Preoperative Microcirculation and Postoperative Outcome After Major Vascular Surgery (MAPOVAS)

Preoperative Microcirculation and Postoperative Outcome After Major Vascular Surgery: a Prospective Cohort Study

The aim of the study is to determine whether there is a correlation between the microcirculation measured preoperatively in patients undergoing major vascular surgery and the postoperative mortality during hospitalization period. The microcirculation will be measured sublingually with the Cytocam-IDF imaging technique.

Study Overview

• Status: Withdrawn
• Conditions: Surgery--Complications
• Intervention / Treatment: Other: Cytocam-IDF imaging device

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Brussel
    • Jette, Brussel, Belgium, 1090
      • UZ Brussel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age ≥ 18 years

  • Males and females
  • ASA III classification
  • Written informed consent obtained by the patient
  • Elective hospital admission for major vascular surgery, both open and endovascular

Exclusion Criteria:

• Emergency surgery

  • Minor vascular procedures (e.g. varicose vein stripping; thromboembolectomy; vascular access formation)
  • Pregnancy
  • Refusal or inability to provide written informed consent (language barrier, mental retardation)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Cytocam-IDF Imaging; All patients will undergo the same interventional test.	Other: Cytocam-IDF imaging device; Observation of the microcirculation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative high-sensitive troponin T (hsTnT)	Indicator of acute coronary syndrome	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cause of death	Causes of death	30 days
Non-cardiovascular adverse events and serious adverse events	Incidence of non-cardiovascular complications	30 days
Cardiovascular adverse events and serious adverse events	Incidence of cardiovascular complications	30 days
Correlation between preoperative microcirculation and postoperative outcome during the hospitalization period.	In addition, demographic parameters (age, weight, height) and comorbidities will be taken into account.	30

Collaborators and Investigators

• Sponsor: Universitair Ziekenhuis Brussel

Study record dates

Study Major Dates

• Study Start (Anticipated): February 1, 2021
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): February 1, 2022

Study Registration Dates

• First Submitted: December 9, 2020
• First Submitted That Met QC Criteria: December 17, 2020
• First Posted (Actual): December 22, 2020

Study Record Updates

• Last Update Posted (Actual): May 12, 2023
• Last Update Submitted That Met QC Criteria: May 10, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: MAPOVAS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

IPD Plan Description

Presentations of both the study protocol and the study results will be held at conferences.

After completion of the study and analysis of the data results will be made publicly without re striction, independent of the outcome. They will be submitted for publication to an international peer-reviewed journal.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No