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International Journal of Medical Science and Current Research (IJMSCR)

Available online at: www.ijmscr.com

Volume2, Issue 4, Page No: 330-338 July-August2019

330

Medicine ID-101739732

IJMSCR

Hemovigilance -A stepping door to enhancement of blood safety with the reporting of

adverse reactions in blood donation and transfusion

DrSmita Mahapatra, DrSabita Palai, Dr Pankaj Parida

Associate Professor1, Assistant Professor2, Professor3

Department of Transfusion Medicine, SCB Medical College & Hospital, Cuttack

*Corresponding Author:

DrSabitaPalai

Assistant Professor

SCB Medical College & Hospital, Cuttack

Type of Publication: Original Research Paper Conflicts of Interest: Nil

ABSTRACT

Background: Though blood donation is considered to be a safe procedure, still, at times, it can lead to mild to severe adverse reactions. Similarly, adverse effects may occur during or after blood transfusion which are called transfusion reactions.

Objectives: The aim of the present study is to study the frequency and type of adverse events in blood donors , transfusion reactions in patients, various factors predisposing to develop transfusion reaction and adoption of methods to reduce the their occurrence.

Methods/materials: The study was conducted retrospectively to review all the adverse events in donors and transfusion reactions reported to the blood bank during a period of two years and two months. All the reactions were evaluated according to protocol and classified as per standard definitions.

Results: About 168 adverse events in 56,731 blood donors and 37 transfusion reactions were reported in 1, 05,101 blood units issued. Vasovagal attack(60%) was the most common adverse event noted in donors and among the patients, febrile non- haemolytic transfusion reactions(56.8%) was the commonest followed by allergic reaction(32.4%), transfusion related acute lung injury(5.4% ) and acute non immunological haemolytic transfusion reaction(5.4% ).

Conclusion: Necessary steps should be taken to reduce thecomplications relating to blood donations which may have detrimental effect on the return of the same donor for subsequent donation & may lead to long term morbidity with disablement in some cases. Adverse reaction following blood transfusions is a complication to be kept in mind, and hence, transfusions should be given only when necessary.

Keywords:Adverse reaction; Blood donor; Hemovigilance

INTRODUCTION

Blood along with its components has no substitute and safe blood transfusion can save many lives. For assuring safe blood transfusion recent surveillance system has evolved from Pharmacovigilance aiming at collecting and assessing the adverse drug reactions in human beings. Hemovigilance is derived by the amalgamation of Greek word, “haema” means blood and the Latin word, “vigilans” which means watchful

(de Vrieset al.2011). The term ‘hemovigilance’

(he’movigilance in French) was coined in France in 1991. Faber defined Hemovigilance as a set of

surveillance procedures covering the whole

transfusion chain (from the donation of blood and it’s components to the follow-up of recipients of

transfusion), intended to collect and assess

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resulting from the therapeutic use of labile blood products and to prevent the occurrence or recurrence

of such incidents (Faber et al.2004). The initial work

was first initiated in France in 1994 through a “blood transfusion committee” and national haemovigilance system. Nowadays, ‘International hemovigilance network’ (IHN) is working along with ‘International Society of Blood Transfusion’ (ISBT) to ensure a

better service (Jain Aet al. 2012).

Ideally, the hemovigilance system should cover the entire transfusion chain starting from the blood donation, processing, and transfusion to patients for monitoring, reporting, and investigation of adverse events and reactions and near misses related to the blood transfusion. It should be well coordinated between the blood transfusion service, hospital clinical staff and transfusion laboratories, hospital transfusion committee, regulatory agency, and national health authorities. An adverse event resulting in morbidity or mortality of a recipient is called adverse reaction and when it affects a donor it is called complication. Hemovigilance for recipients is based on an internationally accepted scale which is used to grade the severity of an adverse reaction in recipient. The donor hemovigilance include reporting of unexpected events in blood donation in donors and the action taken as a result. With the increase in awareness over last few years on hemovigilance and blood safety, many centers in India have published

data on adverse events (Vasudevet al.2016, Negi et

al.2015, Shramaet al.2015).Thus considering the

gravity of the problem, a national hemovigilance program as an intergral part of the Pharmacovigilance Programme of India (PvPI) at a national level was

launched on December10,2012(Bishtet al.2013).The

aim of the present study was to detect and analyze adverse events in blood donors and transfusion related adverse reactions in patients receiving the transfusions to be reported to the National Institute of Biological (NIB) for hemovigilance programme.

MATERIALS & METHODS:

A retrospective study was carried out on adverse events of blood donors both voluntary & exchange and of all the transfusion reactions which were reported to Department of Transfusion Medicine over a period of two years from May 1st 2016 to August

31st 2018. Among the 56,731 units, 1, 05,101 blood

units collected and issued respectively, 168 and 37

adverse events in blood donors and transfusion reactions in patients receiving blood transfusions were reported.

