HLA Sensitization in Severely Burned Patients

November 20, 2017 updated by: University of Zurich
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 Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Jan Plock, M.D.
  • Phone Number: 0041 (0)44 2551111
  • Email: jan.plock@usz.ch

Study Locations

  • Switzerland
      • Zurich, Switzerland, 8091
        • Recruiting
        • University Hospital Zurich
        • Contact:
          • Jan Plock, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Severely burned patients

Description

Inclusion Criteria:

  • severely burned patients in need for hospitalization

Exclusion Criteria:

  • hematologic diseases
  • Cancer

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 %.
Change from Baseline (admission) in HLA antibody count at 2 weeks, 4 weeks, 3 months and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Zurich

Investigators

  • Principal Investigator: Jan Plock, M.D., Raemistrasse 100, 8091

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

July 1, 2015

First Submitted That Met QC Criteria

August 28, 2015

First Posted (Estimate)

September 2, 2015

Study Record Updates

Last Update Posted (Actual)

November 21, 2017

Last Update Submitted That Met QC Criteria

November 20, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PKSF-01-2014

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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