Venous ThrombosesNCT04341272
Intermittent Pneumatic Compression of the Upper Extremity for Post-Operative VTE Prophylaxis
A study testing Intermittent Pneumatic Compression Device (FDA approved) in people with Venous Thromboses, run by Baltimore VA Medical Center.
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)… Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Venous Thromboses
- What is being tested?
- Intermittent Pneumatic Compression Device (FDA approved)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2014to 5 Apr 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Males aged > 18 years who could provide informed consent
Who cannot join
- 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.
About this study
Official title: Intermittent Pneumatic Compression of the Upper Extremity for Post-Operative VTE Prophylaxis: A Pilot Randomized Trial
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.
Read the 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.
- Conditions
- Venous Thromboses
- Being tested
- Intermittent Pneumatic Compression Device (FDA approved)
- Medical subject headings
- Venous Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intermittent Pneumatic Compression Device (FDA approved)Device
Compression Device placed on either upper or lower extremity for DVT prophylaxis following surgery
| Study group | Role | What they receive |
|---|---|---|
| Upper Extremity Compression Device | Active comparator | Patients randomized to have pneumatic compression device placed on upper extremity following surgery Receives: Device: Intermittent Pneumatic Compression Device (FDA approved) |
| Control | Other | Patients randomized to have pneumatic compression device placed on lower extremity following surgery Receives: Device: Intermittent Pneumatic Compression Device (FDA approved) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: within 45 days following surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2020
- Study start1 Apr 2014
- Primary completion5 Apr 2017
- Study completion5 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous ThrombosesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baltimore VA Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Preeti R. John, MD, MPH, FACS, Baltimore VA Medical Center
- Investigators
- Preeti R John, MD, MPH, FACS, Principal investigator, Baltimore VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04341272
- Sponsor's protocol ID
- HP-00051138
- Status last verified
- Apr 2020
- First submitted
- 7 Apr 2020
- Last updated
- 10 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intermittent Pneumatic Compression of the Upper Extremity for Post-Operative VTE Prophylaxis: A Pilot Randomized Trial
- ClinicalTrials.gov ID
- NCT04341272
- Acronym / sponsor ID
- HP-00051138
- Conditions
- Venous Thromboses
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Baltimore VA Medical CenterUS federal agency
- Study start
- 1 Apr 2014 (actual)
- Primary completion
- 5 Apr 2017 (actual)
- Study completion
- 5 Apr 2017 (actual)
- First posted
- 10 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Upper Extremity Compression Device | Active comparator | Device: Intermittent Pneumatic Compression Device (FDA approved)Patients randomized to have pneumatic compression device placed on upper extremity following surgery |
| Control | Other | Device: Intermittent Pneumatic Compression Device (FDA approved)Patients randomized to have pneumatic compression device placed on lower extremity following surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Males aged > 18 years who could provide informed consent
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intermittent Pneumatic Compression Device (FDA approved)Compression Device placed on either upper or lower extremity for DVT prophylaxis following surgery | Device | Control, Upper Extremity Compression Device |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2020.
- Priliminary data published in Journal of American College of Surgeons abstractLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Preeti R John, MD, MPH, FACS principal investigator
Baltimore VA Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing Intermittent Pneumatic Compression Device (FDA approved) in people with Venous Thromboses, run by Baltimore VA Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
venous thromboembolic event following surgery (time frame: within 45 days following surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2020.