sPLA2 in EBC During Acute Chest Syndrome
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|ClinicalTrials.gov Identifier: NCT03250585|
Recruitment Status : Completed
First Posted : August 15, 2017
Last Update Posted : September 26, 2018
|Condition or disease||Intervention/treatment|
|Sickle Cell Disease Acute Chest Syndrome||Diagnostic Test: Exhaled Breath Condensate (EBC) Diagnostic Test: Plasma Sample|
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 people with sickle cell disease during an attack of acute chest syndrome. sPLA2 levels have been reported to be much higher in persons with acute chest syndrome and might be useful to diagnose and to evaluate the effects of therapy.
Serial monitoring of plasma sPLA2 levels might lead to earlier or more accurate detection of acute chest syndrome and monitoring of its progression or improvement in patients with sickle cell disease. However, there is a significant inherent risk of frequent blood collection further dropping the blood (hemoglobin) levels of an already anemic patient. If sPLA2 can be measured in exhaled breath condensate, this non-invasive and well-tolerated sample collection might allow for serial monitoring of the enzyme without depleting the patient's already diminished blood supply.
|Study Type :||Observational|
|Actual Enrollment :||6 participants|
|Official Title:||Secretory Phospholipases A2 in Exhaled Breath Condensate From Sickle Cell Patients With Acute Chest Syndrome: A Feasibility Study|
|Actual Study Start Date :||January 19, 2018|
|Actual Primary Completion Date :||June 14, 2018|
|Actual Study Completion Date :||June 14, 2018|
Sickle Cell Patients with Acute Chest Syndrome
Sickle cell patients with active acute chest syndrome (ACS) from which samples of EBC and plasma will be collected during acute illness within 48 hours of admission with or diagnosis of ACS (Time point 1) in 3 sessions each 1 hour apart (Time point 1a, 1b, and 1c), and 2 weeks after discharge when have returned to steady-state (Time point 2). Time point 2 samples will serve as control (baseline) samples.
Diagnostic Test: Exhaled Breath Condensate (EBC)
Serial EBC samples will be collected within 48 hours of acute chest syndrome (ACS) diagnosis and at 2 week follow up
Diagnostic Test: Plasma Sample
Serial plasma samples will be collected within 48 hours of acute chest syndrome (ACS) diagnosis and at 2 week follow up
- sPLA2 Measurement in EBC during ACS [ Time Frame: Time point 1 (within either 48 hours of admission or time of diagnosis of ACS, if not present on admission) ]sPLA2 level in EBC at Time point 1 (during acute ACS episode) as measured by ELISA
- sPLA2 Levels in EBC during ACS versus Steady-State [ Time Frame: Time point 1 to Time point 2 (at 2 week follow-up) ]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).
- sPLA2 levels in EBC versus Plasma [ Time Frame: Time point 1 (within either 48 hours of admission or time of diagnosis of ACS, if not present on admission)] ]Difference in sPLA2 levels from EBC compared with Plasma during Time point 1 (during acute illness)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03250585
|United States, Virginia|
|Virginia Commonwealth University|
|Richmond, Virginia, United States, 23298|
|Principal Investigator:||Davis D Michael, PhD||Virginia Commonwealth University|