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Transfusion Safety Study (TSS)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00005301
First Posted: May 26, 2000
Last Update Posted: April 15, 2016
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 Heart, Lung, and Blood Institute (NHLBI)
  Purpose
To evaluate factors influencing the risk of transfusion-transmitted human immunodeficiency virus (HIV) infection and its progression to clinically significant manifestations.

Condition
Acquired Immunodeficiency Syndrome Blood Transfusion HIV Infections

Study Type: Observational

Resource links provided by NLM:


Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Study Start Date: September 1984
Estimated Study Completion Date: February 1998
  Show Detailed Description

  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:   up to 100 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria
No eligibility criteria
  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): NCT00005301


Sponsors and Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
OverallOfficial: James Mosley
  More Information

Publications:
Niland-Weiss J, Azen SP, Odom-Maryon T, Lui F, Hagerty C. A microcomputer-based distributed data management system for a large cooperative study of transfusion associated acquired immunodeficiency syndrome. Comput Biomed Res. 1987 Jun;20(3):225-43.
Fletcher MA, Baron GC, Ashman MR, Fischl MA, Klimas NG. Use of whole blood methods in assessment of immune parameters in immunodeficiency states. Diagn Clin Immunol. 1987;5(2):69-81.
Perkins HA, Cordell R, Bueno C, Shiota J, Hitchcock B. The progressive decrease in the proportion of blood donors with antibody to the human immunodeficiency virus (HIV). Transfusion. 1987 Nov-Dec;27(6):502-3.
Kaplan J, Sarnaik I, Lusher J. Increase in Leu 2+ Leu 7+ lymphocytes in HIV 1-seropositive patients with hemophilia repeatedly treated with clotting factor concentrates. Clin Immunol Immunopathol. 1988 Mar;46(3):337-41.
Brown NA, Kovacs A, Lui CR, Hur C, Zaia JA, Mosley JW. Prevalence of antibody to human herpesvirus 6 among blood donors infected with HIV. Lancet. 1988 Nov 12;2(8620):1146.
Aledort LM. Blood products and immune changes: impacts without HIV infection. Semin Hematol. 1988 Apr;25(2 Suppl 1):14-9.
Bishop PC, Boone D, Parker JW. Immunophenotypes by flow cytometry: a longitudinal study in healthy individuals. Diagn Clin Immunol. 1988;5(5):232-40.
Gjerset GF, Vyas GN, Bhat R, Operskalski EA. Phenotypes for group-specific component among patients exposed to human immunodeficiency virus by transfusions. J Infect Dis. 1988 Mar;157(3):609-10.
Govindarajan S, Edwards VM, Stuart ML, Operskalski EA, Mosley JW and the Transfusion Safety Study Group: Influence of Human Immunodeficiency Virus Infection Upon Expression of Chronic Hepatitis B and D Virus Infections. In: Zuckerman AJ (Ed), Viral Hepatitis and Liver Disease, Alan R Liss, Inc, New York, pp 210-214, 1988
McClure E, Gaynor S, Veiga-Benach A, O'Neil D, and the Transfusion Safety Study Group: Notification of Recipients of Human Immunodeficiency Virus (HIV) Antibody Positive Transfusions. Nursing, Jan; 10, 1989
Norman GL, Barker SS, Rasheed S. Immunoblot reactivity of a non-HIV protein with human sera. Transfusion Safety Study Group. J Clin Lab Anal. 1989;3(3):148-51.
Mosley JW, Nowicki M, Kleinman SH, Dietrich SL and the Transfusion Safety Study Group: Reactivation of Hepatitis B. Lancet, 1:1083-1084, 1989
Fletcher MA, Azen SP, Adelsberg B, Gjerset G, Hassett J, Kaplan J, Niland JC, Odom-Maryon T, Parker JW, Stites DP, et al. Immunophenotyping in a multicenter study: the Transfusion Safety Study experience. Clin Immunol Immunopathol. 1989 Jul;52(1):38-47.
Kleinman SH, Niland JC, Azen SP, Operskalski EA, Barbosa LH, Chernoff AI, Edwards VM, Lenes BA, Marshall GJ, Nemo GJ, et al. Prevalence of antibodies to human immunodeficiency virus type 1 among blood donors prior to screening. The Transfusion Safety Study/NHLBI Donor Repository. Transfusion. 1989 Sep;29(7):572-80.
Lang DJ, Kovacs AA, Zaia JA, Doelkin G, Niland JC, Aledort L, Azen SP, Fletcher MA, Gauderman J, Gjerset GJ, et al. Seroepidemiologic studies of cytomegalovirus and Epstein-Barr virus infections in relation to human immunodeficiency virus type 1 infection in selected recipient populations. Transfusion Safety Study Group. J Acquir Immune Defic Syndr. 1989;2(6):540-9.
Operskalski EA, Schiff ER, Kleinman SH, Busch M, Taylor PE, Parks WP, Lee H, Tomasulo PA, Donegan E, Stuart M, et al. Epidemiologic background of blood donors with antibody to human T-cell lymphotropic virus. Transfusion Safety Study Group. Transfusion. 1989 Oct;29(8):746-8.
Edwards VM, Mosley JW. Reproducibility in quality control of protein (Western) immunoblot assay for antibodies to human immunodeficiency virus. Am J Clin Pathol. 1989 Jan;91(1):75-8.
Parker JW, Adelsberg B, Azen SP, Boone D, Fletcher MA, Gjerset GF, Hassett J, Kaplan J, Niland JC, Odom-Maryon T, et al. Leukocyte immunophenotyping by flow cytometry in a multisite study: standardization, quality control, and normal values in the Transfusion Safety Study. The Transfusion Safety Study Group. Clin Immunol Immunopathol. 1990 May;55(2):187-220.
Donegan E, Busch MP, Galleshaw JA, Shaw GM, Mosley JW. Transfusion of blood components from a donor with human T-lymphotropic virus type II (HTLV-II) infection. The Transfusion Safety Study Group. Ann Intern Med. 1990 Oct 1;113(7):555-6.
Busch MP, Donegan E, Stuart M, Mosley JW. Donor HIV-1 p24 antigenaemia and course of infection in recipients Transfusion Safety Study Group. Lancet. 1990 Jun 2;335(8701):1342.
Busch MP, Taylor PE, Lenes BA, Kleinman SH, Stuart M, Stevens CE, Tomasulo PA, Allain JP, Hollingsworth CG, Mosley JW. Screening of selected male blood donors for p24 antigen of human immunodeficiency virus type 1. The Transfusion Safety Study Group. N Engl J Med. 1990 Nov 8;323(19):1308-12.
Dietrich SL, Mosley JW, Lusher JM, Hilgartner MW, Operskalski EA, Habel L, Aledort LM, Gjerset GF, Koerper MA, Lewis BH, et al. Transmission of human immunodeficiency virus type 1 by dry-heated clotting factor concentrates. Transfusion Safety Study Group. Vox Sang. 1990;59(3):129-35.
Donegan E, Stuart M, Niland JC, Sacks HS, Azen SP, Dietrich SL, Faucett C, Fletcher MA, Kleinman SH, Operskalski EA, et al. Infection with human immunodeficiency virus type 1 (HIV-1) among recipients of antibody-positive blood donations. Ann Intern Med. 1990 Nov 15;113(10):733-9.
Busch MP, Young MJ, Samson SM, Mosley JW, Ward JW, Perkins HA. Risk of human immunodeficiency virus (HIV) transmission by blood transfusions before the implementation of HIV-1 antibody screening. The Transfusion Safety Study Group. Transfusion. 1991 Jan;31(1):4-11.
Parks WP, Lenes BA, Tomasulo PA, Schiff ER, Parks ES, Shaw GM, Lee H, Yan HQ, Lai S, Hollingsworth CG, et al. Human T-cell lymphotropic virus infection among blood donors in south Florida. The Transfusion Safety Study Group. J Acquir Immune Defic Syndr. 1991;4(1):89-96.
Aledort LM, Hilgartner MW, Pike MC, Gjerset GF, Koerper MA, Lian EY, Lusher JM, Mosley JW. Variability in serial CD4 counts and relation to progression of HIV-I infection to AIDS in haemophilic patients. Transfusion Safety Study Group. BMJ. 1992 Jan 25;304(6821):212-6.
Busch MP, Henrard DR, Hewlett IK, Mehaffey WF, Epstein JS, Allain JP, Lee TH, Mosley JW. Poor sensitivity, specificity, and reproducibility of detection of HIV-1 DNA in serum by polymerase chain reaction. The Transfusion Safety Study Group. J Acquir Immune Defic Syndr. 1992;5(9):872-7.
Fletcher MA, Mosley JW, Hassett J, Gjerset GF, Kaplan J, Parker JW, Donegan E, Lusher JM, Lee H. Effect of age on human immunodeficiency virus type 1-induced changes in lymphocyte populations among persons with congenital clotting disorders. Transfusion Safety Study Group. Blood. 1992 Aug 1;80(3):831-40.
