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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Venous Thromboses

Intervention / Treatment
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* Device: Intermittent Pneumatic Compression Device (FDA approved)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Upper Extremity Compression Device<br>Patients randomized to have pneumatic compression device placed on upper extremity following surgery | Device: Intermittent Pneumatic Compression Device (FDA approved)<br>* Compression Device placed on either upper or lower extremity for DVT prophylaxis following surgery<br>|
| Other: Control<br>Patients randomized to have pneumatic compression device placed on lower extremity following surgery | Device: Intermittent Pneumatic Compression Device (FDA approved)<br>* Compression Device placed on either upper or lower extremity for DVT prophylaxis following surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| venous thromboembolic event following surgery | venous 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 | within 45 days following surgery |