Status:
COMPLETED
sPLA2 in EBC During Acute Chest Syndrome
Lead Sponsor:
Virginia Commonwealth University
Conditions:
Sickle Cell Disease
Acute Chest Syndrome
Eligibility:
All Genders
7-30 years
Brief Summary
Secretory phosholipases A2 (sPLA2) are significantly elevated in the plasma of sickle cell disease patients with acute chest syndrome (ACS), and similar enzymes have been measured in exhaled breath co...
Detailed Description
The purpose of this research study is to test the ease and effectiveness of collecting exhaled breath condensate (liquid) to measure levels of a biomarker, secretory phospholipases A2 (sPLA2) in peopl...
Eligibility Criteria
Inclusion
- Diagnosis of sickle cell anemia (the most severe types of sickle cell disease) as demonstrated by one of the following genotypes: HbSS, HbSβ0
- Age ≥ 7 and \< 40 years
- Diagnosis of ACS as defined below
- EBC collection able to be initiated within 48 hours of diagnosis of ACS
- Definition of acute chest syndrome to be used: New radiographic pulmonary infiltrate of at least one complete lung segment in addition to 2 or more of the following symptoms: fever, chest pain, dyspnea, tachypnea, hypoxia. Given the small number of subjects in this feasibility study, we are using the more conservative definition in order to ensure samples are from patients with true ACS. This will increase the likelihood that sPLA2 levels will be high enough for measurement.
Exclusion
- Blood product transfusion in the previous 3 months (due to potential alterations in biomarkers, including sPLA2)
- Chronic inflammatory conditions other than sickle cell (due to elevation from baseline of sPLA2 in inflammatory conditions)
- Physical inability to correctly breathe into the mouthpiece for the required amount of time without compromising respiratory status
- Intubated patients (though EBC can be measured in intubated patients, we will not include this subpopulation for the purpose of this study)
- Pregnancy (due to the hematologic and respiratory changes that physiologically occur during gestation)
Key Trial Info
Start Date :
January 19 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 14 2018
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT03250585
Start Date
January 19 2018
End Date
June 14 2018
Last Update
September 26 2018
Active Locations (1)
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1
Virginia Commonwealth University
Richmond, Virginia, United States, 23298