An observational study in Sickle Cell Disease (SCD), sponsored by National Heart, Lung, and Blood Institute (NHLBI). Completed at 1 site in United States. Open to participants aged 10 Years to 85 Years. Per ClinicalTrials.gov, last updated 2023-07-17.
Sponsored by National Heart, Lung, and Blood Institute (NHLBI) · Observational
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 15th 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: 10 Years to 85 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 65 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:
National Heart, Lung, and Blood Institute (NHLBI) is the lead sponsor of 1,144 studies on the registry; 72 are open to participants now.
Of its 58 completed or terminated interventional studies of FDA-regulated products, 51 (88%) have results posted.
National Heart, Lung, and Blood Institute (NHLBI) has 3 studies 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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Background:
Painful vasoocclusive crisis (VOC) occurs in people with sickle cell disease (SCD). People with VOC have many visits to the hospital. About 10 30 percent of these people will go on to develop acute chest syndrome (ACS). ACS can cause further ill health. It can also cause death. Researchers want to find ways to diagnose ACS more quickly. To do this, they want to use stored blood samples and scans from a study (the DeNOVO trial) that was closed in 2015. They want to see if scans and samples taken of people with VOC who later developed ACS could help diagnose ACS faster. The data of people in the DeNOVO study who did not develop ACS will serve as controls.
Objectives:
To look at data from the DeNOVO trial to find a way to diagnose ACS more quickly.
Eligibility:
People 10 85 years old who took part in NHLBI Protocol number 05-H-0019 (the DeNOVO trial). The trial lasted from 2004 to 2008. The study was closed in November 2015.
Design:
Scans and intact, frozen samples from a study that was closed in 2015 will be studied. No new participants will be enrolled.
...
Painful vasoocclusive crisis (VOC) is the most frequent acute clinical manifestation of sickle cell disease (SCD), frequently necessitating emergency department visits and/or hospitalization. Approximately 10-30% of patients admitted to the hospital with a VOC will go on to develop acute chest syndrome (ACS), a complication of SCD resulting in significant morbidity and mortality. While ACS related mortality appears to be improving in the United States, the number of hospital admissions for ACS is on the rise. Unfortunately, the diagnosis of ACS is often delayed with up to 50% of cases diagnosed two to three days after an admission for VOC. The clinical diagnosis of ACS is often delayed as it mimics other respiratory diseases. Furthermore, the lack of definitive laboratory and radiological biomarkers further confounds the ability to detect rapidly progressive ACS, a phenotype accounting for considerable ACS-related mortality. Currently, a key criterion for the diagnosis of ACS is the presence of new airspace disease on a chest radiograph in a sickle cell patient with respiratory symptoms. However, the appearance of abnormalities on chest radiography (CXR) often lags behind clinical signs and diagnostic techniques such as computed tomography (CT) which tends to reveal radiologic changes much earlier than CXR. Early diagnosis and treatment of ACS improves outcomes, hence the scientific rationale to perform such studies and develop diagnostic algorithms to facilitate early detection of ACS.
In the current study proposal, we will utilize stored blood samples and review CT scans and CXRs from 65 participants of the DeNOVO trial (NHLBI protocol # 05-H-0019). This multicenter trial conducted between 2004-08 at 11 centers including the NIH, showed that among patients with SCD hospitalized with VOC, the use of inhaled nitric oxide compared with placebo did not improve time to crisis resolution. In this study, patients enrolled at the NIH study site had baseline admission research blood drawn and thoracic CT scans performed. A repeat CT scan and repeat blood work was subsequently obtained during the development of ACS. The archived data from this subset of the study cohort therefore provides an opportunity to rigorously test the hypothesis that CT scans performed early in the setting of VOC in patients going on to develop ACS would have utility in the rapid diagnosis of this condition. Furthermore, the availability of stored plasma samples from this cohort permits the study of both imaging and plasma biomarkers in a prospectively defined sample of SCD patients. Specifically, we will identify patients admitted with VOC that went on to develop ACS and study their CT scans and plasma to determine whether these biomarkers will rapidly diagnose ACS. The patients in the same study who did not develop ACS will serve as controls.
40 studies on the registry are indexed under Acute Chest Syndrome; 11 are open to participants now.
This study's enrollment of 65 is below the median of 133 across 10 observational studies indexed under Acute Chest Syndrome.
Browse Acute Chest Syndrome studies →National Heart, Lung, and Blood Institute (NHLBI) is the lead sponsor of 1,144 studies on the registry; 72 are open to participants now.
Of its 58 completed or terminated interventional studies of FDA-regulated products, 51 (88%) 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 →
65 participants of the DeNOVO study enrolled at the NIH
samples and review radiological images from these patients.
Subjects previously enrolled onto protocol 05-H-0019 who were hospitalized with vasoocclusivecrisis.
Radiological, clinical diagnosis of Acute Chest Syndrome
CT scans can help in the early diagnosis of acute chest syndrome.
Time frame: 15 days from admission
Hematological clinical diagnosis of acute chest syndrome
sPLA2 biomarker can predict acute chest syndrome
Time frame: 15 days from admission
Ran from Feb 2018 to primary completion in Dec 2019, 22 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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National Heart, Lung, and Blood Institute (NHLBI) →