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Preoperative CareVALIANCENCT04973397

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

An observational study of Preoperative Care and Surgery--Complications, run by Centre hospitalier de l'Université de Montréal (CHUM) at 16 sites in 4 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 45 years and older
How many people
15,000 participants
Where
16 sitesin 4 countries
Study dates
17 Nov 2021to Apr 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: All eligible adults undergoing elective same-day noncardiac surgery

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

16 sites in 4 countries. Contact the study team or a site near you to ask about taking part.

Melodie Fanay Boko, MSc contact

514-890-8000 ext. 31541

valiance.chum@ssss.gouv.qc.ca

16 sites in 4 countries

Canada9 sites, 5 recruiting

  • St-Joseph's Healthcare Hamilton

    Hamilton, Ontario, L8N 4A6

    Active, not recruiting

  • Hamilton General Hospital

    Hamilton, Ontario

    John Harlock, MD, MSc

    Recruiting

  • Juravinski Hospital and Cancer Centre

    Hamilton, Ontario

    Ameen Patel, MD

    Recruiting

  • McMaster University Medical Centre

    Hamilton, Ontario

    Active, not recruiting

  • Centre Hospitalier de l'Université de Montréal (CHUM)

    Montreal, Quebec, H2X0C1

    Melodie Fanay Boko, BSc, 514-890-8000 ext. 31541, melodie.fanay.boko.chum@ssss.gouv.qc.ca

    Emmanuelle Duceppe, MD, PhD

    Recruiting

  • Centre Hospitalier Universitaire de Sherbrooke

    Sherbrooke, Quebec

    Active, not recruiting

  • Mount Sinai Hospital

    Toronto, Ontario, M5G 1X5

    James Khan, MD

    Recruiting

  • Toronto Western Hospital

    Toronto, Ontario, M5T 2S8

    Mandeep Singh, MBBS, MD, MSc, FRCPC

    Recruiting

  • St-Micheal's Hospital

    Toronto, Ontario

    Active, not recruiting

Other trials in Canada

United States5 sites, 4 recruiting

  • Cleveland Clinic Foundation Fairview Campus

    Cleveland, Ohio, 44111

    Sabry Ayad, MD, MBA

    Recruiting

  • Cleveland Clinic Foundation Main Campus

    Cleveland, Ohio, 44195

    Active, not recruiting

  • MD Anderson Cancer Center

    Houston, Texas, 77030

    Juan P Cata, MD

    Recruiting

  • Memorial Hermann Texas Medical Center UT Health

    Houston, Texas, 77030

    Mehmet Alparslan Turan, MD

    Recruiting

  • Wake Forest Baptist Medical Centre

    Winston-Salem, North Carolina, 27157

    Ashish K Khanna, MD, MSc

    Recruiting

Other trials in United States

Netherlands1 site, 1 recruiting

  • Maasstad Ziekenhuis Rotterdam

    Rotterdam

    Joseph Koopman, MD, PhD

    Recruiting

Other trials in Netherlands

Spain1 site, 1 recruiting

  • Hospital Clinic Barcelona

    Barcelona

    Eva Rivas, MD, PhD

    Recruiting

Other trials in Spain

About this study

Official title: 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

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.

Read the detailed description

The VALIANCE Study is a 15,000 patient, multicentre, prospective observational cohort of adults undergoing elective same-day noncardiac surgery and who will be followed for 90 days after surgery. The primary objective of the study is to determine the incidence of major cardiovascular complications after same-day surgery. Patients will also be followed for the occurence of other adverse postoperative complications and determine their change in quality of life at 90 days after surgery. VALIANCE will inform on the risk factors for postoperative complications and allow to develop risk prediction tools to guide patient selection and risk stratification of patients undergoing same-day surgery. The study will also look at validating the use of the Duke Activity Status Index questionnaire, Clinical Frailty Scale, and the Revised Cardiac Risk Index. Postoperative pain will be evaluated using the Brief pain inventory score and quality of life using the EQ-5D-5L questionnaire.

