Point-of-Care Systemshb levelsNCT03509987
The Evaluation of Point of Care Testing for Determining Hemoglobin Levels in Geriatric Intensive Care Patients
A study testing HemaCue in people with Point-of-Care Systems, run by Kecioren Education and Training Hospital at 1 site in Turkey (Türkiye).
Trial summary
The aim of the present study was to compare hemoglobin (Hb) levels determined by point of care testing HemaCue and arterial blood gas analyzer with an automated hematology analyzer in critically ill geriatric patients.Forty geriatric patients requiring intensive care treatment were included in the study. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Point-of-Care Systems
- What is being tested?
- HemaCue
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2018to 5 Apr 2018
- Phase
- Interventional
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- geriatric patients requiring intensive care treatment
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
The aim of the present study was to compare hemoglobin (Hb) levels determined by point of care testing HemaCue and arterial blood gas analyzer with an automated hematology analyzer in critically ill geriatric patients.Forty geriatric patients requiring intensive care treatment were included in the study. Arterial blood sample was analyzed using HemaCue (HbHemaCueArterial), blood gas analyzer (Techno Medica, Gastat1800 series) (HbBGA) and an automated hematology analyzer (Cell Dyne 3700 System, Abbot Laboratories)(HbLab) as a reference method. Capillary blood measurements were performed (HbHemaCueCapillary) by HemaCue at bedside.
Read the detailed description
The aim of the present study was to compare hemoglobin (Hb) levels determined by point of care testing HemaCue and arterial blood gas analyzer with an automated hematology analyzer in critically ill geriatric patients.Forty geriatric patients requiring intensive care treatment were included in the study. Arterial blood sample was analyzed using HemaCue (HbHemaCueArterial), blood gas analyzer (Techno Medica, Gastat1800 series) (HbBGA) and an automated hematology analyzer (Cell Dyne 3700 System, Abbot Laboratories)(HbLab) as a reference method. Capillary blood measurements were performed (HbHemaCueCapillary) by HemaCue at bedside. Bland Altman Analysis was applied to the results .
- Conditions
- Point-of-Care Systems
- Being tested
- HemaCue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HemaCueDevice
Also called Blood gas analyser
comparing hemoglobin (Hb) levels determined by point of care testing HemaCue and arterial blood gas analyzer with an automated hematology analyzer in critically ill geriatric patients.
| Study group | Role | What they receive |
|---|---|---|
| hb analysis with Hemacue | Other | Hb analysis with Hemacue and with arterial blood gas analyser in geriatric ill patients requiring intensive care Receives: Device: HemaCue |
What is being measured
The primary outcome is the main question the study is designed to answer.
hemoglobin levels
comparing hemoglobin (Hb) levels determined by point of care testing HemaCue and arterial blood gas analyzer with an automated hematology analyzer in critically ill geriatric patients.
Measured: 1 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2018
- Study start1 Mar 2018
- Primary completion1 Apr 2018
- Study completion5 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Point-of-Care SystemsStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kecioren Education and Training Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MEHTAP HONCA, MD, Kecioren Education and Training Hospital
- Investigators
- MEHTAP HONCA, Ass. Prof, Principal investigator, Kecioren training and research Hospital , Department of Anesthesiology and Reanimation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03509987
- Sponsor's protocol ID
- KeciorenTRH
- Acronym
- hb levels
- Status last verified
- Apr 2018
- First submitted
- 16 Apr 2018
- Last updated
- 1 May 2018
- 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 1 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Evaluation of Point of Care Testing for Determining Hemoglobin Levels in Geriatric Intensive Care Patients
- ClinicalTrials.gov ID
- NCT03509987
- Acronym / sponsor ID
- hb levels / KeciorenTRH
- Conditions
- Point-of-Care Systems
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Kecioren Education and Training HospitalUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 1 Apr 2018 (actual)
- Study completion
- 5 Apr 2018 (actual)
- First posted
- 27 Apr 2018 (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 aim of the present study was to compare hemoglobin (Hb) levels determined by point of care testing HemaCue and arterial blood gas analyzer with an automated hematology analyzer in critically ill geriatric patients.Forty geriatric patients requiring intensive care treatment were included in the study. Arterial blood sample was analyzed using HemaCue (HbHemaCueArterial), blood gas analyzer (Techno Medica, Gastat1800 series) (HbBGA) and an automated hematology analyzer (Cell Dyne 3700 System, Abbot Laboratories)(HbLab) as a reference method. Capillary blood measurements were performed (HbHemaCueCapillary) by HemaCue at bedside.
Detailed description
The aim of the present study was to compare hemoglobin (Hb) levels determined by point of care testing HemaCue and arterial blood gas analyzer with an automated hematology analyzer in critically ill geriatric patients.Forty geriatric patients requiring intensive care treatment were included in the study. Arterial blood sample was analyzed using HemaCue (HbHemaCueArterial), blood gas analyzer (Techno Medica, Gastat1800 series) (HbBGA) and an automated hematology analyzer (Cell Dyne 3700 System, Abbot Laboratories)(HbLab) as a reference method. Capillary blood measurements were performed (HbHemaCueCapillary) by HemaCue at bedside. Bland Altman Analysis was applied to the results .
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| hb analysis with Hemacue | Other | Device: HemaCueHb analysis with Hemacue and with arterial blood gas analyser in geriatric ill patients requiring intensive care |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- geriatric patients requiring intensive care treatment
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| HemaCueAlso: Blood gas analysercomparing hemoglobin (Hb) levels determined by point of care testing HemaCue and arterial blood gas analyzer with an automated hematology analyzer in critically ill geriatric patients. | Device | hb analysis with Hemacue |
Primary outcome
hemoglobin levels
Time frame: 1 months
comparing hemoglobin (Hb) levels determined by point of care testing HemaCue and arterial blood gas analyzer with an automated hematology analyzer in critically ill geriatric patients.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2018.
- 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.
MEHTAP HONCA, Ass. Prof principal investigator
Kecioren training and research Hospital , Department of Anesthesiology and Reanimation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HemaCue in people with Point-of-Care Systems, run by Kecioren Education and Training Hospital at 1 site in Turkey (Türkiye).
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: finished, as of the sponsor's last update on 1 May 2018. 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 Turkey (Türkiye). 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
hemoglobin levels (time frame: 1 months). 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 1 May 2018.