Clinical Trials Directory

Trials / Completed

CompletedNCT01282021

Molecular Immunohematology in Ethiopian Sub-Populations

Status
Completed
Phase
Study type
Observational
Enrollment
95 (actual)
Sponsor
National Institutes of Health Clinical Center (CC) · NIH
Sex
All
Age
18 Years – 100 Years
Healthy volunteers
Not accepted

Summary

Alloimmunization to blood products in transfused patients is a recognized management challenge in the clinical setting. In particular the ethnic and racial specificity of RBC antigens and the limited availability of matched healthy volunteer blood donors have intensified the dilemma. The presence of low prevalence clinically significant RBC antigens among minorities account for the higher rate of alloimmunization observed in patients from this group. This is partly due to the racial and ethnic differences between the blood donor and recipient populations in the U.S. The increasing number of new Ethiopian-American immigrants in the US presenting to the health care system with blood transfusion requirements makes understanding the unique transfusion needs of this minority population imperative. Although the majority of African Americans claim origin to West Africa, Ethiopians, being from East Africa, represent a rapidly growing population in the United States. Furthermore, identifying genetic similarities and disparities to their West African counterparts will certainly have clinical implications in terms of transfusion support and disease modifiers. This additional information would help in understanding the natural history and transfusion requirements of certain debilitating diseases, such as Sickle Cell Disease (SCD), which are known to occur more commonly in African Americans. Identifying ethnically and racially similar individuals could assist in recruiting healthy volunteer donors with similar RBC antigen profiles potentially supplementing the rare donor pool. Although extensive archeological and sporadic serologic RBC antigen studies have been conducted in Ethiopia, there are no population wide RBC antigen molecular studies. Our study population is selected by altitude and migration history. Ethiopia, being in close proximity to the Red Sea in the northeast, Indian Ocean in the southeast and the rest of Africa in the south/west has diverse population. The study is a population based analysis of genetic variation of blood group antigens in three distinct and conserved Ethiopian sub-populations. Statistical analysis using Chi-square tests will be performed for each blood group antigen to detect differences in the distribution between the three sub-populations. The The Lead Associate Investigator (LAI), and, as appropriate, additional Investigators, will travel to Ethiopia to collect blood samples, which will be analyzed in the Department of Transfusion Medicine (DTM) at the National Institutes of Health (NIH) using the standard serologic methods and currently available molecular genotyping systems. Samples will also be stored for future high throughput sequencing analysis and other studies. The study will be a systematic analysis of the distribution of blood group antigens in Ethiopian sub-populations. Furthermore, new variants could be detected allowing insight into the correlation of particular genotypes and phenotypes.

Detailed description

Alloimmunization to blood products in transfused patients is a recognized management challenge in the clinical setting. In particular the ethnic and racial specificity of RBC antigens and the limited availability of matched healthy volunteer blood donors have intensified the dilemma. The presence of low prevalence clinically significant RBC antigens among minorities account for the higher rate of alloimmunization observed in patients from this group. This is partly due to the racial and ethnic differences between the blood donor and recipient populations in the U.S. The increasing number of new Ethiopian-American immigrants in the US presenting to the health care system with blood transfusion requirements makes understanding the unique transfusion needs of this minority population imperative. Although the majority of African Americans claim origin to West Africa, Ethiopians, being from East Africa, represent a rapidly growing population in the United States. Furthermore, identifying genetic similarities and disparities to their West African counterparts will certainly have clinical implications in terms of transfusion support and disease modifiers. This additional information would help in understanding the natural history and transfusion requirements of certain debilitating diseases, such as Sickle Cell Disease (SCD), which are known to occur more commonly in African Americans. Identifying ethnically and racially similar individuals could assist in recruiting healthy volunteer donors with similar RBC antigen profiles potentially supplementing the rare donor pool. Although extensive archeological and sporadic serologic RBC antigen studies have been conducted in Ethiopia, there are no population wide RBC antigen molecular studies. Our study population is selected by altitude and migration history. Ethiopia, being in close proximity to the Red Sea in the northeast, Indian Ocean in the southeast and the rest of Africa in the south/west has diverse population. The study is a population based analysis of genetic variation of blood group antigens in three distinct and conserved Ethiopian sub-populations. Statistical analysis using Chi-square tests will be performed for each blood group antigen to detect differences in the distribution between the three sub-populations. The The Lead Associate Investigator (LAI), and, as appropriate, additional Investigators, will travel to Ethiopia to collect blood samples, which will be analyzed in the Department of Transfusion Medicine (DTM) at the National Institutes of Health (NIH) using the standard serologic methods and currently available molecular genotyping systems. Samples will also be stored for future high throughput sequencing analysis and other studies. The study will be a systematic analysis of the distribution of blood group antigens in Ethiopian sub-populations. Furthermore, new variants could be detected allowing insight into the correlation of particular genotypes and phenotypes.

Conditions

Timeline

Start date
2012-11-03
First posted
2011-01-24
Last updated
2026-04-01

Locations

1 site across 1 country: Ethiopia

Source: ClinicalTrials.gov record NCT01282021. Inclusion in this directory is not an endorsement.