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sPLA2 in EBC During Acute Chest Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03250585
Recruitment Status : Completed
First Posted : August 15, 2017
Last Update Posted : September 26, 2018
Sponsor:
Information provided by (Responsible Party):
Virginia Commonwealth University

Study Description
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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.

Condition or disease Intervention/treatment
Sickle Cell Disease Acute Chest Syndrome Diagnostic Test: Exhaled Breath Condensate (EBC) Diagnostic Test: Plasma Sample

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.

Study Design
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Study Type : Observational
Actual Enrollment : 6 participants
Observational Model: Case-Only
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. 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).


Secondary Outcome Measures :
  1. 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)


Eligibility Criteria
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Ages Eligible for Study:   7 Years to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Sickle cell patients with acute chest syndrome
Criteria

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, HbSβ0
  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)
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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United States, Virginia
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
Virginia Commonwealth University
Investigators
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Principal Investigator: Davis D Michael, PhD Virginia Commonwealth University
More Information
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Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT03250585    
Other Study ID Numbers: HM20010698
First Posted: August 15, 2017    Key Record Dates
Last Update Posted: September 26, 2018
Last Verified: September 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Virginia Commonwealth University:
acute chest syndrome
secretory phospholipases A2
exhaled breath condensate
sickle cell disease
Additional relevant MeSH terms:
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Acute Chest Syndrome
Anemia, Sickle Cell
Syndrome
Disease
Pathologic Processes
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
 Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders