Role of Placenta Growth Factor in Sickle Acute Chest Syndrome

Completed

• Conditions: Anemia, Sickle Cell

• Registration Number: NCT00448370
• Lead Sponsor: Children's Hospital Medical Center, Cincinnati

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 (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.

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 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.

Study Timeline

• Study Start: 2007-03
• Study First Submitted: 2007-03-14
• Study First Submitted QC: 2007-03-14
• Study First Posted: 2007-03-16
• Primary Completion: 2012-12
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-19
• Last Update Posted: 2017-12-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 136

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in plasma PlGF levels and urine LT levels in SCD patients	Baseline and serially through the development of an Acute Sickle Event

Secondary Outcome Measures

Name	Time	Method
Relationship of clinical parameters of severity of SCD and circulating levels of PlGF, leukotrienes, proinflammatory cytochemokines and pulmonary function tests	Baseline and serially through the development of an Acute Sickle Event

Trial Locations

Locations (1)

Cincinnati Children's Hospital Medical Center; 🇺🇸 Cincinnati, Ohio, United States