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HEALTH HANOI MEDICAL UNIVERSITY HA HUU NGUYEN STUDY OF CHANGES IN SOME HEMATOLOGICAL INDICES, SERUM IRON, AND THE RESULTS OF IRON SUPPLEMENTATION IN REPEAT BLOOD DONORS AT THE NATION

HEALTH HANOI MEDICAL UNIVERSITY

HA HUU NGUYEN

STUDY OF CHANGES IN SOME HEMATOLOGICAL

INDICES, SERUM IRON, AND THE RESULTS OF

IRON SUPPLEMENTATION IN REPEAT BLOOD DONORS

AT THE NATIONAL INSTITUTE OF HEMATOLOGY

AND BLOOD TRANSFUSION

ABSTRACT OF THESIS

HANOI – 2024

HANOI MEDICAL UNIVERSITY

Supervisors:

1 Assoc Bui Thi Mai An, MD, PhD

2 Bach Quoc Khanh, MD, PhD

1 Ha Huu Nguyen, Bui Thi Mai An, Bach Quoc Khanh (2020) Study some characteristics of hematological indices, serum iron, and serum ferritin in repeat blood donors at the National Institute

of Hematology and Blood Transfusion Vietnam Medical Journal, Volume 496, pp.33-37

2 Ha Huu Nguyen, Bach Quoc Khanh, Bui Thi Mai An (2021) Some factors related to decreased serum iron and ferritin concentrations

in donors repeat blood at the National Institute of Hematology and

Blood Transfusion Ho Chi Minh City Journal of Medicine,

Volume 25, No 6, pp 174-179

INTRODUCTION

1 Stating the problem

Up to now, there is no substitute for blood, so there is a safe and stable source of volunteer blood donor (VBD) to provide blood for treatment According to WHO estimates, in 2018 there were 118.5 million fans in 171 countries, including 106.1 million fans donating whole blood and 12.4 million fans donating partial blood According to recommendations of the World Health Organization, having a safe source

of VBD is also one of the measures to ensure blood transfusion safety The rate of VBD in developed countries has now reached 95.6%, while

in low-income countries it has only reached about 62.8% Currently, the amount of blood received only meets about 70% of the blood need for treatment The rate of VBD in our country has reached over 98%, especially the rate of repeat volunteer blood donor (RVBD) has also gradually increased and initially met the demand for blood for treatment

To have a safe and sustainable source of VBD, health care for VBD in general and people is very necessary and important In Vietnam, no author has comprehensively researched blood cell parameters, serum iron reduction, and serum ferritin in RVBD To ensure there are enough safe sources of VBD and meet the needs of blood and products for treatment, while protecting and taking good care of the health of VBD Early detection of IDUs with reduced serum iron and ferritin levels and counseling them to promptly supplement iron will prevent iron deficiency anemia in RVBD, while also maintaining Maintain a safe and stable source of VBD With the above analysis, we proceed to research

the topic “Study of changes in some hematological indices, serum iron, and the results of iron supplementation in repeat blood donors at the National Institute of Hematology and Blood Transfusion” with the

following 3 goals:

1 Analysis of characteristics of some hematological indices, serum iron, serum ferritin in repeat blood donors at the National Institute

of Hematology and Blood Transfusion

2 Investigation of factors associated with changes in some hematological indices, serum iron, serum ferritin in repeat blood donors at the National Institute of Hematology and Blood Transfusion

3 Evaluation of the effectiveness of iron supplementation in regular repeat blood donors

2 The urgency of the dissertation

Blood is crucial for treatment, emergency care, deploying advanced techniques, and disaster prevention To ensure an adequate blood supply for treatment needs, maintaining the RVBD is essential, as frequently emphasized This is also the safest source of blood donation according to the World Health Organization's recommendations When donating blood, the body loses a certain amount of iron With regular blood donation, blood donors may be at risk of iron deficiency, or even iron-deficiency anemia Early detection of these donors and timely iron supplementation is one of the effective measures to prevent iron deficiency and has been implemented in many developed countries Therefore, monitoring hematological parameters, serum iron and serum ferritin levels in blood donors, early detection of iron deficiency and timely iron supplementation are necessary and urgent This is one of the measures to ensure the health of blood donors, contributing to the maintenance and development of a safe and stable VRBD at the Central Hematology - Blood Transfusion Institute

