BloodNCT03242525
Examination of the Time Advantage Between POCT and Conventional Central Laboratory Analysis
An observational study of Blood and Point-of-Care Systems, run by Johann Wolfgang Goethe University Hospital at 1 site in Germany.
Trial summary
The aim of the present study is to quantify the time advantage achieved by the use of POCT compared to conventional coagulation diagnostics. A further objective of this study is an analysis of the result quality of POCT for the prothrombin time / international normalized ratio. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Blood, Point-of-Care Systems, Analysis, Event History
- What is being tested?
- POCT and central laboratory blood analysis
- How many people
- 24 participants
- Where
- 1 siteGermany
- Study dates
- 26 Oct 2017to 28 Feb 2019
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: All bleeding patients assigned to the emergency department and delivery room.
Who may be able to join
- Age > 18 years
Who cannot join
- Missing written consent
- Withdrawal
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Examination of the Time Advantage of Point of Care Testing (POCT) Compared to the Conventional Central Laboratory Analysis in Intraclinical Patient Care
The aim of the present study is to quantify the time advantage achieved by the use of POCT compared to conventional coagulation diagnostics. A further objective of this study is an analysis of the result quality of POCT for the prothrombin time / international normalized ratio.
Read the detailed description
In order to be able to carry out a targeted coagulation therapy for the time-critical treatment of coagulopathic emergency patients, knowledge of the hemostatic potential is necessary.
After taking blood samples for coagulation diagnostics, they are sent to the central laboratory. After the analysis and validation the electronic provision of the results takes place. The loss of time by sample transport, analysis and breadth of the results extends the duration until therapy can be started.
The period of time until these analysis results are determined depends on several factors like daytime, day of week and location of the sample consignor and the availability of the laboratory. Not every clinic is connected to an internal tube mail system so that the samples have to be sent partly with a transport service.
In recent years, Point of Care (POCT) devices have become an increasingly important tool for diagnosing coagulopathic patients.
- Conditions
- Blood, Point-of-Care Systems, Analysis, Event History
- Being tested
- POCT and central laboratory blood analysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
POCT and central laboratory blood analysisDiagnostic test
In every participant blood analysis will be performed by POCT and central laboratory investigating the time advantage.
| Study group | Role | What they receive |
|---|---|---|
| Emergency room | Twelve bleeding patients who are assigned to the emergency department receive a simultaneous blood analysis with POCT and central laboratory. Receives: Diagnostic Test: POCT and central laboratory blood analysis | |
| Delivery room | Twelve bleeding patients who are assigned to the delivery room receive a simultaneous blood analysis with POCT and central laboratory. Receives: Diagnostic Test: POCT and central laboratory blood analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time advantage
Duration until laboratory results are available after sampling for central laboratory versus POCT
Measured: 2-4 hours
Secondary outcomes (3)
Correlation between central laboratory and POCT results.
Correlation of prothrombin time / international normalized ratio results between POCT and central laboratory analysis.
Measured: 2-4 hours
Influence of transport type.
Difference of results availability weather probes are transported by transport service or tube-mail.
Measured: 2-4 hours
Influence of daytime and weekday on results availability.
Difference of results availability in dependence of daytime and weekday on transport duration.
Measured: 2-4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2017
- Study start26 Oct 2017
- Primary completion30 Nov 2018
- Study completion28 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BloodStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johann Wolfgang Goethe University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. med. Florian Raimann, Johann Wolfgang Goethe University Hospital
- Investigators
- Kai Zacharowski, Prof. Dr., Study director, Department of Anesthesia, Intensive Care Medicine and Pain Therapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03242525
- Sponsor's protocol ID
- 279/17
- Status last verified
- Mar 2019
- First submitted
- 4 Aug 2017
- Last updated
- 19 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examination of the Time Advantage of Point of Care Testing (POCT) Compared to the Conventional Central Laboratory Analysis in Intraclinical Patient Care
- ClinicalTrials.gov ID
- NCT03242525
- Acronym / sponsor ID
- 279/17
- Conditions
- Blood, Point-of-Care Systems, Analysis, Event History
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Johann Wolfgang Goethe University HospitalUniversity, hospital or other
- Study start
- 26 Oct 2017 (actual)
- Primary completion
- 30 Nov 2018 (actual)
- Study completion
- 28 Feb 2019 (actual)
- First posted
- 8 Aug 2017 (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 is to quantify the time advantage achieved by the use of POCT compared to conventional coagulation diagnostics. A further objective of this study is an analysis of the result quality of POCT for the prothrombin time / international normalized ratio.
Detailed description
In order to be able to carry out a targeted coagulation therapy for the time-critical treatment of coagulopathic emergency patients, knowledge of the hemostatic potential is necessary.
After taking blood samples for coagulation diagnostics, they are sent to the central laboratory. After the analysis and validation the electronic provision of the results takes place. The loss of time by sample transport, analysis and breadth of the results extends the duration until therapy can be started.
The period of time until these analysis results are determined depends on several factors like daytime, day of week and location of the sample consignor and the availability of the laboratory. Not every clinic is connected to an internal tube mail system so that the samples have to be sent partly with a transport service.
In recent years, Point of Care (POCT) devices have become an increasingly important tool for diagnosing coagulopathic patients.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Emergency room | – | Diagnostic Test: POCT and central laboratory blood analysisTwelve bleeding patients who are assigned to the emergency department receive a simultaneous blood analysis with POCT and central laboratory. |
| Delivery room | – | Diagnostic Test: POCT and central laboratory blood analysisTwelve bleeding patients who are assigned to the delivery room receive a simultaneous blood analysis with POCT and central laboratory. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All bleeding patients assigned to the emergency department and delivery room.
Key inclusion criteria (1 listed)
- Age > 18 years
Key exclusion criteria (2 listed)
- Missing written consent
- Withdrawal
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 |
|---|---|---|
| POCT and central laboratory blood analysisIn every participant blood analysis will be performed by POCT and central laboratory investigating the time advantage. | Diagnostic test | Delivery room, Emergency room |
Primary outcome
Time advantage
Time frame: 2-4 hours
Duration until laboratory results are available after sampling for central laboratory versus POCT
3 secondary outcomes
Correlation between central laboratory and POCT results.
Time frame: 2-4 hours
Influence of transport type.
Time frame: 2-4 hours
Influence of daytime and weekday on results availability.
Time frame: 2-4 hours
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 19 Mar 2019.
- 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.
Kai Zacharowski, Prof. Dr. study director
Department of Anesthesia, Intensive Care Medicine and Pain Therapy
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 Blood and Point-of-Care Systems, run by Johann Wolfgang Goethe University Hospital at 1 site in Germany.
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 2 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 19 Mar 2019. 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 Germany. 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?
Time advantage (time frame: 2-4 hours). 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 19 Mar 2019.