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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04333693
Recruitment Status : Unknown
Verified March 2020 by Vascular Investigation Network Spanish Society for Angiology and Vascular Surgery.
Recruitment status was:  Not yet recruiting
First Posted : April 3, 2020
Last Update Posted : April 3, 2020
Sponsor:
Information provided by (Responsible Party):
Vascular Investigation Network Spanish Society for Angiology and Vascular Surgery

Brief Summary:

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.


Condition or disease Intervention/treatment
Vascular Surgical Procedures COVID-19 Postoperative Complications Procedure: Vascular surgery

Show Show detailed description

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months
Official Title: Outcomes of Vascular Surgery in COVID-19 Infection: National Cohort Study (Covid-VAS)
Estimated Study Start Date : April 1, 2020
Estimated Primary Completion Date : October 1, 2020
Estimated Study Completion Date : November 1, 2020

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 30-days mortality [ Time Frame: 30-days ]
    30-days mortality after vascular surgery in patients with COVID-19 infection


Secondary Outcome Measures :
  1. 7-days mortality [ Time Frame: 7-days ]
    7-days mortality after vascular surgery in patients with COVID-19 infection

  2. 30-days reoperation [ Time Frame: 30-days ]
    30-days reoperation after vascular surgery in patients with COVID-19 infection

  3. Postoperative ICU admission [ Time Frame: 30-days ]
    Postoperative ICU admission after vascular surgery in patients with COVID-19 infection

  4. Postoperative respiratory failure [ Time Frame: 30-days ]
    Postoperative respiratory failure after vascular surgery in patients with COVID-19 infection

  5. 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

  6. Postoperative sepsis [ Time Frame: 30-days ]
    Postoperative sepsis after vascular surgery in patients with COVID-19 infection



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with COVID-19 infection who undergo vascular surgery.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04333693


Contacts
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Contact: Enrique M San Norberto, MD, PhD, MsC 0034686754618 esannorberto@hotmail.com
Contact: Investigator Council 0034910569145 secretaria@seacv.es

Locations
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Spain
Spanish Society for Angiology and Vascular Surgery
Madrid, Spain, 28006
Contact: Enrique M San Norberto, MD, PhD, MsC    0034686754618    esannorberto@hotmail.com   
Contact: Investigator Council    0034910569145    secretaria@seacv.es   
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         
Sponsors and Collaborators
Vascular Investigation Network Spanish Society for Angiology and Vascular Surgery
Additional Information:
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Vascular Investigation Network Spanish Society for Angiology and Vascular Surgery
ClinicalTrials.gov Identifier: NCT04333693    
Other Study ID Numbers: RIV-2020-1
First Posted: April 3, 2020    Key Record Dates
Last Update Posted: April 3, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: No sharing plan available nowadays.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Vascular Investigation Network Spanish Society for Angiology and Vascular Surgery:
Vascular surgical procedures
Endovascular procedures
COVID-19
Postoperative complications
Prognosis
Additional relevant MeSH terms:
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COVID-19
Postoperative Complications
Infections
Respiratory Tract Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Pathologic Processes