RAJIVGANDHIUNIVERSITY OF HEALTH SCIENCE, KARNATAKA, BANGALORE -41

PROFORMA FOR REGISTRATION OF SUBJECT FOR DISSERTATION

NAME OF THE CANDIDATE / : / MOHAMMED FARHAN T
ADDRESS / : / MOHAMMED FARHAN T
MSc MLT STUDENT (HEMATOLOGY AND TRANFUSION MEDICINE)
ST.JOHN’S MEDICALCOLLEGEHOSPITAL
BANGALORE-34
COURSE OF STUDY / : / MSc MLT
SUBJECT / : / HEMATOLOGY AND TRANFUSION MEDICINE
DATE OF ADMISSION TO THE COURSE / : / 01 SEPTEMBER 2009
TITLE / : / COMPARATIVE STUDY OF THE PROFILE OF VOLUNTARY AND REPLACEMENT DONORS IN A HOSPITAL BLOOD BANK.

NEED FOR STUDY

Blood transfusion is an important part of modern medicine and often a life saving procedure, but it carries the major risk of transmission of infection. Blood collected from potentially infectious donor may be transfused directly to a large number of recipients.1

Transmission of infectious disease through donated blood is of concern to blood safety, though improved blood donors screening and testing has significantly reduced transfusion transmitted disease in most of developed nations, this has not been so in many developing nations.2

To minimize transmission of disease, three levels of safety strategies are used

LEVEL I: The predonation screening, to defer unsuitable donors and donors donating for other purposes. Favour and encourage voluntary donation.1

LEVEL II: Include screening of the donated unit for the presence of infectious disease marker.

LEVEL III: Involves minimizing blood transfusion to the extent possible and using blood only when truly needed.1

The main source of blood (65%) is from replacement donors with another (10%) from professional donors, only (25%) of total blood donation comes from voluntary donors.3

This study is aimed at assaying the LEVEL I grade of prevention by comparing the profiles among the voluntary donors and replacement donors in making the blood transfusion safe and to form a rationale to increase the proportion of voluntary donors.

REVIEW OF LITERATURE

The blood donors can be the voluntary donors, the professional (paid) donors, the replacement donors, the directed donors and the autologus donors.1

Voluntary donors / Donate for the benefit of others, receive no financial gain.
Professional(paid) donors / Receive payment for donation.
Replacement donors / Donor recruited from patient, friends and relatives to replace unit used.
Directed donors / Family or friends of patient donate specifically for that patient use.
Autologus donors / Patient blood collected for own use.4

The voluntary donors give blood with the purely altruistic motive of helping an unknown patient and not for payment or any favour. They readily agree to donate blood and do so regularly. Since they are not under duress to donate they give more reliable information at the time of donor screening, therefore the incidence of transfusion transmissible infection is very low in this donors group.1, 5,6

The replacement donors replace the blood issued by the blood centre to their relative or friend. Since they may be under pressure or inducement to donate, they may not give reliable answers when asked screening questions and are less likely to self defer, thus compromising blood safety. This above risk is markedly increased in professional or paid donors.1, 6

The number of viruses, bacteria and protozoa which can transfused through blood transfusion are Hepatitis B and C, HIV 1 and HIV 2, Human T-cell leukemia virus [HTLV-I], HTLV –II, Cytomegalovirus, Treponema pallidum, Salmonella, Brucella, Plasmodium species, Toxoplasma and trypanosome1.

In India as per the drug control mandate, every unit of blood collected should be screened for antibodies to Syphilis, HIV 1, HIV 2, Hepatitis B surface antigen, Hepatitis C and Malarial parasite.1,6 Only the units which are non reactive to all mandated tests should be released. All reactive units are disposed as per biohazardous waste guidelines.

Studies have shown that blood obtained from regular voluntary blood donors show less seropositivity for infectious diseases than blood obtained from the replacement donors.1, 7

Various such studies have been carried out in India. A study done in Mumbai on 23,068 donors, showed majority (70.37%) being voluntary, and Seroprevalence rate recorded was; only 7.02%. Of the positive units 2.15% were due to Syphilis, 1.98%, 0.9% and 1.96% due to Hepatitis B, C and HIV respectively.8

Another study done in Delhi showed significant lower seropositivity in voluntary donors than in replacement donors (p<0.05) especially for HBsAg, VDRL and HIV.9

OBJECTIVES

  1. To evaluate the different profiles of voluntary donors and replacement donors with respect to blood safety.
  2. To form a rationale to increase the proportion of voluntary donation.

DESIGN OF STUDY

  1. SOURCE OF DATA

Prospective study of 1000 units of blood will be analyzed for transfusion transmitted disease in blood bank of St. John’sMedicalCollegeHospital between January 2010 to December 2010.

INCLUSION CRITERIA

Donors who satisfy all the criteria given below

The donor shall be in good health mentally alert and physically fit and shall not be inmate of jail, person having multiple sex partner and drug addicts.The donor shall fulfill the following requirement namely

  1. Age:18 to 55 years
  2. Weight: Not less than 45 kg.
  3. Temperature: Less than 37.50 C (99.60F)
  4. Pulse: 60-100 beats/min regular
  5. Blood pressure: Systolic 110-140 mm Hg

Diastolic 70-90 mm Hg

  1. Skin lesion: Skin at site of venipuncture must be free of skin

lesion and needle prick.

