Vascular Events In Patients Undergoing Same-day Noncardiac Surgery (VALIANCE) Study

NCT04973397 | Recruiting

• 1 other identifier: MP-02-2022-9889
• Study Type: observational
• Target: 15,000
• Locations: 4 countries
• Sites: 16

Brief Summary

The proportion of noncardiac surgeries performed as same-day surgery is increasing worldwide, with more complex surgeries being performed on higher risk patients in the outpatient setting. Little is known on the risk factors, incidence and prognosis of patients undergoing same-day noncardiac surgery. The main objective of this study is to inform on the incidence and risk factors of cardiovascular and other adverse events after same-day surgery and to develop risk prediction tools to better inform on the risk and selection of patients undergoing same-day surgery.

Conditions

Preoperative Care; Surgery--Complications; Myocardial Infarction

Keywords

Preoperative Care; Surgery; Postoperative complications; Same-day surgery; Ambulatory surgery; Outpatient surgery

Outcome Measures

Primary Outcomes (1)

• Unplanned healthcare utilization

  the number of patients who have at least one of the following: unplanned admission after surgery, unplanned outpatient visit, emergency room visit and rehospitalization after same-day surgery

  90 days

Secondary Outcomes (21)

• unplanned admission

  90 days

• unplanned outpatient visit

  90 days

• emergency room visit

  90 days

• re-hospitalization

  90 days

• major cardiovascular complications

  90 days

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All eligible adults undergoing elective same-day noncardiac surgery

You may qualify if:

• years of age with at least one risk factor, or ≥65 years of age;
• undergoing elective noncardiac same-day surgery;
• planned duration in the operating room 60 minutes or more;
• provided written consent.

You may not qualify if:

• intervention does not require the presence of an anesthesiologist;
• procedure is performed by a nonsurgical specialty (e.g., gastroenterology, pneumology, radio-oncology or radiology);
• intervention is an ophthalmologic procedure;
• previously enrolled in the VALIANCE study.

Sponsors & Collaborators

• Université de Montréal: collaborator
• Fonds de la Recherche en Santé du Québec: collaborator
• Canadian Institutes of Health Research (CIHR): collaborator
• Centre hospitalier de l'Université de Montréal (CHUM): lead

Study Sites (16)

Wake Forest Baptist Medical Centre

Winston-Salem, North Carolina, 27157, United States

RECRUITING

Cleveland Clinic Foundation Fairview Campus

Cleveland, Ohio, 44111, United States

RECRUITING

Cleveland Clinic Foundation Main Campus

Cleveland, Ohio, 44195, United States

RECRUITING

MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Memorial Hermann Texas Medical Center UT Health

Houston, Texas, 77030, United States

RECRUITING

St-Joseph's Healthcare Hamilton

Hamilton, Ontario, L8N 4A6, Canada

ACTIVE NOT RECRUITING

Hamilton General Hospital

Hamilton, Ontario, Canada

RECRUITING

Juravinski Hospital and Cancer Centre

Hamilton, Ontario, Canada

RECRUITING

McMaster University Medical Centre

Hamilton, Ontario, Canada

RECRUITING

Mount Sinai Hospital

Toronto, Ontario, M5G 1X5, Canada

RECRUITING

Toronto Western Hospital

Toronto, Ontario, M5T 2S8, Canada

RECRUITING

St-Micheal's Hospital

Toronto, Ontario, Canada

RECRUITING

Centre Hospitalier de l'Université de Montréal (CHUM)

Montreal, Quebec, H2X0C1, Canada

RECRUITING

Centre Hospitalier Universitaire de Sherbrooke

Sherbrooke, Quebec, Canada

ACTIVE NOT RECRUITING

Maasstad Ziekenhuis Rotterdam

Rotterdam, Netherlands

RECRUITING

Hospital Clinic Barcelona

Barcelona, Spain

RECRUITING

Related Publications (1)

• Boko MF, Khanna AK, D'Aragon F, Spence J, Conen D, Patel A, Ayad S, Wijeysundera DN, Choiniere M, Sessler DI, Carrier FM, Harlock J, Koopman JSHA, Durand M, Bhojani N, Turan A, Page G, Devereaux PJ, Duceppe E; VALIANCE Study Collaborators. Incidence and Risk Factors of Chronic Postoperative Pain in Same-day Surgery: A Prospective Cohort Study. Anesthesiology. 2024 Aug 1;141(2):286-299. doi: 10.1097/ALN.0000000000005030.

  PMID: 38669010 RESULT

MeSH Terms

Conditions

Myocardial Infarction; Postoperative Complications

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Emmanuelle Duceppe, MD, PhD

  Centre Hospitalier de l'Universite de Montreal (CHUM)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Melodie Fanay Boko, MSc

CONTACT

514-890-8000; melodie.fanay.boko.chum@ssss.gouv.qc.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2021
• First Posted: July 22, 2021
• Study Start: November 17, 2021
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): April 1, 2027
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (9); ES (1); NL (1); US (5)