Blood from all donors were collected using 16 gauge needles from the antecubital vein after cleaning the venipunture site using Betadine and alcohol. Blood was collected from donors with Hemoglobin level of more than 12.5 gm/Dl. 350 ml of whole blood was collected from donors weighing between 45-55 kilogram (Kg) and 450 ml from donors weighing more than 55 Kg. Attention was prioritized towards

the donors complaining of giddiness, light

headedness, pallor, etc., and they were given immediate attention by stopping the donation with urgent basis and were asked to raise their legs to prevent vasovagal reactions. After the donation, donors were given refreshments and retained in the recovery room for at least 30 minutes before being released.

The adverse events as suggested by American Red Cross Hemovigilance were classified as Major/Minor according to the Severity rating. (Mangwana et al. 2013)Presyncopal symptoms consisting of pallor, sweating or light-headedness without loss of consciousness, were considered to be minor. Syncopal types of events with transient loss of consciousness for more than a minute were classified as Minor, and the Major ones are those which are complicated by loss of bowel/bladder control, seizures or convulsions. Local adverse events were

hematomas which can be small (< 25.8 mm2) or large

(> 25.8 mm2), bruises, infiltration, allergic reactions

and a tingling/burning sensation.

Adverse events like nausea, vasovagal attack, hematoma, bleeding, head reeling, anxiety,and sweating, local reactions at the puncture site were encountered in blood donors.

Following details were noted in the adverse blood donor reaction reporting form:

1. Donor information

2. Details of the blood collected

3. Details of complications – outcome

&imputability

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hours of packed red bloodcells(PRBC),whole blood(WB),random donor platelet(RDP) and fresh frozen plasma(FFP) transfusion administrated were noted.

Vital signs such as blood pressure, pulse, peripheral oxygen saturation, and breaths number were measured 5 min after beginning of blood transfusion

and every 15 min during 1st hour thereafter

according to the guidance of blood transfusion.

We followed a protocol whenever a case of transfusion reaction was reported.

• All the documents were rechecked to identify any clerical error

• Post-transfusion blood sample was asked for direct and indirect antiglobulin (Coomb’s) tests

• Grouping and cross matching were repeated on the post-transfusion sample. At the same time, pre-transfusion sample was rechecked for grouping and cross matching

• Post-transfusion urine sample was sent for testing hemoglobinuria and myoglobinuria

• The concerned blood bag which is received along with the transfusion set was sent to

Microbiology Department for culture

• Following things were documented in the transfusion reaction form and transfusionreaction investigation form.

1. Details of the patient

2. Details of the blood unit

3. Details of transfusion reaction

4. History of previous transfusion

5. Volume of the blood transfused before

transfusion reaction

6. Time lag between onset of transfusion and

onset of reaction

7. Details of transfusion reaction-

Pre-transfusion vitals and vitals at the time of transfusion, symptoms seen in patient

8. Results of the investigations done on pre and post-transfusion samples.

9. Details of adverse reaction- Date, time of onset of reactions, date & time of

recovery/death and outcome Imputability details

The study was conducted on the basis of this work up, and transfusion reactions were studied with respect to above features.

Transfusion reactions were classified as immediate (occurring within 24 hours (hrs) of transfusion) and delayed (occurring after 24 hrs of transfusion). Febrile reactions were defined as temperature rise

more than 1°C of the pre-transfusion temperature.

Allergic reactions included rash and urticaria. Hemolytic reactions were classified on the basis of direct antiglobulin (Coomb’s) test and indirect antiglobulin (Coomb’s) test results, hemoglobinuria, and myoglobinuria. Transfusion related acute lung injury (TRALLI) was identified by acute pulmonary complications during or within six hours of transfusion.

RESULTS: The study was conducted from May 2016 to August 2018 on 56,731 blood donations by 54,072 male and 2659 female donors. Blood units were collected by voluntary donations from 29,931 donors from which 29,385 donations were from the outdoor voluntary blood donation camps and 26,800 donations were by replacement. Total donor reactions noted were 168 on 146 (86.9%) male donors and 22 (13.1%) female donors respectively. Maximum donor reactions, i.e, 124 (73%) cases were seen in first time donors followed by 44 (26%) cases of repeat donors.(Fig 1) All reactions noted were minor and the frequency in decreasing order were vasovagal reactions (101 cases), haematoma (28 cases),nausea

(19 cases),bleeding(7 cases),anxiety(7 cases),

sweating (7 cases),head reeling (3 cases), double puncture( 3 cases), thromboplebitis (2 cases) and irritation over puncture sites ( one case),irritation over puncture sites ( one case).(Fig 2) All the reactions could be managed in the donation premises.

