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

NCT03044574 | Completed Results DMC FDA Device

• 1 other identifier: IPCSUPER
• Study Type: interventional
• Target: 407
• Locations: 1 country
• Sites: 2

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.

Conditions

Venous Thromboembolism; Venous Thrombosis

Keywords

venous thromboembolism; deep vein thrombosis; pulmonary embolism; prevention; intermittent pneumatic compression; sequential pneumatic compression; surgery; elastic compression; low-molecular weight heparin; prophylaxis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• 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

• 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

• Number of Patients With Pulmonary Embolism

  time of discharge from the hospital or death, up to 45 days

• Number of Patients Died From Any Reason

  time of discharge from the hospital or death, up to 45 days

• Number of Patients With Leg Skin Injury

  time of discharge from the hospital or death, up to 45 days

Other Outcomes (1)

• Duration of Inpatient Period of Treatment

  time of discharge from the hospital or death, up to 45 days

Study Arms (2)

Experimental group (SCD + GCS + LMWH)

EXPERIMENTAL

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; Device: GCS; Drug: LMWH

Control group (GCS + LMWH)

ACTIVE COMPARATOR

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; Drug: LMWH

Interventions

SCD DEVICE

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.

Experimental group (SCD + GCS + LMWH)

GCS DEVICE

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

Control group (GCS + LMWH); Experimental group (SCD + GCS + LMWH)

LMWH DRUG

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); Experimental group (SCD + GCS + LMWH)

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age over 40
• Major surgery undergone\*
• High risk of postoperative VTE according to a National guideline\*\*
• + Caprini scores
• Informed consent is given

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pirogov Russian National Research Medical University: lead
• Medtronic: collaborator

Study Sites (2)

Clinical Hospital no.1 of the President's Administration of Russian Federation

Moscow, 121352, Russia

Location

Moscow Clinical Hospital no.24

Moscow, 127015, Russia

Location

Related Publications (2)

• 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.

  PMID: 32348101 RESULT

• 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.

  PMID: 33201130 DERIVED

MeSH Terms

Conditions

Venous Thromboembolism; Venous Thrombosis; Pulmonary Embolism

Interventions

Heparin, Low-Molecular-Weight

Condition Hierarchy (Ancestors)

Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Thrombosis; Lung Diseases; Respiratory Tract Diseases; Embolism

Intervention Hierarchy (Ancestors)

Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates

Results Point of Contact

• Title: Dr. Kirill Lobastov, Associated professor at the Department of General Surgery and Radiology
• Organization: Pirogov Russian National Researching Medical University

lobastov_kv@hotmail.com

+7-985-211-63-31

Study Officials

• Kirill Lobastov, PhD

  Pirogov Russian National Research Medical University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associated Professor

Model Details: 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.

Study Record Dates

• First Submitted: February 1, 2017
• First Posted: February 7, 2017
• Study Start: February 1, 2017
• Primary Completion: September 30, 2018
• Study Completion: December 31, 2018
• Last Updated: February 4, 2021
• Results First Posted: February 5, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

RU (2)