An observational study in Sickle Cell Disease and Acute Chest Syndrome, sponsored by Virginia Commonwealth University. Completed at 1 site in United States. Open to participants aged 7 Years to 30 Years. Per ClinicalTrials.gov, last updated 2018-09-26.
Sponsored by Virginia Commonwealth University · Observational
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Among 20 studies in Acute Chest Syndrome with a site in United States — 3 open to participants now, 3 under way, none of them phase 3. Acute Chest Syndrome · United States.
Among the 20 studies in Acute Chest Syndrome with a site in United States, this one is one of 3 that started in 2018, is one of 3 observational ones, and was the 14th registered.
40 studies on the registry are indexed under Acute Chest Syndrome; 11 are open to participants now.
Browse Acute Chest Syndrome studies →3 of the 20 studies in Acute Chest Syndrome with a site in United States are open now. Recruiting first, the newest first:
CSL Behring · Sites in United States, Turkey, United Kingdom
Ages 12+
University of Chicago · Sites in United States
Ages 12+
National Heart, Lung, and Blood Institute (NHLBI) · Sites in United States
Ages 2–90
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 7 Acute Chest Syndrome studies recruiting now, 5 set no upper age limit and 1 stops at 75 or younger; 5 take children under 18; none take healthy volunteers.
This study: 7 Years to 30 Years · all sexes · no healthy volunteers.
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20 studies; the count open now beside each. This study's row is marked.
First in 2001; this study’s year is marked. 3 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 6 is below the median of 133 across 10 observational studies indexed under Acute Chest Syndrome.
Median enrollment 36 across the 17 interventional studies, 65 across the 3 observational. Of the 16 that completed or were terminated, 8 (50%) have results posted.
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2 of 20 have an industry lead sponsor. The 10 most frequent:
Virginia Commonwealth University is the lead sponsor of 648 studies on the registry; 80 are open to participants now.
Of its 90 completed or terminated interventional studies of FDA-regulated products, 64 (71%) have results posted.
Virginia Commonwealth University has 1 study filed under Acute Chest Syndrome — fewer than ten, so there is no comparison to draw.
2 of the studies in Acute Chest Syndrome with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05640271University of ChicagoTocilizumab for Acute Chest Syndrome | 2026-12 |
| NCT06699849CSL BehringSafety, Efficacy, and Pharmacokinetics of CSL889 in Adults and Adolescents With Sickle Cell Disease During Vaso-Occlusive Crisis | 2027-10-22 |
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Among the 20 studies in Acute Chest Syndrome with a site in United States, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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.
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.
40 studies on the registry are indexed under Acute Chest Syndrome; 11 are open to participants now.
This study's enrollment of 6 is below the median of 133 across 10 observational studies indexed under Acute Chest Syndrome.
Browse Acute Chest Syndrome studies →Virginia Commonwealth University is the lead sponsor of 648 studies on the registry; 80 are open to participants now.
Of its 90 completed or terminated interventional studies of FDA-regulated products, 64 (71%) have results posted.
Compared within Acute Chest Syndrome, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Anemia, Sickle Cell. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Sickle cell patients with acute chest syndrome
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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:
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
Serial EBC samples will be collected within 48 hours of acute chest syndrome (ACS) diagnosis and at 2 week follow up
Serial plasma samples will be collected within 48 hours of acute chest syndrome (ACS) diagnosis and at 2 week follow up
sPLA2 Measurement in EBC during ACS
sPLA2 level in EBC at Time point 1 (during acute ACS episode) as measured by ELISA
Time frame: 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 frame: Time point 1 to Time point 2 (at 2 week follow-up)
sPLA2 levels in EBC versus Plasma
Difference in sPLA2 levels from EBC compared with Plasma during Time point 1 (during acute illness)
Time frame: Time point 1 (within either 48 hours of admission or time of diagnosis of ACS, if not present on admission)]
Ran from Jan 2018 to primary completion in Jun 2018, 4 months.
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This study is completed, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.
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