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REDS-III Phase 1 Studies

In Phase 1, the following studies were conducted and have resulted in multiple publications.

Domestic

1.  The effect of TMPRSS6 polymorphisms on hemoglobin and iron stores in high intensity blood donors
The TMPRSS6 gene is part of the pathway that regulates iron absorption in the gut. Iron uptake is an important part of recovery of the iron that is lost when blood is donated. This study examined the role of genetic variation in TMPRSS6 in hemoglobin levels and iron stores in individuals who donated blood repeatedly.

2.  The Genetic Basis of Allo-Antibody Formation and Persistence in Blood Donors
Allo-immunization occurs when transfusion recipients form antibodies against proteins in the blood that they receive. A person who develops allo-antibodies can experience severe reactions to blood in future transfusions if the blood is not properly matched to his or her antibody profile. There is some evidence that the risk of developing allo-antibodies varies considerably among individuals. The goal of this study was to determine whether genetic variation among blood donors influences the risk of development of allo-antibodies.

3.  Mechanisms of GB Virus type C (GBV-C) reduction in mortality and viral load in HIV-infected patients with transfusion-transmitted GBV-C infection in the NHLBI Viral Activation Transfusion Study
In previous studies, infection with GBV-C through blood transfusion has been shown to reduce mortality and viral load in HIV-infected persons with late stage disease. The mechanism by which this effect occurs is not understood. The goal of this study was to examine the effect of GBV-C infection on the immune system of HIV-infected patients. The investigators compared measures of immune function before and after GBV-C infection in a group of patients infected with GBV-C through transfusion as well as changes in immune function over time in another group of HIV-infected patients who received transfusions but did not become infected with GBV-C.

4.  Hemoglobin and Iron Recovery Study (HEIRS)
In the United States, persons who donate whole blood are not eligible to donate again for a minimum of 8 weeks. Some persons are known to take considerably longer to recover the hemoglobin and iron lost at donation. Accelerating recovery in these donors would allow them to donate blood more frequently. This study was a randomized trial to examine the effect of taking iron pills after blood donation on the time required to recover the hemoglobin lost at donation. The investigators also looked at the effect of iron pills on recovery of body iron stores after blood donation and whether recovery of hemoglobin or iron depended on sex, age or pre-donation iron stores. This study is posted on ClinicalTrials.govOffsite icon

5.   A population-based study of the detection and prediction of in-hospital transfusion-related adverse events
A population-based study that examined inpatient transfusion practice and trends in blood utilization within an integrated healthcare delivery system from 2009 through 2013. Within a large community hospital network, blood transfusion was examined in relation to predictors at the time of hospitalization, inpatient clinical outcomes such as mortality, as well as pulmonary transfusion-related adverse events.

6.  A Retrospective Cohort Study of Plasma Use,and Risk Associated with Use of ABO compatible, non-identical Plasma
In the United States, the rate of plasma transfusions has increased annually for over 20 years. Recently, the national rate of plasma transfusion exceeded 4.4 million units per year. However, the patterns of plasma utilization have not been well characterized. In this study, the investigators used hospital records to examine use of plasma for transfusion over the course of 12 months. They described the clinical services, patient populations and clinical circumstances in which plasma was most widely used. They defined the range of plasma doses in transfusion orders and the laboratory measures, such as coagulation measurements that are associated with the decision to order a plasma transfusion.

7.  Opinions and Perspectives about the Current Blood Donation Policy for Men Who Have Sex with Men
Researchers conducted focus groups and surveys to gather more in-depth information on opinions and perspectives about the current U.S. blood donation policy for men who have sex with men (MSM). (Frequently Asked Questions) 


International

8.  HIV Molecular Epidemiology study (South Africa)
This study seeks to evaluate the genetic diversity in circulating HIV in South Africa as well as to compare contemporary HIV subtypes with that of founder virus, using stored repository samples that were collected from blood donors identified as HIV positive during screening. (South Africa)

9.  Establish an HIV-reactive Donor Sample Repository and Conduct Epidemiological and Molecular Studies in HIV-infected Donors ( China)
Confirmed HIV-reactive specimens are placed into an HIV sample repository. This repository is used to study molecular epidemiological features of HIV infection among Chinese blood donors including HIV subtyping, drug resistance mutations, environment/gene characteristics, and full genome of the virus in incident HIV infections using new HIV testing technologies. The repository will also be valuable for monitoring the evolution of HIV molecular epidemiological characteristics of both newly and long-term HIV infected donors.

10.  Monitor the Prevalence and Incidence of TTDs (HIV, HBV, HCV, and Syphilis) (China)
Supplemental (confirmatory) testing for HIV, HBV, HCV, and syphilis is conducted for REDS III research purposes at IBT. Supplementary test results are merged with the REDS III China donor and donation database at RTI International. Associations between TTDs and donor and donation characteristics will be analyzed and the results will be invaluable in guiding the design of safer and more effective donor recruitment and selection and donation screening strategies. In addition, using data from the REDS III donor and donation database, investigators monitor HIV prevalence and incidence rates, estimate residual risk of transfusion-transmitted HIV infections in China, and analyze prevalent and incident infections in the context of donor and donation characteristics.

11.  A study of Severe Fever with Thrombocytopenia Syndrome Virus (SFTSV) seroprevalence and rates of asymptomatic viremia in Chinese blood donors from four Chinese regions (China)
A virus that causes severe fever and thrombocytopenia (low platelet count) and that is carried by ticks was recently identified in some regions of China. Because the virus can be transmitted from person to person through contact with body fluids, there is concern that it might be a threat to the blood supply. The purpose of this study was to assess the prevalence of infection with SFTSV in blood donors in regions where the virus is most common in comparison to regions where it is less common.

12.  DENGUE Virus Incidence and Prevalence in Brazilian Donors and Recipients, Rates and Correlates of Transfusion-Transmission, and Clinical  Outcomes of Infection in Recipients (Brazil)
The dengue virus, which is transmitted by certain species of mosquitoes is widespread in tropical and subtropical regions of the world. Epidemics occur frequently, especially during the rainy season when mosquitoes are abundant. In this study, the investigators tested blood donors and transfusion recipients to estimate the risk of transmission of the dengue virus through transfusion.

13. Obstetrical Hemorrhage Pilot Project (South Africa)
Obstetric hemorrhage (OH) is the foremost contributor to obstetric mortality in South Africa, as it is in many other countries. Lack of recognition of risk factors for recurrent OH exacerbates the problem, particularly in resource poor settings. Heavy blood loss through OH frequently creates a need for transfusion. However, it is not clear whether appropriate transfusion practices are used in many settings where OH occurs most frequently. The problem is further complicated by the high prevalence of HIV in South Africa. The effects of liberal blood transfusion on pregnant women who are infected with HIV have not been well studied. To address these issues, the investigators conducted a large scale pilot study to collect data on rates of obstetric hemorrhage and related transfusion practices.


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