Viewing Study NCT01619605


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Study NCT ID: NCT01619605
Status: COMPLETED
Last Update Posted: 2012-06-15
First Post: 2012-06-12
Is NOT Gene Therapy: False
Has Adverse Events: False

Brief Title: The Utility of Serum Tryptase in the Diagnosis of Shrimp- Induced Anaphylaxis
Sponsor: Mahidol University
Organization:

Study Overview

Official Title: The Utility of Serum Tryptase in the Diagnosis of Shrimp- Induced Anaphylaxis
Status: COMPLETED
Status Verified Date: 2012-06
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: The purpose of this study was to investigate the utility of serum tryptase for the confirmation of shrimp-induced anaphylaxis.
Detailed Description: The diagnosis of anaphylaxis is based primarily on the clinical history. In some circumstances, inability to confirm the clinical diagnosis such as present with unusual manifestation, or when skin signs are absent likely contributes to underrecognition and undertreatment of the disease.

Currently, products of mast cell activation (histamine and total tryptase) can be measure in clinical laboratories as markers of acute anaphylaxis events, however these tests have clinically relevant limitations.

Therefore, development of laboratory tests with improved sensitivity and specificity that will support the clinical diagnosis of anaphylaxis are needed.

In addition, shrimp is the major cause of seafood anaphylaxis among Thai children.

Study Oversight

Has Oversight DMC: True
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: