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

NCT04341272 | Completed DMC

• 1 other identifier: HP-00051138
• Study Type: interventional
• Target: 106
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Venous Thromboses

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Upper Extremity Compression Device

ACTIVE COMPARATOR

Patients randomized to have pneumatic compression device placed on upper extremity following surgery

Device: Intermittent Pneumatic Compression Device (FDA approved)

Control

OTHER

Patients randomized to have pneumatic compression device placed on lower extremity following surgery

Device: Intermittent Pneumatic Compression Device (FDA approved)

Interventions

Intermittent Pneumatic Compression Device (FDA approved) DEVICE

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

Control; Upper Extremity Compression Device

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males aged \> 18 years who could provide informed consent

You may not qualify if:

• 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.

Sponsors & Collaborators

• Baltimore VA Medical Center: lead

Related Links

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

MeSH Terms

Conditions

Venous Thrombosis

Interventions

Intermittent Pneumatic Compression Devices

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Officials

• Preeti R John, MD, MPH, FACS

  Baltimore VA Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: April 7, 2020
• First Posted: April 10, 2020
• Study Start: April 1, 2014
• Primary Completion: April 5, 2017
• Study Completion: April 5, 2017
• Last Updated: April 10, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share