Role of Placenta Growth Factor in Sickle Acute Chest Syndrome

Completed

Conditions studied: Anemia, Sickle Cell

In brief

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 (SCD) during a period where patients are well and during admission to the hospital for an acute sickle event to see if these measures can predict the development of ACS. Understanding events precipitating ACS may lead to preventative and interventional therapies which will improve patient outcomes and quality of life.

Key facts

Study ID

NCT00448370

Run by

Children's Hospital Medical Center, Cincinnati

People needed

136

Starts

2007-03-01

Last updated by the study team

2017-12-21

Who can join

Age: 6 and older, up to 30. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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