Intermittent Pneumatic Compression of the Upper Extremity for Post-Operative VTE Prophylaxis
Primary Purpose
Venous Thromboses
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Intermittent Pneumatic Compression Device (FDA approved)
Sponsored by
About this trial
This is an interventional prevention trial for Venous Thromboses
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Other
Arm Label
Upper Extremity Compression Device
Control
Arm Description
Patients randomized to have pneumatic compression device placed on upper extremity following surgery
Patients randomized to have pneumatic compression device placed on lower extremity following surgery
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT04341272
First Posted
April 7, 2020
Last Updated
April 9, 2020
Sponsor
Baltimore VA Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT04341272
Brief Title
Intermittent Pneumatic Compression of the Upper Extremity for Post-Operative VTE Prophylaxis
Official Title
Intermittent Pneumatic Compression of the Upper Extremity for Post-Operative VTE Prophylaxis: A Pilot Randomized Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
April 1, 2014 (Actual)
Primary Completion Date
April 5, 2017 (Actual)
Study Completion Date
April 5, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baltimore VA Medical Center
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Thromboses
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
106 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Upper Extremity Compression Device
Arm Type
Active Comparator
Arm Description
Patients randomized to have pneumatic compression device placed on upper extremity following surgery
Arm Title
Control
Arm Type
Other
Arm Description
Patients randomized to have pneumatic compression device placed on lower extremity following surgery
Intervention Type
Device
Intervention Name(s)
Intermittent Pneumatic Compression Device (FDA approved)
Intervention Description
Compression Device placed on either upper or lower extremity for DVT prophylaxis following surgery
Primary Outcome Measure Information:
Title
venous thromboembolic event following surgery
Description
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
Time Frame
within 45 days following surgery
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Preeti R John, MD, MPH, FACS
Organizational Affiliation
Baltimore VA Medical Center
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://www.journalacs.org/article/S1072-7515(16)31034-1/abstract
Description
Priliminary data published in Journal of American College of Surgeons abstract
Learn more about this trial
Intermittent Pneumatic Compression of the Upper Extremity for Post-Operative VTE Prophylaxis
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