Clinical Trials Directory

Trials / Completed

CompletedNCT04341272

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
Phase
N/A
Study type
Interventional
Enrollment
106 (actual)
Sponsor
Baltimore VA Medical Center · Federal
Sex
Male
Age
18 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
DEVICEIntermittent Pneumatic Compression Device (FDA approved)Compression Device placed on either upper or lower extremity for DVT prophylaxis following surgery

Timeline

Start date
2014-04-01
Primary completion
2017-04-05
Completion
2017-04-05
First posted
2020-04-10
Last updated
2020-04-10

Source: ClinicalTrials.gov record NCT04341272. Inclusion in this directory is not an endorsement.