Vascular Boot Warming Program After Acute Deep Vein Thrombosis (DVT) ± Pulmonary Embolism (PE)

Acute DVT of Lower Extremity Clinical Trial

Official title:

Efficacy and Safety of Vascular Boot Warming Program After Acute DVT±PE for Earlier Resolution of Venous Thromboembolism (VTE) and Prevention of Post Thrombotic Syndrome: A Pilot Study.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03465735
• Other study ID #: 16-008129
• Status: Terminated
• Phase: N/A
• Start date: January 13, 2017
• Est. completion date: January 3, 2020

Study information

• Verified date: May 2020
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 15
• Est. completion date: January 3, 2020
• Est. primary completion date: August 29, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute DVT of Lower Extremity
• Thromboembolism
• Thrombosis

Intervention

Combination Product:
• Vascular Boot
The Vascular Boot is one size fits all, insulated fleece padding, and cell foam to enhance and maintain lower limb warmth while maintaining no pressure points on the lower extremity.

Drug:
• Standard of Care
Anticoagulant therapy will be decided by physician and patient.

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

References & Publications (19)

Caprini JA, Arcelus JI, Hoffman KN, Size G, Laubach M, Traverso CI, Coats R, Finke N, Reyna JJ. Venous duplex imaging follow-up of acute symptomatic deep vein thrombosis of the leg. J Vasc Surg. 1995 Mar;21(3):472-6. — View Citation

Centers for Disease Control and Prevention (CDC). Venous thromboembolism in adult hospitalizations - United States, 2007-2009. MMWR Morb Mortal Wkly Rep. 2012 Jun 8;61(22):401-4. — View Citation

Heit JA, Ashrani AA, Crusan DJ, Petterson TM, Bailey KR. Trends in venous thromboembolism incidence, 1981-2010: a population-based cohort study. JAMA. 2015, in submission.

Heit JA, Crusan DJ, Ashrani AA, Petterson TM, Bailey KR. Venous thromboembolism attack rates among recently hospitalized vs. community residents: a population-based cohort study. JAMA. 2015 in submission.

Heit JA. The epidemiology of venous thromboembolism in the community. Arterioscler Thromb Vasc Biol. 2008 Mar;28(3):370-2. doi: 10.1161/ATVBAHA.108.162545. Review. — View Citation

Kahn SR, Azoulay L, Hirsch A, Haber M, Strulovitch C, Shrier I. Acute effects of exercise in patients with previous deep venous thrombosis: impact of the postthrombotic syndrome. Chest. 2003 Feb;123(2):399-405. — View Citation

Kahn SR, Comerota AJ, Cushman M, Evans NS, Ginsberg JS, Goldenberg NA, Gupta DK, Prandoni P, Vedantham S, Walsh ME, Weitz JI; American Heart Association Council on Peripheral Vascular Disease, Council on Clinical Cardiology, and Council on Cardiovascular and Stroke Nursing. The postthrombotic syndrome: evidence-based prevention, diagnosis, and treatment strategies: a scientific statement from the American Heart Association. Circulation. 2014 Oct 28;130(18):1636-61. doi: 10.1161/CIR.0000000000000130. Epub 2014 Sep 22. Erratum in: Circulation. 2015 Feb 24;131(8):e359. — View Citation

Kahn SR, Shapiro S, Wells PS, Rodger MA, Kovacs MJ, Anderson DR, Tagalakis V, Houweling AH, Ducruet T, Holcroft C, Johri M, Solymoss S, Miron MJ, Yeo E, Smith R, Schulman S, Kassis J, Kearon C, Chagnon I, Wong T, Demers C, Hanmiah R, Kaatz S, Selby R, Rathbun S, Desmarais S, Opatrny L, Ortel TL, Ginsberg JS; SOX trial investigators. Compression stockings to prevent post-thrombotic syndrome: a randomised placebo-controlled trial. Lancet. 2014 Mar 8;383(9920):880-8. doi: 10.1016/S0140-6736(13)61902-9. Epub 2013 Dec 6. — View Citation

Killewich LA, Bedford GR, Beach KW, Strandness DE Jr. Spontaneous lysis of deep venous thrombi: rate and outcome. J Vasc Surg. 1989 Jan;9(1):89-97. — View Citation

Killewich LA, Macko RF, Cox K, Franklin DR, Benjamin ME, Lilly MP, Flinn WR. Regression of proximal deep venous thrombosis is associated with fibrinolytic enhancement. J Vasc Surg. 1997 Nov;26(5):861-8. — View Citation

