Severely Burned Patients Clinical Trial
Official title:
HLA Sensitization in Severely Burned Patients
| NCT number | NCT02537821 |
| Other study ID # | PKSF-01-2014 |
| Secondary ID | |
| Status | Recruiting |
| Phase | N/A |
| First received | July 1, 2015 |
| Last updated | November 20, 2017 |
| Start date | June 2015 |
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.
| Status | Recruiting |
| Enrollment | 50 |
| Est. completion date | |
| Est. primary completion date | December 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - severely burned patients in need for hospitalization Exclusion Criteria: - hematologic diseases - Cancer |
| Country | Name | City | State |
|---|---|---|---|
| Switzerland | University Hospital Zurich | Zurich |
| Lead Sponsor | Collaborator |
|---|---|
| University of Zurich |
Switzerland,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 %. | Change from Baseline (admission) in HLA antibody count at 2 weeks, 4 weeks, 3 months and 6 months |