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Sponsors and Collaborators: |
Children's Hospital Medical Center, Cincinnati National Heart, Lung, and Blood Institute (NHLBI) |
Information provided by: | Children's Hospital Medical Center, Cincinnati |
ClinicalTrials.gov Identifier: | NCT00448370 |
The purpose of this research study is to find out whether PlGF and related tests can predict the development of ACS in patients with 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.
Condition |
Anemia, Sickle Cell |
Genetics Home Reference related topics: | sickle cell disease |
MedlinePlus related topics: | Anemia Sickle Cell Anemia |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Official Title: | Role of Placenta Growth Factor in Sickle Acute Chest Syndrome |
Estimated Enrollment: | 175 |
Study Start Date: | March 2007 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
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 of the degree of airway obstruction; and that acute elevations in PlGF levels will occur during an acute sickle event and precede clinical and radiological recognition of ACS. This is a biological study that does not fall into the criteria of a phase I-IV trial.
Measurements will be done at two stages. First, patients who are admitted to the hospital with an acute sickle event will have a daily evaluation for the first 4 days of the admission or up until the patient has an ACS event. Measurements of inpatient spirometry (at primary site only) and impulse oscillometry will be performed daily. Measurements on 35 ACS events with ACS developing on the 3rd/4th day of admission will be collected. Measurements on patients developing ACS will be compared to those who do not develop ACS will allow for earlier prediction of ACS. Finally, patients who have an ACS or admission for an acute sickling event will be evaluated again after 3-4 weeks in order to get a baseline measurement. One hundred baseline measurements will be made. Twenty of these baseline patients will also have one or two additional baseline evaluations at subsequent clinic visits to evaluate the overall non-event baseline distribution and intra-subject baseline variability. Patients will have measurements repeated if admitted for an acute event greater than one year since the last baseline measurement . These measurements will be used to see if there is any prognostic information for a subsequent acute or ACS event. Some patients may only have baseline data collected.
Ages Eligible for Study: | 7 Years to 30 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Participants will have sickle cell disease (HbSS, HbSC, or Hb Sbeta-thalassemia) and will be equal to or greater than 7 years old.
Inclusion criteria:
Exclusion criteria:
Patients on chronic transfusions will be ineligible.
Contact: Karen Kalinyak, MD | 513-636-4541 | karenann.kalinyak@cchmc.org |
Contact: Punam Malik, MD | 513-636-8588 | punam.malik@cchmc.org |
United States, Missouri | |||||
Washington University St. Louis | Not yet recruiting | ||||
St. Louis, Missouri, United States, 63110 | |||||
Contact: Lisa Garrett 314-286-1208 garrett_l@kids.wustl.edu | |||||
Principal Investigator: Michael DeBaun, MD, MPH | |||||
United States, Ohio | |||||
Cincinnati Children's Hospital Medical Center | Recruiting | ||||
Cincinnati, Ohio, United States, 45229 | |||||
Contact: Tamara Nordheim, RN 513-636-7374 tamara.nordheim@cchmc.org | |||||
Contact: Laurie Vanderah, RN 513-803-0003 laurie.vanderah@cchmc.org |
Children's Hospital Medical Center, Cincinnati |
National Heart, Lung, and Blood Institute (NHLBI) |
Principal Investigator: | Karen Kalinyak, MD | Children's Hospital Medical Center, Cincinnati |
Cincinnati Children's Hospital Medical Center 
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Cincinnati Comprehensive Sickle Cell Center 
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Responsible Party: | Cincinnati Children's Hospital Medical Center ( Karen Kalinyak, MD ) |
Study ID Numbers: | CCHMC 06-09-57 |
First Received: | March 14, 2007 |
Last Updated: | August 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00448370 |
Health Authority: | United States: Institutional Review Board; United States: Federal Government |
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