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Amini-kafiabad S, Teimourpour A, Rafiee M, Maghsudlu M, Moghtadaee M. Analysis of Trends in Lookback Units Based on Post-Donation information in Plasma Shipments for Contract fractionation, 2018-2021. Sci J Iran Blood Transfus Organ 2025; 22 (1) :1-11
URL: http://bloodjournal.ir/article-1-1570-en.html
Analysis of Trends in Lookback Units Based on Post-Donation information in Plasma Shipments for Contract fractionation, 2018-2021
S. Amini-kafiabad * , A. Teimourpour , M.H. Rafiee , M. Maghsudlu , M. Moghtadaee
Keywords: Plasma, Plasma fractionation, Blood Donors, Blood Safety
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Sci J Iran Blood Transfus Organ 2025;22 (1): 1-11
Original Article
 
Analysis of Trends in Lookback Units Based on
Post-Donation information in Plasma Shipments
 for Contract fractionation, 2018-2021
 ‎
Amini-Kafiabad S.1, Teimourpour A.2, Rafiee M.H.1, Maghsudlu M.1, Moghtadaee M.1

 
1Blood Transfusion Research Center, High Institute For Research and Education in Transfusion Medicine, Tehran, Iran
2Biological Products and Blood Safety Resaerch Center, High Institute for Research and Education in Transfusion Medicine, Tehran, Iran


Abstract
Background and Objectives
With the establishment of the lookback process in the country, an essential part of the lookback in 2006 is based on post-donation information which is crucial in ensuring blood safety. The most important item in post-donation information is donor high-risk behaviors that were not disclosed during the donor selection process. In this study, trends in lookback units related to high-risk behaviors in plasma for contract fractionation were examined over time.

Materials and Methods
This cross-sectional study collected data from authorized blood transfusion centers and categorized them according to risk factor categories. The Cochran-Armitage test was employed to assess the linear trend in lookback risk over time and to separate the different causes of lookback related to high-risk behaviors. The relative risk index was calculated and reported as the effect size of the Cochran-Armitage test with a 95% confidence interval using the epitools package of R software.

Results
The number of lookback units based on post-donation information decreased during the study (RR: 0.73; 95% CI: 0.68-0.78; p< 0.001). Furthermore, significant changes were observed in trends of risk factors leading to lookbacks, including drug abuse (p= 0.001), high-risk sexual behavior (p< 0.001) with the decreasing trend, and tattoos (p= 0.01), cupping (Hijama) and acupuncture (p< 0.001) with the increasing trend.

Conclusions 
According to this study, in the donor selection process, it is recommended to pay more attention to high-risk behaviors that are important in the number of lookback units and blood safety.

Key words: Plasma, Plasma fractionation, Blood Donors, Blood Safety



Received: 25 Jan  2025
Accepted:  5 Mar 2025



Correspondence: Amini Kafi-Abad S., MD. Pathologist. Professor of Blood Transfusion Research Center, High Institute for Research and Education in Transfusion Medicine.
P.O.Box: 14665-1157, Tehran, Iran. Tel: (+9821) 88601573; Fax: (+9821) 88601555
E-mail: s.amini@ibto.ir






