Clinical Trials Directory

Trials / Completed

CompletedNCT03250585

sPLA2 in EBC During Acute Chest Syndrome

Secretory Phospholipases A2 in Exhaled Breath Condensate From Sickle Cell Patients With Acute Chest Syndrome: A Feasibility Study

Status
Completed
Phase
Study type
Observational
Enrollment
6 (actual)
Sponsor
Virginia Commonwealth University · Academic / Other
Sex
All
Age
7 Years – 30 Years
Healthy volunteers
Not accepted

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 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.

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 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.

Conditions

Interventions

TypeNameDescription
DIAGNOSTIC_TESTExhaled 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_TESTPlasma SampleSerial plasma samples will be collected within 48 hours of acute chest syndrome (ACS) diagnosis and at 2 week follow up

Timeline

Start date
2018-01-19
Primary completion
2018-06-14
Completion
2018-06-14
First posted
2017-08-15
Last updated
2018-09-26

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT03250585. Inclusion in this directory is not an endorsement.