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Intermittent Pneumatic Compression of the Upper Extremity for Post-Operative VTE Prophylaxis

Intermittent Pneumatic Compression of the Upper Extremity for Post-Operative VTE Prophylaxis: A Pilot Randomized Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04341272
Enrollment
106
Registered
2020-04-10
Start date
2014-04-01
Completion date
2017-04-05
Last updated
2020-04-10

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

Conditions

Venous Thromboses

Brief summary

Venous thromboembolism (VTE) is an important cause of morbidity and mortality following surgery.A combination of chemical and mechanical prophylaxis using lower extremity compression devices (CD) is recommended in patients who are considered at 'moderate risk' (Caprini score 2 - 4) or 'high risk' (Caprini score \> 4) of developing VTE. The aim of this study was to determine whether upper extremity (UE) CD are as effective as lower extremity (LE) CD in preventing VTE following surgery. A total of 106 patients were recruited.

Detailed description

Hospitals throughout the United States currently utilize mechanical compression devices on patients' limbs for prevention of blood clots, in addition to blood thinning medication - heparin. The compression devices act by affect blood clotting mechanism and there is evidence from previous research studies that blood is less likely to develop clots when these compression devices are placed on the arms or legs. The use of compression devices on arms and legs is within standard of care, but use on legs tends to be more common. Research studies have shown that use of compression devices in combination with heparin is more effective in preventing blood clots than either one alone. Not many clinicians remember the option of placing compression devices on arms, and patients who do not get compression devices placed on their legs following surgery, often get only medication (heparin) with no compression device placed at all. This study will compare the effectiveness of compression devices used on patients' arms with those used on patients' legs, at preventing blood clots. Non-invasive ultrasound studies will be used after surgery to check for blood clots in the legs.

Interventions

DEVICEIntermittent Pneumatic Compression Device (FDA approved)

Compression Device placed on either upper or lower extremity for DVT prophylaxis following surgery

Sponsors

Baltimore VA Medical Center
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

• Males aged \> 18 years who could provide informed consent

Exclusion criteria

* Patients on coumadin or post-operative therapeutic heparin * Known history of venous thromboembolism (VTE) * Known history of hematological disorders * Diagnosed malignancy requiring or undergoing treatment * Presence of upper extremity arterio-venous access for hemodialysis * Females were excluded to eliminate the confounding thrombogenic effect of estrogen.

Design outcomes

Primary

MeasureTime frameDescription
venous thromboembolic event following surgerywithin 45 days following surgeryvenous thrombosis (VT) or pulmonary embolism (PE): number of screening lower extremity venous duplex ultrasound studies showing VT and any CT scans showing PE in symptomatic patients

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026