NCT03044574

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 407 (actual)
• Sponsor: Pirogov Russian National Research Medical University · Academic / Other
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Venous Thromboembolism
• Venous Thrombosis

Interventions

Type	Name	Description
DEVICE	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.
DEVICE	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
DRUG	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.

Timeline

• Start date: 2017-02-01
• Primary completion: 2018-09-30
• Completion: 2018-12-31
• First posted: 2017-02-07
• Last updated: 2021-02-04
• Results posted: 2020-02-05

Locations

2 sites across 1 country: Russia

Regulatory

• FDA-regulated device study