sPLA2 in EBC During Acute Chest Syndrome

Completed

Conditions studied: Sickle Cell Disease, Acute Chest Syndrome

In brief

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.

Key facts

Study ID

NCT03250585

Run by

Virginia Commonwealth University

People needed

6

Starts

2018-01-19

Expected to finish

2018-06-14

Last updated by the study team

2018-09-26

Who can join

Age: 7 and older, up to 30. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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)

Where it is running

• Virginia Commonwealth University — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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