NCT05208957

Brief Summary

This is a registry-based study of elective vascular surgical patients undergoing intermediate or high-risk vascular surgical interventions at Groote Schuur hospital, a tertiary academic center, over a 12 month period.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
175

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2022

Geographic Reach
1 country

1 active site

Status
completed

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

January 12, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 26, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

May 17, 2022

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2023

Completed
Last Updated

July 16, 2024

Status Verified

July 1, 2024

Enrollment Period

1.5 years

First QC Date

January 12, 2022

Last Update Submit

July 15, 2024

Conditions

Perioperative ComplicationCardiovascular Complication

Outcome Measures

Primary Outcomes (1)

  • Determine in-hospital mortality in elective vascular surgical patients

    12 months

Secondary Outcomes (3)

  • Determine incidence of MACE in elective vascular surgical patients.

    12 months

  • Describe the risk factors associated with MACE in elective vascular surgical patients

    12 months

  • Determine incidence of post-operative complications in elective vascular surgical patients

    12 months

Interventions

No interventionOTHER

No intervention

Eligibility Criteria

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

The study population comprises all patients, 18 years and older, undergoing any elective moderate- to high-risk vascular surgical intervention at Groote Schuur Hospital. Surgical risk as defined by ESC/ESA 2014 guidelines.

You may qualify if:

  • All patients undergoing vascular surgery:
  • years and older
  • Elective procedures
  • Moderate- to high-risk surgical interventions

You may not qualify if:

  • Emergency vascular procedures
  • Low risk vascular surgery, i.e. venous stripping
  • All non-vascular surgical interventions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Groote Schuur Hospital

Cape Town, Western Cape, 7708, South Africa

Location

Study Officials

  • Christella Alphonsus, MBChB

    University of Cape Town

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Study Principal investigator

Study Record Dates

First Submitted

January 12, 2022

First Posted

January 26, 2022

Study Start

May 17, 2022

Primary Completion

November 30, 2023

Study Completion

November 30, 2023

Last Updated

July 16, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will share

Data will be shared by PI

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
Not limited
Access Criteria
Contact PI

Locations

ZA(1)