Sickle Cell Disease Clinical Trial
Official title:
Secretory Phospholipases A2 in Exhaled Breath Condensate From Sickle Cell Patients With Acute Chest Syndrome: A Feasibility Study
NCT number | NCT03250585 |
Other study ID # | HM20010698 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | January 19, 2018 |
Est. completion date | June 14, 2018 |
Verified date | September 2018 |
Source | Virginia Commonwealth University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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 condensate (EBC), which is collected easily and non-invasively. The investigators hypothesize that sPLA2 will be measurable in EBC samples from sickle cell patients with acute chest syndrome.
Status | Completed |
Enrollment | 6 |
Est. completion date | June 14, 2018 |
Est. primary completion date | June 14, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 7 Years to 30 Years |
Eligibility |
Inclusion Criteria: 1. Diagnosis of sickle cell anemia (the most severe types of sickle cell disease) as demonstrated by one of the following genotypes: HbSS, HbSĂ0 2. Age = 7 and < 40 years 3. Diagnosis of ACS as defined below 4. 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 Criteria: 1. Blood product transfusion in the previous 3 months (due to potential alterations in biomarkers, including sPLA2) 2. Chronic inflammatory conditions other than sickle cell (due to elevation from baseline of sPLA2 in inflammatory conditions) 3. Physical inability to correctly breathe into the mouthpiece for the required amount of time without compromising respiratory status 4. Intubated patients (though EBC can be measured in intubated patients, we will not include this subpopulation for the purpose of this study) 5. Pregnancy (due to the hematologic and respiratory changes that physiologically occur during gestation) |
Country | Name | City | State |
---|---|---|---|
United States | Virginia Commonwealth University | Richmond | Virginia |
Lead Sponsor | Collaborator |
---|---|
Virginia Commonwealth University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | sPLA2 Measurement in EBC during ACS | sPLA2 level in EBC at Time point 1 (during acute ACS episode) as measured by ELISA | Time point 1 (within either 48 hours of admission or time of diagnosis of ACS, if not present on admission) | |
Primary | sPLA2 Levels in EBC during ACS versus Steady-State | Comparison of sPLA2 levels in EBC from Time point 1 (during acute illness) and Time Point 2 (return to baseline status at 2 week follow up). | Time point 1 to Time point 2 (at 2 week follow-up) | |
Secondary | sPLA2 levels in EBC versus Plasma | Difference in sPLA2 levels from EBC compared with Plasma during Time point 1 (during acute illness) | Time point 1 (within either 48 hours of admission or time of diagnosis of ACS, if not present on admission)] |
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