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

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.

Study Overview

• Status: Completed
• Conditions: Venous Thromboses
• Intervention / Treatment: Device: Intermittent Pneumatic Compression Device (FDA approved)

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.

• Study Type: Interventional
• Enrollment (Actual): 106
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Upper Extremity Compression Device; Patients randomized to have pneumatic compression device placed on upper extremity following surgery	Device: Intermittent Pneumatic Compression Device (FDA approved); Compression Device placed on either upper or lower extremity for DVT prophylaxis following surgery
OTHER: Control; Patients randomized to have pneumatic compression device placed on lower extremity following surgery	Device: Intermittent Pneumatic Compression Device (FDA approved); Compression Device placed on either upper or lower extremity for DVT prophylaxis following surgery

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Baltimore VA Medical Center
• Investigators: Principal Investigator: Preeti R John, MD, MPH, FACS, Baltimore VA Medical Center

Publications and helpful links

Helpful Links

• Priliminary data published in Journal of American College of Surgeons abstract

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 1, 2014
• Primary Completion (ACTUAL): April 5, 2017
• Study Completion (ACTUAL): April 5, 2017

Study Registration Dates

• First Submitted: April 7, 2020
• First Submitted That Met QC Criteria: April 9, 2020
• First Posted (ACTUAL): April 10, 2020

Study Record Updates

• Last Update Posted (ACTUAL): April 10, 2020
• Last Update Submitted That Met QC Criteria: April 9, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Thrombosis; Venous Thrombosis
• Other Study ID Numbers: HP-00051138

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No