  1. Hemoglobin: Not less than 12.5 gm/dl
  2. Frequency of donation:12 weeks(Males)

10 weeks (Females)

  1. Free from acute respiratory illness

EXCLUSION CRITERIA

Donors who are not eligible to donate as per the donors criteria given below:

Permanent Deferral

Cancer, Heart disease, Abnormal bleeding, Weight loss, Diabetes, Hepatitis B infection, Acute pulmonary tuberculosis, Polycythemia vera, Severe bronchial asthma, Epilepsy, Endocrine disorder, Liver disease, Fainting spells, Veneral disease, Psychiatric disorders, Severe allergic to drugs, Chronic nephritis, Leprosy, Sign and symptom suggestive of AIDS.

Temporary Deferral

5 Years: Jaundice (Exceptable if HBs Ag Negative)

2 Years: Malaria

1 year: History of Hepatitis in family, in close contact, typhoid, severe illness,

major surgery, after delivery, Rabies vaccine, Recipient of

immunoglobulin.

6 Months: Minor illness e.g.: Chicken pox, Mumps, Measles, Recipient of blood or

blood component, Skin Graft, Tattooing, Ear/Nose Piercing, Abortion.

4 Weeks: German measles(Rubella)vaccine

2 Weeks: Immunization –Cholera, Typhoid, Deptheria,Tetanus, Plague,

Gammaglobulin.

72 Hours: Minor surgery e.g.: Tooth extraction

24 Hours:Other type of vaccine.

12 Hours:After consumption of alcohol.

Temporary: Menstruating and lactating females, pregnant women, fasting person, person on medication to be evaluated by blood bank physician.

  1. SAMPLE COLLECTION

Anticoagulated EDTA and Clot blood sample are collected from each donor.

  1. METHODOLOGY

The following test will be done for each blood unit

1. Hemoglobin will be estimated by cyanmethaemaglobin method

2. Blood smear will be taken and stained with Leishman stain and smear is examined for malarial parasite.

With the clotted blood, serum will be separated by centrifugation and screened for HBsAg, HIV, HCV antibodies following manufacturer’s instruction by ELISA method. The kits which will be use are Hepanostika HBsAg Ultra manufactured by Biomerieux for HBsAg, Vironostika HIV uniform II Ag/Ab manufactured by Biomerieux for HIV 1and 2, Hepanostika HCV Ultra manufactured by Beijing united biomedical Co., Ltd. for HCV. Test for syphilis will be done by Rapid Plasma Reagin using VDRL Antigen manufactured by laboratories of serologist, Calcutta.

Statistics analysis

  • Descriptive statistics
  • Paired t test

REFERENCE

  1. Jagannathan Latha. Organization and operation of regional blood transfusion center in India. In: Handbook of blood banking and transfusion medicine, Ed: Gundu HR Rao, Eastlund Ted; 1st edition Jaypee publication .2006; 11-26.
  2. Mathai Jaisy, Sulochana P V, Satyabhama S, Ravindran Nair P K, Sivakumar S. Profile of transfusion transmissible infections and associated risk factors among blood donors of Kerala. Indian J. Pathol. Microbiol. 2002; (45):319-322.
  3. El-Nageh M. An overview of blood transfusion service in countries of the eastern Mediterranean region. Transfusion today.1998; 37:12-19.
  4. Brennan Mary and Caffrey Liz. Donors and blood collection. In: Practical Transfusion medicine, Ed: Murphy Michael F and Pamphilon Derwood H.; 1stedition Blackwell science.2001; 213-221.
  5. Kawthalkar Shrish M. Collection of donor blood processing and storage. In: Essential of hematology, 1st edition Jaypee publication. 2008;447-454.
  6. Bastiaans MJ, Nath N, Dodd RY, et al Hepatitis associated marker in the American Red Cross volunteer blood donor population. Vox sang 1982; 42:203-210.
  7. Bharat singh, Monika Verma, Mrinalini Kotru, Karttikaye Verma and Madhu Batra. Prevalence of HIV and VDRL seropositivity in blood donors of Delhi. Indian Journal of medical research 2005;(122): 234-236.
  8. Shinda S.V, Puranik G.V. A study-screening of blood donors for blood transmissible diseases, Indian J. Hematol. Blood tranfus. 2008 (23):99-103.
  9. Ambika Nanu, Sharma.S.P, Charrerjee Kabita, Jyothi.P. Marker for transfusion transmissible infectios in north Indian voluntary and replacement blood donors:Prevalence and trends 1989-1996,Vox sang 1997;73:70-73

SIGNATURE OF CANDIDATE
NAME AND DESIGNATION OF GUIDE / Dr. VANAMALA A ALWAR MD
ASST. PROFESSOR,
DEPT.OF CLINICAL PATHOLOGY
ST.JOHN’S MEDICALCOLLEGEHOSPITAL,
BANGALORE – 34.
REMARKS OF THE GUIDE
SIGNATURE OF THE GUIDE
HEAD OF THE DEPARTMENT / Dr. KARUNA RAMESH KUMARMD, DCP, PhD.
PROFESSOR AND HEAD,
DEPT.OF CLINICAL PATHOLOGY,
ST.JOHN’S MEDICALCOLLEGEHOSPITAL,
BANGALORE – 34.
SIGNATURE OF THE HOD
SIGNATURE OF THE DEAN