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

Pirogov Russian National Research Medical University

Status: Completed

Conditions: Venous Thromboembolism; Venous Thrombosis

Treatments: Device: GCS; Device: SCD; Drug: LMWH

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03044574

IPCSUPER

Details and patient eligibility

About

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.

Full 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.

Enrollment: 407 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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407 participants in 2 patient groups

Experimental group (SCD + GCS + LMWH)

Experimental group

Description:

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.

Treatment:

Drug: LMWH

Device: SCD

Device: GCS

Control group (GCS + LMWH)

Active Comparator group

Description:

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.

Treatment:

Drug: LMWH

Device: GCS