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

Baltimore VA Medical Center

Status: Completed

Conditions: Venous Thromboses

Treatments: Device: Intermittent Pneumatic Compression Device (FDA approved)

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT04341272

HP-00051138

Details and patient eligibility

About

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.

Full 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.

Enrollment: 106 patients

Sex: Male

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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106 participants in 2 patient groups

Upper Extremity Compression Device

Active Comparator group

Description:

Patients randomized to have pneumatic compression device placed on upper extremity following surgery

Treatment:

Device: Intermittent Pneumatic Compression Device (FDA approved)

Control

Other group

Description:

Patients randomized to have pneumatic compression device placed on lower extremity following surgery

Treatment:

Device: Intermittent Pneumatic Compression Device (FDA approved)