Please select the eligibility criteria that correspond to the clinical trial below.
Title: Preventing Acute Chest Syndrome by Transfusion Feasibility Study( PROACTIVE Feasibility Study)
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.


Options:
A: 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
B: Pediatric patients, ages 24 months to 16 years, with sickle cell anemia or S-beta zero thalassemia.
C: Inclusion Criteria:

* Have SCD \[homozygous sickle cell (HbSS) or hemoglobin (HbS) Beta\^0 thalassemia\]
* Are participants with SCD who have had ≥2 episodes of vaso-occlusive crisis (VOC) in the past year
* Have a body weight ≥19 kilograms (kg) and are ≥2 and \<18 years of age, inclusive at the time of screening
* If participants are ≥2 and ≤16 years of age, must have had a transcranial Doppler within the last year

Exclusion Criteria:

* History of: transient ischemic attack (TIA)/ ischemic or hemorrhagic stroke, severe head trauma, intracranial hemorrhage, intracranial neoplasm, arteriovenous malformation, or aneurysm
* History of abnormal or conditional \[velocity in middle or anterior cerebral, or internal carotid artery ≥170 centimeter per second (cm/sec)\] transcranial Doppler within the last year
* History of, or are undergoing treatment with, chronic red blood cell (RBC) transfusion therapy
* Are at an increased risk for bleeding complications
* Are receiving chronic treatment with nonsteroidal anti-inflammatory drug (NSAID)s and cannot be switched to another analgesic
D: No eligibility criteria

Answer: A