Preventing Acute Chest Syndrome by Transfusion Feasibility Study
- Conditions
- Sickle Cell Disease
- Interventions
- Biological: Single blood transfusionBehavioral: Standard care
- Registration Number
- NCT00951808
- Lead Sponsor
- Carelon Research
- Brief Summary
Acute chest syndrome (ACS) is similar to severe pneumonia and is a common cause of hospitalizations for people with sickle cell disease (SCD). Blood transfusions are one treatment option for ACS. High levels of an enzyme called secretory phospholipase A2 (sPLA2) may be present in people before they develop ACS. This study will determine how well sPLA2 levels can predict the onset of ACS and whether identifying high sPLA2 levels allows enough time to prevent ACS with blood transfusions. Results from this study will help to determine the feasibility of conducting a larger study that would further examine the use of sPLA2 levels and blood transfusions to prevent ACS in people with SCD.
- Detailed Description
SCD is an inherited blood disorder, and symptoms include anemia, infections, organ damage, and intense episodes of pain, which are called "sickle cell crises." ACS, characterized by fever, respiratory distress, and lung tissue damage, is the second most common cause of hospitalization and the leading cause of death among people with SCD. Most people with SCD will experience at least one episode of ACS, and repeated episodes can result in progressive lung disease. ACS can appear suddenly and often requires immediate hospitalization and treatment, which can include blood transfusions. People with elevated blood levels of sPLA2 may be at risk for developing ACS, and this enzyme is often detectable before the onset of ACS symptoms. The purpose of this study is to examine the use of sPLA2 as a predictor of ACS and to determine whether subsequent blood transfusions can be administered early enough to prevent the onset of ACS in people with SCD who are at risk for ACS. Study researchers will also assess the feasibility of conducting a larger study that would further examine the effectiveness of using sPLA2 levels and blood transfusions to prevent ACS.
This study will involve two parts. In the first part of the study, participants with SCD who are admitted to the hospital with an acute sickle cell pain event will be randomly assigned to receive either a single blood transfusion or standard care for ACS and no blood transfusion. All participants will be closely monitored while in the hospital for the development of ACS, and study researchers will review participants' medical records. All participants will undergo daily blood collections, which will include testing for sPLA2 levels, and at least two chest x-rays. Twenty-eight days after hospital discharge, all participants will attend a follow-up study visit for blood collection, again to determine sPLA2 levels.
In the second part of the study, participants who are not eligible or who do not choose to participate in the first part of the study will be enrolled into an observational group. These participants will receive standard care for ACS, but will not receive a blood transfusion. They will undergo daily blood collection during their hospital stay and at least one chest x-ray. While participants are in the hospital and 28 days after discharge, study researchers will review participants' medical records.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 237
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Blood Transfusion Trial Cohort Single blood transfusion Twenty participants will receive a blood transfusion while in the hospital. Standard Care Trial Cohort Standard care Twenty participants will not receive a blood transfusion and will receive standard care. Standard Care Observational Cohort Standard care Approximately 300 participants who are ineligible for or decline the blood transfusion part of the study will participate in the observational portion of the study and receive standard care.
- Primary Outcome Measures
Name Time Method Acute Chest Syndrome Chest x-rays (CXR) were ordered for trial eligibility, as a result of clinical indications, or at discharge or 72 hours if no prior CXR. First occurence of positive infiltrate on chest x-ray
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (24)
Emory University School of Medicine
🇺🇸Atlanta, Georgia, United States
Johns Hopkins
🇺🇸Baltimore, Maryland, United States
Ohio State University
🇺🇸Columbus, Ohio, United States
St. Christopher's Hospital for Children
🇺🇸Philadelphia, Pennsylvania, United States
Children's Hospital and Research Center
🇺🇸Oakland, California, United States
A.I. duPont Hospital for Children
🇺🇸Wilmington, Delaware, United States
Kosair Children's Hospital
🇺🇸Louisville, Kentucky, United States
University of Illinois Sickle Cell Center
🇺🇸Chicago, Illinois, United States
Children's Memorial Hospital
🇺🇸Chicago, Illinois, United States
Medical College of Georgia
🇺🇸Augusta, Georgia, United States
New York Methodist Hospital
🇺🇸Brooklyn, New York, United States
Howard University Hospital
🇺🇸Washington, District of Columbia, United States
Boston Medical Center
🇺🇸Boston,, Massachusetts, United States
Cincinnati Children's Hospital Medical Center
🇺🇸Cincinnati, Ohio, United States
The University of North Carolina at Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States
Nationwide Children's Hospital
🇺🇸Columbus, Ohio, United States
Children's Hospital of Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Virginia Commonwealth University Health Systems
🇺🇸Richmond, Virginia, United States
University of Mississippi Medical Center
🇺🇸Jackson, Mississippi, United States
Children's Hospital Boston
🇺🇸Boston, Massachusetts, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Brigham & Women's Hospital
🇺🇸Boston,, Massachusetts, United States
Children's National Medical Center
🇺🇸Washington, District of Columbia, United States
Interfaith Medical Center
🇺🇸Brooklyn, New York, United States