Skip to main content
OpenTrials
Completed

NCT Number: NCT00011180

Risk Factors for Venous Thromboembolism in the Community

To evaluate the trends in the incidence of venous thromboembolism, to determine the risk factors for venous thromboembolism in patients with medical and surgical illness, and to evaluate the efficacy of the anticoagulant therapy in reducing venous thromboembolism.

Completed

Looking for future studies?

Notify Me

Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

About this study

BACKGROUND:

Venous thromboembolism (VTE) occurs frequently among patients hospitalized for major surgery or hospitalized for a medical illness primarily due to prolonged duration of immobilization. However, many patients undergo major surgery without any occurrence of VTE. Standard prophylactic therapy after surgery is heparin, which reduces the risk of VTE. However, heparin is associated with bleeding complications. Thus, it would be desirable to identify patients at high risk for VTE who might benefit the most from heparin therapy. An important focus of the study is to look at genetic factors which might play an important role in VTE incidence.

DESIGN NARRATIVE:

The study is a population based, retrospective case and case-control investigation of the genetic and environmental determinants of venous thromboembolism in the Rochester Minnesota Olmsted County population. The first five years of the study had three specific aims. The first specific aim was to update the 1966-1995 inception cohort to include Olmsted County residents with VTE during the five year period, 1996-2000. The second aim was to extend the analysis of risk factors for VTE by identifying two Olmsted County residents (controls) without VTE matched by age and gender to each definite or probable case within the 1996-2000 cohort, and to obtain plasma and genomic DNA from all cases and controls and perform a case-control study. The third specific aim was to evaluate the efficacy of anticoagulant therapy to prevent VTE recurrence.

The study was extended through March, 2009 to investigate trends in the incidence of venous thromboembolism, new risk factors including lipid-lowering, beta-blocker, and ACE-inhibitor therapies, and introduction of low molecular weight heparin (LMWH) therapy.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

No eligibility criteria

Treatment and study plan

Primary outcomes

  1. Mean time interval between commencing unfractionated heparin therapy and achieving a therapeutic activated partial thromboplastin time (aPTT)

    Time frame: Day 1 in hospital

    The time interval (minutes) was measured retrospectively, using the electronic medical record for each subject.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

Subtherapeutic Heparin Anticoagulation as a Predictor of Recurrent Venous Thromboembolism: A Population-Based Cohort Study

Important dates

Study start
2001
Primary completion
2009
Study completion
2009
First posted
Feb 13, 2001
Registry last updated
Dec 6, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.