Viral DiseaseNCT00023023
Study of Transfusion-Transmitted Infections
An observational study of Viral Disease and Blood Donation, run by National Institutes of Health Clinical Center (CC) at 3 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Viral Disease, Blood Donation, Transfusion-Transmitted Infections
- How many people
- 1,771 participants
- Where
- 3 sitesUnited States
- Study dates
- 17 Jan 2002to not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Under an established collaborative agreement and IRB authorization agreement between NIH and Suburban Hospital/Johns Hopkins Health System (JHHS), TRIPS will enroll patients undergoing open heart surgery at SH.
Who may be able to join
- All adult (greater than or equal to 18 years) patients who are transfused at NIH will be eligible if:
- they have not been transfused in the 6 weeks preceding the index transfusion;
- they are expected to remain in the continental USA for at least six months post the index transfusion; and
- if they are consented and a pre-sample is obtained
- if they receive a transfusion during their NIH stay
Who cannot join
None listed.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
NIH Heart Center at Suburban Hospital Johns Hopkins Medicine
Bethesda, Maryland, 20814
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
Childrens National Medical Center
Washington D.C., District of Columbia, 20010
About this study
Official title: 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.
Read more
All participants will have a 20- to 25-milliliter (about 2 tablespoonfuls) blood sample drawn before their transfusion and again at 1, 2, 4, 12 and 24 weeks 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.
...
Read the detailed description
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 agents 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-transfusion and 1, 2, 4, 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.
- Keywords
- Hepatitis, Blood Bank, Viruses, Blood Donors, Blood Recipients, Natural History
- Medical subject headings
- Virus Diseases, Transfusion Reaction, Hepatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Adults and children subjects | The NIH and SH components will enroll and follow only adult (age >=18) blood donor or recipient subjects. CNMC will enroll and follow children between the ages of 6 months and 18 years. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive viral DNA or RNA result
Patients tests positive for any number of viral RNA/DNA which could infer transfusion-transmission.
Measured: 1, 2, and 4 wk post-Txn
Positive viral antibody result
Patients tests positive for any number of viral antibodies which could infer transfusion-transmission.
Measured: 12, 24 and/or 6mo
Secondary outcomes (1)
Viral discovery
Pre- and post- transfusion samples can be used for viral discovery programs employing GWAS, full genome sequencing or other methods that may evolve.
Measured: 1, 2, and 4 wk and 12, 24 and/or 6mo
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2001 (estimated)
- Study start17 Jan 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Viral DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,771 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institutes of Health Clinical Center (CC)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Valeria De Giorgi, Ph.D., Principal investigator, National Institutes of Health Clinical Center (CC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00023023
- Sponsor's protocol ID
- 010231
- Other IDs
- 01-CC-0231
- Status last verified
- 2 Oct 2026
- First submitted
- 18 Aug 2001
- Last updated
- 29 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Schreiber GB, Busch MP, Kleinman SH, Korelitz JJ. The risk of transfusion-transmitted viral infections. The Retrovirus Epidemiology Donor Study. N Engl J Med. 1996 Jun 27;334(26):1685-90. doi: 10.1056/NEJM199606273342601.
PubMed 8637512Kleinman S, Busch MP, Korelitz JJ, Schreiber GB. The incidence/window period model and its use to assess the risk of transfusion-transmitted human immunodeficiency virus and hepatitis C virus infection. Transfus Med Rev. 1997 Jul;11(3):155-72. doi: 10.1053/tmrv.1997.0110155. No abstract available.
PubMed 9243769Alter HJ, Houghton M. Clinical Medical Research Award. Hepatitis C virus and eliminating post-transfusion hepatitis. Nat Med. 2000 Oct;6(10):1082-6. doi: 10.1038/80394. No abstract available.
PubMed 11017126
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study of Transfusion-Transmitted Infections
- ClinicalTrials.gov ID
- NCT00023023
- Acronym / sponsor ID
- 010231
- Keywords
- Hepatitis, Blood Bank, Viruses, Blood Donors, Blood Recipients, Natural History
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,771 participants (actual)
- Lead sponsor
- National Institutes of Health Clinical Center (CC)US National Institutes of Health
- Study start
- 17 Jan 2002 (actual)
- First posted
- 20 Aug 2001 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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, 4, 12 and 24 weeks 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.
...
Detailed description
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 agents 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-transfusion and 1, 2, 4, 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adults and children subjects | – | –The NIH and SH components will enroll and follow only adult (age >=18) blood donor or recipient subjects. CNMC will enroll and follow children between the ages of 6 months and 18 years. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Under an established collaborative agreement and IRB authorization agreement between NIH and Suburban Hospital/Johns Hopkins Health System (JHHS), TRIPS will enroll patients undergoing open heart surgery at SH.
Key inclusion criteria (5 listed)
- All adult (greater than or equal to 18 years) patients who are transfused at NIH will be eligible if:
- they have not been transfused in the 6 weeks preceding the index transfusion;
- they are expected to remain in the continental USA for at least six months post the index transfusion; and
- if they are consented and a pre-sample is obtained
- if they receive a transfusion during their NIH stay
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Positive viral DNA or RNA result
Time frame: 1, 2, and 4 wk post-Txn
Patients tests positive for any number of viral RNA/DNA which could infer transfusion-transmission.
Positive viral antibody result
Time frame: 12, 24 and/or 6mo
Patients tests positive for any number of viral antibodies which could infer transfusion-transmission.
1 secondary outcome
Viral discovery
Time frame: 1, 2, and 4 wk and 12, 24 and/or 6mo
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Background: PubMed 8637512Schreiber GB, Busch MP, Kleinman SH, Korelitz JJ. The risk of transfusion-transmitted viral infections. The Retrovirus Epidemiology Donor Study. N Engl J Med. 1996 Jun 27;334(26):1685-90. doi: 10.1056/NEJM199606273342601.
- Background: PubMed 9243769Kleinman S, Busch MP, Korelitz JJ, Schreiber GB. The incidence/window period model and its use to assess the risk of transfusion-transmitted human immunodeficiency virus and hepatitis C virus infection. Transfus Med Rev. 1997 Jul;11(3):155-72. doi: 10.1053/tmrv.1997.0110155. No abstract available.
- Background: PubMed 11017126Alter HJ, Houghton M. Clinical Medical Research Award. Hepatitis C virus and eliminating post-transfusion hepatitis. Nat Med. 2000 Oct;6(10):1082-6. doi: 10.1038/80394. No abstract available.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Valeria De Giorgi, Ph.D. principal investigator
National Institutes of Health Clinical Center (CC)
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Viral Disease and Blood Donation, run by National Institutes of Health Clinical Center (CC) at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positive viral DNA or RNA result (time frame: 1, 2, and 4 wk post-Txn). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00023023, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.