Status:
COMPLETED
Role of Placenta Growth Factor in Sickle Acute Chest Syndrome
Lead Sponsor:
Children's Hospital Medical Center, Cincinnati
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Anemia, Sickle Cell
Eligibility:
All Genders
66-30 years
Brief Summary
The purpose of this research study is to find out whether Placenta Growth Factor (PlGF) and related tests can predict the development of acute chest syndrome (ACS) in patients with sickle cell disease...
Detailed Description
The proposed research is a clinical study designed to test the hypothesis that PlGF levels in blood at baseline in patients with SCD will correlate with leukotriene (LT) levels and will be reflective ...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Patients must have a diagnosis of SCD (HbSS, HbSC or HbS beta/thal) by hemoglobin electrophoresis or gene mapping. Very few patients with HbSC or HbS beta/thal would go onto develop ACS, but they will serve as important controls.
- Patients must be ≥5.5 years of age and ≤30 years of age.
- Patients must be able to comply with pulmonary function tests.
- Exclusion criteria:
- Patients taking anti-leukotriene medications such as montelukast (Singulair®) or zileuton (Zyflo®) 30 days prior to enrollment will be ineligible, although patients with SCD and asthma who are not on leukotriene inhibitors will be eligible.
- Patients with known congenital heart disease or with congenital lung abnormality/disease that will affect the pulmonary function testing and methacholine challenge testing will be ineligible (examples include patients with cyanotic heart disease, immotile cilia syndrome, cystic fibrosis, diaphragmatic hernia).
- Any patient with neurologic abnormalities, stroke, developmental delay, or other medical condition that would preclude cooperation with pulmonary function testing or compliance with protocol procedures will be ineligible.
- Patients over 30 years of age will be ineligible.
- Patients who are pregnant or nursing.
- Patients on chronic transfusions will be ineligible.
- If patients come off transfusion therapy, they will be eligible 3 months following the last transfusion.
- Patients receiving simple transfusions will be eligible, but baseline measurements will be made 3 months following the simple transfusion.
Exclusion
Key Trial Info
Start Date :
March 1 2007
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
136 Patients enrolled
Trial Details
Trial ID
NCT00448370
Start Date
March 1 2007
Last Update
December 21 2017
Active Locations (1)
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1
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229