3 The new contributions of the dissertation

The study was conducted on a total of 573,733 VRBD who participated in whole blood donation at the Institute of Hematology - Blood Transfusion from 2017 to 2023 The research has made the following new contributions:

- During the period from 2017 to 2023, out of 573,733 VRBD, donation hemoglobin screening using the copper sulfate method identified and deferred blood donation for 30,777 donors with low hemoglobin levels (5.4%), contributing to protecting the health of blood donors

pre Analysis of changes in various hematological parameters, serum iron, serum ferritin, and factors related to these changes was conducted for 6,054 RVBD

- 158 RVBD with decreased serum ferritin levels were identified and advised to take iron supplements to prevent iron deficiency anemia

- The data from these research results have demonstrated that focusing on maintaining a healthy blood donor community through reminders and regular care is a crucial focus of healthcare services for blood donors, ensuring an adequate and safe blood supply for treatment

- This is the first dissertation to comprehensively study the characteristics

of hematological parameters, serum iron, and serum ferritin in blood donors The research also evaluated factors related to decreased iron and serum ferritin levels in blood donors and provided timely iron supplementation advice to protect their health for continued blood donation in the future

4 The structure of the dissertation

- Introduction (2 pages)

- Literature Review (Chapter 1) - 32 pages

- Objectives and Research Methodology (Chapter 2) - 20 pages

- Result (Chapter 3) - 43 pages

- Discussion (Chapter 4) - 29 pages

- Conclusion and Recommendations (3 pages)

- Research findings - 27 tables, 26 charts

- 151 references (29 in Vietnamese, 122 in English)

1.2 Analysis some characteristics of health indicators of blood donors

According to WHO, it is necessary to generally assess the health status

of VBD through indicators of age, gender, weight, vital signs and iron index

of VBD VBD's minimum Hb standard is 12.5 g/dl for women and 13.5 g/dl for men In Vietnam, general standards stipulate that VBD must have a minimum Hb concentration of 120 g/l or higher A decrease in Hb concentration and mean red blood cell volume and mean red blood cell hemoglobin in RVBD may also lead to a decrease in serum ferritin concentration in VBD

1.3 Measures to protect the health of blood donors

- Examination and selection of blood donors: Providing information for VBD (screening results for diseases transmitted through blood transfusion, guide VBD to contact the blood center if necessary after donating blood); examination and selection; medical staff check VBD 's weight and vital signs such as pulse, blood pressure, and body temperature

- Measures to assess Hb concentration and HBsAg testing by rapid kit before blood donation: Circular 26/BYT/2013 requires Hb screening tests for all VBD and rapid HBsAg screening tests for first-time blood donors Hb screening tests and rapid HBsAg tests help ensure VBD health and the quality of blood units

- Screening test for pathogens transmitted through blood transfusion:

WHO recommends mandatory screening for HIV, HBV, HCV and syphilis Screening tests using serological and molecular biology methods have helped keep donated blood units safe and VBD can detect blood-borne diseases early

- Care for blood donors encompasses both during and after the blood donation process, aiming to ensure the donors' health and encourage them to donate blood regularly

1.4 The importance of detecting iron deficiency in VBD and iron supplementation plan for VBD

- Iron is an essential mineral and is important for metabolic processes and body functions Iron contributes to: oxygen transport in the blood; essential trace elements that help cells produce energy; maintains normal immune system, contributes to normal cognitive function

- The process of iron absorption begins in the stomach, mainly taking place

in the duodenum To absorb iron, ferric iron (Fe3+) must be converted into ferrous iron (Fe2+) The control of iron absorption and the amount of iron absorbed into the portal blood depends on the body's iron needs and the body's iron stores The importance of detecting iron deficiency in NHM

- Normally, each whole blood donation with a volume of 500 ml loses about 250 mg of iron Iron absorption and iron storage are limited, so regular VBD are at risk of iron deficiency The progression of iron deficiency follows the following stages: initially there is a lack of stored iron, then it develops into iron deficiency and red blood cell deficiency, and finally to the stage of iron deficiency anemia

- Iron deficiency affects health conditions including: fatigue, reduced physical activity, cognitive dysfunction, and for pregnant women, it can cause perinatal death, premature birth, and low birth weight low birth weight, newborn cognitive abnormalities In addition, iron deficiency also causes pica syndrome, restless leg syndrome, and hearing loss

- Iron deficiency in VBD is quite common in many countries around the world The rate of iron deficiency in male undergoing first-time treatment is very low (0 - 1.3%) The prevalence of iron deficiency in male RVBD in the United States is 16.4%; for women 27.1%

- The first step in improving the risk of iron deficiency in VBD: According

to the American Association of Blood Banks (AABB), blood receiving centers must increase the provision of iron deficiency risk factors in VBD after donating blood According to AABB, there are recommendations for blood centers to minimize iron deficiency in patients, including supplementing patients with iron, increasing the time interval between blood

donations, or doing ferritin tests to encourage patients to supplement iron after donating blood After donating blood, iron supplements for fans with a dose of 19 - 38 mg of iron/day and taken within 60 days is an effective measure to prevent iron deficiency Iron tablets can be used alone or combined with iron combination with other vitamins

Chapter 2 METHODOLOGY 2.1 Study population

2.1.1 Study population

Group I: Objective 1:

− Selected from 573,733 RVBD to donate whole blood at National Institute of Hematology and Blood Transfusion and cite belong National Institute of Hematology and Blood Transfusion in the period 2017-2023

− Inclusion criteria: All of these RVBD meet selection criteria specified in chapter II "Blood donor selection and blood collection" in Circular 26/TT-BYT on providing guidance on the blood transfusion that was issued by the Ministry of Health in 2013

− All RVBD are given Hb screening tests before blood donation, and HIV, HBV, HCV and syphilis screening tests

Group II: Objective 2:

− Agree to participate in the research group

− Inclusion criteria: Selected from 573,733 RVBD who donated blood

in the period 2017 - 2023, RVBD were directly advised to do additional blood iron concentration tests and serum ferritin levels and complete blood cell analysis tests, these patients will be given iron supplements if their serum iron levels and serum ferritin levels test results decrease

− Have tests for blood cell analysis tests, serum iron and ferritin

Group III: Objective 3:

− Regular RVBD

− Selection criteria: Regular RVBD has donated blood at least 3 times/year for men and donated blood 2 times/year with women Agree to participate in the research group; reduced serum iron concentration and serum ferritin concentration received iron supplements

− Have tests for serum iron concentration and total serum ferritin concentration, cell analysis blood, iron concentration and serum ferritin

2.1.2 Study area and Duration of study

− Study area and Duration of study: National Institute of Hematology and Blood Transfusion in the period 2017-2023

2.2 Study design

2.2.1 Objective 1:

2.2.1.1 Study design: Cross-sectional

2.2.1.2 Sample size and sampling methods

− Sampling method: Total population sampling

− Blood donors are tested to ensure the health of blood recipients and ensure the safety of blood recipients according to the provisions of Circular 26/TT-BYT

− RVBD with HIV, HBV, HCV and syphilis screening tests who have negative results are advised to have additional blood cell analysis tests, iron levels and serum ferritin

2.2.1.3 Research variables

− Independent variables: gender, number of blood donations, age, weight

− Dependent variable: Hb decreased (<120 g/l); hematological index:

Hb, MCV, MCH; serum iron concentration, serum ferritin

2.2.1.4 Data collection: Collected on blood donation registration form and

RVBD management software

2.2.1.5 Research process: Consulting on test indications, collecting test

result data from blood donor management software, processing data on SPSS software, analyzing results

2.2.1.6 Tests performed in the study: Hb screening test before blood

donation, total blood cell analysis, serum ferritin iron concentration

2.2.1.7 Materials

Sysmex and DxH 900 laser cell counter systems from Beckman Coulter; Snibe Maglumi 800; chemiluminescent testing machine; PK 7300; Roche Cobas 6800 and Procleix Panther testing machines

2.2.2 Objective 2

2.2.2.1 Study design: Cross-sectional

2.2.2.2 Sample size and sampling methods: Select RVBD from objective 1 2.2.2.3 Research variables

- Independent variables: gender, number of donations, Hb

- Dependent variable: decreased serum iron, decreased serum ferritin

2.2.2.4 Data collection: VBD management software

2.2.2.5 Research process: analyze data objective 2

2.2.3 Objective 3

2.2.3.1 Study design: Uncontrolled interventions Study

2.2.3.2 Sample size and sampling methods:

Sample size: Based on the formula to estimate a proportion

Δ: expected deviation Δ = 0.065; α: Statistical significance level, Z a/2: reliability coefficients; α = 0.05 (95% confidence interval), Z value1-a/2is 1.96 The proportion of patients with frequent decreased serum ferritin levels was 0.22

1-➔ The sample size of RVBD who regularly requires iron supplementation is at least 157

2.2.3.3 Research variables

− Independent variables: gender, before and after taking iron pills

− Dependent variables: SLHC, Hb, Hct, MCV, MCH, MCHC; serum iron; Serum ferritin

2.2.3.4 Data collection: VBD management software

2.2.3.5 Research process:

- Step 1: Select regular RVBD with ferritin <26 ng/ml

- Step 2: Supplement iron for regularly RVBD and following medication use

- Step 3: Invite regularly RVBD to test again

- Step 4: Collect data from VBD management software

- Step 5: Evaluate the results of iron intake in regularly RVBD

Tests for objective 3: Iron test, blood cell, serum iron and ferritin

2.3 Data analysis

Data were processed using SPSS 20.0 software Research parameters are frequency, percentage for qualitative variables; mean and standard deviation for quantitative variables For quantitative variables non-normally distributed use the Kruskal - Wallis test For qualitative variables, use the χ2 test Evaluate the some factors related using ratios Odd ratio, testing the difference as statistically significant when p < 0.05

2.4 Ethical Considerations

The ethical considerations was approved by the Ethics committee of Hanoi Medical University on May 10, 2017 and issued under number 82/HĐĐĐDHYHN on May 30, 2017

The study was conducted on healthy VBD who participated in blood donation in accordance with the regulations of Circular 26 BYT/2013 For blood donors: Clinical and laboratory indicators are done according to the regulations of Circular 26 BYT/2013 If the blood donor agrees to use iron tablets, the research team will deliver the iron by express delivery to the blood

donor with a prescription and instructions for use RVBD after 60 days of use are invited to have blood tested and all tests are free

Chapter 3 RESULTS 3.1 Analysis of characteristics of some hematological indices, serum iron, serum ferritin in repeat blood donors at the National Institute of Hematology and Blood Transfusion

