Elastic Compression Stockings for Prevention of Post-thrombotic Syndrome

NCT01578122 | Completed DMC

• 2 other identifiers: CVE301-10 (Themas) : DCIC/10282010-A01078-31
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 57

Brief Summary

Post thrombotic syndrome (PTS) is a frequent and burdensome complication of proximal deep-vein thrombosis.Therapeutic options for PTS are limited and mainly rely on its prevention. Therapeutic trials evidenced that elastic compression stockings (ECS) applying 30-40mmHg of pressure at the ankle reduced the rate of PTS by 50%. Although ECS are unlikely to cause harm, in clinical practice, compliance to this treatment appears to be low as ECS may be difficult to apply and to wear. ECS with a lighter compression strength (20-30mmHg) might be easier to apply and be more comfortable. This could favor a better compliance. CELEST is a randomized, multicentre, double-blind trial which aims to determine whether ECS applying 25mmHg of targeted pressure at the ankle are non inferior to ECS applying 35mmHg of targeted pressure at the ankle

Conditions

Deep Vein Thrombosis; Post-thrombotic Syndrome

Keywords

post-thrombotic syndrome; prevention; deep vein thrombosis; elastic compression stockings; compliance; quality of life

Outcome Measures

Primary Outcomes (1)

• To show that elastic compression with ankle pressure targeted at 25 mm Hg is not inferior in preventing the onset of clinical post-thrombotic syndrome to a target ankle pressure of 35 mm Hg (recommended pressure being greater than 30 mm Hg)

  cumulative incidence 24 months after inclusion of PTS apparition defined by the Villalta score \> or equal to 5. A visual guide will be given to investigators to assist them and standardize PTS evaluation. Investigators will receive a Villalta training during set up visits.

  24 months

Secondary Outcomes (14)

• superiority of targeted pressure at 35 mm Hg for compliant patients. Analysis of the primary endpoint per protocol amongst patients responding to the definition of compliance for compression scheduled by randomization

  24 months

• Superiority of 25 mm Hg on the therapeutic compliance criterion

  24 months

• superiority of 25 mm Hg for constraints related to compression and chronic venous insufficiency quality of life (CIVIQ)

  3 months, 12 months, 24 months

• non inferiority of 25 mm Hg for the comparative evaluation of the symptomatic effect of short-term compression (pain, sensation of oedema) form baseline to 3 months

  3 months

• Non-inferiority of 25 mm Hg for changes in overall quality of life evaluated on the basis of the EUROQUOL questionnaire

  3months, 12 months, 24 months

Study Arms (2)

25mmHg ECS

EXPERIMENTAL

Thigh-length graduated elastic compression stockings applying 25mmhg of targeted pressure at the ankle worn daily for two years

Device: 25mmHg ECS

35mmHg ECS

ACTIVE COMPARATOR

Thigh-length graduated elastic compression stockings applying 35 mmhg of targeted pressure at the ankle worn daily for two years

Device: 35 mmHg ECS

Interventions

25mmHg ECS DEVICE

Thigh-length graduated elastic compression stockings applying 25 mmhg of targeted pressure at the ankle worn daily (from morning to night) for two years. Before receiving the randomly allocated treatment, each patient will wear cotton, class III Varisma Comfort® stay-up stockings (20-36 mm Hg).

Also known as: ACTYS 25® for women, LEGGER 25® for men

25mmHg ECS

35 mmHg ECS DEVICE

Thigh-length graduated elastic compression stockings applying 35mmhg of pressure at the ankle worn daily (from morning to night) for two years Before receiving the randomly allocated treatment, each patient will wear cotton, class III Varisma Comfort® stay-up stockings (20-36 mm Hg).