Keywords
Preoperative Care, Surgery, Postoperative complications, Same-day surgery, Ambulatory surgery, Outpatient surgery
Medical subject headings
Myocardial Infarction, Postoperative Complications

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 90 days

Secondary outcomes (21)

  1. unplanned admission

    the number of patients who have to be admitted to the hospital after undergoing a surgery planned as same-day

    Measured: 90 days

  2. unplanned outpatient visit

    the number of patient who had a medical visit in an outpatient setting after undergoing same-day surgery

    Measured: 90 days

  3. emergency room visit

    the number of patients who visited the emergency room without subsequent hospitalization after undergoing same-day surgery

    Measured: 90 days

  4. re-hospitalization

    the number of patients who have to be readmitted to the hospital after being discharged home following their same-day surgery

    Measured: 90 days

  5. major cardiovascular complications

    the number of patients who have at least one of the following: myocardial injury or infarction, non-fatal cardiac arrest, coronary revascularization, stroke, transient ischemic attack, new clinically significant arrythmia, congestive heart failure, unplanned postoperative admission for vascular reasons, emergency room visit for vascular reasons, rehospitalization for vascular reasons, and all-cause mortality

    Measured: 90 days

  6. myocardial injury after noncardiac surgery (MINS)

    the number of patients who experience a MINS

    Measured: 90 days

  7. myocardial infarction

    the number of patients who experience a myocardial infarction

    Measured: 90 days

  8. non-fatal cardiac arrest

    the number of patients who experience a non-fatal cardiac arrest

    Measured: 90 days

  9. coronary revascularization

    the number of patients who undergo coronary revascularization

    Measured: 90 days

  10. stroke

    the number of patients who experience a stroke

    Measured: 90 days

  11. transient ischemic attack

    the number of patients who experience a transient ischemic attack

    Measured: 90 days

  12. new clinically important arrythmia

    the number of patients who experience a new clinically important arrythmia

    Measured: 90 days

  13. acute congestive heart failure

    the number of patients who experience an acute congestive heart failure episode

    Measured: 90 days

  14. deep vein thrombosis

    the number of patients who experience a deep vein thrombosis

    Measured: 90 days

  15. pulmonary embolism

    the number of patients who experience a pulmonary embolism

    Measured: 90 days

  16. major postoperative and life-threatening bleeding

    the number of patients who experience a major postoperative and/or life-threatening bleeding

    Measured: 90 days

  17. postoperative infection

    the number of patients who experience a postoperative infection

    Measured: 90 days

  18. acute kidney injury

    the number of patients who experience a acute kidney injury

    Measured: 90 days

  19. quality of life score on the 5-level EQ-5D version (EQ-5D-5L) questionnaire

    score on the EQ-5D-5L questionnaire on 4 health profiles (level 1 to 5), overall self-rated health status (0-100 visual analogue scale), and EQ-5D-5L index value (0.01-0.99)

    Measured: 90 days

  20. functional capacity score on the Duke Activity Status Index (DASI)

    change in the score on the Duke Activity Status Index (DASI) questionnaire (0 to 58.2 points)

    Measured: 90 days

  21. frailty

    change in the level on the Clinical Frailty Scale (level 1 to 9)

    Measured: 90 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jul 2021
  2. Study start17 Nov 2021
  3. Primary completionDec 2026 (estimated)
  4. Study completionApr 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
15,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04973397
Sponsor's protocol ID
MP-02-2022-9889
Acronym
VALIANCE
Status last verified
Mar 2026
First submitted
13 Jul 2021
Last updated
4 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 38669010

Questions about this trial

What is this clinical trial studying?

An observational study of Preoperative Care and Surgery--Complications, run by Centre hospitalier de l'Université de Montréal (CHUM) at 16 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in Canada, United States, Netherlands, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Melodie Fanay Boko, MSc (514-890-8000 ext. 31541, valiance.chum@ssss.gouv.qc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Unplanned healthcare utilization (time frame: 90 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04973397, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026; AzTrials last refreshed its copy on 7 Nov 2026.

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