During a period of more than two years study 10,5101 number of blood units were issued consisting of 30,784 units of PRBC,24,934 units of whole blood, 28,969 units of FFP, 20,297 units of RDP and 117 units of SDP, out of which transfusion reactions were found in 37 cases.(Fig 3) All these transfusion reactions were acute ( onset within 24 hours) .The transfusion reactions seen were 21

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reaction(FNHTR), 12 cases of allergy, 2 cases of Transfusion Related Acute Lung Injury

(TRALI) where one death occurred and two cases of non-immune hemolytic transfusion reaction which consisted of one death.(Fig 4)

Febrile Non-hemolytic Transfusion Reaction (FNHTR):

21 cases had FNHTR consisting of 14 male and 07 female patients had this reaction presenting symptoms with descending order of frequency were fever (20 cases), rigour(18 cases), chill(15 cases), itching (5 cases), and one case each with nausea,

vomiting, jaundice, dyspnea, back pain,

oliguria.(Table 1) The number of transfusion reactions were 15 due to the transfusion of PRBC and

6 due to WB. In 7 cases there was increase of 10 C of

fever, in 13 cases 20 C rise and no fever was

encountered in only one case.

2. Allergic reactions:

These were seen in 12 cases comprising of 8 male and 4 female patients. The clinical presentation which appeared in patient according to the decrease order of frequency were itching (12 cases), two cases each with urticarial, vomiting and one case each with

chill, restlessness, hypotension, periorbital

oedema.(Table 2) The allergic reactions were found with the transfusion of PRBC in 7 cases, WB in 2cases, FFP in 2 cases and RDP in one case.

Transfusion related acute lungs injury (TRALI):

Two cases presented with TRALI, one male and another female patient. The female patient developed chest pain, dyspnoea, tachycardia, hypertension and hypoxemia within two hours of initiation WB transfusion. The male patient developed fever, dyspnoea, wheeze, tachycardia, hypotension after 30 milliliter (ml) of transfusion of FFP. In both cases chest X-Ray showed bilateral infiltrate with cannon ball appearance.

Acute Non immunological Hemolytic transfusion reaction:

Both of two cases were found in female patients, one after transfusion of WB after 6 days of issue (within 15 minutes of transfusion), and another after transfusion of one unit of PRBC after 2 days of issue from the Blood Bank. The first case developed rigour, reddish discoloration of urine. Both pre and

post transfusion serum were normal. Blood in the bag was reddish in color. The other case received total unit of PRBC followed by reddish discoloration of urine in the urobag followed by hemoglobinuria and hemoglobinuria. Direct antiglobulin test (DAT) was negative in both the cases. None showed any signs like fever, chills, backache and hypotension suggestive of immune haemolytic transfusion reaction. In the second case, the condition of the patient deteriorated and succumbed to death within two days of transfusion. All other causes of non-immune hemolysis like addition of medication, use of blood warmer or infusion pump were ruled out. The cause was due to improper storage of the blood units after issue from the blood bank in the clinical ward.

DISCUSSION:

Blood transfusion gives focus on the supply of adequate number of safe blood and blood components to the needy patients as well as the safety of the donors while and after blood donations. In the present study we found out the frequency of adverse events in donors, which were more common in first time donors than the repeat ones (Causter et al.2007, Eder et al. 2008)thus steps should be taken to prevent or reduce the occurrence of these reactions and retaining the first time donors who, later on, can be converted to repeat donors.

In the present study, the incidence of adverse events found was 168 in 56,731 donations (0.3%) which is in accordance with various studies conducted all over the World in which rate of adverse events associated with donations ranged from 0.3% to 3.8% (Franchini et al.2002, Newman et al.2004,Eder et al.2006, Crocco et al.2007). The most common type of complications found was vasovagal reaction (60%). Local reactions like hematoma, swelling, double

puncture, irritation over puncture site and

thrombophlebitis were caused by blood donation-related neurological needle injuries. Recovery time for these complications ranged from less than three

days to more than six months (Sorensen et al. 2008).

All the adverse events were minor which could be managed at the collection site.

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adverse reactions. It is essential to provide friendly, warm and comfortable atmosphere for the donor and to distract the attention by engaging him in conversation. In our center, we allow the donor to leave the blood bank after having cold milk, biscuits & cakes and resting for at least half an hour. We also advise for avoidance of strenuous physical activity and post-donation alcohol consumption. On the onset of head reeling, giddiness, the donation procedure is immediately stopped and the legs are raised (anti-shock position) to prevent further consequences of severe vasovagal reactions. These strategies have not only minimized the adverse effects but also motivated the donors to become repeat Donors.

