Venous ThromboembolismNCT04940377
Effect of the Genotype on Postoperative DVT
An observational study of Venous Thromboembolism, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Venous Thromboembolism
- How many people
- 502,505 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jun 2020to 1 Jun 2021
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Healthy volunteers followed by the UK biobank consortium
Who may be able to join
- All patients included in the UK biobank repository
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Postoperative Venous Thromboembolism Risk in 140,831 Surgical Patients - a Genetic Association Cohort Study
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.
Read the detailed description
Data extracted from the participants in the UK Biobank collaborative study. Two cohorts will be examined:
- Surgical cohort, consisting of all patients with a registered surgical procedure in the UK biobank repository
- 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).
- Conditions
- Venous Thromboembolism
- Medical subject headings
- Venous Thromboembolism
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative VTE event
Measured: 30 days of a surgical procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2021
- Study start1 Jun 2020
- Primary completion1 Mar 2021
- Study completion1 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous ThromboembolismStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 502,505 participants (actual)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Martin Sillesen, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04940377
- Sponsor's protocol ID
- 60861
- Status last verified
- Jun 2021
- First submitted
- 17 Jun 2021
- Last updated
- 30 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Venous Thromboembolism Risk in 140,831 Surgical Patients - a Genetic Association Cohort Study
- ClinicalTrials.gov ID
- NCT04940377
- Acronym / sponsor ID
- 60861
- Conditions
- Venous Thromboembolism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 502,505 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 1 Mar 2021 (actual)
- Study completion
- 1 Jun 2021 (actual)
- First posted
- 25 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Data extracted from the participants in the UK Biobank collaborative study. Two cohorts will be examined:
- Surgical cohort, consisting of all patients with a registered surgical procedure in the UK biobank repository
- 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).
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 10 Years
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Healthy volunteers followed by the UK biobank consortium
Key inclusion criteria (1 listed)
- All patients included in the UK biobank repository
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Postoperative VTE event
Time frame: 30 days of a surgical procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Venous Thromboembolism, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative VTE event (time frame: 30 days of a surgical procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2021.