WHITE Study: WHIch Decision After a First Venous ThromboEmbolism?

NCT04646993 | Completed

• 1 other identifier: WHITE_Final_20170920
• Study Type: observational
• Target: 1,200
• Locations: 1 country
• Sites: 1

Brief Summary

The WHITE study is a multicenter, multinational, investigators-initiated, observational, prospective study conducted in a consecutive series of ambulatory patients who had completed the recommended or practicable period of anticoagulation after a first-ever episode of venous thromboembolism (VTE) The general aim of the study is to evaluate the distribution of decisions and of the reasons guiding the physician's decision on the modality to manage the secondary prevention of VTE in patients treated for a first-ever episode of VTE, after the initial 3-12 months of anticoagulant therapy.

Conditions

Venous Thromboembolism

Keywords

Deep vein thrombosis Anticoagulant Treatment; Lower limbs; Pulmonary embolism; Oral Anticoagulant Treatment

Outcome Measures

Primary Outcomes (1)

• Number of patients who continue or stop the anticoagulant treatment

  Registration of number of patients who continue or stop the treatment; registration of type reasons guiding the attending physician's decision on the management of secondary prevention (eg: Bleeding score, laboratory test, presence of residual vein trombosis, risk or recurrence)

  From the end of the 3rd month to the end of 12th month of anticoagulant treatment

Secondary Outcomes (1)

• Frequence of adverse events during follow-up

  Frome the first day of enrollment up to 24 monhts

Eligibility Criteria

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

Study Population

All patients of any ethnicity having had a first-ever event of provoked or unprovoked DVT of the lower limbs and/or PE given maintenance anticoagulants (NOACs, VKAs, or LMWHs) according to the local procedures (usually for 3 to 12 months) and to be re-evaluated to decide the treatment to be prescribed after such period by the attending physicians

You may qualify if:

• subjects who provided a written informed consent and authorization for disclosure of protected health information;
• male and female adult or elderly patients of any ethnicity having had a first-ever event of provoked or unprovoked DVT of the lower limbs and/or PE and treated with oral anticoagulant
• for whom the center is in possession of all the data relevant to the index event;
• having a permanent reference contact.

You may not qualify if:

• subjects \<18 years old;
• subjects unable or unwilling to issue the written informed consent;
• subjects for whom the information relevant to the index event are incomplete or inaccessible to the Investigator;
• subject in whom the index event was a DVT not of the lower limbs;
• subjects with life expectancy of less than 2 years;
• subjects participating in any other clinical study, regardless of its nature;
• subjects considered, by the attending physician, unable to comply with the study procedures.

Sponsors & Collaborators

• Arianna Anticoagulazione Foundation: lead

Study Sites (1)

Clinical Trial Centre, MATMED

Hodonín, 695 01, Czechia

Location

MeSH Terms

Conditions

Venous Thromboembolism; Pulmonary Embolism

Condition Hierarchy (Ancestors)

Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Lung Diseases; Respiratory Tract Diseases; Embolism

Study Officials

• Jiří Matuška, Prof

  Clinical Trial Centre, Hodonin, Czech Republic

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2020
• First Posted: November 30, 2020
• Study Start: February 1, 2018
• Primary Completion: December 30, 2021
• Study Completion: February 28, 2022
• Last Updated: March 11, 2022

Record last verified: 2021-03

Locations

CZ (1)