Long-Term Post Thrombotic Syndrome Assessment (CELEST Long Term).

NCT06046807 | Unknown

• 1 other identifier: 2023-A00528-37
• Study Type: observational
• Target: 288
• Locations: 1 country
• Sites: 1

Brief Summary

The CELEST Long term is a prospective study, assessing the very long term risk of post thrombotic syndrome (PTS) in patients enrolled in the CELEST double-blind RCT. All patients enrolled in CELEST RCT will benefit from a 7-year follow-up visit conducted over the phone. The primary objective is to assess the proportion of patients with moderate-severe PTS assessed with the patient reported Villalta score and the 2 main secondary objectives are to assess predictors of moderate to severe PTS and the impact of initial compression stockings strength (25mmHg vs. 35mmHg) on the development of moderate-severe PTS. Up to 288 patients may participate. The investigators believe that this study has the potential to significantly improve the knowledge on the epidemiology of burdensome PTS and on the impact of different initial compression stockings strengths on the risk of PTS.

Conditions

Post Thrombotic Syndrome

Keywords

Post thrombotic syndrome; Elastic compression stockings; long-term follow-up; Deep vein Thrombosis

Outcome Measures

Primary Outcomes (1)

• Proportion of patients with moderate-severe PTS in the whole cohort

  PTS defined with the patient reported Villalta score (PRVS). Moderate-severe PTS: PRVS≥10 or presence of a venous leg ulcer in the leg ipsilateral to index DVT The Villalta score consists in 11 questions (5 on subjective symptoms and 6 on objective signs). Each question is coded between 0 and 3 (0: none - 1: mild - 2: moderate - 3: severe). The total score is the sum of the 11 questions and therefore ranges from 0 to 33, where a high value indicates a high level of disability. An additional question asks about the presence of ulcers. If the calculated score is \< 15, a value of 15 is assigned to the ulcer score. The thresholds used are as follows: * presence of PTS if Villalta ≥ 5 * presence of disabling PTS (moderate, severe) if Villalta ≥ 10 * presence of severe PTS if Villalta ≥ 15

  At the phone follow-up up to 3 months

Secondary Outcomes (11)

• Predictors of moderate-severe PTS

  Since enrolment in the CELEST CRT

• Impact of initial ECS strength on the development of moderate-severe PTS

  Since enrollment in the CELEST study

• Impact of initial type of ECS on the development of moderate-severe PTS

  Since enrollment in the CELEST study

• Impact of adherence to RCT's ECS on the development of moderate-severe PTS

  Since enrollment in the CELEST study

• Assessment of the use of ECS after the end of the RCT in terms of use, strength, length, adherence, duration

  Since enrolment in the CELEST study with focus on the period end of RCT to long-term follow-up

Study Arms (2)

35mmHg ECS

Subjects with first proximal DVT allocated to wear 35 mmHg elastic compression stockings (ECS) for 2 years during the CELEST RCT

Other: Phone call

25mmHg ECS

Subjects with first proximal DVT allocated to wear 25 mmHg elastic compression stockings (ECS) for 2 years during the CELEST RCT

Other: Phone call

Interventions

Phone call OTHER

This follow-up will be conducted over the phone and by mail (some questionnaire may be sent by patient, as per his/her preference)

25mmHg ECS; 35mmHg ECS

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who were enrolled in the CELEST RCT

You may qualify if:

• Patients enrolled and followed in the CELEST RCT\*

You may not qualify if:

• Patients who withdrew consent or died during the 2-year follow-up of the CELEST RCT.
• Patients who decline or are unable to participate (including severe memory loss issues) to the long-term follow-up

Sponsors & Collaborators

• Laboratoires Innothera: lead
• Floralis: collaborator

Study Sites (1)

ROLLAND

Grenoble, France

RECRUITING

Related Publications (10)

• Ten Cate-Hoek AJ. Lower strength stockings: is less better? Lancet Haematol. 2022 Dec;9(12):e865-e866. doi: 10.1016/S2352-3026(22)00266-6. No abstract available.

  PMID: 36455603 BACKGROUND

• Utne KK, Ghanima W, Foyn S, Kahn S, Sandset PM, Wik HS. Development and validation of a tool for patient reporting of symptoms and signs of the post-thrombotic syndrome. Thromb Haemost. 2016 Jan;115(2):361-367. doi: 10.1160/th15-04-0318. Epub 2015 Sep 17.

  PMID: 26422814 BACKGROUND

• Ageno W, Squizzato A, Wells PS, Buller HR, Johnson G. The diagnosis of symptomatic recurrent pulmonary embolism and deep vein thrombosis: guidance from the SSC of the ISTH. J Thromb Haemost. 2013 Aug;11(8):1597-602. doi: 10.1111/jth.12301. No abstract available.

  PMID: 23682905 BACKGROUND

• Kaatz S, Ahmad D, Spyropoulos AC, Schulman S; Subcommittee on Control of Anticoagulation. Definition of clinically relevant non-major bleeding in studies of anticoagulants in atrial fibrillation and venous thromboembolic disease in non-surgical patients: communication from the SSC of the ISTH. J Thromb Haemost. 2015 Nov;13(11):2119-26. doi: 10.1111/jth.13140. No abstract available.

  PMID: 26764429 BACKGROUND

• Kraaijpoel N, Tritschler T, Guillo E, Girard P, Le Gal G. Definitions, adjudication, and reporting of pulmonary embolism-related death in clinical studies: A systematic review. J Thromb Haemost. 2019 Oct;17(10):1590-1607. doi: 10.1111/jth.14570. Epub 2019 Jul 31.

  PMID: 31301689 BACKGROUND

• Launois R, Reboul-Marty J, Henry B. Construction and validation of a quality of life questionnaire in chronic lower limb venous insufficiency (CIVIQ). Qual Life Res. 1996 Dec;5(6):539-54. doi: 10.1007/BF00439228.

  PMID: 8993100 BACKGROUND

• Makedonov I, Kahn SR, Galanaud JP. Prevention and Management of the Post-Thrombotic Syndrome. J Clin Med. 2020 Mar 27;9(4):923. doi: 10.3390/jcm9040923.

  PMID: 32230912 BACKGROUND

• 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. No abstract available.

  PMID: 25246013 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 RESULT

• Galanaud JP, Genty-Vermorel C, Rolland C, Comte A, Ouvry P, Bertaina I, Verriere F, Bosson JL. Compression stockings to prevent postthrombotic syndrome: Literature overview and presentation of the CELEST trial. Res Pract Thromb Haemost. 2020 Oct 30;4(8):1239-1250. doi: 10.1002/rth2.12445. eCollection 2020 Nov.

  PMID: 33313464 RESULT

MeSH Terms

Conditions

Postthrombotic Syndrome; Venous Thrombosis

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Venous Insufficiency

Study Officials

• Jean Luc Bosson, MD, PhD

  University Grenoble Alpes, France

  PRINCIPAL INVESTIGATOR

• Jean Philippe Galanaud, MD, PhD

  University of Toronto, Canada

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carole Rolland, MSc

CONTACT

04 76 76 50 40; carole.rolland@univ-grenoble-alpes.fr

Alexa Comte, MSc

CONTACT

04 76 76 50 40; alexa.comte@univ-grenoble-alpes.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2023
• First Posted: September 21, 2023
• Study Start: July 24, 2023
• Primary Completion: October 24, 2023
• Study Completion: December 24, 2023
• Last Updated: September 21, 2023

Record last verified: 2023-09

Locations

FR (1)