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A Single-Center, Open-Label, Randomized Controlled Trial of Wearable Patch Ultrasound for Deep Vein Thrombosis Monitoring in High-risk Patients

A Single-Center, Open-Label, Randomized Controlled Trial of Wearable Patch Ultrasound for Deep Vein Thrombosis Monitoring in High-risk Patients

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600118899
Enrollment
Unknown
Registered
2026-02-12
Start date
2026-03-01
Completion date
Unknown
Last updated
2026-02-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Deep Vein Thrombosis (DVT) of the Lower Extremities

Interventions

Intervention group:In the intervention group, lower-extremity veins will be monitored using a patch-based ultrasound system. Monitoring will continue until the first detection of DVT, ICU discharge/tr
Control group:Routine ultrasound

Sponsors

Shanghai sixth peolple' s hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: Patients will be eligible for enrollment only if all of the following criteria are met: 1) Age >= 18 years; 2)Newly admitted to the ICU, with an expected ICU stay = 3 weeks; 3)Caprini venous thromboembolism (VTE) risk assessment score = 5, indicating high-risk or very high-risk for VTE.

Exclusion criteria

Exclusion criteria: Patients meeting any of the following criteria will be excluded: 1)Lower-extremity DVT confirmed by ultrasound at ICU admission; 2)Severe trauma, ulcers, or infection in both lower limbs that prevents wearing the device or performing ultrasound examinations; 3)Receiving therapeutic anticoagulation (e.g., for confirmed atrial fibrillation, VTE, etc.); 4)End-stage disease with a markedly limited life expectancy (expected survival < 72 hours).

Design outcomes

Primary

MeasureTime frame
Time from ICU admission to the first ultrasound-confirmed detection of DVT;

Secondary

MeasureTime frame
Incidence of false negatives and their causes during evaluation;

Countries

China

Contacts

Public ContactZheng Yuanyi

Shanghai sixth peolple' s hospital

zhengyuanyi@163.com+86 21 6436 9181

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 19, 2026