NCT04333693

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 31, 2020

Completed
1 day until next milestone

Study Start

First participant enrolled

April 1, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 3, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2020

Completed
Last Updated

April 3, 2020

Status Verified

March 1, 2020

Enrollment Period

6 months

First QC Date

March 31, 2020

Last Update Submit

April 2, 2020

Conditions

Vascular Surgical ProceduresCOVID-19Postoperative Complications

Keywords

Vascular surgical proceduresEndovascular proceduresCOVID-19Postoperative complicationsPrognosis

Outcome Measures

Primary Outcomes (1)

  • 30-days mortality

    30-days mortality after vascular surgery in patients with COVID-19 infection

    30-days

Secondary Outcomes (6)

  • 7-days mortality

    7-days

  • 30-days reoperation

    30-days

  • Postoperative ICU admission

    30-days

  • Postoperative respiratory failure

    30-days

  • Postoperative acute respiratory distress syndrome (ARDS)

    30-days

  • +1 more secondary outcomes

Study Arms (1)

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

Interventions

Vascular surgeryPROCEDURE

Open vascular, endovascular or hybrid procedures

Cases

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with COVID-19 infection who undergo vascular surgery.

You may qualify if:

  • 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.

You may not qualify if:

  • Not informed consent signed.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Spanish Society for Angiology and Vascular Surgery

Madrid, 28006, Spain

Location

Related Publications (6)

  • Zoia C, Bongetta D, Veiceschi P, Cenzato M, Di Meco F, Locatelli D, Boeris D, Fontanella MM. Neurosurgery during the COVID-19 pandemic: update from Lombardy, northern Italy. Acta Neurochir (Wien). 2020 Jun;162(6):1221-1222. doi: 10.1007/s00701-020-04305-w. Epub 2020 Mar 28. No abstract available.

    PMID: 32222820BACKGROUND

  • Aminian A, Safari S, Razeghian-Jahromi A, Ghorbani M, Delaney CP. COVID-19 Outbreak and Surgical Practice: Unexpected Fatality in Perioperative Period. Ann Surg. 2020 Jul;272(1):e27-e29. doi: 10.1097/SLA.0000000000003925.

    PMID: 32221117BACKGROUND

  • Ficarra V, Novara G, Abrate A, Bartoletti R, Crestani A, De Nunzio C, Giannarini G, Gregori A, Liguori G, Mirone V, Pavan N, Scarpa RM, Simonato A, Trombetta C, Tubaro A, Porpiglia F; Research Urology Network (RUN). Urology practice during the COVID-19 pandemic. Minerva Urol Nefrol. 2020 Jun;72(3):369-375. doi: 10.23736/S0393-2249.20.03846-1. Epub 2020 Mar 23.

    PMID: 32202401BACKGROUND

  • Iacobucci G. Covid-19: all non-urgent elective surgery is suspended for at least three months in England. BMJ. 2020 Mar 18;368:m1106. doi: 10.1136/bmj.m1106. No abstract available.

    PMID: 32188602BACKGROUND

  • Guan WJ, Ni ZY, Hu Y, Liang WH, Ou CQ, He JX, Liu L, Shan H, Lei CL, Hui DSC, Du B, Li LJ, Zeng G, Yuen KY, Chen RC, Tang CL, Wang T, Chen PY, Xiang J, Li SY, Wang JL, Liang ZJ, Peng YX, Wei L, Liu Y, Hu YH, Peng P, Wang JM, Liu JY, Chen Z, Li G, Zheng ZJ, Qiu SQ, Luo J, Ye CJ, Zhu SY, Zhong NS; China Medical Treatment Expert Group for Covid-19. Clinical Characteristics of Coronavirus Disease 2019 in China. N Engl J Med. 2020 Apr 30;382(18):1708-1720. doi: 10.1056/NEJMoa2002032. Epub 2020 Feb 28.

    PMID: 32109013BACKGROUND

  • San Norberto EM, De Haro J, Pena R, Riera L, Fernandez-Caballero D, Sesma A, Rodriguez-Cabeza P, Ballesteros M, Gomez-Jabalera E, Taneva GT, Aparicio C, Moradillo N, Soguero I, Badrenas AM, Lara R, Torres A, Sala VA, Vaquero C; COVID-VAS Investigators from the Vascular Investigation Network (RIV) of the Spanish Society of Angiology and Vascular Surgery (SEACV). Outcomes After Vascular Surgery Procedures in Patients with COVID-19 Infection: A National Multicenter Cohort Study (COVID-VAS). Ann Vasc Surg. 2021 May;73:86-96. doi: 10.1016/j.avsg.2021.01.054. Epub 2021 Jan 22.

    PMID: 33493590DERIVED

Related Links

MeSH Terms

Conditions

COVID-19Postoperative Complications

Interventions

Vascular Surgical Procedures

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cardiovascular Surgical ProceduresSurgical Procedures, Operative

Central Study Contacts

Enrique M San Norberto, MD, PhD, MsC

CONTACT

0034686754618esannorberto@hotmail.com

Investigator Council

CONTACT

0034910569145secretaria@seacv.es

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 31, 2020

First Posted

April 3, 2020

Study Start

April 1, 2020

Primary Completion

October 1, 2020

Study Completion

November 1, 2020

Last Updated

April 3, 2020

Record last verified: 2020-03

Locations

ES(1)