Viewing Study NCT00951808



Ignite Creation Date: 2024-05-05 @ 9:45 PM
Last Modification Date: 2024-10-26 @ 10:08 AM
Study NCT ID: NCT00951808
Status: COMPLETED
Last Update Posted: 2013-04-24
First Post: 2009-07-31

Brief Title: Preventing Acute Chest Syndrome by Transfusion Feasibility Study
Sponsor: Carelon Research
Organization: Carelon Research

Study Overview

Official Title: Preventing Acute Chest Syndrome by Transfusion Feasibility Study PROACTIVE Feasibility Study
Status: COMPLETED
Status Verified Date: 2013-04
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: PROACTIVE
Brief Summary: Acute chest syndrome ACS is similar to severe pneumonia and is a common cause of hospitalizations for people with sickle cell disease SCD Blood transfusions are one treatment option for ACS High levels of an enzyme called secretory phospholipase A2 sPLA2 may be present in people before they develop ACS This study will determine how well sPLA2 levels can predict the onset of ACS and whether identifying high sPLA2 levels allows enough time to prevent ACS with blood transfusions Results from this study will help to determine the feasibility of conducting a larger study that would further examine the use of sPLA2 levels and blood transfusions to prevent ACS in people with SCD
Detailed Description: SCD is an inherited blood disorder and symptoms include anemia infections organ damage and intense episodes of pain which are called sickle cell crises ACS characterized by fever respiratory distress and lung tissue damage is the second most common cause of hospitalization and the leading cause of death among people with SCD Most people with SCD will experience at least one episode of ACS and repeated episodes can result in progressive lung disease ACS can appear suddenly and often requires immediate hospitalization and treatment which can include blood transfusions People with elevated blood levels of sPLA2 may be at risk for developing ACS and this enzyme is often detectable before the onset of ACS symptoms The purpose of this study is to examine the use of sPLA2 as a predictor of ACS and to determine whether subsequent blood transfusions can be administered early enough to prevent the onset of ACS in people with SCD who are at risk for ACS Study researchers will also assess the feasibility of conducting a larger study that would further examine the effectiveness of using sPLA2 levels and blood transfusions to prevent ACS

This study will involve two parts In the first part of the study participants with SCD who are admitted to the hospital with an acute sickle cell pain event will be randomly assigned to receive either a single blood transfusion or standard care for ACS and no blood transfusion All participants will be closely monitored while in the hospital for the development of ACS and study researchers will review participants medical records All participants will undergo daily blood collections which will include testing for sPLA2 levels and at least two chest x-rays Twenty-eight days after hospital discharge all participants will attend a follow-up study visit for blood collection again to determine sPLA2 levels

In the second part of the study participants who are not eligible or who do not choose to participate in the first part of the study will be enrolled into an observational group These participants will receive standard care for ACS but will not receive a blood transfusion They will undergo daily blood collection during their hospital stay and at least one chest x-ray While participants are in the hospital and 28 days after discharge study researchers will review participants medical records

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
U10HL083721 NIH None httpsreporternihgovquickSearchU10HL083721