NCT03282747

Brief Summary

Venous thromboembolism occurs with an incidence of about 1 per 1000 per year in adults . The main consequences are death, recurrence, post-thrombotic syndrome and major bleeding due to anticoagulation. Mortality rates are lower among patients with idiopathic venous thrombosis and higher among those in whom thrombosis occurs in the presence of cancer. The risk increases with the age for unclear reasons. There are also differences in the incidence according to ethnicity; however, data in subjects of European ancestry are scarce. Several studies have documented an association between thrombosis and ABO group. Specifically, non-O blood groups have a higher risk of myocardial infarction, angina, peripheral vascular disease, cerebral ischemia and venous thromboembolism than O. While there are numerous studies carried out in patients who have already shown thromboembolic events, data on the incidence of risk factors in the healthy population are completely inadequate. Understanding the risk factors for venous thrombosis is necessary to maximize the prevention of this disease in individuals and groups of high-risk patients . For this purpose a self-administered questionnaire will be used. Data obtained by blood donors on exposure to risk factors will be used to set up a clinical score to validate in future studies to carry out in patients with VTE.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 15, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 10, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 14, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2018

Completed
Last Updated

January 31, 2019

Status Verified

January 1, 2019

Enrollment Period

1 year

First QC Date

September 10, 2017

Last Update Submit

January 30, 2019

Conditions

Venous ThromboembolismRisk Factor, CardiovascularBlood Type

Outcome Measures

Primary Outcomes (1)

  • Distribution of risk factors in blood donors

    questionnaire

    1 year

Interventions

no interventionBEHAVIORAL

no intervention

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Blood donors consecutively observed

You may qualify if:

  • Blood donors

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS Casa Sollievo della Sofferenza

Foggia, 71013, Italy

Location

MeSH Terms

Conditions

Venous Thromboembolism

Condition Hierarchy (Ancestors)

ThromboembolismEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

September 10, 2017

First Posted

September 14, 2017

Study Start

July 15, 2017

Primary Completion

July 15, 2018

Study Completion

December 30, 2018

Last Updated

January 31, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)