Effectiveness of Point of Care Complete Blood Cell Count Analyzer in Reducing Time to Results

The current process for getting complete blood cell counts (CBC) results in the operating room during surgery relies on sending blood samples from the operating room to the hospital's central lab. This workflow is complex and often results in handing off the blood sample to 4 or more different staff members before arriving in the lab for analysis. This often causes delayed CBC results, which may lead to inappropriate or delayed clinical decision making. By providing prompt access to CBC results with the use of a point of care CBC analyzer, the clinical workflow efficiency can be significantly improved. This should resulting in better clinical decision making, reductions in costs, increase in patient satisfaction and facilitation of hospital processes.

Study Overview

• Status: Unknown
• Conditions: Laboratory Problem
• Intervention / Treatment: Device: Central Lab based CBC; Device: Point of Care CBC

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Lake Forest, Illinois, United States, 60045
      • Northwestern Lake Forest Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 85 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patients coming for surgery

Description

Inclusion Criteria:

• All English speaking patients, 18 years or older, having surgery in the Lake Forest Hospital operating rooms, with a pre-existing indication for CBC analysis.

Exclusion Criteria:

• All patients not meeting inclusion criteria or protected patient populations, specifically, pregnant women, prisoners, cognitively impaired patients, patients unable to consent, students, employees, and children)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patient; Each patient will undergo simultaneous testing with two different CBC analyzers.	Device: Central Lab based CBC; lab samples will be sent to the central lab for CBC analysis; Device: Point of Care CBC; lab samples will be analyzed at point of care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to result	Time between blood draw and CBC result displayed in Electronic medical record	Through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Northwestern Medicine

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2021
• Primary Completion (Anticipated): March 31, 2022
• Study Completion (Anticipated): March 31, 2022

Study Registration Dates

• First Submitted: February 21, 2021
• First Submitted That Met QC Criteria: February 23, 2021
• First Posted (Actual): February 24, 2021

Study Record Updates

• Last Update Posted (Actual): February 24, 2021
• Last Update Submitted That Met QC Criteria: February 23, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 21-009-LFH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No