Ignite Creation Date:
2024-05-06 @ 10:24 AM
Last Modification Date:
2024-10-26 @ 12:29 PM
Study NCT ID:
NCT03250585
Status:
COMPLETED
Last Update Posted:
2018-09-26
First Post:
2017-08-10
Brief Title:
sPLA2 in EBC During Acute Chest Syndrome
Sponsor:
Virginia Commonwealth University
Organization:
Virginia Commonwealth University
Study Overview
Official Title:
Secretory Phospholipases A2 in Exhaled Breath Condensate From Sickle Cell Patients With Acute Chest Syndrome A Feasibility Study
Status:
COMPLETED
Status Verified Date:
2018-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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 patients already diminished blood supply
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 patients already diminished blood supply
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None