3.1.1 Characteristics of participants

From 2017 to 2023, there were 513,787 first-time blood donors and 573,733 RVBD, with the distribution ratio being 47.2% and 52.8% respectively Among the RVBD 83.2% donated blood 2-5 times, 13.1% donated blood 6-10 times, 3.7% donated blood more than 10 times In terms

of occupation: Office 54,3%; students 27,5%, other 18,2%

3.1.2 Results of Hb screening test

From 2017 to 2023, 573,733 RVBD were tested for Hb screening before blood donation, and the rate of RVBD delayed due to decreased Hb concentration was 5.4% The proportion of female VBD with reduced Hb concentration is higher than that of male VBD There is a statistically significant difference with p<0.05 The proportion of low Hb levels in VRBD males and females aged 18-20 is higher compared to other age groups with p <0.05 VRBD males and females show an increasing trend

in the proportion of decreased Hb levels according to the frequency of blood donation (the group donating blood over 10 times is higher than the group donating blood 6-10 times and higher than the group donating

blood 2-5 times), with statistically significant differences at p <0.05 3.1.3 Hematological characteristics, serum iron and serum ferritin levels in RVBD

The hematological indices, serum iron concentration, and serum ferritin concentration averages in VRBD males and females are all within the range of normal individuals The average levels of Hb concentration, serum iron concentration, and serum ferritin concentration in VRBD males are all higher than those in females, with statistical significance at

p < 0.05

3.1.4 Hematological characteristics, serum iron and ferritin levels according number of blood donations

Table 3.1 Hematological characteristics, serum iron and

ferritin levels according to the number of blood donations

134,0±

10,0 135,7 ± 11,1 138,1 ± 12,0 <0,05 MCV

(in)

89,3 ±

5,8

88,6 ± 5,8 87,9 ± 6,3 <0,05

89,4 ± 5,2 88,8 ± 5,4 87,7 ± 5,4 <0,05 MCH

(pg)

29,5 ±

2,2

29,3 ± 2,2 29,0 ± 2,5 <0,05

29,6 ± 2,0 29,4 ± 2,1 29,0 ± 2,3 <0,05 Iron HT

(µml/L)

16,6 ±

6,1

16,9 ± 6,7 17,0 ± 6,8 ≥0,05 16,0 ±

6,5 16,1 ± 6,5 16,4 ± 7,0 ≥0,05 Ferritin

71,2 ± 73,0 < 0,05

92,2 ± 86,2 78,6 ± 79,2

65,5 ± 70,6 < 0,05

The average Hb concentration of male RVBD between groups of numbers of blood donations has different values p < 0.05 The average serum ferritin concentration in male RVBD decreased gradually with blood donations p < 0.05 The average serum iron concentration between groups of male RVBD according to the number of blood donations did not difference (p ≥ 0.05)

3.1.5 Hematological characteristics, serum iron and ferritin levels by age group

The average hematological indices in VRBD males and females across age groups are all within the range of normal individuals, with no significant differences between age groups (p ≥ 0.05) The differences in serum iron concentration and serum ferritin concentration averages across age groups in both genders are not statistically significant (p≥0.05)

3.1.6 Hematological characteristics, serum iron and ferritin levels by occupation

Table 3.2 Hematological characteristics, serum iron and ferritin

levels by occupation in male

Male

(n =1.479)

X ± SD (n=503)

X± SD (n=742)

X± SD (n=235)

Hb (g/l) 137,0 ±

11,3

136,7 ± 11,7 139,4 ± 12,3 < 0,05

MCV (fl) 88,8 ± 5,6 89,1 ± 6,0 88,6 ± 6,1 ≥ 0,05 MCH (pg) 29,3 ± 2,2 29,5 ± 2,3 29,3 ± 2,3 < 0,05

Iron HT 16,4 ± 6,4 16,9 ± 6,3 16,9 ± 6,4 ≥ 0,05 Ferritin HT

(ng/ml)

80,5 ± 69,9 104,4 ± 98,6 104,1 ± 96,7 < 0,05

In male VBD, the average hematological indices are within the limits of ordinary people, found in all different blood donors The average serum iron concentration did not have a statistically significant difference between jobs (p≥0.05) In male VBD, the average serum ferritin iron concentration showed a statistically significant difference (p < 0.05)

Table 3.3 Hematological characteristics, serum iron and ferritin levels by occupation in female

X