Randomized Trial to Evaluate Mirasol Whole Blood Pathogen Reduction Technology System to Reduce Malaria and Emerging Transfusion Transmitted Infections
Abstract
Objectives and Rationale: The Mirasol Pathogen Reduction Technology (PRT) seeks to reduce the risk of infections obtained from a blood transfusion, called transfusion-transmitted infections (TTIs). These infections include diseases such as HIV/AIDS, hepatitis, and malaria. Domestic blood banks have invested heavily in reducing the threat of TTIs, while the risk of TTIs is higher outside of the U.S., in both emerging nations and in low-resource or forward operating settings. According to the World Health Organization (WHO), in emerging nations over 5% of donations lead to TTIs. Due to its streamlined nature, the Mirasol PRT can be safely and sustainably implemented in low-resource settings like remote care facilities and military forward operating environments. Mirasol PRT is used to reduce the amount of pathogens (such as viruses or bacteria) in whole blood or blood components, thus reducing the risk of TTIs during transfusion and improving the safety and reliability of blood supplies. The Mirasol process uses riboflavin (i.e., vitamin B2) and UV-light. Because Mirasol adds no harmful components, no post-processing is required for the blood after treatment with Mirasol PRT. Currently, no U.S. Food and Drug Administration (FDA)-approved PRT device is available for use with all blood components; the Mirasol PRT System is uniquely positioned to fill this important gap. The Mirasol PRT System represents an important new approach to reducing TTIs, improving population health metrics, and reducing healthcare costs. The proposed clinical trial will establish the effectiveness of Mirasol PRT. We will also evaluate the dependability, quality, reproducibility, ease of operation, and sustainability of Mirasol PRT. In order to demonstrate its effectiveness in low-resource settings, our study will be conducted in Uganda. Uganda is an ideal setting owing to its capable yet resource-limited health infrastructure and the high level of TTIs regionally. This trial will provide good data not only for global public health applications, but also for military and forward operating settings. Our specific aims include: Aim 1: Assess the feasibility and sustainability of whole blood Mirasol PRT in a limited-resource setting. Aim 2: Evaluate the safety and efficacy of the whole blood Mirasol PRT system to reduce TTIs. Aim 3: Determine the cost and public health impact of TTIs in Uganda and for the U.S. military. Topic Area and Alignment with Peer Reviewed Medical Research Program Mission: This proposal aligns with both the Emerging Infectious Diseases and Malaria Areas of Encouragement for development and/or testing of new technologies or methods to reduce transfusion-transmitted malaria and emerging infectious diseases. Military Alignment: Mirasol PRT has critical relevance for the U.S. Warfighter. Hemorrhage is the leading cause of preventable death in combat, and blood transfusions are a crucial aspect of resuscitative therapy for severely injured, bleeding casualties. Collection of blood in-theater, from combatants or support personnel, provides a useful way to supplement FDA-licensed blood components. However, risks for in-theater blood collection and transfusion are incurred by deployment to geographies where blood-borne diseases are endemic and to situations where testing capability is limited by time or austerity of environment. Mirasol PRT will increase the speed and availability of safe blood for injured Warfighters. Public Health Benefit: Contracting an infection like HIV, hepatitis, malaria, or an emerging infection from a blood transfusion is devastating. Blood banks and military health systems alike are committed to eliminating TTIs, but screening assay development lags behind emerging threats. The process of developing new screening tests is slow and expensive. Full testing is beyond the means of developing countries – in which over 5% of transfusions lead to infection. Mirasol PRT helps p
Document Details
- Document Type
- DoD Grant Award
- Publication Date
- Oct 29, 2018
- Source ID
- W81XWH1810742
Entities
People
- Aaron Tobian
Organizations
- Johns Hopkins University
- United States Army