TraumaPOCCETNCT02691650
Point of Care Testing of Cholinesterase Activity During Burn- and Polytrauma
An observational study of Trauma and Burns, run by University Hospital Heidelberg at 1 site in Germany.
Trial summary
Goal of this study is to measure serum cholinesterase activity in patients with traumatic and/or burns injury admitted to the emergency room by using point-of- care-test system (POCT). Read more about this study
- Who is it for?
- Ages 18 years and older
- How many people
- 85 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2016to Oct 2018
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients admitted to the emergency unit of the trauma and burns center
Who may be able to join
- signed written consent
- 18 years and older
- severe trauma (ISS > 15)
- burns injury (2. degree more than 15% body surface or 3 degree more than 10% body surface)
- SIRS
Who cannot join
- not fulfilling the inclusion criteria
- failure to adhere
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Anaesthesia, Intensive Care Medicine and Pain Therapy, BG Trauma Center Ludwigshafen
Ludwigshafen am Rhein, Rhineland-Palatinate, 67071
About this study
Goal of this study is to measure serum cholinesterase activity in patients with traumatic and/or burns injury admitted to the emergency room by using point-of- care-test system (POCT). Serum cholinesterase activity, measured using POCT system, might play an important role in the early diagnosis and prediction of patient outcome in trauma-induced systemic inflammation.
- Keywords
- serum cholinesterase, plasma cholinesterase, pseudocholinesterase, systemic inflammation, SIRS, polytrauma
- Medical subject headings
- Wounds and Injuries, Burns, Butyrylcholinesterase deficiency, Multiple Trauma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| polytrauma patients | Patients with severe traumatic injury, admitted to the emergency unit. Serum cholinesterase activity measurement using 10 µl whole blood, otherwise obtained through routine blood gas analysis upon arrival to the hospital. | |
| burns patients | Patients with burns trauma, admitted to the emergency unit. Serum cholinesterase activity measurement using 10 µl whole blood, otherwise obtained through routine blood gas analysis upon arrival to the hospital. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early diagnosis of the systemic inflammation by using the serum cholinesterase activity measurement
By using Point-of-care measurement of serum cholinesterase activity (U/l) and by observing a change in the enzyme activity over time (reduction of serum cholinesterase activity within the first 6 hours after traumatic injury) would allow an additional tool in early diagnosis and treatment of systemic inflammation.
Measured: after completed patient recruitment, 1 year
Secondary outcomes (1)
correlation of the cholinesterase activity and the trauma/disease severity scores
To evaluate the correlation of the serum cholinesterase activity change with the trauma severity, the obtained serum cholinesterase activities (U/l) will be compared to the trauma severity scores (ISS, %TBSA).
Measured: after completed patient recruitment, 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2016 (estimated)
- Study startFeb 2016
- Primary completionFeb 2018
- Study completionOct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TraumaStudies of the same condition, open and under way.
- More trials run by University Hospital HeidelbergThe sponsor's other registered studies.
- 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
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Heidelberg
- Sponsor type
- University, hospital or other
- Collaborators
- BG Trauma Center Ludwigshafen
- Responsible party
- Principal investigator, Aleksandar Zivkovic, University Hospital Heidelberg
- Investigators
- Stefan Hofer, Prof. Dr., Principal investigator, University Hospital HeidelbergStefan Kleinschmidt, Prof. Dr., Study chair, Department of Anaesthesia, Intensive Care Medicine and Pain Therapy, BG Trauma Centre Ludwigshafen, Ludwigshafen, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02691650
- Sponsor's protocol ID
- Burns and Trauma POC ChE Study
- Acronym
- POCCET
- Status last verified
- Apr 2019
- First submitted
- 16 Feb 2016
- Last updated
- 16 Apr 2019
- 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 16 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Point of Care Testing of Cholinesterase Activity During Burn- and Polytrauma
- ClinicalTrials.gov ID
- NCT02691650
- Acronym / sponsor ID
- POCCET / Burns and Trauma POC ChE Study
- Keywords
- serum cholinesterase, plasma cholinesterase, pseudocholinesterase, systemic inflammation, SIRS, polytrauma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- University Hospital HeidelbergUniversity, hospital or other
- Collaborators
- BG Trauma Center Ludwigshafen
- Study start
- Feb 2016
- Primary completion
- Feb 2018 (actual)
- Study completion
- Oct 2018 (actual)
- First posted
- 25 Feb 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.
Goal of this study is to measure serum cholinesterase activity in patients with traumatic and/or burns injury admitted to the emergency room by using point-of- care-test system (POCT). Serum cholinesterase activity, measured using POCT system, might play an important role in the early diagnosis and prediction of patient outcome in trauma-induced systemic inflammation.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| polytrauma patients | – | –Patients with severe traumatic injury, admitted to the emergency unit. Serum cholinesterase activity measurement using 10 µl whole blood, otherwise obtained through routine blood gas analysis upon arrival to the hospital. |
| burns patients | – | –Patients with burns trauma, admitted to the emergency unit. Serum cholinesterase activity measurement using 10 µl whole blood, otherwise obtained through routine blood gas analysis upon arrival to the hospital. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to the emergency unit of the trauma and burns center
Key inclusion criteria (5 listed)
- signed written consent
- 18 years and older
- severe trauma (ISS > 15)
- burns injury (2. degree more than 15% body surface or 3 degree more than 10% body surface)
- SIRS
Key exclusion criteria (2 listed)
- not fulfilling the inclusion criteria
- failure to adhere
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Early diagnosis of the systemic inflammation by using the serum cholinesterase activity measurement
Time frame: after completed patient recruitment, 1 year
By using Point-of-care measurement of serum cholinesterase activity (U/l) and by observing a change in the enzyme activity over time (reduction of serum cholinesterase activity within the first 6 hours after traumatic injury) would allow an additional tool in early diagnosis and treatment of systemic inflammation.
1 secondary outcome
correlation of the cholinesterase activity and the trauma/disease severity scores
Time frame: after completed patient recruitment, 1 year
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 16 Apr 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.
Stefan Hofer, Prof. Dr. principal investigator
University Hospital Heidelberg
Stefan Kleinschmidt, Prof. Dr. study chair
Department of Anaesthesia, Intensive Care Medicine and Pain Therapy, BG Trauma Centre Ludwigshafen, Ludwigshafen, Germany
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 Trauma and Burns, run by University Hospital Heidelberg 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 5 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 16 Apr 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?
Early diagnosis of the systemic inflammation by using the serum cholinesterase activity measurement (time frame: after completed patient recruitment, 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 16 Apr 2019.