N/A
N=237
Preventing Acute Chest Syndrome by Transfusion Feasibility Study
Sickle Cell Disease
Bottom Line
View on ClinicalTrials.gov: NCT00951808 ↗Enrolled (actual)
237
Serious AEs
—
Results posted
Apr 2013
Primary outcome: Primary: Acute Chest Syndrome — 11; 11; 22; 85 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Single blood transfusion (Biological); Standard care (Behavioral)
- Age
- Pediatric, Adult, Older Adult · 2+ yrs
- Sex
- All
- Sponsor
- Carelon Research
- Primary completion
- Jun 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Acute Chest Syndrome |
11; 11; 22; 85; 96; 181 | — |
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.
Eligibility Criteria
Inclusion Criteria for the Observational and Trial Cohorts:
- Hemoglobin diagnosis of SS (two copies of the hemoglobin S gene), SC (one copy of the hemoglobin S gene and one copy of the hemoglobin C gene), or S-β thalassemia (β+ or β0)
- No clinically apparent ACS
- No prior participation in either part of the study
Inclusion Criteria for the Trial Cohort, in addition to the above criteria:
- sPLA2 level greater than 100 ng/mL within the same 24-hour window that coincides with fever and chest radiograph negative for new pulmonary infiltrate within the last 12 hours of the 24-hour window
- Fever greater than 38.0º C within the same 24-hour window that coincides with elevated sPLA2 level (greater than 100 ng/mL) and chest radiograph negative for new pulmonary infiltrate within the last 12 hours of the 24-hour window
- Chest radiograph negative for new pulmonary infiltrate within the last 12 hours of the 24-hour window of an abnormal sPLA2 level and fever
- Hemoglobin levels equal or less than 10 g/dL at time of study entry
- Informed consent of parent(s) or legal guardian; informed consent or assent of participant as applicable
Exclusion Criteria for Observational and Trial Cohorts:
- Existing diagnosis of a new pulmonary infiltrate diagnosed by chest radiography (pleural effusion not obscuring lung parenchyma will not exclude the person from the study)
- Any coexisting medical condition for which the physician feels that a transfusion may be needed within 24 hours (e.g., severe anemia, stroke)
- Red Blood Cell (RBC) transfusion in the 60 days before study entry
- Unwillingness to sign consent form, or if a minor, unwillingness of parent/guardian to sign consent form
- Treatment with any investigational drug or device in the 30 days before study entry (hydroxyurea is allowable)
- History of alloimmunization that would prevent the participant from receiving blood within 8 hours of eligibility for study entry or history of a life-threatening transfusion reaction
- Objection to transfusion for religious or other reasons from either the participant or guardian
- History of treatment with systemic steroids within 1 week of study entry (inhaled steroids are acceptable)
- Pregnant
Data sourced from ClinicalTrials.gov (NCT00951808). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.