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

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

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.

Study Overview

• Status: Completed
• Conditions: Venous Thrombosis; Venous Thromboembolism
• Intervention / Treatment: Device: SCD; Device: GCS; Drug: LMWH

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.

• Study Type: Interventional
• Enrollment (Actual): 407
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Russian Federation
  • Moscow, Russian Federation, 121352
    • Clinical Hospital no.1 of the President's Administration of Russian Federation
  • Moscow, Russian Federation, 127015
    • Moscow Clinical Hospital no.24

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 38 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group (SCD + GCS + 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.	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.
Active Comparator: Control group (GCS + 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.	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.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of Inpatient Period of Treatment	The inpatient period of treatment suggests time from surgical intervention to discharge from the hospital or death.	time of discharge from the hospital or death, up to 45 days

Collaborators and Investigators

• Sponsor: Pirogov Russian National Research Medical University
• Collaborators: Medtronic

Publications and helpful links

General Publications

• Schastlivtsev I, Lobastov K, Barinov V, Kanzafarova I. Diosmin 600 in adjunction to rivaroxaban reduces the risk of post-thrombotic syndrome after femoropopliteal deep vein thrombosis: results of the RIDILOTT DVT study. Int Angiol. 2020 Oct;39(5):361-371. doi: 10.23736/S0392-9590.20.04356-4. Epub 2020 Apr 29.
• Lobastov K, Sautina E, Alencheva E, Bargandzhiya A, Schastlivtsev I, Barinov V, Laberko L, Rodoman G, Boyarintsev V. Intermittent Pneumatic Compression in Addition to Standard Prophylaxis of Postoperative Venous Thromboembolism in Extremely High-risk Patients (IPC SUPER): A Randomized Controlled Trial. Ann Surg. 2021 Jul 1;274(1):63-69. doi: 10.1097/SLA.0000000000004556.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2017
• Primary Completion (Actual): September 30, 2018
• Study Completion (Actual): December 31, 2018

Study Registration Dates

• First Submitted: February 1, 2017
• First Submitted That Met QC Criteria: February 2, 2017
• First Posted (Estimate): February 7, 2017

Study Record Updates

• Last Update Posted (Actual): February 4, 2021
• Last Update Submitted That Met QC Criteria: January 13, 2021
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: surgery; prevention; prophylaxis; venous thromboembolism; deep vein thrombosis; pulmonary embolism; low-molecular weight heparin; intermittent pneumatic compression; sequential pneumatic compression; elastic compression
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Thrombosis; Venous Thrombosis; Thromboembolism; Venous Thromboembolism
• Other Study ID Numbers: IPCSUPER

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes