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NCT00004848 · ClinicalTrials.gov registry record

A Controlled Prospective Study of Transfusion-Associated Hepatitis

A clinical trial, sponsored by National Institutes of Health Clinical Center (CC).

Completed
Registry status
2,000
Enrollment target

NCT00004848: Completed study, sponsored by National Institutes of Health Clinical Center (CC).

NCT00004848 is a clinical trial that has completed, run by National Institutes of Health Clinical Center (CC). The registered enrollment target is 2,000 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00004848 has completed, sponsored by National Institutes of Health Clinical Center (CC).

COMPLETED
Registry status
2,000 participants
Enrollment target

Study Summary

This protocol represents a continuation of a series of prospective studies to define the incidence and etiology of transfusion-associated hepatitis (TAH) and to examine the impact on TAH of various modifications in the selection of blood donors. The primary goal of the study will be to determine TAH incidence after the institution of a variety of interventive measures to exclude hepatitis and AIDS virus carriers: including surrogate assays (ALT, anti-HBc), a specific assay for the hepatitis C virus (HCV), a specific assay for the human immunodeficiency virus (HIV) and intensified donor questioning for high-risk behavior patterns. There is high probability that the exclusion of donors at high risk for AIDS transmission will also exclude donors at high risk for hepatitis transmission. Incidence data obtained in the study will be enhanced by the simultaneous follow-up of a control population undergoing identical surgical procedures, but receiving no blood or only autologous blood. This control population, made possible by the recent dramatic increase in the amount of autologous blood utilized, will allow for a clear distinction between transfusion-associated hepatitis and that due to nosocomial transmission or other background causes of hepatocellular inflammation in cardiac surgery patients.

Trial Details

FieldValue
Enrollment Target 2,000 participants
Start Date 1981-07
Est. Completion 2000-05

What the finished NCT00004848 record still lists

NCT00004848 is an observational study that tracks outcomes without assigning an intervention. Its 2,000 participants enrollment target places it among the larger protocols in the corpus.

The record links to 0 conditions, and to 0 interventions.

NCT00004848 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00004848 about?

NCT00004848 is a clinical study titled "A Controlled Prospective Study of Transfusion-Associated Hepatitis". This protocol represents a continuation of a series of prospective studies to define the incidence and etiology of transfusion-associated hepatitis (TAH) and to examine the impact on TAH of various modifications in the selection of blood donors. The primary goal of the study will be to determine TA...

What is the current status of trial NCT00004848?

This trial is currently completed. The enrollment target is 2,000 participants. The study started on 1981-07. Estimated completion is 2000-05.

Who is sponsoring clinical trial NCT00004848?

This trial is sponsored by National Institutes of Health Clinical Center (CC), which has 338 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT00004848, the US trial registry maintained by the National Library of Medicine. NCT00004848 (large enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.