Viewing Study NCT04341272



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Last Modification Date: 2024-10-26 @ 1:32 PM
Study NCT ID: NCT04341272
Status: COMPLETED
Last Update Posted: 2020-04-10
First Post: 2020-04-07

Brief Title: Intermittent Pneumatic Compression of the Upper Extremity for Post-Operative VTE Prophylaxis
Sponsor: Baltimore VA Medical Center
Organization: Baltimore VA Medical Center

Study Overview

Official Title: Intermittent Pneumatic Compression of the Upper Extremity for Post-Operative VTE Prophylaxis A Pilot Randomized Trial
Status: COMPLETED
Status Verified Date: 2020-04
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: Venous thromboembolism VTE is an important cause of morbidity and mortality following surgeryA 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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: False
Is an FDA AA801 Violation?: None