Trial to Assess the Effectiveness of Intermittent Pneumatic Compression in the Prevention of Postoperative Venous Thromboembolism in Surgical Patients at Extremely High Risk
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 407
- 试验地点
- 2
- 主要终点
- Number of Patients With Asymptomatic Venous Thrombosis of Lower Limbs as Detected by Duplex Ultrasound
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age over 40
- •Major surgery undergone*
- •High risk of postoperative VTE according to a National guideline**
- •11+ Caprini scores
- •Informed consent is given
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: SCD (Device)
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.
干预措施: GCS (Device)
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.
干预措施: LMWH (Drug)
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.
干预措施: GCS (Device)
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.
干预措施: LMWH (Drug)
结局指标
主要结局
Number of Patients With Asymptomatic Venous Thrombosis of Lower Limbs as Detected by Duplex Ultrasound
时间窗: 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.
次要结局
- Number of Patients With Symptomatic and Asymptomatic VTE Events at 30 Days After Surgery(30 days)
- Number of Patients Who Died From VTE at 30 Days After Surgery(30 days)
- Number of Patients With Symptomatic and Asymptomatic VTE Events at 180 Days After Surgery(180 days)
- Number of Patients Who Died From VTE at 180 Days After Surgery(180 days)
- 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)
研究者
Kirill Lobastov
Associated Professor
Pirogov Russian National Research Medical University