References:
  1. Amini Kafi-abad S, Rezvan H, Abolghasemi H, Talebian A. Prevalence and trends of human immunodeficiency virus, hepatitis B virus, and hepatitis C virus among blood donors in Iran, 2004 through 2007. Transfusion 2009; 49(10): 2214-20.
  2. Cohn Claudia S, Delaney M, Johnson ST, Louis MK. Technical Manual. 21st ed. USA: AABB; 2023. p. 169-214.
  3. WHO. Blood donor counselling: implementation guidelines. USA: WHO; 2014.
  4. WHO. Blood donor selection: guidelines on assessing donor suitability for blood donation. USA: WHO; 2012.
  5. WHO. Guidelines for blood donor counselling on human immunodeficiency virus (‎HIV). USA: WHO; 1994.
  6. Byrne L, Brant LJ, Davison K, Hewitt P. Transfusion transmitted human immunodeficiency virus (HIV) from seroconverting donors is rare in England and Wales: results from HIV lookback, October 1995 through December 2008. Transfusion 2011; 51(6): 1339-45.
  7. Gill M, Towns D, Allaire S, Meyers G. Transmission of human immunodeficiency virus through blood transfusion: the use of lookback and traceback approaches to optimize recipient identification in a regional population. Transfusion 1997; 37(5): 513-6.
  8. FDA. Nucleic Acid Testing (NAT) for Human Immunodeficiency Virus Type 1 (HIV-1) and HepatitisC Virus (HCV): Testing, Product Disposition, and Donor Deferral and Reentry. USA: Department of Health and Human Sciences; 2017.
  9. FDA. Guidance for Industry: “Lookback” for Hepatitis C Virus HCV): Product Quarantine, Consignee Notification, Further Testing, Product Disposition, and Notification of Transfusion Recipients Based on Donor Test Results Indicating Infection with HCV. USA: Department of Health and Human Sciences; 2013.
  10. Pawson R, Rajan S, Hazlehurst G, Dusheiko G, Miller R, Hewitt P, et al. Hepatitis C lookback programme: a single hospital experience. Transfus Med 1999; 9(3): 189-93. 
  11. Christensen PB, Groenbæk K, Krarup HB, Gaub J, Møller A, Skinhøj P, et al. Transfusion-acquired hepatitis C: the Danish lookback experience. Transfusion 1999; 39(2): 188-93.
  12. Tynell E. Prevention of transfusion transmitted infections. Donor screening and characteristics of recipient populations [Thesis]. Stockholm: Karolinska University; 2005. p. 29-30.
  13. Menozzi D, Udulutch T, Llosa AE, Galel SA. HCV lookback in the United States: effectiveness of an extended lookback program. Transfusion 2000; 40(11): 1393-8.
  14. IBTO. Iranian National Standards for Blood Transfusion. 3rd ed. Tehran: Teimourzadeh Pub; 2016. p. 33. [Persian]
  15. JPAC. Chapter 5.7: Whole blood  donation.  Guidelines for the Blood Transfusion and Tissue Transplantation Services in the UK. https://www. transfusionguidelines. org. Accessed 24 October 2024.
  16. Health Canada. Guidance Document: Blood Regulations. Canada: Health Canada; 2016. p. 242.
  17. Vuk T, Garraud O, Politis C. Post-donation information management. Transfus Clin Biol 2021; 28(4): 407-13.
  18. Teimourpour A, Moghtadaee M, Amini-Kafiabad S, Maghsoodlu M, Rafiee M. Investigating the trend of look-back units in the plasma for contract fractionation during 2018-2021. Sci J  Iran Blood Transfus Organ 2024; 21(3): 185-96. [Article in Farsi]
  19. FDA. Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products. USA: Department of Health and Human Sciences; 2020.
  20. Kiely P, Hoad VC, Wood EM. False positive viral marker results in blood donors and their unintended consequences. Vox Sang 2018; 113(6): 530-9.
  21. Ramsey G. Blood component recalls and market withdrawals: frequency, reasons, and management in the United States. Transfus Med Rev 2013; 27(2): 82-90.
  22. Williams AE, Thomson RA, Schreiber GB, Watanabe K, Bethel J, Lo A, et al. Estimates of infectious disease risk factors in US blood donors. JAMA 1997; 277(12): 967-72.
  23. Agresti A. Categorical Data Analysis. USA: John Wiley & Sons; 2018. p. 46.
  24. Rafiee MH, Kafiabad SA, Maghsudlu M. Analysis of blood donors’ characteristics and deferrals related to COVID-19 in Iran. Transfus Apher Sci 2021; 60(2): 103049.
  25. Iranian Blood Transfusion Organization's Booklet; 2023. Available from: https://en.ibto.ir/uploads/En-ketabche1-final.pdf.
  26. Ranjbar Kermani F, Chegini A, Sharifi Sh, Zadsar M. Changing Blood Donor’s Characteristics after COVID-19 Emergence, the Young and Female Blood Donors’ Role to Maintain A Safe Supply. Iranian Red Crescent Medical Journal (IRCMJ) 2024; 26(1): 1-7.
  27. Divkolaye N, Arabkhazaeli A, Hajibeigi B, Eshghi P. The impact of COVID-19 on blood safety and availability in the Islamic Republic of Iran. East Mediterr Health J 2022; 28(11): 823-8.
  28. Conti G, Notari IV EP, Dodd RY, Kessler D, Custer B, Bruhn R, et al. Changes in transfusion-transmissible infection prevalence and demographics among US blood donors during the COVID-19 pandemic. Transfusion 2024; 64(6): 1040-9.
  29. Burananayok S, Nachatri W, Choothanorm P, Kusolthammarat K, Jaruthamsophon K, Yodsawad C, et al. COVID-19 impact on blood donor characteristics and seroprevalence of transfusion-transmitted infections in southern Thailand between 2018 and 2022. Sci Rep 2024; 14(1): 7920.
  30. Loua A, Kasilo OMJ, Nikiema JB, Sougou AS, Kniazkov S, Annan EA. Impact of the COVID-19 pandemic on blood supply and demand in the WHO African region. Vox Sang 2021; 116(7): 774-84.
  31. Yazer MH, Jackson B, Pagano M, Rahimi-Levene N, Peer V, Bueno JL, et al. Vox Sanguinis international forum on transfusion services' response to COVID-19: summary. Vox Sang 2020; 115(6): 536.
  32. Franchini M, Farrugia A, Velati C, Zanetti A, Romanò L, Grazzini G, et al. The impact of the SARS-CoV-2 outbreak on the safety and availability of blood transfusions in Italy. Vox Sang 2020; 115(8): 603.
  33. Seighali F, Divkolaye NSH, Rezaei N, Kangarloo M. Risk factors associated with human immunodeficiency virus infection in blood donors in Iran: A case–control study. Asian J Transfus Sci 2021; 15(2): 183-8.
  34. Rezaei N, Amini-Kafiabad S, Maghsudlu M, Abolghasemi H. Risk factor analysis of hepatitis C virus seropositivity in Iranian blood donors: a case-control study. Transfusion 2016; 56(7): 1891-8.
  35. Ranjbar Kermani F, Hosseini KM, Kafi-abad SA, Maghsudlu M, Sharifi Z, Mansournia MA, et al. Update on transmission modes of hepatitis C virus among volunteer Iranian blood donors: analysis of a matched case-control study by penalized conditional logistic regression. Hepat Mon 2018; 18(10): e69395.
  36. Lieshout-Krikke RW, van 't Ende EA, Slot E, Karomi S, Kivit RM, Zaaijer HL. Infectivity of pre-seroconversion donations: an analysis of lookback exercises in The Netherlands, 2000-2006. Vox Sang 2012; 102(3): 193-7. 

