Early Diagnosis of Sickle Acute Chest Syndrome Using a Combination of Plasma Bimarkers and Chest Imaging

NCT03478917 | Completed

• 2 other identifiers: 99991806518-H-N065
• Study Type: observational
• Target: 65
• Locations: 1 country
• Sites: 1

Brief Summary

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. ...

Conditions

Sickle Cell Disease (SCD)

Keywords

Vasoocclusive Crisis (VOC); Sickle Cell Disease (SCD); Acute Chest Syndrome (ACS); Pulmonary Syndrome; Pneumonia; Natural History

Outcome Measures

Primary Outcomes (1)

• Radiological, clinical diagnosis of Acute Chest Syndrome

  CT scans can help in the early diagnosis of acute chest syndrome.

  15 days from admission

Secondary Outcomes (1)

• Hematological clinical diagnosis of acute chest syndrome

  15 days from admission

Study Arms (1)

Arm 1

Subjects previously enrolled onto protocol 05-H-0019 who were hospitalized with vasoocclusivecrisis.

Eligibility Criteria

• Age: 10 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

65 participants of the DeNOVO study enrolled at the NIH

* Patients (aged 10 years and older) presenting with vaso-occlusive crisis requiring admission that were enrolled in the DeNOVO study specifically at the NIH clinical center (n=65).We will use stored blood samples and review radiological images from these patients.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI): lead

Study Sites (1)

National Heart, Lung and Blood Institute (NHLBI)

Bethesda, Maryland, 20892, United States

Location

MeSH Terms

Conditions

Anemia, Sickle Cell; Vaso-Occlusive Crises; Acute Chest Syndrome; Pneumonia

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; Respiratory Tract Infections; Infections

Study Officials

• Arun S Shet, M.D.

  National Heart, Lung, and Blood Institute (NHLBI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2018
• First Posted: March 27, 2018
• Study Start: February 27, 2018
• Primary Completion: December 31, 2019
• Study Completion: October 27, 2021
• Last Updated: July 17, 2023

Record last verified: 2023-07-13

Locations

US (1)