Vascular Boot Warming Program After Acute Deep Vein Thrombosis (DVT) ± Pulmonary Embolism (PE)
| Status: | Enrolling by invitation |
|---|---|
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/17/2018 |
| Start Date: | January 13, 2017 |
| End Date: | December 2018 |
Efficacy and Safety of Vascular Boot Warming Program After Acute DVT±PE for Earlier Resolution of VTE and Prevention of Post Thrombotic Syndrome: A Pilot Study.
The Researchers are studying whether a vascular boot warming program plus standard of care
anticoagulation can be a safe and effective method to resolve Deep Vein Thrombosis (DVT)
±Pulmonary Embolism (PE) earlier and prevent development of post-thrombotic syndrome (PTS).
Additionally, to learn whether a more detailed imaging of the affected lower extremities will
provide a more accurate and reliable method to guide treatment for this condition.
anticoagulation can be a safe and effective method to resolve Deep Vein Thrombosis (DVT)
±Pulmonary Embolism (PE) earlier and prevent development of post-thrombotic syndrome (PTS).
Additionally, to learn whether a more detailed imaging of the affected lower extremities will
provide a more accurate and reliable method to guide treatment for this condition.
Participants with diagnosis of acute lower extremity DVT (proximal and distal) and/or
pulmonary embolism will be identified and approached for participation, when they are seen in
the Thrombophilia Clinic or Mayo Hospital for management of the acute VTE. If they match the
preset inclusion and exclusion criteria, they would then be consented during this visit and
scheduled for baseline studies at a later date. Baseline tests include Venous
plethysmorgraphy, Lower Extremity Ultrasound, and Medical history, will be conducted and if
eligible, participant will then be randomized to vascular boot plus standard anti coagulation
program or standard anti coagulation using a randomization program. Participants will be
randomized into two groups and followed for 3 months. Standard of Care (SOC) Group (no
vascular boot utilized): Patients will receive standard anticoagulation (determined at
discretion of the treating provider), baseline studies, and follow up at the end of treatment
(3months). Vascular Boot (VB) Group (includes vascular boot in addition to SOC): Patients
will receive standard anticoagulation (determined at discretion of the treating provider),
baseline studies and standardized vascular boot warming. All patients randomized to this
group will wear the vascular boot for a minimum of 30 minutes per day for the first 10 days
of participation. Patients in this group may initially be enrolled at either the
thrombophilia clinic or the hospital.
pulmonary embolism will be identified and approached for participation, when they are seen in
the Thrombophilia Clinic or Mayo Hospital for management of the acute VTE. If they match the
preset inclusion and exclusion criteria, they would then be consented during this visit and
scheduled for baseline studies at a later date. Baseline tests include Venous
plethysmorgraphy, Lower Extremity Ultrasound, and Medical history, will be conducted and if
eligible, participant will then be randomized to vascular boot plus standard anti coagulation
program or standard anti coagulation using a randomization program. Participants will be
randomized into two groups and followed for 3 months. Standard of Care (SOC) Group (no
vascular boot utilized): Patients will receive standard anticoagulation (determined at
discretion of the treating provider), baseline studies, and follow up at the end of treatment
(3months). Vascular Boot (VB) Group (includes vascular boot in addition to SOC): Patients
will receive standard anticoagulation (determined at discretion of the treating provider),
baseline studies and standardized vascular boot warming. All patients randomized to this
group will wear the vascular boot for a minimum of 30 minutes per day for the first 10 days
of participation. Patients in this group may initially be enrolled at either the
thrombophilia clinic or the hospital.
Inclusion Criteria:
- Able to tolerate wearing a vascular boot, if randomized to this group.
- Diagnosis of acute DVT±PE (within 24 - 48 hours) and received approximately 24 hours
of anticoagulation prior to starting the study.
Exclusion Criteria:
- Unable to tolerate wearing a vascular boot
- Unable to comply with keeping log of activity/ of wearing a vascular boot.
- Weight > 300 pounds. (weight limit for the venous plethysmography chair)
- Previous history of DVT or PE.
- On anticoagulation for another purpose (example stroke prevention with atrial
fibrillation).
- Patients who do not accept to participate in research studies.
- Pregnant women will not be allowed to participate
- Patients less than 18 yrs
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