Labropoulos N, Giannoukas AD, Nicolaides AN, Veller M, Leon M, Volteas N. The role of venous reflux and calf muscle pump function in nonthrombotic chronic venous insufficiency. Correlation with severity of signs and symptoms. Arch Surg. 1996 Apr;131(4):403-6. — View Citation

Meyer G, Vicaut E, Danays T, Agnelli G, Becattini C, Beyer-Westendorf J, Bluhmki E, Bouvaist H, Brenner B, Couturaud F, Dellas C, Empen K, Franca A, Galiè N, Geibel A, Goldhaber SZ, Jimenez D, Kozak M, Kupatt C, Kucher N, Lang IM, Lankeit M, Meneveau N, Pacouret G, Palazzini M, Petris A, Pruszczyk P, Rugolotto M, Salvi A, Schellong S, Sebbane M, Sobkowicz B, Stefanovic BS, Thiele H, Torbicki A, Verschuren F, Konstantinides SV; PEITHO Investigators. Fibrinolysis for patients with intermediate-risk pulmonary embolism. N Engl J Med. 2014 Apr 10;370(15):1402-11. doi: 10.1056/NEJMoa1302097. — View Citation

Murphy TP, Cutlip DE, Regensteiner JG, Mohler ER, Cohen DJ, Reynolds MR, Massaro JM, Lewis BA, Cerezo J, Oldenburg NC, Thum CC, Goldberg S, Jaff MR, Steffes MW, Comerota AJ, Ehrman J, Treat-Jacobson D, Walsh ME, Collins T, Badenhop DT, Bronas U, Hirsch AT; CLEVER Study Investigators. Supervised exercise versus primary stenting for claudication resulting from aortoiliac peripheral artery disease: six-month outcomes from the claudication: exercise versus endoluminal revascularization (CLEVER) study. Circulation. 2012 Jan 3;125(1):130-9. doi: 10.1161/CIRCULATIONAHA.111.075770. Epub 2011 Nov 16. — View Citation

O'shaughnessy AM, Fitzgerald DE. The patterns and distribution of residual abnormalities between the individual proximal venous segments after an acute deep vein thrombosis. J Vasc Surg. 2001 Feb;33(2):379-84. — View Citation

Ogawa T, Hoshino S, Midorikawa H, Sato K. Intermittent pneumatic compression of the foot and calf improves the outcome of catheter-directed thrombolysis using low-dose urokinase in patients with acute proximal venous thrombosis of the leg. J Vasc Surg. 2005 Nov;42(5):940-4. — View Citation

Piazza G, Hohlfelder B, Jaff MR, Ouriel K, Engelhardt TC, Sterling KM, Jones NJ, Gurley JC, Bhatheja R, Kennedy RJ, Goswami N, Natarajan K, Rundback J, Sadiq IR, Liu SK, Bhalla N, Raja ML, Weinstock BS, Cynamon J, Elmasri FF, Garcia MJ, Kumar M, Ayerdi J, Soukas P, Kuo W, Liu PY, Goldhaber SZ; SEATTLE II Investigators. A Prospective, Single-Arm, Multicenter Trial of Ultrasound-Facilitated, Catheter-Directed, Low-Dose Fibrinolysis for Acute Massive and Submassive Pulmonary Embolism: The SEATTLE II Study. JACC Cardiovasc Interv. 2015 Aug 24;8(10):1382-92. doi: 10.1016/j.jcin.2015.04.020. — View Citation

Recek C. Calf pump activity influencing venous hemodynamics in the lower extremity. Int J Angiol. 2013 Mar;22(1):23-30. doi: 10.1055/s-0033-1334092. Review. — View Citation

Shrier I, Kahn SR. Effect of physical activity after recent deep venous thrombosis: a cohort study. Med Sci Sports Exerc. 2005 Apr;37(4):630-4. — View Citation

van Ramshorst B, van Bemmelen PS, Hoeneveld H, Faber JA, Eikelboom BC. Thrombus regression in deep venous thrombosis. Quantification of spontaneous thrombolysis with duplex scanning. Circulation. 1992 Aug;86(2):414-9. — View Citation

* Note: There are 19 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Affected Leg Pain	Affected leg pain measured on a 0-10 scale. 0 indicating No pain and 10 indicating Worst Possible Pain.	baseline, 10 days

External Links

•   Mayo Clinic Clinical Trials