Study of Transfusion-Transmitted Infections
| Status: | Recruiting |
|---|---|
| Conditions: | Infectious Disease |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/24/2019 |
| Start Date: | January 17, 2002 |
| Contact: | Cathy Schechterly |
| Email: | cschechterly@mail.cc.nih.gov |
| Phone: | (301) 496-4899 |
A Prospective Study of Transfusion-Transmitted Infections
This study will follow blood transfusion recipients for 6 to 9 months following transfusion
to monitor the quality and safety of blood transfusion. Improved viral testing and careful
donor screening in the last several years has dramatically reduced the rates of
transfusion-related HIV and hepatitis. Nevertheless, ongoing surveillance of
transfusion-related infections is essential to maintain a high safety standard and to
determine the transfusion risk of other infectious agents, such as cytomegalovirus,
Epstein-Barr virus, parvovirus B-19, HHV-8 (Kaposi s sarcoma virus) and other possible
hepatitis viruses that might be blood-transmitted. Transfused patients blood will be tested
for various infectious agents. Their blood samples and blood samples from their donors will
be frozen and stored in a repository so that any new infectious agent can be rapidly
evaluated for its danger to the safety of the blood supply.
Adult patients at the National Institutes of Health and children at the Children s National
Medical Center who are scheduled to receive a blood transfusion or to undergo surgery for
which a blood transfusion may be needed are eligible for this study.
All participants will have a 20- to 25-milliliter (about 2 tablespoonfuls) blood sample drawn
before their transfusion and again at 1, 2, 3 and 6 months after the transfusion. Patients
who are transfused on more than one occasion over the course of the study will provide three
additional monthly samples. Patients who develop a transfusion-transmitted infection during
the study will provide up to four more samples to study the infection and its effects.
Participants will complete a brief questionnaire at the end of the study regarding prior
blood transfusions and the development of any illnesses, such as hepatitis, that might have
been caused by the transfusion.
to monitor the quality and safety of blood transfusion. Improved viral testing and careful
donor screening in the last several years has dramatically reduced the rates of
transfusion-related HIV and hepatitis. Nevertheless, ongoing surveillance of
transfusion-related infections is essential to maintain a high safety standard and to
determine the transfusion risk of other infectious agents, such as cytomegalovirus,
Epstein-Barr virus, parvovirus B-19, HHV-8 (Kaposi s sarcoma virus) and other possible
hepatitis viruses that might be blood-transmitted. Transfused patients blood will be tested
for various infectious agents. Their blood samples and blood samples from their donors will
be frozen and stored in a repository so that any new infectious agent can be rapidly
evaluated for its danger to the safety of the blood supply.
Adult patients at the National Institutes of Health and children at the Children s National
Medical Center who are scheduled to receive a blood transfusion or to undergo surgery for
which a blood transfusion may be needed are eligible for this study.
All participants will have a 20- to 25-milliliter (about 2 tablespoonfuls) blood sample drawn
before their transfusion and again at 1, 2, 3 and 6 months after the transfusion. Patients
who are transfused on more than one occasion over the course of the study will provide three
additional monthly samples. Patients who develop a transfusion-transmitted infection during
the study will provide up to four more samples to study the infection and its effects.
Participants will complete a brief questionnaire at the end of the study regarding prior
blood transfusions and the development of any illnesses, such as hepatitis, that might have
been caused by the transfusion.
Improved viral screening assays and more intensive questioning of donors for high-risk
behaviors have resulted in dramatic declines in the rates of transfusion-transmitted
hepatitis and AIDS. Nonetheless, there is need for continued vigilance of the safety of blood
supply. This study will enroll blood donors and prospectively followed blood recipients in
order to: 1) establish ongoing surveillance of the incidence of breakthrough infections from
transfusion-transmitted agents for which there are existing donor-screening assays (e.g. HBV,
HCV, HIV, human T cell lymphotropic virus [HTLV]); 2) monitor the transfusion risk of
established infectious agents that are not routinely screened in blood donors including CMV,
parvovirus B-19, and HHV-8 [Kaposi's sarcoma virus]; 3) establish a repository of linked
donor and recipient samples so that any newly emerging infectious agent can be rapidly
evaluated for its threat to the blood supply.
The risk of these blood transmitted infectious will be assessed by molecular and serologic
assays in adult patients at NIH and Suburban Hospital in children at Children's National
Medical Center. Blood samples from recipients transfused on one occasion will be obtained pre
and 4, 8, 12, and 24 weeks post-transfusion. Recurrently transfused patients will have
additional samples at 16 and 20 weeks after the index transfusion and 24 weeks after the last
eligible transfusion. After initial infectious disease testing, recipient samples and linked
donor samples will be stored in an off-site biorepository. The availability of the repository
will allow for the assessment of transfusion risk for newly emerging pathogens and also for
known agents for which there is no practical assay currently available. For example, this
would allow future testing for prions in new variant Creutzfeld-Jacob disease (human variant
of mad cow disease) or testing for the trypanosome that causes Chagas disease. Informed
consent will be obtained to store and later test samples in the repository. Testing will be
limited to infectious agents that potentially threaten the blood supply. No genetic testing
will be performed.
behaviors have resulted in dramatic declines in the rates of transfusion-transmitted
hepatitis and AIDS. Nonetheless, there is need for continued vigilance of the safety of blood
supply. This study will enroll blood donors and prospectively followed blood recipients in
order to: 1) establish ongoing surveillance of the incidence of breakthrough infections from
transfusion-transmitted agents for which there are existing donor-screening assays (e.g. HBV,
HCV, HIV, human T cell lymphotropic virus [HTLV]); 2) monitor the transfusion risk of
established infectious agents that are not routinely screened in blood donors including CMV,
parvovirus B-19, and HHV-8 [Kaposi's sarcoma virus]; 3) establish a repository of linked
donor and recipient samples so that any newly emerging infectious agent can be rapidly
evaluated for its threat to the blood supply.
The risk of these blood transmitted infectious will be assessed by molecular and serologic
assays in adult patients at NIH and Suburban Hospital in children at Children's National
Medical Center. Blood samples from recipients transfused on one occasion will be obtained pre
and 4, 8, 12, and 24 weeks post-transfusion. Recurrently transfused patients will have
additional samples at 16 and 20 weeks after the index transfusion and 24 weeks after the last
eligible transfusion. After initial infectious disease testing, recipient samples and linked
donor samples will be stored in an off-site biorepository. The availability of the repository
will allow for the assessment of transfusion risk for newly emerging pathogens and also for
known agents for which there is no practical assay currently available. For example, this
would allow future testing for prions in new variant Creutzfeld-Jacob disease (human variant
of mad cow disease) or testing for the trypanosome that causes Chagas disease. Informed
consent will be obtained to store and later test samples in the repository. Testing will be
limited to infectious agents that potentially threaten the blood supply. No genetic testing
will be performed.
- INCLUSION CRITERIA
All adult (greater than or equal to 18 years) patients who are transfused at NIH will be
eligible if:
1. they have not been transfused in the 6 weeks preceding the index transfusion;
2. they are expected to remain in the continental USA for at least six months post the
index transfusion; and
3. if they are consented and a pre-sample is obtained
4. if they receive a transfusion during their NIH stay
We found this trial at
2
sites
Suburban Hospital Suburban Hospital is a community-based, not-for-profit hospital serving Montgomery County and the surrounding...
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9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
Phone: 800-411-1222
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