NCT Number: NCT03044574
The aim of the study is to evaluate efficacy and safety of venous thromboembolism prophylaxis by the combination of graduated compression stockings (GCS), standard doses of low-molecular-weight heparins (LMWH) and sequential compression device (SCD) in the mixed group of surgical patients at high and extremely high risk for venous thromboembolism.
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Notify Me40 year and older
All sexes
Interventional
Not applicable
Clinical Hospital no.1 of the President's Administration of Russian Federation, Moscow, Russia
Venous thromboembolism (VTE) is the most common complication after major surgery, especially in high-risk patients. But the high-risk group is inhomogeneous. Some patients included in this group have an extremely high prevalence of postoperative venous thrombosis and pulmonary embolism, in whom the standard complex prophylaxis with elastic compression and standard anticoagulation is less effective. This is particularly so, in patients having a Caprini score of 11 and more, so that at the background of standard prophylaxis postoperative DVT is 10 times higher. This group of patients needs a more effective protocol for VTE prevention.
Sequential compression devices (SCD) combined with graduated elastic compression stockings (GCS) or without them were found to be effective in the prevention of VTE in high-risk patients, especially after neurosurgical interventions, even without the administration of anticoagulants. However, their efficacy in patients at "extremely high risk", having 11+ Caprini scores has not been assessed yet. The aim of the current study is to evaluate efficacy and safety of VTE prophylaxis by the combination of graduated compression stockings (GCS), standard doses of low-molecular-weight heparins (LMWH) and sequential compression device (SCD) in the mixed group of surgical patients at high and extremely high risk for venous thromboembolism
The expected outcome of the study is a reduction of asymptomatic postoperative venous thrombosis rate in the hospital and reduction in all VTE during 6 months after discharge.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Intermittent pneumatic compression (IPC) with Kendall SCD™ Sequential Compression System 700 used continuously when the patient is in bed with 6-hours night interval free of compression: from 0 a.m. to 6 a.m. In the ICU SCD used continuously all day, and in surgery department - all time of bed resting. SCD used until discharge.
Thigh-length graduated compression stockings with pressure of 18-21 mm. Hg at the ankle used all the time until discharge plus one month after discharge
LMWH enoxaparin (Clexane) 40 mg once a day subcutaneously started on 1st or 2-5th postoperative day according to the bleeding risk and used until discharge.
Time frame: time of discharge from the hospital or death, up to 45 days
Asymptomatic deep and/or superficial vein thrombosis of lower limbs detected by duplex ultrasound performed at baseline and then every 3-5 days after surgery until discharge.
Time frame: time of discharge from the hospital or death, up to 45 days
Proximal deep vein thrombosis defined as thrombus of popliteal, femoral, iliac veins and/or inferior vena cava. Detected by duplex ultrasound performed at baseline and then every 3-5 days after surgery until discharge.
Time frame: time of discharge from the hospital or death, up to 45 days
Isolated calf muscle vein thrombosis was defined as thrombosis of soleal, gastrocnemius or other calf muscle veins not extended into tibial, or peroneal, or popliteal veins. Detected by duplex ultrasound performed at baseline and then every 3-5 days after surgery until discharge.
Time frame: time of discharge from the hospital or death, up to 45 days
Symptomatic pulmonary embolism (PE) that occurred during the inpatient period of treatment and confirmed by computed tomography pulmonary angiogram (CTPA) or single-photon emission computed tomography with computed tomography (SPECT/CT) or autopsy
Time frame: time of discharge from the hospital or death, up to 45 days
Inpatient postoperative mortality: number of patients died from any reason during the inpatient period of treatment
Time frame: time of discharge from the hospital or death, up to 45 days
Leg skin injury defined as any skin hyperemia, maceration, laceration, bubbles, erosion or ulceration in the zone of application for GCS and SCD on the lower limbs revealed by clinical inspection of the skin and soft tissues until discharge
Time frame: 30 days
Taking into account all VTE events: asymptomatic revealed by duplex ultrasound, symptomatic confirmed by duplex ultrasound, CTPA, SPECT/CT, autopsy in patients discharged from the hospital and still receiving inpatients care at 30 days after surgery.
Time frame: 30 days
VTE related deaths that occurred during inpatients and outpatient period of treatment and were confirmed by autopsy
Time frame: 180 days
Taking into account all symptomatic and asymptomatic VTE events confirmed by duplex ultrasound, CTPA, SPECT/CT, autopsy or other appropriate methods of diagnosis that occurred during the inpatient period of treatment and outpatient period of observation
Time frame: 180 days
VTE related deaths that occurred during inpatients and outpatient period of treatment and were confirmed by autopsy
Time frame: time of discharge from the hospital or death, up to 45 days
The inpatient period of treatment suggests time from surgical intervention to discharge from the hospital or death.
Pirogov Russian National Research Medical University
Other
Trial to Assess the Effectiveness of Intermittent Pneumatic Compression in the Prevention of Postoperative Venous Thromboembolism in Surgical Patients at Extremely High Risk
Acronym: IPCSUPER
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