NIH Clinical Center logo     America's Clinical Research Hospital File folder iconExplore the NIH
Clinical Center
Search the Studies - NIH Clinical Research Studies

Protocol Details

A Prospective Study of Transfusion-Transmitted Infections

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

01-CC-0231

Sponsoring Institute

National Institutes of Health Clinical Center (CC)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 18
Max Age: N/A

Referral Letter Required

Yes

Population Exclusion(s)

Children

Special Instructions

Currently Not Provided

Keywords

Hepatitis;
Blood Bank;
Viruses;
Blood Donors;
Blood Recipients

Recruitment Keyword(s)

Blood Donors;
Blood Recipients;
Blood Bank

Condition(s)

Virus Disease

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

NIH Clinical Center

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.

--Back to Top--

Eligibility

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) a pre-transfusion sample is available from the recipient;

3) they have a life-expectancy that exceeds 6 months;

4) they are expected to remain in the continental USA for at least six months post the index transfusion;

5) they provide informed consent.

6) they are not pregnant


--Back to Top--

Citations:

The risk of transfusion-transmitted viral infections The Retrovirus Epidemiology Donor Study

Transient increase in circulating donor leukocytes after allogeneic transfusions in immunocompetent recipients compatible with donor cell proliferation

The use of ATP bioluminescence as a measure of cell proliferation and cytotoxicity

--Back to Top--

Contacts:

Principal Investigator

Referral Contact

For more information:

Harvey J. Alter, M.D.
National Institutes of Health Clinical Center (CC)
BG 10 RM 1C711
10 CENTER DR
BETHESDA MD 20814
(301) 496-8393
halter@mail.cc.nih.gov

Cathy Schechterly
National Institutes of Health Clinical Center (CC)
National Institutes of Health
Building 10
Room 1C711
10 Center Drive
Bethesda, Maryland 20892
(301) 496-4899
cschechterly@mail.cc.nih.gov

Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

prpl@mail.cc.nih.gov

Clinical Trials Number:

NCT00023023

--Back to Top--

QUESTIONS?

Contact the Patient Recruitment and Public Liaison Office for:

  • Details on how to participate in a study
  • Details on how to refer a patient to a study

NIH Clinical Studies Information Request


Contact the Office of Communications for:

  • General information about the NIH Clinical Center

www.cc.nih.gov/contact.shtml


Contact the Department Clinical Research Informatics, (DCRI) for:

  • Technical questions about Adobe Acrobat and the PDF format
  • Technical questions about this web server

webmaster@cc.nih.gov