DVT - Deep Vein ThrombosisPhase 4PDASNCT03027167
Outcomes Study in Patients Receiving Aspirin With Mechanical Compression Devices Versus Aspirin Alone Following Knee and Hip Arthroplasty
A Phase 4 study testing Aspirin and (Post- discharge) Mechanical Compression Device in people with DVT - Deep Vein Thrombosis and PE - Pulmonary Thromboembolism, run by Washington University School of Medicine.
Trial summary
The Purpose is to compare the safety and efficacy of the use of aspirin(ASA) with medical compression devices versus aspirin alone for venous thromboprophylaxis following knee and hip arthroplasty. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- DVT - Deep Vein Thrombosis, PE - Pulmonary Thromboembolism
- What is being tested?
- Aspirin and (Post- discharge) Mechanical Compression Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2017to Jan 2023
- Phase
- Phase 4
- 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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All total knee arthroplasty (TKA), unicompartmental knee arthroplasty (UKA), total hip arthroplasty (THA), and surface replacement arthroplasty (SRA) patients age 18 or older and undergoing an elective primary or revision procedure will be eligible to participate in this study.
Who cannot join
- Patients will be excluded if they are on chronic Coumadin therapy, require prolonged immobilization (i.e. cast/knee immobilizer; inability to be full weight-bearing and out of bed on postoperative day 1), and are scheduled to have multiple surgeries in close proximity to one another. Based on our institution's risk stratification protocol, all patients deemed "high risk" and meeting one of the following criteria will also be excluded as they would receive Coumadin for VTE prophylaxis:
- Patients will be excluded if they are on chronic Coumadin therapy
- History of DVT/PE
- Active Cancer
- Hypercoaguable States (Protein C, Protein S, Factor V Leiden, etc.)
- Family history of thrombosis -note: we may remove this criteria after further discussion
Show all 23Show fewer
- Patients requiring prolonged immobilization (i.e. cast/knee immobilizer),
- Patients having multiple surgeries in close proximity to one another.
- Patients with known allergy or hypersensitivity to Aspirin or Platelet count < 60, 000
- Patients receiving bilateral joint replacement
- Patients who consent to the study and cancel/do not have a surgery scheduled within six months of signing the consent form will not be included. immobilization (i.e. cast/knee immobilizer; inability to be full weight-bearing and out of bed on postoperative day 1), and are scheduled to have multiple surgeries in close proximity to one another. Based on our institution's risk stratification protocol, all patients deemed "high risk" and meeting one of the following criteria will also be excluded as they would receive Coumadin for VTE prophylaxis:
- Patients will be excluded if they are on chronic Coumadin therapy
- History of DVT/PE
- Active Cancer
- Hypercoaguable States (Protein C, Protein S, Factor V Leiden, etc.)
- Family history of thrombosis -note: we may remove this criteria after further discussion
- Patients requiring prolonged immobilization (i.e. cast/knee immobilizer),
- Patients having multiple surgeries in close proximity to one another.
- Patients with known allergy or hypersensitivity to Aspirin or Platelet count < 60, 000
- Patients receiving bilateral joint replacement
- Patients who consent to the study and cancel/do not have a surgery scheduled within six months of signing the consent form will not be included. (Note: The surgery does not have to occur within six months of signing the consent form but must be scheduled/re-scheduled within six months of signing the consent form.) If these patients decide to schedule surgery after the six months has passed, they will be re-consented at the time they schedule surgery.
- Patients who are not willing to participate will also be excluded from the study.
- -
About this study
Official title: Outcomes Study to Determine the Incidence of Symptomatic DVT/PE in Patients Receiving Aspirin With Mechanical Compression Devices Versus Aspirin Alone Following Knee and Hip Arthroplasty
The Purpose is to compare the safety and efficacy of the use of aspirin(ASA) with medical compression devices versus aspirin alone for venous thromboprophylaxis following knee and hip arthroplasty.
Read the detailed description
Venous thromboembolism (VTE), which includes deep vein thrombosis (DVT) and pulmonary embolism (PE), is the most common complication occurring in association with knee and hip arthroplasty procedures due to an activation of the clotting cascade during bone and intramedullary canal preparation.DVT rates ranging from 4% to 15 % and PE rates ranging from 0.83% to 3% have been reported, with fatal PE rates reduced with the use of postoperative anticoagulation. The high risk of thromboembolic disease has led to recommendations that pharmacoprophylaxis be considered routinely. • The combination of short duration outpatient anticoagulation, early mobilization, and mechanical prophylaxis has recently been studied at our institution (Barnes-Jewish Hospital) and has been effective in prophylaxis against VTE. Current American College of Chest Physician (ACCP) guidelines recommend that a longer duration of outpatient anticoagulation following TKA / THA surgery may further reduce the risk of VTE.
Shorter patient hospitalizations and earlier discharge require an outpatient VTE prophylaxis regimen that is simple, effective, easy to monitor, predictable, and has a high patient compliance. Currently, "routine" risk patients receive a combination of ASA 325mg BID (twice daily) for a period of 6 weeks, and portable, mobile pneumatic compression devices (MCDs) for a period of 10 days post- surgery.The study is testing to see whether the use of ASA alone can be equally effective versus the use of ASA with MCDs in "routine" risk patients following total joint arthroplasty.Patients are enrolled fpr 6 months following surgery, and data collection occurs pre-surgery, 14 days after surgery, at the 4-8 wk visit and finally, at 6 months post surgery. We are evaluating the stated outcomes over this 6 month period.
- Being tested
- Aspirin, (Post- discharge) Mechanical Compression Device
- Medical subject headings
- Venous Thrombosis, Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AspirinDrug
(Post- discharge) Mechanical Compression DeviceDevice
Also called MCD, compression pump, mobile pumps
| Study group | Role | What they receive |
|---|---|---|
| Aspirin and MCDs | Active comparator | ASA with MCDs- Patients will receive MCDs intraoperatively and during the immediate post-operative recovery period, and will receive MCDs for a period of 10 days post-surgery. ASA 325mg BID will be prescribed for a period of 6 weeks. Receives: Drug: Aspirin; Device: (Post- discharge) Mechanical Compression Device |
| Aspirin only | Experimental | ASA only- Patients will receive MCDs intraoperatively and during the immediate post-operative recovery period, and will NOT receive MCDs after being discharged from hospital. ASA 325mg BID will be prescribed for a period of 6 weeks. Receives: Drug: Aspirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
VTE/PE
Using the MCS (Mobile Compression Systems) Mobile Pumps system for 10 days after surgery from hospital combined with 6 weeks of aspirin will prove superior to the use of 6 weeks of aspirin in the prophylaxis of VTE/PE in standard risk joint arthroplasty patients. Efficacy will be measured in relation to previously published clinical trials with these agents and with previous patient cohorts at our institution.
Measured: 6 months
Secondary outcomes (2)
Cessation of anticoagulation therapy for any reason
Patient reported data will be collected to capture this information.
Measured: 6 months
Readmission to the hospital for any VTE event or surgical site complication in relation to VTE prophylaxis therapy
Electronic Medical Records will be reviewed and patient reported data will be collected
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2017 (estimated)
- Study startJan 2017
- Primary completionJan 2019 (estimated)
- Study completionJan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DVT - Deep Vein ThrombosisStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Medical Compression Systems
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03027167
- Sponsor's protocol ID
- 201608075
- Acronym
- PDAS
- Status last verified
- May 2017
- First submitted
- 3 Jan 2017
- Last updated
- 12 May 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes Study to Determine the Incidence of Symptomatic DVT/PE in Patients Receiving Aspirin With Mechanical Compression Devices Versus Aspirin Alone Following Knee and Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT03027167
- Acronym / sponsor ID
- PDAS / 201608075
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- Medical Compression Systems
- Study start
- Jan 2017
- Primary completion
- Jan 2019 (estimated)
- Study completion
- Jan 2023 (estimated)
- First posted
- 23 Jan 2017 (estimated)
- 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.
The Purpose is to compare the safety and efficacy of the use of aspirin(ASA) with medical compression devices versus aspirin alone for venous thromboprophylaxis following knee and hip arthroplasty.
Detailed description
Venous thromboembolism (VTE), which includes deep vein thrombosis (DVT) and pulmonary embolism (PE), is the most common complication occurring in association with knee and hip arthroplasty procedures due to an activation of the clotting cascade during bone and intramedullary canal preparation.DVT rates ranging from 4% to 15 % and PE rates ranging from 0.83% to 3% have been reported, with fatal PE rates reduced with the use of postoperative anticoagulation. The high risk of thromboembolic disease has led to recommendations that pharmacoprophylaxis be considered routinely. • The combination of short duration outpatient anticoagulation, early mobilization, and mechanical prophylaxis has recently been studied at our institution (Barnes-Jewish Hospital) and has been effective in prophylaxis against VTE. Current American College of Chest Physician (ACCP) guidelines recommend that a longer duration of outpatient anticoagulation following TKA / THA surgery may further reduce the risk of VTE.
Shorter patient hospitalizations and earlier discharge require an outpatient VTE prophylaxis regimen that is simple, effective, easy to monitor, predictable, and has a high patient compliance. Currently, "routine" risk patients receive a combination of ASA 325mg BID (twice daily) for a period of 6 weeks, and portable, mobile pneumatic compression devices (MCDs) for a period of 10 days post- surgery.The study is testing to see whether the use of ASA alone can be equally effective versus the use of ASA with MCDs in "routine" risk patients following total joint arthroplasty.Patients are enrolled fpr 6 months following surgery, and data collection occurs pre-surgery, 14 days after surgery, at the 4-8 wk visit and finally, at 6 months post surgery. We are evaluating the stated outcomes over this 6 month period.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aspirin and MCDs | Active comparator | Drug: Aspirin, Device: (Post- discharge) Mechanical Compression DeviceASA with MCDs- Patients will receive MCDs intraoperatively and during the immediate post-operative recovery period, and will receive MCDs for a period of 10 days post-surgery. ASA 325mg BID will be prescribed for a period of 6 weeks. |
| Aspirin only | Experimental | Drug: AspirinASA only- Patients will receive MCDs intraoperatively and during the immediate post-operative recovery period, and will NOT receive MCDs after being discharged from hospital. ASA 325mg BID will be prescribed for a period of 6 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All total knee arthroplasty (TKA), unicompartmental knee arthroplasty (UKA), total hip arthroplasty (THA), and surface replacement arthroplasty (SRA) patients age 18 or older and undergoing an elective primary or revision procedure will be eligible to participate in this study.
Key exclusion criteria (23 listed)
- Patients will be excluded if they are on chronic Coumadin therapy, require prolonged immobilization (i.e. cast/knee immobilizer; inability to be full weight-bearing and out of bed on postoperative day 1), and are scheduled to have multiple surgeries in close proximity to one another. Based on our institution's risk stratification protocol, all patients deemed "high risk" and meeting one of the following criteria will also be excluded as they would receive Coumadin for VTE prophylaxis:
- Patients will be excluded if they are on chronic Coumadin therapy
- History of DVT/PE
- Active Cancer
- Hypercoaguable States (Protein C, Protein S, Factor V Leiden, etc.)
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 |
|---|---|---|
| Aspirin | Drug | Aspirin and MCDs, Aspirin only |
| (Post- discharge) Mechanical Compression DeviceAlso: MCD, compression pump, mobile pumps | Device | Aspirin and MCDs |
Primary outcome
VTE/PE
Time frame: 6 months
Using the MCS (Mobile Compression Systems) Mobile Pumps system for 10 days after surgery from hospital combined with 6 weeks of aspirin will prove superior to the use of 6 weeks of aspirin in the prophylaxis of VTE/PE in standard risk joint arthroplasty patients. Efficacy will be measured in relation to previously published clinical trials with these agents and with previous patient cohorts at our institution.
2 secondary outcomes
Cessation of anticoagulation therapy for any reason
Time frame: 6 months
Readmission to the hospital for any VTE event or surgical site complication in relation to VTE prophylaxis therapy
Time frame: 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2017.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Aspirin and (Post- discharge) Mechanical Compression Device in people with DVT - Deep Vein Thrombosis and PE - Pulmonary Thromboembolism, run by Washington University School of Medicine.
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 23 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: withdrawn, as of the sponsor's last update on 12 May 2017. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
VTE/PE (time frame: 6 months). 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 12 May 2017.