Clinical Trial: Determination of Specific Biomarkers of Acute Attack of Angioedema Within Pediatric Population

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title:

Brief Summary:

In emergency room, this is crucial to diagnose an acute attack of hereditary angioedema (HAE) to quickly provide the efficient treatment. Currently, there is no specific biomarker for acute attack of bradykinin-mediated angioedema to help clinicians for patient care. However, previous works are carried out for that purpose. All the potential candidate biomarkers must be validated in prospective studies to estimate their specificity and sensitivity values, and to understand their potential utility in patient care.

The main goal of this clinical trial is to estimate the diagnostic value of VE-cadherin in pediatric population, for the differential diagnosis between HAE crisis and angioedema resulting of mast cell activation crisis (the main differential diagnosis of HAE).


Detailed Summary:
Sponsor: University Hospital, Grenoble

Current Primary Outcome: VE-cadherin level [ Time Frame: Half a day ]

For the diagnosis of acute attack of hereditary angioedema


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Dosage of VE-cadherin (vascular endothelial) [ Time Frame: Half a day ]
    Analysis of the cleaved fragments from high molecular weight kininogen
  • Dosage of Fc KHPM [ Time Frame: Half a day ]
    Analysis of the cleaved fragments from high molecular weight kininogen
  • Dosage of D-dimer [ Time Frame: Half a day ]
    Analysis of the cleaved fragments from high molecular weight kininogen
  • Dosage of Tryptase [ Time Frame: Half a day ]
    Analysis of the cleaved fragments from high molecular weight kininogen


Original Secondary Outcome: Same as current

Information By: University Hospital, Grenoble

Dates:
Date Received: July 18, 2016
Date Started: February 2016
Date Completion: December 2017
Last Updated: July 29, 2016
Last Verified: June 2016