Understanding risks of same-day noncardiac surgery
Vascular Events In Patients Undergoing Same-day Noncardiac Surgery (VALIANCE) Study - A Prospective Observational Cohort Study Evaluating Major Cardiovascular and Adverse Events in Patients Undergoing Elective Same-day Noncardiac Surgery
Centre hospitalier de l'Université de Montréal (CHUM) · NCT04973397
This study looks at the risks and complications that may happen to adults having same-day noncardiac surgery to help doctors better understand how to keep patients safe and improve their quality of life.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 15000 (estimated) |
| Ages | 45 Years and up |
| Sex | All |
| Sponsor | Centre hospitalier de l'Université de Montréal (CHUM) (other) |
| Locations | 16 sites (Winston-Salem, North Carolina and 15 other locations) |
| Trial ID | NCT04973397 on ClinicalTrials.gov |
What this trial studies
The VALIANCE Study is a large-scale observational cohort involving 15,000 adults undergoing elective same-day noncardiac surgery, followed for 90 days post-surgery. The study aims to identify the incidence of major cardiovascular complications and other adverse events, while also assessing changes in quality of life. It will develop risk prediction tools based on various validated assessments, including the Duke Activity Status Index and Clinical Frailty Scale, to better inform patient selection and risk stratification. This research addresses a growing trend in outpatient surgery, particularly among higher-risk patients.
Who should consider this trial
Good fit: Ideal candidates are adults aged 45-64 with at least one risk factor or those aged 65 and older, who are undergoing elective noncardiac same-day surgery.
Not a fit: Patients undergoing procedures that do not require an anesthesiologist or those with nonsurgical specialties may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance patient safety and outcomes by improving risk assessment for same-day surgeries.
How similar studies have performed: Other studies have shown success in identifying risks associated with outpatient surgeries, but this specific approach is novel in its scale and focus on same-day noncardiac procedures.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 45-64 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. Exclusion Criteria: * 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.
Where this trial is running
Winston-Salem, North Carolina and 15 other locations
- Wake Forest Baptist Medical Centre — Winston-Salem, North Carolina, United States (RECRUITING)
- Cleveland Clinic Foundation Fairview Campus — Cleveland, Ohio, United States (RECRUITING)
- Cleveland Clinic Foundation Main Campus — Cleveland, Ohio, United States (RECRUITING)
- MD Anderson Cancer Center — Houston, Texas, United States (RECRUITING)
- Memorial Hermann Texas Medical Center UT Health — Houston, Texas, United States (RECRUITING)
- St-Joseph's Healthcare Hamilton — Hamilton, Ontario, 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, Canada (RECRUITING)
- Toronto Western Hospital — Toronto, Ontario, Canada (RECRUITING)
- St-Micheal's Hospital — Toronto, Ontario, Canada (RECRUITING)
- Centre Hospitalier de l'Université de Montréal (CHUM) — Montreal, Quebec, 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)
Study contacts
- Principal investigator: Emmanuelle Duceppe, MD, PhD — Centre hospitalier de l'Université de Montréal (CHUM)
- Study coordinator: Melodie Fanay Boko, MSc
- Email: melodie.fanay.boko.chum@ssss.gouv.qc.ca
- Phone: 514-890-8000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Preoperative Care, Surgery--Complications, Myocardial Infarction, Surgery, Postoperative complications, Same-day surgery, Ambulatory surgery, Outpatient surgery