Intermittent Pneumatic Compression in Surgical Patients at Extremely-high Risk for Venous Thromboembolism

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Trial to Assess the Effectiveness of Intermittent Pneumatic Compression in the Prevention of Postoperative Venous Thromboembolism in Surgical Patients at Extremely High Risk

Conditions
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Venous Thrombosis, Venous Thromboembolism

Intervention / Treatment
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* Device: SCD
* Device: GCS
* Drug: LMWH


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age over 40 Major surgery undergone* High risk of postoperative VTE according to a National guideline** 11+ Caprini scores Informed consent is given Exclusion Criteria: Acute deep vein thrombosis (DVT) at baseline Performed inferior vena cava (IVC) plication or implanted IVC filter Regular preoperative anticoagulation Postoperative anticoagulation needed at therapeutic doses Absence of anticoagulation for more than 5 days after surgery Coagulopathy (not related to Disseminated intravascular coagulation syndrome) Thrombocytopenia Hemorrhagic diathesis Lower limb soft tissue infection Ankle-brachial index < 0.6 Major surgery - intervention under endotracheal anesthesia with duration of more than 60 min. In accordance with a standard stratification system, high risk of VTE group includes patients over 60 years old after major surgery and patients 40-60 years old with additional risk factors after major surgery.

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A randomized clinical study to assess efficacy and safety of intermittent pneumatic compression device (SCD) application in combined prevention of postoperative VTE in surgical patients at high and extremely high risk receiving graduated compression stockings and early/delayed prophylactic anticoagulation with low-molecular weight heparins.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group (SCD + GCS + LMWH)<br>SCD: 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. GCS: 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: 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. | Device: SCD<br>* 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.<br>Device: GCS<br>* 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<br>Drug: LMWH<br>* 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.<br>|
| Active Comparator: Control group (GCS + LMWH)<br>GCS: 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: 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. | Device: GCS<br>* 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<br>Drug: LMWH<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients With Asymptomatic Venous Thrombosis of Lower Limbs as Detected by Duplex Ultrasound | 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 of discharge from the hospital or death, up to 45 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients With Proximal Deep Venous Thrombosis as Detected by Duplex Ultrasound | 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 of discharge from the hospital or death, up to 45 days | 
| Number of Patients With Isolated Calf Muscle Vein Thrombosis as Detected by Duplex Ultrasound | 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 of discharge from the hospital or death, up to 45 days | 
| Number of Patients With Pulmonary Embolism | 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 of discharge from the hospital or death, up to 45 days | 
| Number of Patients Died From Any Reason | Inpatient postoperative mortality: number of patients died from any reason during the inpatient period of treatment | time of discharge from the hospital or death, up to 45 days | 
| Number of Patients With Leg Skin Injury | 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 of discharge from the hospital or death, up to 45 days | 
| Number of Patients With Symptomatic and Asymptomatic VTE Events at 30 Days After Surgery | 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. | 30 days | 
| Number of Patients Who Died From VTE at 30 Days After Surgery | VTE related deaths that occurred during inpatients and outpatient period of treatment and were confirmed by autopsy | 30 days | 
| Number of Patients With Symptomatic and Asymptomatic VTE Events at 180 Days After Surgery | 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 | 180 days | 
| Number of Patients Who Died From VTE at 180 Days After Surgery | VTE related deaths that occurred during inpatients and outpatient period of treatment and were confirmed by autopsy | 180 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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venous thromboembolism, deep vein thrombosis, pulmonary embolism, prevention, intermittent pneumatic compression, sequential pneumatic compression, surgery, elastic compression, low-molecular weight heparin, prophylaxis