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| Name | Class |
|---|---|
| Medtronic | INDUSTRY |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
| 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 |
Inclusion Criteria:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Kirill Lobastov, PhD | Pirogov Russian National Research Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Hospital no.1 of the President's Administration of Russian Federation | Moscow | 121352 | Russia | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32348101 | Result | 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. | |
| 33201130 | Derived |
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The total amount of 812 patients were screened during the enrollment period, 405 of them were excluded: Caprini score of <11 (n=304); a various regimen of anticoagulation (n=48); venous thrombosis at the baseline (n=31); declined participation (n=18); implanted inferior vena cava filter (n=4).
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| ID | Title | Description |
|---|---|---|
| FG000 | Experimental Group (SCD + GCS + LMWH) | Sequential Compression 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. Graduated Compression Stockings (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 Low-Molecular-Weight-Heparin (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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Experimental Group (SCD + GCS + LMWH) | Sequential Compression Device (SCD): Intermittent pneumatic compression (IPC) with Kendall SCD™ Sequential Compression System 700 used continuously when the patient is in bed with a 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 the surgery department - all time of bed rest. SCD used until discharge. Graduated Compression Stockings (GCS): Thigh-length graduated compression stockings with a pressure of 18-21 mm. Hg at the ankle used all the time until discharge plus one month after discharge Low-Molecular-Weight Heparin: 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | time of discharge from the hospital or death, up to 45 days |
|
30 days after surgery for most of the adverse events except all-cause mortality that reported over 6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Major bleeding | Blood and lymphatic system disorders | Systematic Assessment | Major bleeding defined by the International Society of Thrombosis and Hemostasis (ISTH) (no enough space to provide full definition from Journal of Thrombosis and Haemostasis, 8: 202-204) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Skin hyperemia on lower limbs | Injury, poisoning and procedural complications | Systematic Assessment | Irritation of the skin on lower limbs in the zone of application of GCS and SCD |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Kirill Lobastov, Associated professor at the Department of General Surgery and Radiology | Pirogov Russian National Researching Medical University | +7-985-211-63-31 | lobastov_kv@hotmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 15, 2016 | Apr 2, 2020 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D054556 | Venous Thromboembolism |
| D020246 | Venous Thrombosis |
| D011655 | Pulmonary Embolism |
| ID | Term |
|---|---|
| D013923 | Thromboembolism |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D006495 | Heparin, Low-Molecular-Weight |
| ID | Term |
|---|---|
| D006493 | Heparin |
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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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.
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|
| 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 |
|
| 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. |
|
| 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 |
| Moscow Clinical Hospital no.24 |
| Moscow |
| 127015 |
| Russia |
| 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. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Surgical profile | Abdominal surgery suggests oned and laparoscopic interventions of abdominal cavity and abdominal wall. Non-abdominal surgery contains open and endoscopic interventions on thoracic cavity and thoracic wall, head, and neck, gynecological and urological pelvic surgery, intracranial surgery | Count of Participants | Participants |
|
| Malignancy | Malignancy suggests that patients required surgery due to verified (previously or intraoperatively) malignant tumor | Count of Participants | Participants |
|
| Caprini score | Caprini score is a combination of 39 individual risk factors for postoperative venous thromboembolism (VTE), evaluated from 1 to 5 scores. The total amount of scores ranges from 0 to 87: score of 0 suggests the very low risk for VTE; a score of 1-2 suggests the low risk for VTE; a score of 3-4 suggests the intermediate risk for VTE; a score of 5-10 suggests the high fisk for VTE and a score of 11 and higher suggests the extremely high risk for VTE. Patients will a score of 11 and higher represent the target population for the current trial. | Mean | Standard Deviation | units on a scale |
|
| Number of patients with Caprini score of 11 and higher | Caprini score is a combination of 39 individual risk factors for postoperative VTE, evaluated from 1 to 5 scores. The total amount of scores ranges from 0 to 87: score of 0 suggests the very low risk for VTE; a score of 1-2 suggests the low risk for VTE; a score of 3-4 suggests the intermediate risk for VTE; a score of 5-10 suggests the high fisk for VTE and a score of 11 and higher suggests the extremely high risk for VTE. Patients will a score of 11 and higher represent the target population for the current trial. | Count of Participants | Participants |
|
| OG001 | 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. |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | time of discharge from the hospital or death, up to 45 days |
|
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | time of discharge from the hospital or death, up to 45 days |
|
|
|
|
| Secondary | 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 | Posted | Count of Participants | Participants | time of discharge from the hospital or death, up to 45 days |
|
|
|
|
| Secondary | Number of Patients Died From Any Reason | Inpatient postoperative mortality: number of patients died from any reason during the inpatient period of treatment | Posted | Count of Participants | Participants | time of discharge from the hospital or death, up to 45 days |
|
|
|
|
| Secondary | 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 | Posted | Count of Participants | Participants | time of discharge from the hospital or death, up to 45 days |
|
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | 30 days |
|
|
|
|
| Secondary | 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 | Posted | Count of Participants | Participants | 30 days |
|
|
|
| Secondary | 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 | Posted | Count of Participants | Participants | 180 days |
|
|
|
|
| Secondary | 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 | Posted | Count of Participants | Participants | 180 days |
|
|
|
| Other Pre-specified | Duration of Inpatient Period of Treatment | The inpatient period of treatment suggests time from surgical intervention to discharge from the hospital or death. | Posted | Median | Inter-Quartile Range | days | time of discharge from the hospital or death, up to 45 days |
|
|
|
| 11 |
| 204 |
| 5 |
| 204 |
| 27 |
| 204 |
| EG001 | 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. | 18 | 203 | 4 | 203 | 22 | 203 |
|
|
| Skin blisters on lower limbs | Injury, poisoning and procedural complications | Systematic Assessment | Deeper skin injury with the formation of blisters in the zone of application of GCS and SCD |
|
| Skin necrosis on lower limbs | Injury, poisoning and procedural complications | Systematic Assessment | Deep lesion of the skin and soft tissues in the zone of application of GCS and SCD |
|
| Clinical relevant non-major bleeding | Blood and lymphatic system disorders | Systematic Assessment | Bleeding, that does not match the criteria of major but needs some specific measures for hemostasis and/or interruption or preliminary abortion of anticoagulation |
|
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| D013927 |
| Thrombosis |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D004617 | Embolism |