NCT02537821

Brief 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. 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 1, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 2, 2015

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Last Updated

November 21, 2017

Status Verified

November 1, 2017

Enrollment Period

3.5 years

First QC Date

July 1, 2015

Last Update Submit

November 20, 2017

Conditions

Severely Burned Patients

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Severely burned patients

You may qualify if:

  • severely burned patients in need for hospitalization

You may not qualify if:

  • hematologic diseases
  • Cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Zurich

Zurich, 8091, Switzerland

RECRUITING

Study Officials

  • Jan Plock, M.D.

    Raemistrasse 100, 8091

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jan Plock, M.D.

CONTACT

0041 (0)44 2551111jan.plock@usz.ch

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 1, 2015

First Posted

September 2, 2015

Study Start

June 1, 2015

Primary Completion

December 1, 2018

Last Updated

November 21, 2017

Record last verified: 2017-11

Locations

CH(1)