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

Venous Thromboses Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04341272
• Other study ID #: HP-00051138
• Status: Completed
• Phase: N/A
• Start date: April 1, 2014
• Est. completion date: April 5, 2017

Study information

• Verified date: April 2020
• Source: Baltimore VA Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: April 5, 2017
• Est. primary completion date: April 5, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Thrombosis
• Venous Thromboses
• Venous Thrombosis

Intervention

Device:
• Intermittent Pneumatic Compression Device (FDA approved)
Compression Device placed on either upper or lower extremity for DVT prophylaxis following surgery

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Baltimore VA Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

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