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NCT04940377 Clinical Trial

Effect of the Genotype on Postoperative DVT

Venous Thromboembolism Clinical Trial

Official title:
Postoperative Venous Thromboembolism Risk in 140,831 Surgical Patients - a Genetic Association Cohort Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04940377
Other study ID # 60861
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 1, 2020
Est. completion date June 1, 2021

Study information
Verified date June 2021
Source Rigshospitalet, Denmark
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

Postoperative Venous Thromboembolism Events (VTE) constitute a major source of morbidity and mortality after surgery. The aim of this study was to investigate whether commonly occurring Single Nucleotide Polymorphisms (SNPs) are associated with VTE in the surgical setting.

Description:

Data extracted from the participants in the UK Biobank collaborative study. Two cohorts will be examined: 1. Surgical cohort, consisting of all patients with a registered surgical procedure in the UK biobank repository 2. Validation cohort, consisting of all non-surgical patients in the UK biobank repository. A GWAS approach will be used to associated commonly occurring single nucleotide polymorphisms (SNPs) with a postoperative venous thromboembolic event (VTE) within 30 days of a surgical procedure in the surgical cohort. Findings from the surgical GWAS step will be replicated in the Validation cohort in order to assess whether the same SNPs drive both surgical and non-surgical VTE risk. A final GWAS model will be fielded, correction for confounders including sex, age, smoking, obesity and open/minimal invasive surgery (surgical discovery GWAS only).

Recruitment information / eligibility
Status Completed
Enrollment 502505
Est. completion date June 1, 2021
Est. primary completion date March 1, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - All patients included in the UK biobank repository Exclusion criteria: - None

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Denmark Rigshospitalet Copenhagen

Sponsors (1)
Lead Sponsor Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary Postoperative VTE event 30 days of a surgical procedure
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