 
Type of Study: Research | Subject: Blood Transfusion
Published: 2025/03/17
References
1. Amini Kafi-abad S, Rezvan H, Abolghasemi H, Talebian A. Prevalence and trends of human immunodeficiency virus, hepatitis B virus, and hepatitis C virus among blood donors in Iran, 2004 through 2007. Transfusion 2009; 49(10): 2214-20. [DOI:10.1111/j.1537-2995.2009.02245.x] [PMID]
2. Cohn Claudia S, Delaney M, Johnson ST, Louis MK. Technical Manual. 21st ed. USA: AABB; 2023. p. 169-214.
3. WHO. Blood donor counselling: implementation guidelines. USA: WHO; 2014.
4. WHO. Blood donor selection: guidelines on assessing donor suitability for blood donation. USA: WHO; 2012.
5. WHO. Guidelines for blood donor counselling on human immunodeficiency virus (‎HIV). USA: WHO; 1994.
6. Byrne L, Brant LJ, Davison K, Hewitt P. Transfusion transmitted human immunodeficiency virus (HIV) from seroconverting donors is rare in England and Wales: results from HIV lookback, October 1995 through December 2008. Transfusion 2011; 51(6): 1339-45. [DOI:10.1111/j.1537-2995.2010.02996.x] [PMID]
7. Gill M, Towns D, Allaire S, Meyers G. Transmission of human immunodeficiency virus through blood transfusion: the use of lookback and traceback approaches to optimize recipient identification in a regional population. Transfusion 1997; 37(5): 513-6. [DOI:10.1046/j.1537-2995.1997.37597293883.x] [PMID]
8. FDA. Nucleic Acid Testing (NAT) for Human Immunodeficiency Virus Type 1 (HIV-1) and Hepatitis C Virus (HCV): Testing, Product Disposition, and Donor Deferral and Reentry. USA: Department of Health and Human Sciences; 2017.
9. FDA. Guidance for Industry: "Lookback" for Hepatitis C Virus HCV): Product Quarantine, Consignee Notification, Further Testing, Product Disposition, and Notification of Transfusion Recipients Based on Donor Test Results Indicating Infection with HCV. USA: Department of Health and Human Sciences; 2013.
10. Pawson R, Rajan S, Hazlehurst G, Dusheiko G, Miller R, Hewitt P, et al. Hepatitis C lookback programme: a single hospital experience. Transfus Med 1999; 9(3): 189-93. [DOI:10.1046/j.1365-3148.1999.00197.x] [PMID]
11. Christensen PB, Groenbæk K, Krarup HB, Gaub J, Møller A, Skinhøj P, et al. Transfusion-acquired hepatitis C: the Danish lookback experience. Transfusion 1999; 39(2): 188-93. [DOI:10.1046/j.1537-2995.1999.39299154734.x] [PMID]
12. Tynell E. Prevention of transfusion transmitted infections. Donor screening and characteristics of recipient populations [Thesis]. Stockholm: Karolinska University; 2005. p. 29-30.
13. Menozzi D, Udulutch T, Llosa AE, Galel SA. HCV lookback in the United States: effectiveness of an extended lookback program. Transfusion 2000; 40(11): 1393-8. [DOI:10.1046/j.1537-2995.2000.40111393.x] [PMID]
14. IBTO. Iranian National Standards for Blood Transfusion. 3rd ed. Tehran: Teimourzadeh Pub; 2016. p. 33. [Persian]
15. JPAC. Chapter 5.7: Whole blood donation. Guidelines for the Blood Transfusion and Tissue Transplantation Services in the UK. https://www. transfusionguidelines. org. Accessed 24 October 2024.
16. Health Canada. Guidance Document: Blood Regulations. Canada: Health Canada; 2016. p. 242.
17. Vuk T, Garraud O, Politis C. Post-donation information management. Transfus Clin Biol 2021; 28(4): 407-13. [DOI:10.1016/j.tracli.2021.08.006] [PMID]
18. Teimourpour A, Moghtadaee M, Amini-Kafiabad S, Maghsoodlu M, Rafiee M. Investigating the trend of look-back units in the plasma for contract fractionation during 2018-2021. Sci J Iran Blood Transfus Organ 2024; 21(3): 185-96. [Article in Farsi]
19. FDA. Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products. USA: Department of Health and Human Sciences; 2020.
20. Kiely P, Hoad VC, Wood EM. False positive viral marker results in blood donors and their unintended consequences. Vox Sang 2018; 113(6): 530-9. [DOI:10.1111/vox.12675] [PMID]
