NCT04769336

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 21, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 24, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2021

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2022

Completed
Last Updated

February 24, 2021

Status Verified

February 1, 2021

Enrollment Period

12 months

First QC Date

February 21, 2021

Last Update Submit

February 23, 2021

Conditions

Laboratory Problem

Outcome Measures

Primary Outcomes (1)

  • Time to result

    Time between blood draw and CBC result displayed in Electronic medical record

    Through study completion, an average of 1 year

Study Arms (1)

Patient

Each patient will undergo simultaneous testing with two different CBC analyzers.

Device: Central Lab based CBCDevice: Point of Care CBC

Interventions

Central Lab based CBCDEVICE

lab samples will be sent to the central lab for CBC analysis

Patient
Point of Care CBCDEVICE

lab samples will be analyzed at point of care

Patient

Eligibility Criteria

Age10 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients coming for surgery

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwestern Lake Forest Hospital

Lake Forest, Illinois, 60045, United States

Location

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Anesthesiologist

Study Record Dates

First Submitted

February 21, 2021

First Posted

February 24, 2021

Study Start

April 1, 2021

Primary Completion

March 31, 2022

Study Completion

March 31, 2022

Last Updated

February 24, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)