SepsisNCT05118048
StatStrip Lactate, Hemoglobin, and Hematocrit Meter in Whole Blood
An observational study of Sepsis and Anemia, run by Nova Biomedical at 3 sites in United States.
Trial summary
The purpose of this study is to evaluate the clinical utility of the StatStrip Lactate, Hemoglobin and Hematocrit Hospital Meter System in the testing of whole blood specimens from patients in hospital settings by CLIA waived operators, over a period of at least twenty days. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Lactate, Hemoglobin, Hematocrit
- How many people
- 285 participants
- Where
- 3 sitesUnited States
- Study dates
- 18 Jan 2021to 22 Oct 2021
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: Each site will recruit at least 120 patients for a total of 360 adult patients in all three (3) sites for each of the tests and specimen types. An attempt will be made to enroll 50% males and 50% females. Each Study Subject will provide: 1. Two (2) capillary whole blood fingerstick specimens 1. One Lactate capillary test using the Fingerstick Blood Contamination Barrier 2. One Hb/Hct capillary test following traditional fingerstick protocol 2. One (1) venous whole blood specimen obtained by venipuncture collected in a lithium heparin tube or heparinized syringe: 1. One lactate venous test 2. One Hb/Hct venous test
Who may be able to join
- Adult subjects (over or equal to 18 years old) with ordered hemoglobin and hematocrit
Who cannot join
- Pediatric
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Buffalo General Medical Center
Buffalo, New York, 14203
Erie County Medical Center
Buffalo, New York, 14203
Millard Fillmore Suburban Hospital
Williamsville, New York, 14221
About this study
Official title: CLIA Waived Study: StatStrip Lactate, Hemoglobin, and Hematocrit Meter in Whole Blood
The purpose of this study is to evaluate the clinical utility of the StatStrip Lactate, Hemoglobin and Hematocrit Hospital Meter System in the testing of whole blood specimens from patients in hospital settings by CLIA waived operators, over a period of at least twenty days. The specimens shall include capillary (obtained by fingerstick), and venous whole blood. The study will also evaluate the use of a Fingerstick Blood Contamination Barrier for capillary sampling from the fingertip. This submission to the FDA is intended for a Point of Care (POC), CLIA waived device for whole blood capillary and venous lactate, and hemoglobin and hematocrit measurements.
Read the detailed description
The study will be conducted at three (3) different healthcare settings (hereafter referred to as "testing sites") in POC sites/departments, by at least nine (9) CLIAW operators (at least 3 in each healthcare setting), over a period of at least twenty days at each healthcare setting. Examples of hospital departments include (but are not limited to) Emergency Department (ED), Intensive Care Unit (ICU), Pediatric Intensive Care Unit (PICU), Surgical Intensive Care Unit (SICU), Medical Intensive Care Unit (MICU), Cardiac Intensive Care Unit (CICU), Operating Room (OR), where point-of-care lactate, hemoglobin and hematocrit testing can be utilized.
Each site will recruit at least 120 patients for a total of 360 adult patients in all three (3) sites for each of the tests and specimen types. An attempt will be made to enroll 50% males and 50% females.
Each Study Subject will provide:
- Two (2) capillary whole blood fingerstick specimens
- One Lactate capillary test using the Fingerstick Blood Contamination Barrier
- One Hb/Hct capillary test following traditional fingerstick protocol
- One (1) venous whole blood specimen obtained by venipuncture collected in a lithium heparin tube or heparinized syringe:
- One lactate venous test
- One Hb/Hct venous test
- Conditions
- Sepsis, Anemia, Bleeding, Erythrocytosis
- Being tested
- Lactate, Hemoglobin, Hematocrit
- Keywords
- Lactate, Hemoglobin, Hematocrict
- Medical subject headings
- Sepsis, Anemia, Hemorrhage, Polycythemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactate, Hemoglobin, HematocritDiagnostic test
Compare diagnostic tests to reference methods
What is being measured
The primary outcome is the main question the study is designed to answer.
Analytical verification of StatStrip Lactate, Hemoglobin and Hematocrit Hospital Meter System - Lactate comparison
StatStrip Lactate, Hemoglobin and Hematocrit Hospital Meter System, a point of care testing instrument is as effective as a reference laboratory method for Lactate blood results in mmol/L
Measured: 20 days
Analytical verification of StatStrip Lactate, Hemoglobin and Hematocrit Hospital Meter System - Hemoglobin comparison
StatStrip Lactate, Hemoglobin and Hematocrit Hospital Meter System, a point of care testing instrument is as effective as a reference laboratory method for Hemoglobin blood results in g/dL
Measured: 20 days
Analytical verification of StatStrip Lactate, Hemoglobin and Hematocrit Hospital Meter System - Hematocrit comparison
StatStrip Lactate, Hemoglobin and Hematocrit Hospital Meter System, a point of care testing instrument is as effective as a reference laboratory method for Hematocrit blood results in %
Measured: 20 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2021
- Study start18 Jan 2021
- Primary completion22 Oct 2021
- Study completion22 Oct 2021
Why it stopped: Patient recruitment too slowly
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 285 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nova Biomedical
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Buffalo General Medical Center, Erie County Medical Center, Millard Fillmore Suburban Hospital
- Responsible party
- Sponsor
- Investigators
- Brooke Lerner, PhD, FAEMS, Principal investigator, Buffalo General Medical CenterBrooke Lerner, PhD, FAEMS, Principal investigator, Erie County Medical CenterBrooke Lerner, PhD, FAEMS, Principal investigator, Millard Fillmore Suburban Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05118048
- Sponsor's protocol ID
- NB19-SSLHH-NA-FDA
- Status last verified
- Jul 2021
- First submitted
- 28 Jul 2021
- Last updated
- 11 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- 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 11 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CLIA Waived Study: StatStrip Lactate, Hemoglobin, and Hematocrit Meter in Whole Blood
- ClinicalTrials.gov ID
- NCT05118048
- Acronym / sponsor ID
- NB19-SSLHH-NA-FDA
- Conditions
- Sepsis, Anemia, Bleeding, Erythrocytosis
- Keywords
- Lactate, Hemoglobin, Hematocrict
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Patient recruitment too slowly
- Enrolment
- 285 participants (actual)
- Lead sponsor
- Nova BiomedicalIndustry (pharma, biotech, devices)
- Collaborators
- Buffalo General Medical Center, Erie County Medical Center, Millard Fillmore Suburban Hospital
- Study start
- 18 Jan 2021 (actual)
- Primary completion
- 22 Oct 2021 (actual)
- Study completion
- 22 Oct 2021 (actual)
- First posted
- 11 Nov 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 purpose of this study is to evaluate the clinical utility of the StatStrip Lactate, Hemoglobin and Hematocrit Hospital Meter System in the testing of whole blood specimens from patients in hospital settings by CLIA waived operators, over a period of at least twenty days. The specimens shall include capillary (obtained by fingerstick), and venous whole blood. The study will also evaluate the use of a Fingerstick Blood Contamination Barrier for capillary sampling from the fingertip. This submission to the FDA is intended for a Point of Care (POC), CLIA waived device for whole blood capillary and venous lactate, and hemoglobin and hematocrit measurements.
Detailed description
The study will be conducted at three (3) different healthcare settings (hereafter referred to as "testing sites") in POC sites/departments, by at least nine (9) CLIAW operators (at least 3 in each healthcare setting), over a period of at least twenty days at each healthcare setting. Examples of hospital departments include (but are not limited to) Emergency Department (ED), Intensive Care Unit (ICU), Pediatric Intensive Care Unit (PICU), Surgical Intensive Care Unit (SICU), Medical Intensive Care Unit (MICU), Cardiac Intensive Care Unit (CICU), Operating Room (OR), where point-of-care lactate, hemoglobin and hematocrit testing can be utilized.
Each site will recruit at least 120 patients for a total of 360 adult patients in all three (3) sites for each of the tests and specimen types. An attempt will be made to enroll 50% males and 50% females.
Each Study Subject will provide:
- Two (2) capillary whole blood fingerstick specimens
- One Lactate capillary test using the Fingerstick Blood Contamination Barrier
- One Hb/Hct capillary test following traditional fingerstick protocol
- One (1) venous whole blood specimen obtained by venipuncture collected in a lithium heparin tube or heparinized syringe:
- One lactate venous test
- One Hb/Hct venous test
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Each site will recruit at least 120 patients for a total of 360 adult patients in all three (3) sites for each of the tests and specimen types. An attempt will be made to enroll 50% males and 50% females. Each Study Subject will provide: 1. Two (2) capillary whole blood fingerstick specimens 1. One Lactate capillary test using the Fingerstick Blood Contamination Barrier 2. One Hb/Hct capillary test following traditional fingerstick protocol 2. One (1) venous whole blood specimen obtained by venipuncture collected in a lithium heparin tube or heparinized syringe: 1. One lactate venous test 2. One Hb/Hct venous test
Key inclusion criteria (1 listed)
- Adult subjects (over or equal to 18 years old) with ordered hemoglobin and hematocrit
Key exclusion criteria (1 listed)
- Pediatric
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 |
|---|---|---|
| Lactate, Hemoglobin, HematocritCompare diagnostic tests to reference methods | Diagnostic test | – |
Primary outcome
Analytical verification of StatStrip Lactate, Hemoglobin and Hematocrit Hospital Meter System - Lactate comparison
Time frame: 20 days
StatStrip Lactate, Hemoglobin and Hematocrit Hospital Meter System, a point of care testing instrument is as effective as a reference laboratory method for Lactate blood results in mmol/L
Analytical verification of StatStrip Lactate, Hemoglobin and Hematocrit Hospital Meter System - Hemoglobin comparison
Time frame: 20 days
StatStrip Lactate, Hemoglobin and Hematocrit Hospital Meter System, a point of care testing instrument is as effective as a reference laboratory method for Hemoglobin blood results in g/dL
Analytical verification of StatStrip Lactate, Hemoglobin and Hematocrit Hospital Meter System - Hematocrit comparison
Time frame: 20 days
StatStrip Lactate, Hemoglobin and Hematocrit Hospital Meter System, a point of care testing instrument is as effective as a reference laboratory method for Hematocrit blood results in %
Results and safety
The study was stopped early (reason given: Patient recruitment too slowly). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2021.
- Individual participant dataSharing planned: No
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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.
Brooke Lerner, PhD, FAEMS principal investigator
Buffalo General Medical Center
Brooke Lerner, PhD, FAEMS principal investigator
Erie County Medical Center
Brooke Lerner, PhD, FAEMS principal investigator
Millard Fillmore Suburban Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis and Anemia, run by Nova Biomedical at 3 sites 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: stopped early, as of the sponsor's last update on 11 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
The study was stopped early (reason given: Patient recruitment too slowly). 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?
Analytical verification of StatStrip Lactate, Hemoglobin and Hematocrit Hospital Meter System - Lactate comparison (time frame: 20 days). The study lists 3 primary outcomes in all. 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 11 Nov 2021.