Also known as: ACTYS 35® for women, LEGGER 35® for men

35mmHg ECS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient (male/female) at least 18 years old
• Patient presenting with an initial episode of proximal deep vein thrombosis (DVT) confirmed by an additional examination (echo-Doppler scan) taken no more than 8 days previously :
• the proximal character defined by a DVT from the collecting trunk extending from the tibial-peroneal trunk to the inferior vena cava inclusive the unilateral character concerns only the proximal part. Patients with a distal DVT on the contralateral member the day of diagnosis can be included The notion of initial episode concerns only the proximal part. Patients with a preceding DVT limited to distal part can be included
• with no trophic disorders at baseline (CEAP class 4, 5 or 6 excluded)
• with or without pulmonary embolism
• Patient capable of benefiting from anticoagulant therapy of at least 3 months duration
• Available to participate in a clinical trial with a 24-month follow-up period and for which a delivery of study products may be possible throughout its participation (delivery possible only in Metropolitan France)
• Life expectancy greater than 24 months
• Volunteer to take part in the study, having signed the consent form after receiving sufficient information and the information leaflet
• Person affiliated to social security or the recipient of a similar scheme.
• Patients with at least one of these contraindications to compression treatment:
• phlegmasia cerulea dolens,
• septic thrombosis,
• product intolerance, allergic reaction to one of the components
• Arteritis obliterans stage III and IV of the lower limbs (IPS\<0.6),

Sponsors & Collaborators

• Laboratoires Innothera: lead
• University Hospital, Grenoble: collaborator
• Floralis: collaborator

Study Sites (57)

Cabinet

Lyon, Rhônes Alpes, 69003, France

Location

Cabinet

Aix-les-Bains, 73100, France

Location

Cabinet

Alençon, 61000, France

Location

Clinique Victor PAUCHET

Amiens, 80000, France

Location

CHRU Amiens

Amiens, 80054, France

Location

Cabinet

Amiens, 80094, France

Location

Chu Angers

Angers, 49933, France

Location

Cabinet

Annecy, 74000, France

Location

Chra Annecy

Annecy, 74374, France

Location

Centre Hospitalier d'Armentieres

Armentières, 59280, France

Location

CH Armentières

Armentières, 59280, France

Location

Cabinet

Bordeaux, 33300, France

Location

Cabinet

Bourgoin, 38300, France

Location

Ch Bourgoin-Jallieu

Bourgoin, 38300, France

Location

Hia Brest

Brest, 29200, France

Location

Chu Brest

Brest, 29609, France

Location

CHU

Caen, 14033, France

Location

Cabinet

Carcassonne, 11000, France

Location

Cabinet

Chalon-sur-Saône, 71100, France

Location

Ch Chalon Sur Saone

Chalon-sur-Saône, 71321, France

Location

CH de Chambéry

Chambéry, 73000, France

Location

Cabinet

Clapiers, 34830, France

Location

Chu Clermont-Ferrand

Clermont-Ferrand, 63003, France

Location

CHU Gabriel Montpied

Clermont-Ferrand, 63003, France

Location

Cabinet

Dijon, 21000, France

Location

Hôpital du bocage

Dijon, 21079, France

Location

Cabinet

Échirolles, 38130, France

Location

Cabinet

Genas, 69740, France

Location

Cabinet

Grenoble, 38000, France

Location

Chu Grenoble

Grenoble, 38043, France

Location

Cabinet

Hennebont, 56700, France

Location

Cabinet

Issy-les-Moulineaux, 92130, France

Location

Ch La Rochelle

La Rochelle, 17000, France

Location

Cabinet

Lille, 59000, France

Location

Chru Lille

Lille, 59037, France

Location

Hopital Saint Philibert

Lomme, 59462, France

Location

CH Pierre-Bénite

Lyon, 69310, France

Location

CH Mâcon

Mâcon, 71018, France

Location

Cabinet

Montbonnot-Saint-Martin, 38330, France

Location

Cabinet

Montélimar, 26200, France

Location

Cabinet

Montigny-lès-Metz, 57950, France

Location

Cabinet

Montluçon, 03100, France

Location

Chu Montpellier

Montpellier, 34295, France

Location

Chu Hotel Dieu

Nantes, 44039, France

Location

CHR Orléans

Orléans, 45067, France

Location

HEGP

Paris, 75015, France

Location

Hôpital St Joseph

Paris, 75674, France

Location

Cabinet

Péronne, 80200, France

Location

Cabinet

Saint-Alban, 31140, France

Location

Cabinet

Saint-Aubin-sur-Scie, 76550, France

Location

Chu St Etienne

Saint-Etienne, 42055, France

Location

Cabinet

Sélestat, 67600, France

Location

Cabinet

Thonon-les-Bains, 74200, France

Location

Chu Toulouse

Toulouse, 31059, France

Location

Cabinet

Tournefeuille, 31170, France

Location

Cabinet

Villeurbanne, 69100, France

Location

Cabinet

Vizille, 38220, France

Location

Related Publications (21)

• Fowkes FJ, Price JF, Fowkes FG. Incidence of diagnosed deep vein thrombosis in the general population: systematic review. Eur J Vasc Endovasc Surg. 2003 Jan;25(1):1-5. doi: 10.1053/ejvs.2002.1778.

  PMID: 12525804 BACKGROUND

• Oger E. Incidence of venous thromboembolism: a community-based study in Western France. EPI-GETBP Study Group. Groupe d'Etude de la Thrombose de Bretagne Occidentale. Thromb Haemost. 2000 May;83(5):657-60.

  PMID: 10823257 BACKGROUND

• Prandoni P, Kahn SR. Post-thrombotic syndrome: prevalence, prognostication and need for progress. Br J Haematol. 2009 May;145(3):286-95. doi: 10.1111/j.1365-2141.2009.07601.x. Epub 2009 Feb 13.

  PMID: 19222476 BACKGROUND

• Prandoni P, Lensing AW, Cogo A, Cuppini S, Villalta S, Carta M, Cattelan AM, Polistena P, Bernardi E, Prins MH. The long-term clinical course of acute deep venous thrombosis. Ann Intern Med. 1996 Jul 1;125(1):1-7. doi: 10.7326/0003-4819-125-1-199607010-00001.

  PMID: 8644983 BACKGROUND

• Prandoni P, Villalta S, Bagatella P, Rossi L, Marchiori A, Piccioli A, Bernardi E, Girolami B, Simioni P, Girolami A. The clinical course of deep-vein thrombosis. Prospective long-term follow-up of 528 symptomatic patients. Haematologica. 1997 Jul-Aug;82(4):423-8.

  PMID: 9299855 BACKGROUND

• Gabriel F, Labios M, Portoles O, Guillen M, Corella D, Frances F, Martinez M, Gil J, Saiz C. Incidence of post-thrombotic syndrome and its association with various risk factors in a cohort of Spanish patients after one year of follow-up following acute deep venous thrombosis. Thromb Haemost. 2004 Aug;92(2):328-36. doi: 10.1160/TH03-11-0700.

  PMID: 15269829 BACKGROUND

• Kahn SR, Ginsberg JS. Relationship between deep venous thrombosis and the postthrombotic syndrome. Arch Intern Med. 2004 Jan 12;164(1):17-26. doi: 10.1001/archinte.164.1.17.

  PMID: 14718318 BACKGROUND

• Kahn SR, Hirsch A, Shrier I. Effect of postthrombotic syndrome on health-related quality of life after deep venous thrombosis. Arch Intern Med. 2002 May 27;162(10):1144-8. doi: 10.1001/archinte.162.10.1144.

  PMID: 12020185 BACKGROUND

• Bergqvist D, Jendteg S, Johansen L, Persson U, Odegaard K. Cost of long-term complications of deep venous thrombosis of the lower extremities: an analysis of a defined patient population in Sweden. Ann Intern Med. 1997 Mar 15;126(6):454-7. doi: 10.7326/0003-4819-126-6-199703150-00006.

  PMID: 9072931 BACKGROUND

• Brandjes DP, Buller HR, Heijboer H, Huisman MV, de Rijk M, Jagt H, ten Cate JW. Randomised trial of effect of compression stockings in patients with symptomatic proximal-vein thrombosis. Lancet. 1997 Mar 15;349(9054):759-62. doi: 10.1016/S0140-6736(96)12215-7.

  PMID: 9074574 BACKGROUND

• Prandoni P, Lensing AW, Prins MH, Frulla M, Marchiori A, Bernardi E, Tormene D, Mosena L, Pagnan A, Girolami A. Below-knee elastic compression stockings to prevent the post-thrombotic syndrome: a randomized, controlled trial. Ann Intern Med. 2004 Aug 17;141(4):249-56. doi: 10.7326/0003-4819-141-4-200408170-00004.

  PMID: 15313740 BACKGROUND

• Milne AA, Ruckley CV. The clinical course of patients following extensive deep venous thrombosis. Eur J Vasc Surg. 1994 Jan;8(1):56-9. doi: 10.1016/s0950-821x(05)80121-5.

  PMID: 8307217 BACKGROUND

• Partsch H, Blattler W. Compression and walking versus bed rest in the treatment of proximal deep venous thrombosis with low molecular weight heparin. J Vasc Surg. 2000 Nov;32(5):861-9. doi: 10.1067/mva.2000.110352.

  PMID: 11054217 BACKGROUND

• Kahn SR, Elman E, Rodger MA, Wells PS. Use of elastic compression stockings after deep venous thrombosis: a comparison of practices and perceptions of thrombosis physicians and patients. J Thromb Haemost. 2003 Mar;1(3):500-6. doi: 10.1046/j.1538-7836.2003.00098.x.

  PMID: 12871457 BACKGROUND

• Benko T, Cooke EA, McNally MA, Mollan RA. Graduated compression stockings: knee length or thigh length. Clin Orthop Relat Res. 2001 Feb;(383):197-203.

  PMID: 11210954 BACKGROUND

• Sajid MS, Tai NR, Goli G, Morris RW, Baker DM, Hamilton G. Knee versus thigh length graduated compression stockings for prevention of deep venous thrombosis: a systematic review. Eur J Vasc Endovasc Surg. 2006 Dec;32(6):730-6. doi: 10.1016/j.ejvs.2006.06.021. Epub 2006 Aug 23.

  PMID: 16931066 BACKGROUND

• Nelson EA, Harper DR, Prescott RJ, Gibson B, Brown D, Ruckley CV. Prevention of recurrence of venous ulceration: randomized controlled trial of class 2 and class 3 elastic compression. J Vasc Surg. 2006 Oct;44(4):803-8. doi: 10.1016/j.jvs.2006.05.051.

  PMID: 17012004 BACKGROUND

• Arpaia G, Cimminiello C, Mastrogiacomo O, de Gaudenzi E. Efficacy of elastic compression stockings used early or after resolution of the edema on recanalization after deep venous thrombosis: the COM.PRE Trial. Blood Coagul Fibrinolysis. 2007 Mar;18(2):131-7. doi: 10.1097/MBC.0b013e328011f2dd.

  PMID: 17287629 BACKGROUND

• Roumen-Klappe EM, den Heijer M, van Rossum J, Wollersheim H, van der Vleuten C, Thien T, Janssen MC. Multilayer compression bandaging in the acute phase of deep-vein thrombosis has no effect on the development of the post-thrombotic syndrome. J Thromb Thrombolysis. 2009 May;27(4):400-5. doi: 10.1007/s11239-008-0229-7. Epub 2008 May 15.

  PMID: 18480967 BACKGROUND

• Delluc A, Gouedard C, De Saint Martin L, Garcia C, Roguedas AM, Bressollette L, Misery L, Mottier D, Le Gal G. [Incidence, risk factors and skin manifestations of post-thrombotic syndrome: a four-year follow-up of patients included in the EDITH study]. Rev Med Interne. 2010 Nov;31(11):729-34. doi: 10.1016/j.revmed.2010.07.018. Epub 2010 Sep 29. French.

  PMID: 20880613 BACKGROUND

• Galanaud JP, Genty-Vermorel C, Barrellier MT, Becker F, Jabbour V, Blaise S, Bura-Riviere A, Comte A, Grange C, Guenneguez H, Maufus M, Ouvry P, Richaud C, Rolland C, Schmidt J, Sevestre MA, Verriere F, Bosson JL; CELEST trial investigators. 25 mm Hg versus 35 mm Hg elastic compression stockings to prevent post-thrombotic syndrome after deep vein thrombosis (CELEST): a randomised, double-blind, non-inferiority trial. Lancet Haematol. 2022 Dec;9(12):e886-e896. doi: 10.1016/S2352-3026(22)00247-2.

  PMID: 36455606 DERIVED

MeSH Terms

Conditions

Venous Thrombosis; Postthrombotic Syndrome; Patient Compliance

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Venous Insufficiency; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Jean-Luc BOSSON, MD, PhD

  CIC Grenoble

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2012
• First Posted: April 16, 2012
• Study Start: June 29, 2012
• Primary Completion: June 28, 2019
• Study Completion: June 28, 2019
• Last Updated: January 22, 2020

Record last verified: 2019-08

Locations

FR (57)