Venous ThromboembolismIPCSUPERNCT03044574
Intermittent Pneumatic Compression in Surgical Patients at Extremely-high Risk for Venous Thromboembolism
A study testing SCD, GCS and LMWH in people with Venous Thromboembolism and Venous Thrombosis, run by Pirogov Russian National Research Medical University at 2 sites in Russia.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Venous Thromboembolism, Venous Thrombosis
- What is being tested?
- SCD, GCS and LMWH
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 407 participants
- Where
- 2 sitesRussia
- Study dates
- 1 Feb 2017to 31 Dec 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age over 40
- Major surgery undergone*
- High risk of postoperative VTE according to a National guideline**
- 11+ Caprini scores
- Informed consent is given
Who cannot join
- 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)
Show all 12Show fewer
- 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 locations and contacts
2 sites in 1 country.
Russia2 sites
Clinical Hospital no.1 of the President's Administration of Russian Federation
Moscow, 121352
Moscow Clinical Hospital no.24
Moscow, 127015
About this study
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
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.
Read the 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
- Being tested
- SCD, GCS, LMWH
- Keywords
- venous thromboembolism, deep vein thrombosis, pulmonary embolism, prevention, intermittent pneumatic compression, sequential pneumatic compression, surgery, elastic compression, low-molecular weight heparin, prophylaxis
- Medical subject headings
- Venous Thromboembolism, Venous Thrombosis, Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SCDDevice
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.
GCSDevice
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
LMWHDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: GCS; Drug: LMWH |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2017 (estimated)
- Study start1 Feb 2017
- Primary completion30 Sep 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Venous ThromboembolismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Outcomes assessor
- Enrolment
- 407 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pirogov Russian National Research Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Responsible party
- Principal investigator, Kirill Lobastov, Pirogov Russian National Research Medical University
- Investigators
- Kirill Lobastov, PhD, Principal investigator, Pirogov Russian National Research Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03044574
- Sponsor's protocol ID
- IPCSUPER
- Acronym
- IPCSUPER
- Status last verified
- Apr 2020
- First submitted
- 1 Feb 2017
- Last updated
- 4 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
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.
PubMed 32348101Lobastov 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.
PubMed 33201130
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03044574
- Acronym / sponsor ID
- IPCSUPER / IPCSUPER
- Conditions
- Venous Thromboembolism, Venous Thrombosis
- Keywords
- venous thromboembolism, deep vein thrombosis, pulmonary embolism, prevention, intermittent pneumatic compression, sequential pneumatic compression, surgery, elastic compression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 407 participants (actual)
- Lead sponsor
- Pirogov Russian National Research Medical UniversityUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 30 Sep 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 7 Feb 2017 (estimated)
- Results
- Posted 5 Feb 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Experimental group (SCD + GCS + LMWH) | Experimental | Device: SCD, Device: GCS, Drug: LMWHSCD: 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. |
| Control group (GCS + LMWH) | Active comparator | Device: GCS, Drug: LMWHGCS: 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. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age over 40
- Major surgery undergone*
- High risk of postoperative VTE according to a National guideline**
- 11+ Caprini scores
- Informed consent is given
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SCDIntermittent 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 | Experimental group (SCD + GCS + LMWH) |
| GCSThigh-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 | Device | Control group (GCS + LMWH), Experimental group (SCD + GCS + LMWH) |
| LMWHLMWH 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. | Drug | Control group (GCS + LMWH), Experimental group (SCD + GCS + LMWH) |
Primary outcome
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.
9 secondary outcomes
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
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
Number of Patients With Pulmonary Embolism
Time frame: time of discharge from the hospital or death, up to 45 days
Number of Patients Died From Any Reason
Time frame: time of discharge from the hospital or death, up to 45 days
Number of Patients With Leg Skin Injury
Time frame: 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
Time frame: 30 days
Number of Patients Who Died From VTE at 30 Days After Surgery
Time frame: 30 days
Number of Patients With Symptomatic and Asymptomatic VTE Events at 180 Days After Surgery
Time frame: 180 days
Number of Patients Who Died From VTE at 180 Days After Surgery
Time frame: 180 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 32348101Schastlivtsev 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.
- Derived from this study: PubMed 33201130Lobastov 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kirill Lobastov, PhD principal investigator
Pirogov Russian National Research Medical University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SCD, GCS and LMWH in people with Venous Thromboembolism and Venous Thrombosis, run by Pirogov Russian National Research Medical University at 2 sites in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Feb 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03044574, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2021; AzTrials last refreshed its copy on 6 Nov 2026.