Predictors of Outcome After Perioperative Stroke

NCT04214613 | Unknown

• 1 other identifier: H19-02698
• Study Type: observational
• Target: 20,000
• Locations: 1 country
• Sites: 1

Brief Summary

Perioperative stroke is a devastating complication of surgery that is currently poorly characterized with limited clinical tools available to detect and prevent its occurrence. The current literature has identified that patients who experience a stroke after surgery have a higher rate of mortality, length of stay and discharge to a facility, but given the rare nature of this complication relatively little is known about which factors predict these outcomes amongst those who experience a perioperative stroke. The study objectives are to identify predictors of mortality, length of stay and discharge disposition after perioperative stroke in non-cardiac, non-neurological surgery using the prospectively-collected American College of Surgeons National Surgical Quality Improvement Program database between 2004 and 2020.

Conditions

Perioperative Complication; Stroke, Acute

Outcome Measures

Primary Outcomes (1)

• Number of deaths

  death

  within 30 days of surgery

Secondary Outcomes (2)

• length of stay

  within 30 days of surgery

• disposition

  within 30 days of surgery

Other Outcomes (1)

• temporal trend in mortality

  between 2004 to 2015

Interventions

non-cardiac non-neurologic surgery PROCEDURE

non-cardiac non-neurologic surgery

Eligibility Criteria

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

Study Population

The derivation cohort will be extracted from the NSQIP database, a prospective multicentre database of adult surgical patients with high-quality data.3 The most recent year of the dataset (2020) includes data on over 1000000 cases from 708 sites. The validation cohort will be extracted from Population Data BC, a collection of linked provincial databases providing de-identified individual level data on all residents of BC (population 5.1 million). A date range of January 1, 2002 to December 31, 2020 was chosen to reflect contemporary stroke treatment practices (e.g., EVT), and the consistent use of ICD-10-CA coding since 2002. This source will link data from the Discharge Abstract Database (DAD), Medical Services Plan (MSP) Database, and the Population and Vital Statistics Consolidated Database.

You may qualify if:

• Derivation cohort: all patients who received a diagnosis of stroke in the NSQIP database between 2004 and 2020.
• Validation cohort: Patients who experienced an ICD-10-CA admission diagnosis (top 3 positions) of AIS within 30 days of admission for surgery, or as a discharge diagnosis from the index surgical hospitalization. Perioperative patients will be further extracted from the overall AIS cohort if they received surgical billing code in the 30 days prior to admission for stroke.

You may not qualify if:

• Patients who underwent a neurosurgical or interventional radiology procedure.

Sponsors & Collaborators

• University of British Columbia: lead
• University of Ottawa: collaborator

Study Sites (1)

University of British Columbia

Vancouver, British Columbia, Canada

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Study Record Dates

• First Submitted: December 27, 2019
• First Posted: January 2, 2020
• Study Start: February 1, 2022
• Primary Completion: December 31, 2022
• Study Completion: July 1, 2023
• Last Updated: April 15, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)