Ignite Creation Date:
2024-05-05 @ 7:39 PM
Last Modification Date:
2024-10-26 @ 9:52 AM
Study NCT ID:
NCT00719719
Status:
RECRUITING
Last Update Posted:
2024-07-15
First Post:
2008-07-19
Brief Title:
Cause of Unexplained Anaphylaxis
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Studies in the Pathogenesis of Anaphylaxis
Status:
RECRUITING
Status Verified Date:
2024-10-01
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:
This study will explore the possible cause of unexplained or idiopathic anaphylaxis Anaphylaxis is a rapid life-threatening severe reaction that occurs suddenly after contact with an allergy-causing substance usually a particular food drug or stinging insect The allergen triggers mast cells to release several substances including histamine Histamine is responsible for many of the symptoms that may occur such as flushing hives swelling of the palms and soles or tongue and vocal cords nasal congestion itching and tearing of the eyes shortness of breath and wheezing stomach pain vomiting low blood pressure loss of consciousness shock and rarely death Severe episodes of anaphylaxis are treated with epinephrine adrenaline followed by oral antihistamines and steroids In more than half of cases of anaphylaxis a clear cause is not identified These cases are called idiopathic anaphylaxis There is no cure or long-term preventive therapy for patients with recurrent episodes of idiopathic anaphylaxis
People between 13 and 70 years of age who have idiopathic anaphylaxis or have anaphylaxis that is caused by specific allergens such as food venom or drugs and medications may be eligible for this study
Participants are evaluated at the NIH Clinical Center with the following tests and procedures
Medical history physical examination and blood tests
Bone marrow biopsy For this test the skin over the hipbone and the outer surface of the hipbone itself are numbed with local anesthesia Then a needle is inserted into the hipbone and a small amount of bone marrow is drawn into a syringe The needle also cuts a small core of bone marrow which is removed for analysis
Other tests that may be needed for evaluation of the patient s condition
People between 13 and 70 years of age who have idiopathic anaphylaxis or have anaphylaxis that is caused by specific allergens such as food venom or drugs and medications may be eligible for this study
Participants are evaluated at the NIH Clinical Center with the following tests and procedures
Medical history physical examination and blood tests
Bone marrow biopsy For this test the skin over the hipbone and the outer surface of the hipbone itself are numbed with local anesthesia Then a needle is inserted into the hipbone and a small amount of bone marrow is drawn into a syringe The needle also cuts a small core of bone marrow which is removed for analysis
Other tests that may be needed for evaluation of the patient s condition
Detailed Description:
Anaphylaxis is a severe life-threatening systemic hypersensitivity reaction caused by release of mediators from mast cells and basophils characterized by cutaneous respiratory cardiovascular or gastrointestinal signs and symptoms The most common specific causes of anaphylaxis are venom drug and food allergies ie patients with specific anaphylaxis SA When a causative factor is not identified in patients are said to have idiopathic anaphylaxis IA Evidence of an underlying clonal mast cell disease has been found in about I in 15 patients with IA in our studies and in about 1 in 12 patientswith venom induced anaphylaxis in a European study 1 The number of patients with anaphylaxis to foods or drugs who have a clonal mast cell disease is not known and the number or patients with venom induced anaphylaxis in the US with clonal mast cell disease has not been determined Thus a more complete understanding of the prevalence of clonal mast cell disease in those experiencing anaphylaxis and a better understanding of the associated laboratory abnormalities and disrupted molecular signaling pathways will have a substantial impact of the clinical management of patients who present with anaphylaxis
This protocol thus focuses on determining the prevalence of clonal mast cell disorders in patients with the anaphylaxis whether unexplained IA or associated with exposure to an antigen SA and attendant changes in the mast cell compartment Subjects 13 - 75 years old will be evaluated to correlate both clinical and laboratory features of anaphylaxis and to identify genetic and molecular pathways that may predispose to these events Subjects may undergo bone marrow examination in addition to supporting laboratory studies when indicated We plan to enroll up to 200 subjects
This protocol thus focuses on determining the prevalence of clonal mast cell disorders in patients with the anaphylaxis whether unexplained IA or associated with exposure to an antigen SA and attendant changes in the mast cell compartment Subjects 13 - 75 years old will be evaluated to correlate both clinical and laboratory features of anaphylaxis and to identify genetic and molecular pathways that may predispose to these events Subjects may undergo bone marrow examination in addition to supporting laboratory studies when indicated We plan to enroll up to 200 subjects
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 08-I-0184 | None | None | None |