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NCT Number: NCT03250585

sPLA2 in EBC During Acute Chest Syndrome

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.

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Key information

Conditions

Sickle Cell Disease Acute Chest Syndrome Anemia Anemia, Hemolytic Anemia, Hemolytic, Congenital Anemia, Sickle Cell Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemoglobinopathies Lung Diseases Respiration Disorders Respiratory Tract Diseases

Age range

7 year–30 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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)

Treatment and study plan

Exhaled Breath Condensate (EBC)

Diagnostic Test

Serial EBC samples will be collected within 48 hours of acute chest syndrome (ACS) diagnosis and at 2 week follow up

Plasma Sample

Diagnostic Test

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

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Virginia Commonwealth University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Aug 15, 2017
Registry last updated
Sep 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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