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A Controlled Prospective Study of Transfusion-Associated Hepatitis

Primary Purpose

Hepatitis

Status
Completed
Phase
Locations
United States
Study Type
Observational
Intervention
Sponsored by
National Institutes of Health Clinical Center (CC)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Hepatitis focused on measuring AIDS, Autologous Blood, Cardiac Surgery, HIV, Hepatocellular Inflammation, Liver Biopsy, Long Term Sera Storage, Non-A Hepatitis, Non-B Hepatitis

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Warren G. Magnuson Clinical Center (CC)

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
March 2, 2000
Last Updated
March 3, 2008
Sponsor
National Institutes of Health Clinical Center (CC)
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1. Study Identification

Unique Protocol Identification Number
NCT00004848
Brief Title
A Controlled Prospective Study of Transfusion-Associated Hepatitis
Official Title
A Controlled Prospective Study of Transfusion-Associated Hepatitis
Study Type
Observational

2. Study Status

Record Verification Date
July 1999
Overall Recruitment Status
Completed
Study Start Date
July 1981 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2000 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Institutes of Health Clinical Center (CC)

4. Oversight

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis
Keywords
AIDS, Autologous Blood, Cardiac Surgery, HIV, Hepatocellular Inflammation, Liver Biopsy, Long Term Sera Storage, Non-A Hepatitis, Non-B Hepatitis

7. Study Design

Enrollment
2000 (false)

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Warren G. Magnuson Clinical Center (CC)
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
6437308
Citation
Stevens CE, Aach RD, Hollinger FB, Mosley JW, Szmuness W, Kahn R, Werch J, Edwards V. Hepatitis B virus antibody in blood donors and the occurrence of non-A, non-B hepatitis in transfusion recipients. An analysis of the Transfusion-Transmitted Viruses Study. Ann Intern Med. 1984 Dec;101(6):733-8. doi: 10.7326/0003-4819-101-6-733.
Results Reference
background
PubMed Identifier
3006567
Citation
Koziol DE, Holland PV, Alling DW, Melpolder JC, Solomon RE, Purcell RH, Hudson LM, Shoup FJ, Krakauer H, Alter HJ. Antibody to hepatitis B core antigen as a paradoxical marker for non-A, non-B hepatitis agents in donated blood. Ann Intern Med. 1986 Apr;104(4):488-95. doi: 10.7326/0003-4819-104-4-488.
Results Reference
background

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A Controlled Prospective Study of Transfusion-Associated Hepatitis

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