Recruiting

Observational Study

Sponsor:

Brigham and Women's Hospital

Code:

NCT01326741

Conditions

Anaphylaxis

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

Anaphylaxis is a serious allergic reaction that develops rapidly and can cause death. Some patients experience anaphylaxis is association with exercise, a disorder called exercise-induced anaphylaxis. A subset of patients with unexplained anaphylaxis, especially those with hypotension during the anaphylactic episodes, have been shown to have abnormal, clonal populations of a certain cell type, mast cells, in the bone marrow. This has been described in at least one patient with exercise-induced anaphylaxis. The investigators would like review the findings in a group of patients with exercise-induced anaphylaxis who have undergone evaluation for the presence of abnormal, clonal mast cells.

Conditions

Anaphylaxis

Study ID

NCT01326741

Start date

Mar, 2011

Status verified date

Mar, 2011

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Anaphylaxis in association with exercise on at least two occasions
  • During anaphylactic reaction, the subject must have experienced one or more of the following: flushing, hypotension, lack of urticaria

Exclusion Criteria:

  • Pregnancy

Study Design

Enrollment

10 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Number of participants with presence of clonal abnormalities in the bone marrow specimen [ Time Frame: Baseline ]
  • Number of participants with presence of clonal abnormalities in the bone marrow specimen [ Time Frame: Baseline ]

Central Contacts and Locations

Locations

Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Principal Investigator:

Cem Akin, MD, PhD

More Information

Sponsor

Brigham and Women's Hospital

Last update posted

Mar 31, 2011

Last verified

Mar, 2011

Keywords

  • clonal mast cell disorder
  • exercise-induced anaphylaxis
  • hypotension

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Brigham and Women's Hospital on 2011-03-31.