NCT05752162

Brief Summary

A. Primary objective Identifying risk factors for peri-operative complications in patients who have had COVID-19. B. Secondary objectives Identifying peri-operative complications in patients who have had COVID-19. Follow-up of peri-operative complications during hospitalization. Identifying the safe distance at which a patient can be operated after a Sars CoV2 infection without having an increased risk of peri-operative complications. C. Study inclusion and exclusion criteria

  • are scheduled for elective cardiac surgery with extracorporeal circulation (bypass);
  • they give their consent for their data to be included in studies;
  • Exclusion criteria
  • they have emergency surgery;
  • have had Sars Cov 2 infection more recently than 3 months; D. Data Collection It is done in an excel table. Data collection is done anonymously. No patient-identifying data will be collected. The collected data will be about comorbidities, COVID-19 status - disease and vaccination, postoperative complications.

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
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2022

Typical duration for all trials

Geographic Reach
1 country

2 active sites

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

Study Start

First participant enrolled

July 20, 2022

Completed
10 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2022

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

February 28, 2023

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 2, 2023

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
Last Updated

March 2, 2023

Status Verified

February 1, 2023

Enrollment Period

10 days

First QC Date

February 28, 2023

Last Update Submit

February 28, 2023

Conditions

Postoperative ComplicationsCOVID-19

Outcome Measures

Primary Outcomes (1)

  • Identifying risk factors for peri-operative complications in patients who have had COVID-19

    3 years

Secondary Outcomes (2)

  • Identifying peri-operative complications in patients who have had COVID-19

    3 years

  • Identifying the safe distance at which a patient can be operated after a Sars CoV2 infection without having an increased risk of peri-operative complications.

    3 years

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients hospitalized in the Cardiac Intensive Care Unit 2 IUBCV CC Iliescu for postoperative management.

You may qualify if:

  • are scheduled for elective cardiac surgery with extracorporeal circulation (bypass);
  • they give their consent for their data to be included in studies;

You may not qualify if:

  • they have emergency surgery;
  • have had Sars Cov 2 infection more recently than 3 months;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

IUBCV Prof. Dr. CC Iliescu

Bucharest, Romania

RECRUITING

IUBCV Prof. Dr. CC Iliescu

Bucharest, Romania

RECRUITING

Related Publications (2)

  • COVIDSurg Collaborative. Outcomes and Their State-level Variation in Patients Undergoing Surgery With Perioperative SARS-CoV-2 Infection in the USA: A Prospective Multicenter Study. Ann Surg. 2022 Feb 1;275(2):247-251. doi: 10.1097/SLA.0000000000005310.

    PMID: 34793350RESULT

  • Wajekar AS, Solanki SL, Divatia JV. Pre-Anesthesia Re-Evaluation in Post COVID-19 Patients Posted for Elective Surgeries: an Online, Cross-Sectional Survey. Indian J Surg Oncol. 2021 Dec;12(Suppl 2):234-239. doi: 10.1007/s13193-021-01347-z. Epub 2021 May 17.

    PMID: 34025062RESULT

MeSH Terms

Conditions

Postoperative ComplicationsCOVID-19

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Central Study Contacts

Cornelia Elena Predoi, phD student

CONTACT

+40736163107cornelia.florescu@yahoo.ro

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
15 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
phD student

Study Record Dates

First Submitted

February 28, 2023

First Posted

March 2, 2023

Study Start

July 20, 2022

Primary Completion

July 30, 2022

Study Completion

June 30, 2025

Last Updated

March 2, 2023

Record last verified: 2023-02

Locations

RO(2)