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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

106 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-01

Study Completion Date

2017-04-05

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.

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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.

Conditions

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Venous Thromboses

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Upper Extremity Compression Device

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

Group Type ACTIVE_COMPARATOR

Intermittent Pneumatic Compression Device (FDA approved)

Intervention Type DEVICE

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

Control

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

Group Type OTHER

Intermittent Pneumatic Compression Device (FDA approved)

Intervention Type DEVICE

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

Interventions

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Intermittent Pneumatic Compression Device (FDA approved)

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

Intervention Type DEVICE

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.

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes