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Deep Vein ThrombosisCELESTNCT01578122

Elastic Compression Stockings for Prevention of Post-thrombotic Syndrome

A study testing 25mmHg ECS and 35 mmHg ECS in people with Deep Vein Thrombosis and Post-thrombotic Syndrome, run by Laboratoires Innothera at 57 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
25mmHg ECS and 35 mmHg ECS
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
350 participants
Where
57 sitesFrance
Study dates
29 Jun 2012to 28 Jun 2019
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
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 31Show fewer
  • 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.
  • non inclusion criteria
  • 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),
  • Micro-angiopathy, advanced diabetes,
  • Decompensated heart failure,
  • Skin infections: anti-infective treatment must precede compression therapy,
  • Weeping skin diseases of the leg.
  • Compression treatment technically impossible during the study
  • Patients presenting with bilateral venous thrombosis of the lower limbs.
  • Patient having received fibrinolytic treatment, mechanical thrombo-aspiration or venous repermeation surgery for venous thrombosis justifying inclusion
  • Patients having undergone mechanical interruption of the inferior vena cava.
  • Patients for whom long-term elastic compression for the treatment of lymphatic venous insufficiency (patients with lymphoedema), for instance, is indicated prior to DVT. Patients with elastic compression for primary thromboprophylaxis of thromboembolic disease (TED) are eligible.
  • Patients presenting with oedema unrelated to venous insufficiency or in whom oedema is likely to develop within 2 years.
  • Patients receiving diuretic treatment for more than 3 months due to heart failure.
  • Pregnant women
  • Person deprived of liberty by a legal or administrative decision, person under legal protection.
  • Patient currently participating in a clinical trial or having taken part in a clinical trial in the month preceding inclusion
  • Patient presenting with a history of mental or psychiatric illness or any other factor restricting his/her ability to participate in an informed manner and in compliance with the protocol

Who cannot join

None listed.

Trial locations and contacts

57 sites in 1 country.

57 sites in 1 country

France57 sites

  • Cabinet

    Aix-les-Bains, 73100

  • Cabinet

    Alençon, 61000

  • Clinique Victor PAUCHET

    Amiens, 80000

  • CHRU Amiens

    Amiens, 80054

  • Cabinet

    Amiens, 80094

  • Chu Angers

    Angers, 49933

  • Cabinet

    Annecy, 74000

  • Chra Annecy

    Annecy, 74374

  • Centre Hospitalier d'Armentieres

    Armentières, 59280

  • CH Armentières

    Armentières, 59280

  • Cabinet

    Bordeaux, 33300

  • Cabinet

    Bourgoin, 38300

  • Ch Bourgoin-Jallieu

    Bourgoin, 38300

  • Hia Brest

    Brest, 29200

  • Chu Brest

    Brest, 29609

  • CHU

    Caen, 14033

  • Cabinet

    Carcassonne, 11000

  • Cabinet

    Chalon-sur-Saône, 71100

  • Ch Chalon Sur Saone

    Chalon-sur-Saône, 71321

  • CH de Chambéry

    Chambéry, 73000

  • Cabinet

    Clapiers, 34830

  • Chu Clermont-Ferrand

    Clermont-Ferrand, 63003

  • CHU Gabriel Montpied

    Clermont-Ferrand, 63003

  • Cabinet

    Dijon, 21000

  • Hôpital du bocage

    Dijon, 21079

  • Cabinet

    Échirolles, 38130

  • Cabinet

    Genas, 69740

  • Cabinet

    Grenoble, 38000

  • Chu Grenoble

    Grenoble, 38043

  • Cabinet

    Hennebont, 56700

  • Cabinet

    Issy-les-Moulineaux, 92130

  • Ch La Rochelle

    La Rochelle, 17000

  • Cabinet

    Lille, 59000

  • Chru Lille

    Lille, 59037

  • Hopital Saint Philibert

    Lomme, 59462

  • Cabinet

    Lyon, Rhônes Alpes, 69003

  • CH Pierre-Bénite

    Lyon, 69310

  • CH Mâcon

    Mâcon, 71018

  • Cabinet

    Montbonnot-Saint-Martin, 38330

  • Cabinet

    Montélimar, 26200

  • Cabinet

    Montigny-lès-Metz, 57950

  • Cabinet

    Montluçon, 03100

  • Chu Montpellier

    Montpellier, 34295

  • Chu Hotel Dieu

    Nantes, 44039

  • CHR Orléans

    Orléans, 45067

  • HEGP

    Paris, 75015

  • Hôpital St Joseph

    Paris, 75674

  • Cabinet

    Péronne, 80200

  • Cabinet

    Saint-Alban, 31140

  • Cabinet

    Saint-Aubin-sur-Scie, 76550

  • Chu St Etienne

    Saint-Etienne, 42055

  • Cabinet

    Sélestat, 67600

  • Cabinet

    Thonon-les-Bains, 74200

  • Chu Toulouse

    Toulouse, 31059

  • Cabinet

    Tournefeuille, 31170

  • Cabinet

    Villeurbanne, 69100

  • Cabinet

    Vizille, 38220

Other trials in France

About this study

Official title: Evaluation of the Efficacy of Elastic Compression in Preventing Post-thrombotic Syndrome. Randomised Non-inferiority Study for Ankle Pressure Targeted at 25 mm Hg Versus 35 mm Hg

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

Read the detailed description

CELEST trial is a controlled, randomized, multicentre, non-inferiority 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. Patients with a first acute symptomatic proximal DVT will be randomized to wear for two years either ECS applying 25mmHg of targeted pressure at the ankle or ECS applying 35mmHg of targeted pressure at the ankle. All patients will be prescribed anticoagulants for at least three months. The primary outcome will be the rate of PTS assessed with the Villalta scale in both arms of the study during the 2 years study period. Rate of compliance,severity of PTS and quality of life in both groups will constitute the main secondary outcomes.

Being tested
25mmHg ECS, 35 mmHg ECS
Keywords
post-thrombotic syndrome, prevention, deep vein thrombosis, elastic compression stockings, compliance, quality of life
Medical subject headings
Venous Thrombosis, Postthrombotic Syndrome, Patient Compliance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 25mmHg ECSDevice

    Also called ACTYS 25® for women, LEGGER 25® for men

    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).

  • 35 mmHg ECSDevice

    Also called ACTYS 35® for women, LEGGER 35® for men

    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).

Study groups in NCT01578122
Study groupRoleWhat they receive
25mmHg ECSExperimentalThigh-length graduated elastic compression stockings applying 25mmhg of targeted pressure at the ankle worn daily for two years
Receives: Device: 25mmHg ECS
35mmHg ECSActive comparatorThigh-length graduated elastic compression stockings applying 35 mmhg of targeted pressure at the ankle worn daily for two years
Receives: Device: 35 mmHg ECS

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 24 months

Secondary outcomes (14)

  1. 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

    analysis of primary endpoint (cumulative incidence of PTS) amongst patients responding to the definition of observance for compression scheduled by randomization. It means a per protocol analysis. The per protocol analysis defined as follow : patients ideally compliant (see next secondary outcome measure with self declaration of compression carrying superior or equal to 80 % especially)and patients with respect to randomization.

    Measured: 24 months

  2. Superiority of 25 mm Hg on the therapeutic compliance criterion

    Superiority of 25 mm Hg on the therapeutic compliance criterion at 24 months

    Compliance is defined by 2 conditions :

    1. Girerd adapted to elastic compression stocking score adjusted between 0 and 2 (the question 2 will not be taken into account beacause not adapted to the logistics of the study)
    2. because of French clinical practices it should be pertinent to take into consideration 2 compliance type :
    3. ideal compliance : Self declaration ≥ 80 % (reference PRANDONI)
    4. adequate compliance : self declaration between 50 and 79% for (French references Delluc and Optimev study)

    Measured: 24 months

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

    CIVIQ quality of life (CIVIQ 20) specific to chronic venous insufficiency at 3 months, 12 months and 24 months and questionnaire about constraints of compression stockings.

    Measured: 3 months, 12 months, 24 months

  4. 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

    Comparison of evolution at short-term (3 months) of venous thrombosis symptoms (pain, oedema feeling). Self assessment by VAS of pain and oedema feeling once a week during 3 months. Assessment by the investigator at inclusion and during visit at 3 months (ankle measurement, clinical signs) will be done also. A statistical analysis will be done as soon as 3 months follow up data will be verified to evaluate symptoms evolution due to deep venous thrombosis.

    Measured: 3 months

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

    Non-inferiority of 25 mm Hg for changes in overall quality of life evaluated on the basis of the EUROQUOL questionnaire (EQ5D)

    Measured: 3months, 12 months, 24 months

  6. non inferiority of 25 mm Hg for the intensity of long term chronic venous insufficiency symptoms (12 months and 24 months)

    Long term assessment of evolution and intensity of symptoms (pain, oedema feeling) related to potential post-thrombotic syndrome apparition

    • Monthly self-assessment by VAS for pain and oedema feeling during 24 months. It will be done at the end of each month and will focus on symptoms intensity (last week of the month)
    • An assessment will be done by investigator, in addition of previous criterion, at 12 and 24 months
    • Assessment with the Ginsberg score (interview by the investigator at 12 and 24 months)
    • Comparison of averages on Villalta score (quantitative)

    Measured: 12 and 24 months

  7. non inferiority of 25 mm Hg for the onset of permanent trophic disorders

    CEAP classification evaluated by investigator at 3, 12 and 24 months

    Measured: 3 months, 12 and 24 months

  8. non inferiority of 25 mm Hg for the onset of sequalae or post thrombotic residues on an duplex scan at 3 months, 12 and 24 months

    Assessment by duplex scan of deep and superficial veins at 3, 12 and 24 months

    • Assessment by duplex scan of deep reflux (>1s in femoral vein, and/or popliteal vein, tibio peroneal trunck)
    • Assessment by duplex scan of superficial reflux (> 0.5s in great saphenous vein, small saphenous vein, perforating veins)
    • Assessment by echographic score of thickness and location of residual thrombus
    • Assessment by duplex scan of re-canalization of collectors trunks and/or parietal sequalae

    Measured: 3, 12 and 24 months

  9. testing for the prognostic factors of the onset post thrombotic syndrome and comparison of the onset kinetics of post thrombotic syndrome

    variables tested as prognostic factors of post thrombotic syndrome apparition :

    • location of the upper pole of thrombus
    • kinetic of thrombus lysis by duplex scan at 3 months
    • Idiopathic nature of TED
    • Delay of diagnostic of deep venous thrombosis
    • Initial intensity of deep venous thrombosis symptoms
    • Initial evolution of symptoms of deep venous thrombosis between J0 and 3 months
    • Persistence of the symptoms at 3 months
    • Patient's characteristics
    • Kinetic of of Villalta score apparition ≥ 5 by survival curve
    • Kinetic of post thrombotic syndrome apparition by Villalta score

    Measured: 24 months

  10. test for key factors in good compliance

    Compliance evaluation according to the 2 axes defined on third outcome measure and research of determinants of good compliance by specific questionnaire

    Measured: 24 months

  11. Adverse events

    description and comparison of the incidence of adverse events including unexpected adverse events, events expected with this type of disease (recurrence of the venous thromboembolic disease, recurrence of deep vein thrombosis, pulmonary embolism, superficial venous thrombosis, venous ulcer) and events possibly related to the study treatment (arterial decompensation passing to Lerich stage III or IV, skin intolerance)

    Measured: 24 months

  12. Subgroups analysis of the primary objective and secondary objectives according to the gender stratification criterion and age

    Stratification on age (more or less than 65 years-old) for testing the hypothesis by subgroups analysis of the benefit of a better adaptation of compression 25 mm Hg on older subjects, as suggested by S. Khan.

    Measured: 24 months

  13. superiority of 25 mmHg on 35 mmHg in preventing the onset of clinical post thrombotic syndrome

    superiority of 25 mmHg on 35 mmHg in preventing the onset of clinical post thrombotic syndrome. Outcome measure identical to primary endpoint

    Measured: 24 months

  14. sensitivity analysis of primary endpoint excluding patients with a differential diagnosis can explain a Villalta score ≥ 5

    sensitivity analysis of primary endpoint excluding patients with a differential diagnosis which could explain a Villalta score ≥ 5. Outcome measure identical to primary endpoint

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Apr 2012 (estimated)
  2. Study start29 Jun 2012
  3. Primary completion28 Jun 2019
  4. Study completion28 Jun 2019

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
350 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01578122
Sponsor's protocol ID
CVE301-10 (Themas) : DCIC/1028
Other IDs
2010-A01078-31
Acronym
CELEST
Status last verified
Aug 2019
First submitted
13 Apr 2012
Last updated
22 Jan 2020
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 12525804

  • 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.

    PubMed 10823257

  • 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.

    PubMed 19222476

  • 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.

    PubMed 8644983

  • 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.

    PubMed 9299855

  • 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.

    PubMed 15269829

  • 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.

    PubMed 14718318

  • 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.

    PubMed 12020185

  • 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.

    PubMed 9072931

  • 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.

    PubMed 9074574

  • 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.

    PubMed 15313740

  • 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.

    PubMed 8307217

  • 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.

    PubMed 11054217

  • 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.

    PubMed 12871457

  • 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.

    PubMed 11210954

Questions about this trial

What is this clinical trial studying?

A study testing 25mmHg ECS and 35 mmHg ECS in people with Deep Vein Thrombosis and Post-thrombotic Syndrome, run by Laboratoires Innothera at 57 sites in France.

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 31 inclusion and 0 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 22 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 57 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

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) (time frame: 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01578122, which also lists 21 linked publications.

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 22 Jan 2020.

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