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OpenTrials
Completed

NCT Number: NCT04341272

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

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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Key information

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Intermittent Pneumatic Compression Device (FDA approved)

Device

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

Primary outcomes

  1. venous thromboembolic event following surgery

    Time frame: within 45 days 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

Sponsors and collaborators

Lead sponsor

Baltimore VA Medical Center

Fed

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Apr 10, 2020
Registry last updated
Apr 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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