Outcomes of Vascular Surgery in COVID-19 Infection: National Cohort Study (Covid-VAS)

April 2, 2020 updated by: Vascular Investigation Network Spanish Society for Angiology and Vascular Surgery

Outcomes of Vascular Surgery in COVID-19 Infection: National Cohort Study (Covid-VAS)

There is an urgent need to understand the outcomes of COVID-19 infected patients who undergo surgery, specially vascular surgery. Capturing real-world data and sharing Spanish national experience will inform the management of this complex group of patients who undergo surgery throughout the COVID-19 pandemic, improving their clinical care.

The global community has recognised that rapid dissemination and completion of studies in COVID-19 infected patients is a high priority, so we encourage all stakeholders (local investigators, ethics committees, IRBs) to work as quickly as possible to approve this project.

This investigator-led, non-commercial, non-interventional study is extremely low risk, or even zero risk. This study does not collect any patient identifiable information (including no dates) and data will not be analysed at hospital-level.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

To determine 30-day mortality in patients with COVID-19 infection who undergo vascular surgery.

This will inform future risk stratification, decision making, and patient consent.

Inclusion criteria

The inclusion criteria are:

• Adults (age ≥18 years) undergoing ANY type of vascular surgery in an operating theatre, this includes open surgery, endovascular surgery or hybrid procedures.

AND

• Either before or after surgery: (i) lab test confirmed COVID-19 infection or (ii) clinical diagnosis of COVID-19 infection (no test performed).

Therefore this study should capture:

  • emergency surgery patients with clinical diagnosis or lab confirmation of COVID-19 infection before surgery.
  • emergency surgery patients with clinical diagnosis or lab confirmation of COVID-19 infection after surgery.
  • elective surgery patients with clinical diagnosis or lab confirmation of COVID-19 infection after surgery. Patients who meet the inclusion criteria should be included regardless of surgical indication (aneurysm, limb or visceral ischemia, carotid stenosis, vascular trauma), anaesthetic type (local, regional, general), procedure type, or surgical approach (open surgery, endovascular surgery, hybrid procedure).

At most sites it is anticipated that the number of eligible patients is likely to be low. If possible all consecutive patients fulfilling inclusion criteria should be entered.

Study period Overall we plan to close data entry in September 2020 when the global pandemic is likely to be over, however individual centres may select their own study windows, depending on the timing of COVID-19 epidemic in their community.

Patient enrolment Ideally patients should be identified prospectively. However, given the rapid progression of the global pandemic, there may be no further new cases of COVID-19 infection in some hospitals that treated large numbers of COVID-19 earlier in the pandemic. It is important to capture the experience of these centres, therefore retrospective patient identification and data entry is permitted.

Primary outcome

  • 30-day mortality Secondary outcome
  • 7-day mortality
  • 30-day reoperation
  • Postoperative ICU admission
  • Postoperative respiratory failure
  • Postoperative acute respiratory distress syndrome (ARDS)
  • Postoperative sepsis

Data collection Data will be collected and stored online through a secure server running the Spanish Society for Angiology and Vascular Surgery (SEACV) web application. This secure server allows collaborators to enter and store data in a secure system. A designated collaborator at each participating site will be provided with a project server login details, allowing them to securely submit data on to the system. Only anonymised data will be uploaded to the database. No patient identifiable data will be collected. Data collected will be on comorbidities, physiological state, treatment/operation, and outcome. No dates (e.g. date of surgery) will be collected. qSOFA and CURB-65 will be calculated based on the individual data points entered.

Local approvals The principal investigator at each participating site is responsible for obtaining necessary local approvals (e.g. research ethics committee or institutional review board approvals).The first approval will be on the Valladolid East Ethics Committee for Clinical Investigation.

Collaborators will be required to confirm that a local approval is in place at the time of uploading each patient record to the study database.

Where an audit approval is needed, this can be either registered as service evaluation, or to benchmark against an auditable standard (e.g. overall mortality after emergency surgery should be <15%).

Prior to formal local study approval, collaborators may prospectively collect data, but this should not be uploaded to the database until approval is confirmed.

Analysis A detailed statistical analysis plan will be written. Analyses will be overseen by the independent data monitoring committee (DMC). Reports will include description of the primary and secondary outcomes in the cohort. Multivariable modelling will be undertaken to CovidVAS protocol identify risk factors for 30-days mortality. Analyses will be stratified according to whether or not diagnosis of COVID-19 was confirmed by a lab test. Interim analyses will be performed as guided by the independent DMC. The first analysis will be performed once 50 patients have been entered on to the database, and the frequency of subsequent analyses will be agreed with the DMC. The decision to submit data for publication will be agreed by the steering committee with the DMC. Hospital-level data will not be released or published.

Authorship Collaborators from each site who contribute patients will be recognised on any resulting publications as PubMed-citable co-authors.

Study Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Spain
      • Madrid, Spain, 28006
        • Spanish society for Angiology and Vascular Surgery
        • Contact:
        • Contact:
        • Principal Investigator:
          • Enrique M San Norberto, MD, PhD, MsC
        • Sub-Investigator:
          • Joaquin de Haro, MD, PhD
        • Sub-Investigator:
          • Carlos Vaquero, MD, PhD, Prof
        • Sub-Investigator:
          • Luis Riera, MD, PhD
        • Sub-Investigator:
          • Alvaro Torres, MD, PhD
        • Sub-Investigator:
          • Raul Lara, MD, PhD
        • Sub-Investigator:
          • Jorge Cuenca, MD, PhD
        • Sub-Investigator:
          • Jorge Fernández-Noya, MD, PdD
        • Sub-Investigator:
          • Sergi Bellmunt, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with COVID-19 infection who undergo vascular surgery.

Description

Inclusion Criteria:

  • Adults (age ≥18 years) undergoing ANY type of vascular surgery in an operating theatre, this includes obstetrics. AND
  • Either before or after surgery: (i) lab test confirmed COVID-19 infection or (ii) clinical diagnosis of COVID-19 infection (no test performed).

Therefore this study should capture:

  • emergency surgery patients with clinical diagnosis or lab confirmation of COVID-19 infection before surgery.
  • emergency surgery patients with clinical diagnosis or lab confirmation of COVID-19 infection after surgery.
  • elective surgery patients with clinical diagnosis or lab confirmation of COVID-19 infection after surgery.

Exclusion Criteria:

  • Not informed consent signed.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cases
Adults (age>18years) undergoing any type of vascular surgery (open surgery, endovascular surgery or hybrid procedure) in an operating theatre and either before or after surgery: lab test confirmed COVID-19 or clinical diagnosis of COVI-19 infection (no test performed)
Procedure: Vascular surgery
Open vascular, endovascular or hybrid procedures

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
30-days mortality
Time Frame: 30-days
30-days mortality after vascular surgery in patients with COVID-19 infection
30-days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
7-days mortality
Time Frame: 7-days
7-days mortality after vascular surgery in patients with COVID-19 infection
7-days
30-days reoperation
Time Frame: 30-days
30-days reoperation after vascular surgery in patients with COVID-19 infection
30-days
Postoperative ICU admission
Time Frame: 30-days
Postoperative ICU admission after vascular surgery in patients with COVID-19 infection
30-days
Postoperative respiratory failure
Time Frame: 30-days
Postoperative respiratory failure after vascular surgery in patients with COVID-19 infection
30-days
Postoperative acute respiratory distress syndrome (ARDS)
Time Frame: 30-days
Postoperative acute respiratory distress syndrome (ARDS) after vascular surgery in patients with COVID-19 infection
30-days
Postoperative sepsis
Time Frame: 30-days
Postoperative sepsis after vascular surgery in patients with COVID-19 infection
30-days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vascular Investigation Network Spanish Society for Angiology and Vascular Surgery

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 1, 2020

Primary Completion (Anticipated)

October 1, 2020

Study Completion (Anticipated)

November 1, 2020

Study Registration Dates

First Submitted

March 31, 2020

First Submitted That Met QC Criteria

April 2, 2020

First Posted (Actual)

April 3, 2020

Study Record Updates

Last Update Posted (Actual)

April 3, 2020

Last Update Submitted That Met QC Criteria

April 2, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RIV-2020-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

No sharing plan available nowadays.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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