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OpenTrials
Completed

NCT Number: NCT02833675

Determination of Specific Biomarkers of Angioneurotic Crisis

Diagnosis of angioedema (AE) is difficult especially in emergency room. Two forms should be evoked: histaminic AE (allergic or not, which represent 95% of cases) and bradykinic AE (hereditary or acquired deficiency, with or without C1 Inhibitor) rarer but with more severe prognosis. The distinction is based on clinical features (spontaneous crisis duration, presence of concomitant hives, atopic history...). Sometimes it could be difficult to make the difference. Nowadays, there is no biological marker of the crisis. The search for biomarkers could improve the diagnostic and therapeutic management of AE. Previous work has identified targets: D-dimer, C4, and VE-cadherin. We wanted to know the sensitivity and specificity of these markers.

We conducted a prospective study evaluating the D-dimer assays, complement and VE-cadherin during an episode of AE. Three groups of patients were tested: bradykinic AE (peripheral or abdominal attacks), histaminic AE, and abdominal pain (non-bradykinic and non-histaminic etiology) at the time (day 0) and at distance from the crisis (D7).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Grenoble university hospital

Grenoble, 38043, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Histaminergic or bradykinin angioedema
  • Abdominal pain

Exclusion criteria

  • children < 18 years

Treatment and study plan

Primary outcomes

  1. VE CADHERIN SENSITIVITY AND SPECIFICITY

    Time frame: 7 DAYS

Secondary outcomes

  1. D-DIMERS SENSITIVITY AND SPECIFICITY

    Time frame: 7 DAYS

  2. C1INHIBITOR

    Time frame: 7 DAYS

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Registry information

Acronym: BIOBRAD

Important dates

Study start
2012
Primary completion
2017
Study completion
2017
First posted
Jul 14, 2016
Registry last updated
Sep 29, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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