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

Not Applicable

Completed

Conditions: Venous Thromboembolism
Venous Thrombosis

Interventions: Device: SCD
Device: GCS
Drug: LMWH

Registration Number: NCT03044574

Lead Sponsor: Pirogov Russian National Research Medical University

Brief Summary: 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: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 407

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental group (SCD + GCS + LMWH)	SCD	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.
Experimental group (SCD + GCS + LMWH)	GCS	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.
Experimental group (SCD + GCS + LMWH)	LMWH	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.
Control group (GCS + LMWH)	GCS	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.
Control group (GCS + LMWH)	LMWH	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.

Primary Outcome Measures

Name	Time	Method
Number of Patients With Asymptomatic Venous Thrombosis of Lower Limbs as Detected by Duplex Ultrasound	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.

Secondary Outcome Measures

Name	Time	Method
Number of Patients With Symptomatic and Asymptomatic VTE Events at 30 Days After Surgery	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.
Number of Patients Who Died From VTE at 30 Days After Surgery	30 days	VTE related deaths that occurred during inpatients and outpatient period of treatment and were confirmed by autopsy
Number of Patients With Symptomatic and Asymptomatic VTE Events at 180 Days After Surgery	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
Number of Patients Who Died From VTE at 180 Days After Surgery	180 days	VTE related deaths that occurred during inpatients and outpatient period of treatment and were confirmed by autopsy
Number of Patients With Proximal Deep Venous Thrombosis as Detected by Duplex Ultrasound	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.
Number of Patients With Isolated Calf Muscle Vein Thrombosis as Detected by Duplex Ultrasound	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.
Number of Patients With Pulmonary Embolism	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
Number of Patients Died From Any Reason	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
Number of Patients With Leg Skin Injury	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

Trial Locations

Locations (2): Moscow Clinical Hospital no.24
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Moscow, Russian Federation
Clinical Hospital no.1 of the President's Administration of Russian Federation
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Moscow, Russian Federation