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SERUM 233,730

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PDF Protocol Operations Manual (PDF - 5.5 MB)

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Transfusion-Transmitted Viruses Study (TTVS)

Study Type: Epidemiology Study
Prepared on September 3, 2009
Study Dates: 1974-1980
Consent: Restricted Consent
Consent Restrictions: Research restricted to transfusion safety
Commercial Use Restrictions: No
NHLBI Division: DBDR
Collection Type: Open BioLINCC Study - See bottom of this webpage for request information

Objectives

To establish a repository of specimens collected from prospectively identified cases of non-A, non-B (NANB) hepatitis after blood transfusion. The major intentions were to determine the incidence of that occurrence, identify the characteristics of the donors associated with the event, and have a resource available to compare laboratory donor screening methods during the study and in subsequent years following completion of the study.

Background

From July 1974 through June 1980, the TTVS group prospectively identified cases of NANB hepatitis in a cohort of 1,533 transfused patients hospitalized short-term for various routine operative procedures The TTVS collection has been used in a variety of studies, such as the evaluation and validation of Hepatitis C Virus (HCV) immunoassays in screening blood donors (1). In addition, specimens have been requested to evaluate poorly characterized hepatotropic viruses, transmissibility of new viruses (hepatitis G, HHV-8) by transfusion, and the dynamics of HBV/HCV viral replication and seroconversion in recipients.

Subjects

Serum specimens from 5,655 blood donors were collected from 4 participating blood centers distributed across the US. 3,121 patients were consented to participate in a study of viral hepatitis after blood transfusion. The majority of patients were scheduled for elective surgery. Of these subjects, 1,533 subsequently received blood transfusions. Both transfusion recipients and control subjects that did not require transfusion were observed and blood was collected prior to surgery or pre-transfusion and again during visits at 2-3 week intervals during the first 6 months following the transfusion episode and again between 8-10 months.

Design

The collection originally consisted of aliquots of serum acquired at patient observation visits and from the collection agency for every donor to each TTVS recipient. These sera included the pre-transfusion or pre-surgical specimen, all interval blood draws from these patients and the non-transfused control patients, a specimen from the donor at the time of blood collection and in a subpopulation of donors a follow-up specimen from donors implicated in suspected cases of transfusion transmitted hepatitis and a matched set of non-implicated donors.

Conclusions

The TTVS collection provides sera from a large transfusion donor-recipient study in which an untransfused control population with reasonably matched characteristics and of adequate size is available.

Publications

1. Mosley JW, et al. (1990) Non-A, non-B hepatitis and antibody to hepatitis C virus. JAMA 263(1):77-78.