Laboratory ProblemNCT04769336
Effectiveness of Point of Care Complete Blood Cell Count Analyzer in Reducing Time to Results
An observational study of Laboratory Problem, run by Northwestern Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Laboratory Problem
- What is being tested?
- Central Lab based CBC and Point of Care CBC
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2021to 31 Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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 10 to 85 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: All patients coming for surgery
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern Lake Forest Hospital
Lake Forest, Illinois, 60045
About this study
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.
- Conditions
- Laboratory Problem
- Being tested
- Central Lab based CBC, Point of Care CBC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Central Lab based CBCDevice
lab samples will be sent to the central lab for CBC analysis
Point of Care CBCDevice
lab samples will be analyzed at point of care
| Study group | Role | What they receive |
|---|---|---|
| Patient | Each patient will undergo simultaneous testing with two different CBC analyzers. Receives: Device: Central Lab based CBC; Device: Point of Care CBC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to result
Time between blood draw and CBC result displayed in Electronic medical record
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2021
- Study start1 Apr 2021 (estimated)
- Primary completion31 Mar 2022 (estimated)
- Study completion31 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laboratory ProblemStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Other
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwestern Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrew Gostine, MD, Northwestern Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04769336
- Sponsor's protocol ID
- 21-009-LFH
- Status last verified
- Feb 2021
- First submitted
- 21 Feb 2021
- Last updated
- 24 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Point of Care Complete Blood Cell Count Analyzer in Reducing Time to Results
- ClinicalTrials.gov ID
- NCT04769336
- Acronym / sponsor ID
- 21-009-LFH
- Conditions
- Laboratory Problem
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Northwestern MedicineUniversity, hospital or other
- Study start
- 1 Apr 2021 (estimated)
- Primary completion
- 31 Mar 2022 (estimated)
- Study completion
- 31 Mar 2022 (estimated)
- First posted
- 24 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient | – | Device: Central Lab based CBC, Device: Point of Care CBCEach patient will undergo simultaneous testing with two different CBC analyzers. |
Who may qualify
- Ages
- 10 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients coming for surgery
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Central Lab based CBClab samples will be sent to the central lab for CBC analysis | Device | Patient |
| Point of Care CBClab samples will be analyzed at point of care | Device | Patient |
Primary outcome
Time to result
Time frame: Through study completion, an average of 1 year
Time between blood draw and CBC result displayed in Electronic medical record
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2021.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Laboratory Problem, run by Northwestern Medicine at 1 site in United States.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 24 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to result (time frame: Through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Feb 2021.