21. Ramsey G. Blood component recalls and market withdrawals: frequency, reasons, and management in the United States. Transfus Med Rev 2013; 27(2): 82-90. [DOI:10.1016/j.tmrv.2012.11.001] [PMID] []
22. Williams AE, Thomson RA, Schreiber GB, Watanabe K, Bethel J, Lo A, et al. Estimates of infectious disease risk factors in US blood donors. JAMA 1997; 277(12): 967-72. [DOI:10.1001/jama.1997.03540360035027]
23. Agresti A. Categorical Data Analysis. USA: John Wiley & Sons; 2018. p. 46.
24. Rafiee MH, Kafiabad SA, Maghsudlu M. Analysis of blood donors' characteristics and deferrals related to COVID-19 in Iran. Transfus Apher Sci 2021; 60(2): 103049. [DOI:10.1016/j.transci.2020.103049] [PMID] []
25. Iranian Blood Transfusion Organization's Booklet; 2023. Available from: https://en.ibto.ir/uploads/En-ketabche1-final.pdf.
26. Ranjbar Kermani F, Chegini A, Sharifi Sh, Zadsar M. Changing Blood Donor's Characteristics after COVID-19 Emergence, the Young and Female Blood Donors' Role to Maintain A Safe Supply. Iranian Red Crescent Medical Journal (IRCMJ) 2024; 26(1): 1-7.
27. Divkolaye N, Arabkhazaeli A, Hajibeigi B, Eshghi P. The impact of COVID-19 on blood safety and availability in the Islamic Republic of Iran. East Mediterr Health J 2022; 28(11): 823-8. [DOI:10.26719/emhj.22.080] [PMID]
28. Conti G, Notari IV EP, Dodd RY, Kessler D, Custer B, Bruhn R, et al. Changes in transfusion-transmissible infection prevalence and demographics among US blood donors during the COVID-19 pandemic. Transfusion 2024; 64(6): 1040-9. [DOI:10.1111/trf.17851] [PMID]
29. Burananayok S, Nachatri W, Choothanorm P, Kusolthammarat K, Jaruthamsophon K, Yodsawad C, et al. COVID-19 impact on blood donor characteristics and seroprevalence of transfusion-transmitted infections in southern Thailand between 2018 and 2022. Sci Rep 2024; 14(1): 7920. [DOI:10.1038/s41598-024-57584-z] [PMID] []
30. Loua A, Kasilo OMJ, Nikiema JB, Sougou AS, Kniazkov S, Annan EA. Impact of the COVID-19 pandemic on blood supply and demand in the WHO African region. Vox Sang 2021; 116(7): 774-84. [DOI:10.1111/vox.13071] [PMID] []
31. Yazer MH, Jackson B, Pagano M, Rahimi-Levene N, Peer V, Bueno JL, et al. Vox Sanguinis international forum on transfusion services' response to COVID-19: summary. Vox Sang 2020; 115(6): 536. [DOI:10.1111/vox.12943] [PMID] []
32. Franchini M, Farrugia A, Velati C, Zanetti A, Romanò L, Grazzini G, et al. The impact of the SARS-CoV-2 outbreak on the safety and availability of blood transfusions in Italy. Vox Sang 2020; 115(8): 603. [DOI:10.1111/vox.12928] [PMID] []
33. Seighali F, Divkolaye NSH, Rezaei N, Kangarloo M. Risk factors associated with human immunodeficiency virus infection in blood donors in Iran: A case-control study. Asian J Transfus Sci 2021; 15(2): 183-8. [DOI:10.4103/ajts.AJTS_47_18] [PMID] []
34. Rezaei N, Amini-Kafiabad S, Maghsudlu M, Abolghasemi H. Risk factor analysis of hepatitis C virus seropositivity in Iranian blood donors: a case-control study. Transfusion 2016; 56(7): 1891-8. [DOI:10.1111/trf.13660] [PMID]
35. Ranjbar Kermani F, Hosseini KM, Kafi-abad SA, Maghsudlu M, Sharifi Z, Mansournia MA, et al. Update on transmission modes of hepatitis C virus among volunteer Iranian blood donors: analysis of a matched case-control study by penalized conditional logistic regression. Hepat Mon 2018; 18(10): e69395. [DOI:10.5812/hepatmon.69395]
36. Lieshout-Krikke RW, van 't Ende EA, Slot E, Karomi S, Kivit RM, Zaaijer HL. Infectivity of pre-seroconversion donations: an analysis of lookback exercises in The Netherlands, 2000-2006. Vox Sang 2012; 102(3): 193-7. [DOI:10.1111/j.1423-0410.2011.01537.x] [PMID]
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