Ignite Creation Date:
2024-05-05 @ 5:23 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00448370
Status:
COMPLETED
Last Update Posted:
2017-12-21
First Post:
2007-03-14
Brief Title:
Role of Placenta Growth Factor in Sickle Acute Chest Syndrome
Sponsor:
Childrens Hospital Medical Center Cincinnati
Organization:
Childrens Hospital Medical Center Cincinnati
Study Overview
Official Title:
Role of Placenta Growth Factor in Sickle Acute Chest Syndrome
Status:
COMPLETED
Status Verified Date:
2017-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 3rd4th 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
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 3rd4th 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01 | OTHER_GRANT | HL079916 | None |