HemolysisNCT02976610
Clinical Study of a Novel Hemolysis Point of Care Test at an Emergency Department.
A study testing Hemolysis Point-of-Care test in people with Hemolysis and Blood Specimen Collection, run by Hemcheck Sweden AB at 1 site in Sweden.
Trial summary
This study aims to investigate the outcome of hemolysis frequency when a hemolysis point of care test is introduced in an emergency department. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hemolysis, Blood Specimen Collection
- What is being tested?
- Hemolysis Point-of-Care test
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,671 participants
- Where
- 1 siteSweden
- Study dates
- 1 Dec 2016to 5 May 2017
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Blood sample analysis ordered:
- Electrolyte
- Troponin T
- ALAT, ASAT, ALP.
Who cannot join
- Incompletely filled tubes
- Minors (< 18 years)
- Patient not fit according to the health care professional assessment
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Emergency department, Central Hospital Karlstad
Karlstad, Värmland County, 65230
About this study
Official title: Open Label, Single Center Clinical Trial of a Novel Hemolysis Point of Care Test at an Emergency Department.
This study aims to investigate the outcome of hemolysis frequency when a hemolysis point of care test is introduced in an emergency department.
Read the detailed description
In a blood sample process, the preanalytical phase is accountable for a vast majority of laboratory test errors. Among preanalytical errors, hemolysis is the most frequent error of sample rejection. Recollection of blood from the patient causes extra suffering, increased turn-around-time hence delayed treatment, and unnecessary extra costs for the health care system.
Here is a novel method for hemolysis point of care detection (H-POCT) evaluated. The single use test is attached to the blood sample in direct conjunction to the sampling process.
Patients will be selected by consecutive selection at the emergency department if blood tests ordered by the physician meet the inclusion criteria. Patients will be randomized into one of two groups. All health care professionals participating in this study has attended in a standard education program in operating H-POCT.
If Allocated into the control group, n: 750, nurses and enrolled nurses will perform blood sample according to routine.
If allocated into the intervention group, n: 750, nurses and enrolled nurses will perform blood sample according to routine and screen all Lithium Heparin vacuum tubes. (for one or all of the analyzes: Liver status, Electrolytes and Troponin T.)
If the hemolysis point of care test (H-poct) indicate a positive test result the Lithium Heparin vacuum tube and the attached H-poct will be discarded and a new sample will be collected and screened for hemolysis until the user receives a negative sample that is not hemolyzed.
This study takes place in a county hospital with 430 beds and the emergency department treats 59000 patients yearly.
- Conditions
- Hemolysis, Blood Specimen Collection
- Being tested
- Hemolysis Point-of-Care test
- Keywords
- hemolysis
- Medical subject headings
- Hemolysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hemolysis Point-of-Care testDevice
Hemolysis measurement of plasma using a point of care test to determine the hemolysis level in plasma
| Study group | Role | What they receive |
|---|---|---|
| 1 | No intervention | This is the control group where no intervention takes place. Blood sampling carried out according to routine at the emergency department. |
| 2 | Experimental | During the blood sampling the health care professional will screen all vacuum Lithium Heparin tubes, with the Hemolysis point-of-care test (H-POCT). If the health care professional receives a negative test the bloodsample is sent to the local laboratory.
If H-POCT indicates a positive test, of free hemoglobin in plasma, the bloodsample and H-POCT will be discarded and a new sample will be collected and screened for hemolysis. This can be repeated 3 times. Receives: Device: Hemolysis Point-of-Care test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemolysis frequency.
Compare the volume of hemolyzed blood samples in two groups.
Measured: Through 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2016 (estimated)
- Study start1 Dec 2016
- Primary completion5 May 2017
- Study completion5 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemolysisStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,671 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hemcheck Sweden AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Landstinget i Värmland
- Responsible party
- Principal investigator, Lars-Olof Hansson, Landstinget i Värmland
- Investigators
- Lars O Hansson, MD-PhD, Study chair, Landstinget i VärmlandAnders Hallberg, MD-PhD, Study chair, Centrum för klinisk forskning, SCK, Älvgatan 49, 651 85 Karlstad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02976610
- Sponsor's protocol ID
- HC001
- Status last verified
- Jun 2017
- First submitted
- 24 Nov 2016
- Last updated
- 12 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label, Single Center Clinical Trial of a Novel Hemolysis Point of Care Test at an Emergency Department.
