N/A N=407 Randomized Single-blind Prevention

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

Venous Thromboembolism · Venous Thrombosis

Bottom Line

View on ClinicalTrials.gov: NCT03044574 ↗

Enrolled (actual)

407

Serious AEs

2.2%

Results posted

Feb 2020

Primary outcome: Primary: Number of Patients With Asymptomatic Venous Thrombosis of Lower Limbs as Detected by Duplex Ultrasound — 1; 34 Participants — p=<0.001

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: SCD (Device); GCS (Device); LMWH (Drug)
Age: Adult, Older Adult · 40+ yrs
Sex: All
Sponsor: Pirogov Russian National Research Medical University
Primary completion: Sep 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Patients With Asymptomatic Venous Thrombosis of Lower Limbs as Detected by Duplex Ultrasound	1; 34	<0.001 sig
SECONDARY Number of Patients With Proximal Deep Venous Thrombosis as Detected by Duplex Ultrasound	0; 5	0.03 sig
SECONDARY Number of Patients With Isolated Calf Muscle Vein Thrombosis as Detected by Duplex Ultrasound	1; 15	<0.001 sig
SECONDARY Number of Patients With Pulmonary Embolism	0; 5	0.03 sig
SECONDARY Number of Patients Died From Any Reason	6; 10	>0.05
SECONDARY Number of Patients With Leg Skin Injury	25; 15	>0.05
SECONDARY Number of Patients With Symptomatic and Asymptomatic VTE Events at 30 Days After Surgery	1; 35	<0.001 sig
SECONDARY Number of Patients Who Died From VTE at 30 Days After Surgery	0; 2	—
SECONDARY Number of Patients With Symptomatic and Asymptomatic VTE Events at 180 Days After Surgery	1; 35	<0.001 sig
SECONDARY Number of Patients Who Died From VTE at 180 Days After Surgery	0; 3	—

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.

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03044574). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.