Severely Burned PatientsNCT02537821
HLA Sensitization in Severely Burned Patients
An observational study of Severely Burned Patients, run by University of Zurich at 1 site in Switzerland.
Trial summary
Primary goal of this study is the analysis of HLA (Human leucocyte antigen) formation in severly burned patients. Potential HLA triggers in the treatment of severely burned patients are blood products, assist devices or temporary allogeneic skin. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severely Burned Patients
- How many people
- 50 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jun 2015to Dec 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: Severely burned patients
Who may be able to join
- severely burned patients in need for hospitalization
Who cannot join
- hematologic diseases
- Cancer
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
University Hospital Zurich
Zurich, 8091
Jan Plock, M.D.
About this study
Primary goal of this study is the analysis of HLA (Human leucocyte antigen) formation in severly burned patients. Potential HLA triggers in the treatment of severely burned patients are blood products, assist devices or temporary allogeneic skin. Besides that, inflammatory markers, such as WBC (white blood cell count), CRP (C-reactive protein), PCT (Procalcitonin) and two novel biomarkers (PSP (pancreatic stone protein), ST2) are to be investigated in severely burned patients.
- Conditions
- Severely Burned Patients
What is being measured
The primary outcome is the main question the study is designed to answer.
HLA antibody formation (HLA Sensitization) (Unit: PRA in %)
The degree of sensitization is reported as the percentage of CDC (Complement dependent Cytotoxicity) Panel Reactive Antibody (PRA). Unit is %.
Measured: Change from Baseline (admission) in HLA antibody count at 2 weeks, 4 weeks, 3 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2015 (estimated)
- Study startJun 2015
- Primary completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severely Burned PatientsStudies 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jan Plock, M.D., Principal investigator, Raemistrasse 100, 8091
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02537821
- Sponsor's protocol ID
- PKSF-01-2014
- Status last verified
- Nov 2017
- First submitted
- 1 Jul 2015
- Last updated
- 21 Nov 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HLA Sensitization in Severely Burned Patients
- ClinicalTrials.gov ID
- NCT02537821
- Acronym / sponsor ID
- PKSF-01-2014
- Conditions
- Severely Burned Patients
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Dec 2018 (estimated)
- First posted
- 2 Sep 2015 (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.
Primary goal of this study is the analysis of HLA (Human leucocyte antigen) formation in severly burned patients. Potential HLA triggers in the treatment of severely burned patients are blood products, assist devices or temporary allogeneic skin. Besides that, inflammatory markers, such as WBC (white blood cell count), CRP (C-reactive protein), PCT (Procalcitonin) and two novel biomarkers (PSP (pancreatic stone protein), ST2) are to be investigated in severely burned patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Severely burned patients
Key inclusion criteria (1 listed)
- severely burned patients in need for hospitalization
Key exclusion criteria (2 listed)
- hematologic diseases
- Cancer
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
HLA antibody formation (HLA Sensitization) (Unit: PRA in %)
Time frame: Change from Baseline (admission) in HLA antibody count at 2 weeks, 4 weeks, 3 months and 6 months
The degree of sensitization is reported as the percentage of CDC (Complement dependent Cytotoxicity) Panel Reactive Antibody (PRA). Unit is %.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2017.
Related trials for Severely Burned Patients
RecruitingObservational study
Presepsin Diagnostic Performance in Severe Burn Sepsis
Sepsis, Burns
Not yet recruitingObservational study
ASV and Targeted Fluid Resuscitation in Severe Burns
Burn, War-Related Injuries
Not yet recruitingObservational study
The Use of Cultured (Dermal) Epithelial Autografts in Severely Burned Patients
Burn Degree Second, Burn Degree Third
Active, not recruiting
STAT: Standard Therapy Plus Active Therapy
Burn Injury, Physical Injury
Active, not recruiting
Microneedling for Burn Hypertrophic Scars
Burn Scar
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.
Jan Plock, M.D. principal investigator
Raemistrasse 100, 8091
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 Severely Burned Patients, run by University of Zurich at 1 site in Switzerland.
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: status not confirmed, as of the sponsor's last update on 21 Nov 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 Switzerland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jan Plock, M.D. (0041 (0)44 2551111, jan.plock@usz.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HLA antibody formation (HLA Sensitization) (Unit: PRA in %) (time frame: Change from Baseline (admission) in HLA antibody count at 2 weeks, 4 weeks, 3 months and 6 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 21 Nov 2017.