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A Controlled Prospective Study of Transfusion-Associated Hepatitis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00004848
First Posted: December 10, 2002
Last Update Posted: March 4, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Institutes of Health Clinical Center (CC)
  Purpose

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.


Condition
Hepatitis

Study Type: Observational
Official Title: A Controlled Prospective Study of Transfusion-Associated Hepatitis

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 2000
Study Start Date: July 1981
Estimated Study Completion Date: May 2000
Detailed Description:

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Consecutive patients undergoing open-heart surgery at Georgetown University and Fairfax Hospital will be admitted to the study if:

They are 18 years of age or older;

They provide informed consent;

They reside in the United States and will be available for at least six months of follow up.

Patients with known hepatitis C or hepatitis B virus carriers with or without evidence of chronic hepatitis will be excluded.

Persons with a history of prior hepatitis will not be excluded, but will be analyzed as a separate cohort.

Patients with close exposure (household or sexual contact) to hepatitis in the preceding six months will be excluded.

Patients with elevated pre-operative alanine aminotransferase (ALT) will be excluded. An aspartate aminotransferase (AST) of between 45 and 75 IU per L will not serve as cause for exclusion if the corresponding ALT is normal on at least two occasions.

A preoperative AST greater than 75 IU/L will serve to exclude patients from study independent of the ALT.

Patients with blood transfusion in the six months preceding surgery will be excluded. Patients will also be retrospectively excluded if they receive blood more than one month after surgery.

The six month followup period will be timed from the date of the last transfusion.

Patients with alcoholism or other known liver or active biliary tract disease at the time of entrance into the study will be excluded.

Patients with inadequate veins from which to obtain required samples will be excluded.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004848


Locations
United States, Maryland
Warren G. Magnuson Clinical Center (CC)
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Institutes of Health Clinical Center (CC)
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00004848     History of Changes
Other Study ID Numbers: 810110
81-CC-0110
First Submitted: March 2, 2000
First Posted: December 10, 2002
Last Update Posted: March 4, 2008
Last Verified: July 1999

Keywords provided by National Institutes of Health Clinical Center (CC):
AIDS
Autologous Blood
Cardiac Surgery
HIV
Hepatocellular Inflammation
Liver Biopsy
Long Term Sera Storage
Non-A Hepatitis
Non-B Hepatitis

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections