sPLA2 in EBC During Acute Chest Syndrome

NCT03250585 | Completed

• 1 other identifier: HM20010698
• Study Type: observational
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Sickle Cell Disease; Acute Chest Syndrome

Keywords

acute chest syndrome; secretory phospholipases A2; exhaled breath condensate; sickle cell disease

Outcome Measures

Primary Outcomes (2)

• sPLA2 Measurement in EBC during ACS

  sPLA2 level in EBC at Time point 1 (during acute ACS episode) as measured by ELISA

  Time point 1 (within either 48 hours of admission or time of diagnosis of ACS, if not present on admission)

• sPLA2 Levels in EBC during ACS versus Steady-State

  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).

  Time point 1 to Time point 2 (at 2 week follow-up)

Secondary Outcomes (1)

• sPLA2 levels in EBC versus Plasma

  Time point 1 (within either 48 hours of admission or time of diagnosis of ACS, if not present on admission)]

Study Arms (1)

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); Diagnostic Test: Plasma Sample

Interventions

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

Sickle Cell Patients with Acute Chest Syndrome

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

Sickle Cell Patients with Acute Chest Syndrome

Eligibility Criteria

• Age: 7 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Sickle cell patients with acute chest syndrome

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Virginia Commonwealth University: lead

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Anemia, Sickle Cell; Acute Chest Syndrome

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Officials

• Davis D Michael, PhD

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2017
• First Posted: August 15, 2017
• Study Start: January 19, 2018
• Primary Completion: June 14, 2018
• Study Completion: June 14, 2018
• Last Updated: September 26, 2018

Record last verified: 2018-09

Locations

US (1)