- ClinicalTrials.gov ID
- NCT02976610
- Acronym / sponsor ID
- HC001
- Conditions
- Hemolysis, Blood Specimen Collection
- Keywords
- hemolysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,671 participants (actual)
- Lead sponsor
- Hemcheck Sweden ABIndustry (pharma, biotech, devices)
- Collaborators
- Landstinget i Värmland
- Study start
- 1 Dec 2016 (actual)
- Primary completion
- 5 May 2017 (actual)
- Study completion
- 5 May 2017 (actual)
- First posted
- 29 Nov 2016 (estimated)
- 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.
This study aims to investigate the outcome of hemolysis frequency when a hemolysis point of care test is introduced in an emergency department.
Detailed description
In a blood sample process, the preanalytical phase is accountable for a vast majority of laboratory test errors. Among preanalytical errors, hemolysis is the most frequent error of sample rejection. Recollection of blood from the patient causes extra suffering, increased turn-around-time hence delayed treatment, and unnecessary extra costs for the health care system.
Here is a novel method for hemolysis point of care detection (H-POCT) evaluated. The single use test is attached to the blood sample in direct conjunction to the sampling process.
Patients will be selected by consecutive selection at the emergency department if blood tests ordered by the physician meet the inclusion criteria. Patients will be randomized into one of two groups. All health care professionals participating in this study has attended in a standard education program in operating H-POCT.
If Allocated into the control group, n: 750, nurses and enrolled nurses will perform blood sample according to routine.
If allocated into the intervention group, n: 750, nurses and enrolled nurses will perform blood sample according to routine and screen all Lithium Heparin vacuum tubes. (for one or all of the analyzes: Liver status, Electrolytes and Troponin T.)
If the hemolysis point of care test (H-poct) indicate a positive test result the Lithium Heparin vacuum tube and the attached H-poct will be discarded and a new sample will be collected and screened for hemolysis until the user receives a negative sample that is not hemolyzed.
This study takes place in a county hospital with 430 beds and the emergency department treats 59000 patients yearly.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | No intervention | –This is the control group where no intervention takes place. Blood sampling carried out according to routine at the emergency department. |
| 2 | Experimental | Device: Hemolysis Point-of-Care testDuring the blood sampling the health care professional will screen all vacuum Lithium Heparin tubes, with the Hemolysis point-of-care test (H-POCT). If the health care professional receives a negative test the bloodsample is sent to the local laboratory. If H-POCT indicates a positive test, of free hemoglobin in plasma, the bloodsample and H-POCT will be discarded and a new sample will be collected and screened for hemolysis. This can be repeated 3 times. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Electrolyte
- Troponin T
- ALAT, ASAT, ALP.
Key exclusion criteria (3 listed)
- Incompletely filled tubes
- Minors (< 18 years)
- Patient not fit according to the health care professional assessment
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 |
|---|---|---|
| Hemolysis Point-of-Care testHemolysis measurement of plasma using a point of care test to determine the hemolysis level in plasma | Device | 2 |
Primary outcome
Hemolysis frequency.
Time frame: Through 52 weeks
Compare the volume of hemolyzed blood samples in two groups.
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 12 Jun 2017.
- 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.
Lars O Hansson, MD-PhD study chair
Landstinget i Värmland
Anders Hallberg, MD-PhD study chair
Centrum för klinisk forskning, SCK, Älvgatan 49, 651 85 Karlstad
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hemolysis Point-of-Care test in people with Hemolysis and Blood Specimen Collection, run by Hemcheck Sweden AB at 1 site in Sweden.
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 4 inclusion and 3 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 12 Jun 2017. 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 Sweden. 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?
Hemolysis frequency. (time frame: Through 52 weeks). 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 12 Jun 2017.