Sickle Cell DiseaseNCT03250585
sPLA2 in EBC During Acute Chest Syndrome
An observational study of Sickle Cell Disease and Acute Chest Syndrome, run by Virginia Commonwealth University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 30 years
- Conditions the study is for
- Sickle Cell Disease, Acute Chest Syndrome
- What is being tested?
- Exhaled Breath Condensate (EBC) and Plasma Sample
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jan 2018to 14 Jun 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Sickle cell patients with acute chest syndrome
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University
Richmond, Virginia, 23298
About this study
Official title: Secretory Phospholipases A2 in Exhaled Breath Condensate From Sickle Cell Patients With Acute Chest Syndrome: A Feasibility Study
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.
Read the 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
- Sickle Cell Disease, Acute Chest Syndrome
- Being tested
- Exhaled Breath Condensate (EBC), Plasma Sample
- Keywords
- acute chest syndrome, secretory phospholipases A2, exhaled breath condensate, sickle cell disease
- Medical subject headings
- Anemia, Sickle Cell, Acute Chest Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 SampleDiagnostic test
Serial plasma samples will be collected within 48 hours of acute chest syndrome (ACS) diagnosis and at 2 week follow up
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Exhaled Breath Condensate (EBC); Diagnostic Test: Plasma Sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
sPLA2 Measurement in EBC during ACS
sPLA2 level in EBC at Time point 1 (during acute ACS episode) as measured by ELISA
Measured: 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).
Measured: Time point 1 to Time point 2 (at 2 week follow-up)
Secondary outcomes (1)
sPLA2 levels in EBC versus Plasma
Difference in sPLA2 levels from EBC compared with Plasma during Time point 1 (during acute illness)
Measured: Time point 1 (within either 48 hours of admission or time of diagnosis of ACS, if not present on admission)]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2017
- Study start19 Jan 2018
- Primary completion14 Jun 2018
- Study completion14 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sickle Cell DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Davis D Michael, PhD, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03250585
- Sponsor's protocol ID
- HM20010698
- Status last verified
- Sep 2018
- First submitted
- 10 Aug 2017
- Last updated
- 26 Sep 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Secretory Phospholipases A2 in Exhaled Breath Condensate From Sickle Cell Patients With Acute Chest Syndrome: A Feasibility Study
- ClinicalTrials.gov ID
- NCT03250585
- Acronym / sponsor ID
- HM20010698
- Conditions
- Sickle Cell Disease, Acute Chest Syndrome
- Keywords
- acute chest syndrome, secretory phospholipases A2, exhaled breath condensate, sickle cell disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Study start
- 19 Jan 2018 (actual)
- Primary completion
- 14 Jun 2018 (actual)
- Study completion
- 14 Jun 2018 (actual)
- First posted
- 15 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sickle Cell Patients with Acute Chest Syndrome | – | Diagnostic Test: Exhaled Breath Condensate (EBC), Diagnostic Test: Plasma SampleSickle 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. |
Who may qualify
- Ages
- 7 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Sickle cell patients with acute chest syndrome
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Sickle Cell Patients with Acute Chest Syndrome |
| Plasma SampleSerial plasma samples will be collected within 48 hours of acute chest syndrome (ACS) diagnosis and at 2 week follow up | Diagnostic test | Sickle Cell Patients with Acute Chest Syndrome |
Primary outcome
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
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).
1 secondary outcome
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)]
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Davis D Michael, PhD principal investigator
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sickle Cell Disease and Acute Chest Syndrome, run by Virginia Commonwealth University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2018.