Clinical trial NCT03044574: Intermittent Pneumatic Compression in Surgical Patients at Extremely-high Risk for Venous Thromboembolism
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Pirogov Russian National Research Medical University
Sponsor class: OTHER
Collaborators: name: Medtronic
First posted: 2017-02-07
Enrollment: 407
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: PREVENTION

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.

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.

Eligibility 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.

Primary outcomes:
measure: Number of Patients With Asymptomatic Venous Thrombosis of Lower Limbs as Detected by Duplex Ultrasound
timeFrame: time of discharge from the hospital or death, up to 45 days
Secondary outcomes:
measure: Number of Patients With Proximal Deep Venous Thrombosis as Detected by Duplex Ultrasound
timeFrame: time of discharge from the hospital or death, up to 45 days
measure: Number of Patients With Isolated Calf Muscle Vein Thrombosis as Detected by Duplex Ultrasound
timeFrame: time of discharge from the hospital or death, up to 45 days
measure: Number of Patients With Pulmonary Embolism
timeFrame: time of discharge from the hospital or death, up to 45 days
measure: Number of Patients Died From Any Reason
timeFrame: time of discharge from the hospital or death, up to 45 days
measure: Number of Patients With Leg Skin Injury
timeFrame: time of discharge from the hospital or death, up to 45 days
measure: Number of Patients With Symptomatic and Asymptomatic VTE Events at 30 Days After Surgery
timeFrame: 30 days
measure: Number of Patients Who Died From VTE at 30 Days After Surgery
timeFrame: 30 days
measure: Number of Patients With Symptomatic and Asymptomatic VTE Events at 180 Days After Surgery
timeFrame: 180 days
measure: Number of Patients Who Died From VTE at 180 Days After Surgery
timeFrame: 180 days
Other outcomes:
measure: Duration of Inpatient Period of Treatment
timeFrame: time of discharge from the hospital or death, up to 45 days
Locations:
city: Moscow
country: Russian Federation
facility: Clinical Hospital no.1 of the President's Administration of Russian Federation
city: Moscow
country: Russian Federation
facility: Moscow Clinical Hospital no.24
Study officials:
affiliation: Pirogov Russian National Research Medical University
name: Kirill Lobastov, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.