Donegan E, Pell P, Lee H, Shaw GM, Mosley JW. Transmission of human T-lymphotropic virus type I by blood components from a donor lacking anti-p24: a case report. The Transfusion Safety Study Group. Transfusion. 1992 Jan;32(1):68-71.
Fletcher MA, Gjerset GF, Hassett J, Donegan E, Parker JW, Mosley JW. Lymphocyte immunophenotypes among anti-HTLV-I/II-positive blood donors and recipients. The Transfusion Safety Study Group. J Acquir Immune Defic Syndr. 1991;4(6):628-32.
Buckley JD, Pike MC, Mosley JW. Statistical approaches to evaluating prognostic indices in HIV infection. The Transfusion Safety Study Group. AIDS. 1991 Nov;5(11):1398.
Odom-Maryon T, Langholz B, Niland J, Azen S. Generalization of normal discriminant analysis using Fourier series density estimators. Transfusion Safety Study Group. Stat Med. 1991 Mar;10(3):473-85.
Miller K, Donegan E, Curran P, Shelley TJ. Effects of counselling on knowledge about HIV-1 among transfusion recipients and their partners. Transfusion Safety Study Group. AIDS Care. 1990;2(2):155-62.
Operskalski EA, Stram DO, Lee H, Zhou Y, Donegan E, Busch MP, Stevens CE, Schiff ER, Dietrich SL, Mosley JW. Human immunodeficiency virus type 1 infection: relationship of risk group and age to rate of progression to AIDS. Transfusion Safety Study Group. J Infect Dis. 1995 Sep;172(3):648-55.
Diaz RS, Sabino EC, Mayer A, Mosley JW, Busch MP. Dual human immunodeficiency virus type 1 infection and recombination in a dually exposed transfusion recipient. The Transfusion Safety Study Group. J Virol. 1995 Jun;69(6):3273-81.
Wong WY, Powars DR, Operskalski EA, Hassett J, Parker JW, Sarnaik S, Pegelow CH, Hilgartner MW, Johnson CS, Zhou Y, et al. Blood transfusions and immunophenotypic alterations of lymphocyte subsets in sickle cell anemia. The Transfusion Safety Study Group. Blood. 1995 Apr 15;85(8):2091-7.
Busch MP, Operskalski EA, Mosley JW, Stevens CE, Schiff ER, Kleinman SH, Lee H, Lee M, Harris M. Epidemiologic background and long-term course of disease in human immunodeficiency virus type 1-infected blood donors identified before routine laboratory screening. Transfusion Safety Study Group. Transfusion. 1994 Oct;34(10):858-64.
Hilgartner M. Results of the transfusion safety study. Ann Hematol. 1994;68 Suppl 3:S59.
Hilgartner MW. Changes in CD4 count relative to product usage: findings from the transfusion safety study. Semin Hematol. 1993 Oct;30(4 Suppl 5):7-9. Review.
Hilgartner MW, Buckley JD, Operskalski EA, Pike MC, Mosley JW. Purity of factor VIII concentrates and serial CD4 counts. The Transfusion Safety Study Group. Lancet. 1993 May 29;341(8857):1373-4.
Mosley JW. Low CD4+ counts in a study of transfusion safety: correction. N Engl J Med. 1993 Apr 15;328(15):1128.
Aledort LM, Operskalski EA, Dietrich SL, et al: Low CD4+ counts in a study of transfusion safety. The Transfusion Safety Study Group [letter] [published erratum appears in N Engl J Med 1993 Apr 15;328(15):1128]. Comment in: N Engl J Med, 328(6):429-431, 1993. N Engl J Med, 328(6):441-442, 1993
Mosley JW, Nowicki MJ, Kasper CK, Donegan E, Aledort LM, Hilgartner MW, Operskalski EA. Hepatitis A virus transmission by blood products in the United States. Transfusion Safety Study Group. Vox Sang. 1994;67 Suppl 1:24-8.
Hassett J, Gjerset GF, Mosley JW, Fletcher MA, Donegan E, Parker JW, Counts RB, Aledort LM, Lee H, Pike MC. Effect on lymphocyte subsets of clotting factor therapy in human immunodeficiency virus-1-negative congenital clotting disorders. The Transfusion Safety Study Group. Blood. 1993 Aug 15;82(4):1351-7.
Adams M, Lee TH, Busch MP, Heitman J, Marshall GJ, Gjerset GF, Mosley JW. Rapid freezing of whole blood or buffy coat samples for polymerase chain reaction and cell culture analysis: application to detection of human immunodeficiency virus in blood donor and recipient repositories. The Transfusion Safety Study Group. Transfusion. 1993 Jun;33(6):504-8.
