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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03044574
Recruitment Status : Completed
First Posted : February 7, 2017
Results First Posted : February 5, 2020
Last Update Posted : February 5, 2020
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Kirill Lobastov, 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.

Condition or disease Intervention/treatment Phase
Venous Thromboembolism Venous Thrombosis Device: SCD Device: GCS Drug: LMWH Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 407 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Trial to Assess the Effectiveness of Intermittent Pneumatic Compression in the Prevention of Postoperative Venous Thromboembolism in Surgical Patients at Extremely High Risk
Actual Study Start Date : February 1, 2017
Actual Primary Completion Date : September 30, 2018
Actual Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Number of Patients With Asymptomatic Venous Thrombosis of Lower Limbs as Detected by Duplex Ultrasound [ Time Frame: 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 :
  1. Number of Patients With Proximal Deep Venous Thrombosis as Detected by Duplex Ultrasound [ Time Frame: 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.

  2. Number of Patients With Isolated Calf Muscle Vein Thrombosis as Detected by Duplex Ultrasound [ Time Frame: 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.

  3. Number of Patients With Pulmonary Embolism [ Time Frame: 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

  4. Number of Patients Died From Any Reason [ Time Frame: 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

  5. Number of Patients With Leg Skin Injury [ Time Frame: 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

  6. Number of Patients With Symptomatic and Asymptomatic VTE Events at 30 Days After Surgery [ Time Frame: 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.

  7. Number of Patients Who Died From VTE at 30 Days After Surgery [ Time Frame: 30 days ]
    VTE related deaths that occurred during inpatients and outpatient period of treatment and were confirmed by autopsy

  8. Number of Patients With Symptomatic and Asymptomatic VTE Events at 180 Days After Surgery [ Time Frame: 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

  9. Number of Patients Who Died From VTE at 180 Days After Surgery [ Time Frame: 180 days ]
    VTE related deaths that occurred during inpatients and outpatient period of treatment and were confirmed by autopsy


Other Outcome Measures:
  1. Duration of Inpatient Period of Treatment [ Time Frame: time of discharge from the hospital or death, up to 45 days ]
    The inpatient period of treatment suggests time from surgical intervention to discharge from the hospital or death.



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03044574


Locations
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Russian Federation
Clinical Hospital no.1 of the President's Administration of Russian Federation
Moscow, Russian Federation, 121352
Moscow Clinical Hospital no.24
Moscow, Russian Federation, 127015
Sponsors and Collaborators
Pirogov Russian National Research Medical University
Medtronic
Investigators
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Principal Investigator: Kirill Lobastov, PhD Pirogov Russian National Research Medical University
  Study Documents (Full-Text)

Documents provided by Kirill Lobastov, Pirogov Russian National Research Medical University:

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Responsible Party: Kirill Lobastov, Associated Professor, Pirogov Russian National Research Medical University
ClinicalTrials.gov Identifier: NCT03044574    
Other Study ID Numbers: IPCSUPER
First Posted: February 7, 2017    Key Record Dates
Results First Posted: February 5, 2020
Last Update Posted: February 5, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Kirill Lobastov, Pirogov Russian National Research Medical University:
venous thromboembolism
deep vein thrombosis
pulmonary embolism
prevention
intermittent pneumatic compression
sequential pneumatic compression
surgery
elastic compression
low-molecular weight heparin
prophylaxis
Additional relevant MeSH terms:
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Thrombosis
Thromboembolism
Venous Thromboembolism
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Heparin, Low-Molecular-Weight
Enoxaparin
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action