WHITE Study: WHIch Decision After a First Venous ThromboEmbolism? (WHITE)

Which Decision After a First Venous Thromboembolism? The WHITE Study

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.

Study Overview

• Status: Completed
• Conditions: Venous Thromboembolism

Detailed Description

The WHITE study is an international, non-profit, multicenter, observational, prospective and no profit study 3,200 subjects having experienced a first-ever episode of DVT of the lower limbs and/or PE, receive anticoagulation therapy for a period as recommended by international and/or local practice guidelines will be enrolled across all the countries participating to the study.

When this recommended period expires, the attending physician has to decide whether to continue with anticoagulation, switch to anti-thrombotic of another class, or stop any prophylactic pharmacological treatment.

The primary objective of the study is the evaluation of 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 anticoagulation therapy.

The secondary objective is the collection of data during the follow-up: the frequency of thromboembolic complications, of bleeding complications, or death from any cause.

• Study Type: Observational
• Enrollment (Actual): 1200

Contacts and Locations

Study Locations

• Czechia
  • Hodonín, Czechia, 695 01
    • Clinical Trial Centre, MATMED

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

Inclusion Criteria:

1. subjects who provided a written informed consent and authorization for disclosure of protected health information;
2. 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
3. for whom the center is in possession of all the data relevant to the index event;
4. having a permanent reference contact.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequence of adverse events during follow-up	the frequency of thromboembolic complications, of bleeding complications, or death from any cause monitored during the follow-up.	Frome the first day of enrollment up to 24 monhts

Collaborators and Investigators

• Sponsor: Arianna Anticoagulazione Foundation
• Investigators: Study Director: Jiří Matuška, Prof, Clinical Trial Centre, Hodonin, Czech Republic

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2018
• Primary Completion (Actual): December 30, 2021
• Study Completion (Actual): February 28, 2022

Study Registration Dates

• First Submitted: November 18, 2020
• First Submitted That Met QC Criteria: November 21, 2020
• First Posted (Actual): November 30, 2020

Study Record Updates

• Last Update Posted (Actual): March 11, 2022
• Last Update Submitted That Met QC Criteria: March 10, 2022
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Pulmonary embolism; Lower limbs; Deep vein thrombosis Anticoagulant Treatment; Oral Anticoagulant Treatment
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Thromboembolism; Venous Thromboembolism
• Other Study ID Numbers: WHITE_Final_20170920

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No