Viewing Study NCT00005351



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Study NCT ID: NCT00005351
Status: COMPLETED
Last Update Posted: 2016-05-13
First Post: 2000-05-25

Brief Title: Incidence and Outcomes of Venous Thromboembolism
Sponsor: National Heart Lung and Blood Institute NHLBI
Organization: National Heart Lung and Blood Institute NHLBI

Study Overview

Official Title: None
Status: COMPLETED
Status Verified Date: 2002-09
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: To identify the incidence cohort of Olmsted County Minnesota residents with deep venous thrombosis DVTpulmonary embolism PE from 1966 through 1990 Episodes of DVT or PE acquired during hospitalization or in the community were identified for future studies
Detailed Description: BACKGROUND

Deep vein thrombosis and pulmonary embolism most often occur during hospitalization for surgery or chronic medical conditions Consequently information on deep venous thrombosispulmonary embolism is derived from large referral hospitals and there are substantial gaps in our understanding of the incidence risk factors and outcomes of deep venous thrombosispulmonary embolism in the community This was one of the first studies to compare hospital acquired deep venous thrombosispulmonary embolism with deep venous thrombosispulmonary embolism among ambulatory residents in a community

DESIGN NARRATIVE

The five part study 1 identified the incidence cohort and tested the hypotheses that over the 25 year study period the incidence of deep venous thrombosispulmonary embolism had decreased the extent of testing for suspected deep venous thrombosispulmonary embolism had increased and the number of tests obtained for patients with deep venous thrombosispulmonary embolism had increased 2 determined the independent risk factors for deep venous thrombosispulmonary embolism and estimated the population attribute risk due to each independent risk factor for deep venous thrombosispulmonary embolism in a case-control study of the incidence cohort and community controls 3 tested the hypothesis that deep venous thrombosispulmonary embolism were independent risk factors for death after adjusting for age sex and co-morbid conditions 4 described the occurrence of the post-phlebitic syndrome pulmonary hypertension and recurrent deep venous thrombosispulmonary embolism over the 25 year study period and identified the independent risk factors for lower extremity venous ulceration 5 evaluated the accuracy of national pulmonary embolism mortality rates by comparing pulmonary embolism mortality rates calculated from a review of all the inpatient and outpatient medical records of Olmsted County deep venous thrombosispulmonary embolism patients with death certificate pulmonary embolism mortality rates for Olmsted County from the National Center for Health Statistics The study provided the most complete and comprehensive population based estimates of the incidence risk factors survival and outcomes of deep venous thrombosispulmonary embolism available to date

The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System PRS record

Study Oversight

Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
Secondary ID Type Domain Link
R01HL046974 NIH None httpsreporternihgovquickSearchR01HL046974