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Preventing Acute Chest Syndrome by Transfusion Feasibility Study

NCT00951808 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 237

Last updated 2013-04-24

Study results available
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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.

Conditions

Interventions

BIOLOGICAL

Single blood transfusion

Participants will receive a single transfusion of 7-13cc/kg packed red blood cells (RBCs) while in the hospital.

BEHAVIORAL

Standard care

Participants will receive standard care for ACS while in the hospital.

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • Carelon Research

    lead OTHER

Principal Investigators

  • Sonja McKinlay, PhD · Carelon Research

  • Margaret C. Bell, MPH, MS · Carelon Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
2 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-07-31
Primary Completion
2010-06-30
Completion
2010-07-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00951808 on ClinicalTrials.gov