This study is NOT currently recruiting participants.
Number
08-I-0184
Sponsoring Institute
National Institute of Allergy and Infectious Diseases (NIAID)
Recruitment Detail
Type: No longer recruiting/follow-up only Gender: Male & Female Min Age: 13 Years Max Age: 75 Years
Referral Letter Required
Yes
Population Exclusion(s)
None
Keywords
Antigen Specific; Mast Cell; Tryptase; Bone Marrow; Hives; Natural History
Recruitment Keyword(s)
Anaphylaxis
Condition(s)
Idiopathic Anaphylaxis; Drug Anaphylaxis; Venom Anaphylaxis; Food Anaphylaxis
Investigational Drug(s)
Investigational Device(s)
Intervention(s)
Supporting Site
National Institute of Allergy and Infectious Diseases
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.
--Back to Top--
INCLUSION CRITERIA: -Subjects must be at least 13 years of age and no older than 75 years of age. -Subjects with IA must have a diagnosis of anaphylaxis occurring in the absence of an identifiable provoking agent or stimulus by a referral provider. Patient may carry both the diagnosis of 1A and the diagnosis of SA. -Subjects with SA must have a history of a severe reaction to a venom, food or, drug confirmed when possible by relevant skin testing, challenge testing, RAST, immunoCAP, or ELISA. within the past 36 months. -Subject must have had a doctor s office or ER visit, or a hospitalization for evaluation for anaphylaxis and have a history of involvement of the skin and/or mucosal tissue (e.g., flushing, itching, hives, angioedema, tongue swelling), and at least one of the following: -- Respiratory compromise (e.g., dyspnea, hoarseness-laryngeal edema, wheeze-bronchospasm, stridor, reduced peak expiratory flow, hypoxemia). -- Gastrointestinal symptoms of vomiting and/or diarrhea -- Reduced blood pressure and/or associated symptoms of end-organ dysfunction (as evidenced hypotonia, hypoxia, collapse, syncope or incontinence). -Letter of referral from prospective study participant's referring physician, or similar primary provider - with copies of available medical evaluation and laboratory studies -Able and willing to consider a bone marrow biopsy and aspirate EXCLUSION CRITERIA: -Presence of conditions which in the judgment of the investigator or the referring physician may put the subject at undue risk for travel (including frequent episodes of IA not preventable by pre-medication, acute infection, severe thrombocytopenia [minimum platelet count of 30,000], or significant cardiovascular disease) -Any condition that - in the view of the principal investigator would make the subject unsuitable for enrollment in this study -Inability to provide informed consent - Pregnancy
-Subjects must be at least 13 years of age and no older than 75 years of age.
-Subjects with IA must have a diagnosis of anaphylaxis occurring in the absence of an identifiable provoking agent or stimulus by a referral provider. Patient may carry both the diagnosis of 1A and the diagnosis of SA.
-Subjects with SA must have a history of a severe reaction to a venom, food or, drug confirmed when possible by relevant skin testing, challenge testing, RAST, immunoCAP, or ELISA. within the past 36 months.
-Subject must have had a doctor s office or ER visit, or a hospitalization for evaluation for anaphylaxis and have a history of involvement of the skin and/or mucosal tissue (e.g., flushing, itching, hives, angioedema, tongue swelling), and at least one of the following:
-- Respiratory compromise (e.g., dyspnea, hoarseness-laryngeal edema, wheeze-bronchospasm, stridor, reduced peak expiratory flow, hypoxemia).
-- Gastrointestinal symptoms of vomiting and/or diarrhea
-- Reduced blood pressure and/or associated symptoms of end-organ dysfunction (as evidenced hypotonia, hypoxia, collapse, syncope or incontinence).
-Letter of referral from prospective study participant's referring physician, or similar primary provider - with copies of available medical evaluation and laboratory studies
-Able and willing to consider a bone marrow biopsy and aspirate
EXCLUSION CRITERIA:
-Presence of conditions which in the judgment of the investigator or the referring physician may put the subject at undue risk for travel (including frequent episodes of IA not preventable by pre-medication, acute infection, severe thrombocytopenia [minimum platelet count of 30,000], or significant cardiovascular disease)
-Any condition that - in the view of the principal investigator would make the subject unsuitable for enrollment in this study
-Inability to provide informed consent
- Pregnancy
Principal Investigator
Referral Contact
For more information: