Outcomes of Vascular Surgery in COVID-19 Infection: National Cohort Study
Outcomes of Vascular Surgery in COVID-19 Infection: National Cohort Study
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.
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.
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.