Operskalski EA, Busch MP, Mosley JW, Stram DO. Comparative rates of disease progression among persons infected with the same or different HIV-1 strains. The Transfusion Safety Study Group. J Acquir Immune Defic Syndr Hum Retrovirol. 1997 Jun 1;15(2):145-50.
Operskalski EA, Mosley JW, Busch MP, Stram DO. Influences of age, viral load, and CD4+ count on the rate of progression of HIV-1 infection to AIDS. Transfusion Safety Study Group. J Acquir Immune Defic Syndr Hum Retrovirol. 1997 Jul 1;15(3):243-4.
Wong WY, Zhou Y, Operskalski EA, Hassett J, Powars DR, Mosley JW. Hematologic profile and lymphocyte subpopulations in hemoglobin SC disease: comparison with hemoglobin SS and black controls. The Transfusion Safety Study Group. Am J Hematol. 1996 Jul;52(3):150-4.
Busch MP, Operskalski EA, Mosley JW, Lee TH, Henrard D, Herman S, Sachs DH, Harris M, Huang W, Stram DO. Factors influencing human immunodeficiency virus type 1 transmission by blood transfusion. Transfusion Safety Study Group. J Infect Dis. 1996 Jul;174(1):26-33.
Kedes DH, Operskalski E, Busch M, Kohn R, Flood J, Ganem D. The seroepidemiology of human herpesvirus 8 (Kaposi's sarcoma-associated herpesvirus): distribution of infection in KS risk groups and evidence for sexual transmission. Nat Med. 1996 Aug;2(8):918-24. Erratum in: Nat Med 1996 Sep;2(9):1041.
Gjerset GF, Pike MC, Mosley JW, Hassett J, Fletcher MA, Donegan E, Parker JW, Counts RB, Zhou Y, Kasper CK, et al. Effect of low- and intermediate-purity clotting factor therapy on progression of human immunodeficiency virus infection in congenital clotting disorders. Transfusion Safety Study Group. Blood. 1994 Sep 1;84(5):1666-71.
Diaz RS, Zhang L, Busch MP, Mosley JW, Mayer A. Divergence of HIV-1 quasispecies in an epidemiologic cluster. AIDS. 1997 Mar 15;11(4):415-22.
Zhang L, Diaz RS, Ho DD, Mosley JW, Busch MP, Mayer A. Host-specific driving force in human immunodeficiency virus type 1 evolution in vivo. J Virol. 1997 Mar;71(3):2555-61.
Diaz RS, Sabino EC, Mayer A, deOliveira CF, Mosley JW, Busch MP. Lack of dual HIV infection in a transfusion recipient exposed to two seropositive blood components. AIDS Res Hum Retroviruses. 1996 Sep 1;12(13):1291-5.
Mosley JW. Has hepatitis A virus been transmitted by clotting factor concentrates among hemophiliacs in the United States? Vox Sang. 1994;67 Suppl 4:12-5; discussion 24-6. Review.
Operskalski EA, Stram DO, Busch MP, Huang W, Harris M, Dietrich SL, Schiff ER, Donegan E, Mosley JW. Role of viral load in heterosexual transmission of human immunodeficiency virus type 1 by blood transfusion recipients. Transfusion Safety Study Group. Am J Epidemiol. 1997 Oct 15;146(8):655-61.
Vasil'eva VF, Vorob'eva KP. [Study of magnesium transport in the dog kidney by the method of stopping urine emission in chronic experiments]. Fiziol Zh SSSR Im I M Sechenova. 1975 Jan;61(1):130-5. Russian.
Wilkinson DA, Operskalski EA, Busch MP, Mosley JW, Koup RA. A 32-bp deletion within the CCR5 locus protects against transmission of parenterally acquired human immunodeficiency virus but does not affect progression to AIDS-defining illness. J Infect Dis. 1998 Oct;178(4):1163-6.

Study Data/Documents: Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: TSS
Samples and characterization data. NHLBI provides controlled access to samples through BioLINCC. Access requires registration, evidence of local IRB approval or certification of exemption from IRB review, and completion of a materials use agreement.

ClinicalTrials.gov Identifier: NCT00005301     History of Changes
Other Study ID Numbers: 3002
First Submitted: May 25, 2000
First Posted: May 26, 2000
Last Update Posted: April 15, 2016
Last Verified: August 2001

Additional relevant MeSH terms:
HIV Infections
Immunologic Deficiency Syndromes
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immune System Diseases
Slow Virus Diseases


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