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Distribution of Risk Factors for Venous Thromboembolism in Blood Donors (ANEMONE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03282747
Recruitment Status : Completed
First Posted : September 14, 2017
Last Update Posted : January 31, 2019
Sponsor:
Collaborator:
University of Bari
Information provided by (Responsible Party):
Elvira Grandone, MD, Head of Unit, Casa Sollievo della Sofferenza IRCCS

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.


Condition or disease Intervention/treatment
Venous Thromboembolism Risk Factor, Cardiovascular Blood Type Behavioral: no intervention

Detailed Description:

Venous thromboembolism, defined by deep vein thrombosis (DVT) and / or pulmonary embolism (PE), occurs with an incidence of about 1 per 1000 per year in adult populations. Rates are slightly higher in men than women. About two-thirds of the episodes are manifested as DVT and one third as PE with or without DVT. The main consequences of venous thrombosis are death, recurrence, post-thrombotic syndrome and major bleeding due to anticoagulation. Thrombosis is also associated with impaired quality of life, especially when developing posttrombotic syndrome. The mortality rate within one month from an episode is about 6% in patients with DVT and 10% in those with PE. The mortality rate for PE was estimated to be around 30% in the studies that included the PE diagnosis of autopsy, pointing out that many PEs are not clinically recognized before death. Mortality rates are lower among patients with idiopathic venous thrombosis and higher among those in whom thrombosis occurs in the presence of cancer.

Venous thrombosis is a most frequent disease in elderly patients with a low rate of about 1 per 10,000 per year before the fourth decade of life, which increases rapidly after the age of 45 and approaches 5-6 per 1000 per year at the age of 80 years. In a study, the rate of events over a period of 8 years and in individuals over 85 years of age was 13 times greater than that of individuals between 45 and 55 years, with an absolute rate of 7 per 1000 per year and a greater mortality in older people. It is likely that thrombosis is less diagnosed in some debilitated elderly patients so that these estimates are probably underestimated. The reasons for an increased risk of thrombosis with age are not clear, but may include the increasing presence of other thrombotic diseases, increased coagulation potential, or some combination of these.

There are also differences in the incidence of venous thrombosis diagnosed among lower-rate ethnic groups in the United States, Asians, Pacific Islanders, and Hispanics than Whites and with some studies showing an approximate rate of 25% higher in Afro-Americans. There is little information on the epidemiology of thrombosis in Europe.

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 (VTE) than O, probably because factor VIII, factor von Willebrand is lower in group 0 patients. While there are numerous studies conducted on 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 blood donors will be requested to fill in a self-administered questionnaire. Healthy blood donors will be requested to give personal and family information regarding previous use of current of anticoagulant drugs, surgery, contraceptive use, pregnancy, previous blood transfusion. The presence of one or more risk factors will be used to set up a clinical score to validate in future studies on patients with previous VTE.

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Study Type : Observational
Actual Enrollment : 10000 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Risk Factors for Venous Thrombosis and Pulmonary Embolism in Blood Donors
Actual Study Start Date : July 15, 2017
Actual Primary Completion Date : July 15, 2018
Actual Study Completion Date : December 30, 2018

Resource links provided by the National Library of Medicine



Intervention Details:
  • Behavioral: no intervention
    no intervention


Primary Outcome Measures :
  1. Distribution of risk factors in blood donors [ Time Frame: 1 year ]
    questionnaire



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Blood donors consecutively observed
Criteria

Inclusion Criteria:

  • Blood donors

Exclusion Criteria:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03282747


Locations
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Italy
IRCCS Casa Sollievo della Sofferenza
Foggia, Italy, 71013
Sponsors and Collaborators
Casa Sollievo della Sofferenza IRCCS
University of Bari

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Responsible Party: Elvira Grandone, MD, Head of Unit, MD, Casa Sollievo della Sofferenza IRCCS
ClinicalTrials.gov Identifier: NCT03282747    
Other Study ID Numbers: ANEMONE/01
First Posted: September 14, 2017    Key Record Dates
Last Update Posted: January 31, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Thromboembolism
Venous Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases