N/A
Completed N=407
Intermittent Pneumatic Compression in Surgical Patients at Extremely-high Risk for Venous Thromboembolism
Source: ClinicalTrials.gov NCT03044574 ↗Enrolled (actual)
407
Serious AEs
2.2%
Results posted
Feb 2020
Primary outcomePrimary: Number of Patients With Asymptomatic Venous Thrombosis of Lower Limbs as Detected by Duplex Ultrasound — 1; 34 Participants — p=<0.001
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.
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 | — |
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.
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. Informational only — not medical advice.