In the present study conducted for more than two years, 37 cases of transfusion reactions were reported to our blood bank among the 105101 units issued during that period accounting to 0.04%. Similar

finding was found in a study by Kumar et al. who

found the frequency of transfusion reaction to be

0.05% (Kumar et al.2013). Whereas Bhattacharya et

al. in PGI over a period of 1-year reported 0.18%

incidence of transfusion reaction (Bhattacharya et

al.2011). A study was conducted by Lubartet al.in

elderly patients in a geriatric hospital over a period of 1-year. The incidence of transfusion reaction was higher in their study (11%) in comparison to the

present study (Lubartet al.2014). Most common

reaction noted in our study was febrile non immune haemolytic transfusion reaction (56.8%) followed by allergic reaction of (32.4%), the former finding was

slightly higher than the finding of Bhattacharya et

al(41%), but the later was in accordance(34%) . One

death occurred in TRALI, but other reactions were successfully managed.

All the 21 cases except one case had fever in FNHTR in our study. In one study, out of 108 reactions characterized by chills, cold or rigors, rise in

temperature was seen in only 18 cases (Heddle et

al.2002). Data on the incidence of FNHTR vary

greatly in the literature. Possible reasons for this variation include differences in recording of symptoms by the bedside staff, case ascertainment, and use of pretransfusion medications to control fever. With the concept of universal leukoreduction there is dramatic risk reduction for FNHTR. In our study, we had issued non-leukoreduced PRBC/WB, which should be replenished by leukoreduced blood components for avoiding FNHTR.

Moore et al. reported a 3% rate of mild allergic reactions from Mayo Clinic. This mild allergic reaction was defined as hive or localized urticaria. Incidence in other studies varies from 0.2% to 3

%(Robillardet al.2002) . Higher incidence of allergic

reactions of 3-4.8% was reported in studies with platelet transfusion in hemato-oncology patients

(Heddleet al.1993). But, in the present study higher

allergic reactions were seen with PRBC (0.2%) followed by WB (0.008%), FFP (0.007%)and RDP (0.005%).These can further be prevented by using washed PRBC.

The incidence of TRALI is rare in the Indian subcontinent where most donors are male. The incidence of TRALI reported in various studies from Western literature ranged from 0.014% to 0.08% per

units transfused (Kathryn et al.2003).But, in the

present study TRALI was reported in two cases, a female patient receiving one unit of WB and a male patient who had already received 8 units of FFP and developed clinical symptoms and finally succumbed to death after receiving around 30 ml of FFP which had been issued three hours back from the Blood Bank. TRALI can be prevented by not accepting the mulitiparous female donors.

Two cases of acute non-immunological haemolytic transfusion reactions were due to the unmonitored storage condition in the ward which led to death of one case in our study who received the complete unit of PRBC after two days of issue from the inventory. Overall risks for acute hemolytic reactions which were observed in different studies ranges from 0.02 to 0.07% (Lichtigeret al.1984). Improper storage conditions in unmonitored refrigerators outside the department led to deterioration of red cell units. Hence awareness among the bedside staff is essential to reduce this risk.

Delayed reactions and transfusion reactions after use of components were not reported in the present study, thus, user departments need to be educated about the same. Here, hemovigilance plays an important role. Hemovigilance system should be well coordinated between blood transfusion service, hospital clinical staff and transfusion laboratories, hospital transfusion committee, regulatory agency, and national health authorities.

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The hemovigilance system plays a very important role in improving blood safety. To have a well-organized hemovigilance system in developing countries like India, a comprehensive approach is required. The preliminary transfusion reactions data highlight the importance of establishing functional hospital transfusion committees at institute level and at the same time developing a national hemovigilance program for policy making in transfusion services. An encouraging environment for reporting of adverse events in donors and transfusion reactions in patients are required to have an effective hemovigilance system which will remarkably improve transfusion services along with the safety.

ACKOWLEDGEMENT:

Authors are thankful to Dr Prasant Ku Dash, Junior resident for managing the transfusion reactions of the patients. There no conflict of interest among all authors. This research did not receive any specific grant from funding agencies in the public,

commercial, or not-for-profit sectors.

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Whole Blood Donation.Jr of Pathology Nepal,3,459-463.

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FIGURE LEGENDS:

Fig 1. Percentage of donor reactions in repeat and first time blood donors

Fig 2. Number of different adverse events found in blood donors

Fig 3: Number of blood and blood components issued

Fig 4: Number of cases of different type transfusion reactions

Table 1: Number cases of clinical presentations of febrile hemolytic transfusion reaction

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Keywords used to search through the databases were depression, unipolar major depression, pathogenesis, etiology, pathophysiology, genetic and environmental factors,

We also observed a significant relationship between attitudes and knowledge which is in consistent with the results of other studies (1, 4, 5, 10, 14, 17).According to the logic

Eswarlal; Vague ideals and normal vague ideals in semirings, International Journal of Computational Cognition, 6(3):6065, 2008.. Biswas; Vague relations, International Journal