (less than 3 months prior to randomization) brain spinal, or ophthalmologic surgery • Patients where epidural or spinal anesthesia is planned and undertaken. • Known cerebral metastasis • Participants in whom haemostasis had not been established 6 hours after surgical closure • Current thrombocytopenia eg platelets <70 • Renal Impairment GFR <30 and or Creatinine level above 2.0 mg/dL (180 µmol/L) in a well-hydrated participants • Pregnant and breastfeeding women • Participant with evidence of leg ischemia caused by peripheral vascular disease, unable to wear IPCD and graduated compression stockings. • Participants life expectancy < 6 months, • Clinical sign of VTE and/or history of recent VTE • Participants who have pre-existing indication for heparins (including LMWH)