Current Industry and Federal Contracts

Preventing Acute Chest Syndrome by Transfusion Feasibility Study (PROACTIVE)
Principal Investigator: Victor R. Gordeuk, MD
Clinical Coordinator: Sharmin Diaz and Kevin Cole

For more information on this study, Please visit the official ClinicalTrials.gov page.

Purpose:

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.

Primary Outcome Measures:

  • Assess the feasibility of conducting a larger study in terms of elapsed time between eligibility, randomization, and transfusion (Time Frame: Measured at the end of the 13-month study).
  • Assess the feasibility of conducting a larger study in terms of elapsed time between eligibility, randomization, and transfusion (Time Frame: Measured at the end of the 13-month study).

Secondary Outcome Measures:

  • Assess timely completion of 3 sPLA2 measurements for participants with persistently low sPLA2 levels, % of screened participants who are eligible for randomization and % who are randomized, child/adult ratio, and timing and results of sPLA2 samples (Time Frame: Measured at the end of the 13-month study).

Return to Research