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For a blood bank to properly function, there should be a continuous supply of safe and adequate blood. There should be a healthy pool of donors to maintain this supply . Donor experience determines whether the donor will be willing to return for blood donation or not. So donor adverse reactions should be minimized as much as possible .

Donor adverse reactions :

Donor adverse reactions Working Definition : Any untoward event or complication experienced by the donor before, during or after the blood donation process. Serious adverse reaction Any unintended response in donor or in patient associated with the collection or transfusion of blood or blood components that is fatal, life-threatening, disabling, incapacitating, or which results in, or prolongs, hospitalisation or morbidity. Official Journal of the European Union, L33, 8/02/2003, p.30

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Common Working Group on Complications Related to Blood Donation (DOCO)2004 Standard for Surveillance of Complications Related to Blood Donation Definition: Complications related to blood donation are adverse reactions and adverse events with a temporal relation to a blood donation.

Standard for Surveillance of Complications Related to Blood Donation 2008:

Standard for Surveillance of Complications Related to Blood Donation 2008

Incidence :

Incidence The overall incidence of complications directly related to blood donation is 1% Karin Amrein ,Angelika Valentin ,Gerhard Lanzer ,Camilla Drexler Blood Reviews 26 (2012) 33–42

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The study was conducted on allogeneic whole blood donors over a period of 14 months, i.e., from January 2002 to February 2003. A total of 37,896 donors were monitored for any AEs: 22587 (59.6%) were voluntary donors (VD) and 15,309 (40.4%) were replacement donors (RD). Results: Overall reaction rate was 2.5% with vasovagal reactions constituting 63.5% and hematomas 35.0% of all reactions. Vasovagal reactions showed a significant association with young age, lower weight, first time donation status, female gender, and nature of blood donation camps. Amongst male donors, RDs had more reactions ( P=0.03) than VDs.

Variables associated with increased donor reactions:

Variables associated with increased donor reactions Rossi 4thed., p987 First-time donation Greater percentage of blood volume removed Admitted anxiety History of fainting Female gender History of prior reactions Age less than 30 Tall/thin habitus Greater than 4 hours from last meal Mobile blood drive Low diastolic blood pressure

Hematoma :

Hematoma Haematoma is an accumulation of blood in the tissues outside the vessels. Symptoms : B ruising, D iscolouration, Swelling L ocal pain. Causes : I nadequate pressure on the site after donation, N eedle going through the vein Adjustment of the needle, B leeding tendency A natomic variation, V essel or tissue friability.

Hematoma :

Hematoma Treatment : Ice or cold compresses for the first 48 hours. Heat Inattention to an enlarging hematoma can result in a forearm compartment syndrome with consequent neural and vascular compromise and massive tissue necrosis.

Arterial injury:

Arterial injury Arterial puncture is a puncture of the brachial artery or of one of its branches by the needle used for bleeding of donor. Signs: Unusually rapid flow of bright red blood ; P ulsating flow of blood Treatment: N eedle should be withdrawn immediately F irm pressure applied for at least 10 min, followed by a pressure dressing. Referral, if necessary. Rare complications : P seudoaneurysm formation Transfusion  1994 Oct;34(10): 935. Newman B ,  Popovsky M . D evelopment of an arteriovenous fistula Transfusion 2005 Feb;45(2): 270-3. Omura MC ,  Haimowitz MD ,  Ahn SS .

Delayed bleeding:

Delayed bleeding Delayed bleeding is spontaneous recommencement of bleeding from the venipuncture site, which occurs after donor has left the donation site. Due to dislodging of the clot by lifting weight or strenuous exercises. Raise the arm and give pressure with a cotton.

Nerve irritation :

Nerve irritation Irritation of a nerve by pressure from a hematoma. Symptoms : R adiating pain and/or paraesthesiae in association with a hematoma. The hematoma may not always be apparent at the time. Symptoms do not occur immediately on insertion of the needle but start when the hematoma has reached a sufficient size, some time after insertion of the needle.

Nerve injury:

Nerve injury Transsection of a nerve, particularly the median nerve can occur while inserting the needle. Present with numbness and tingling, excessive or radiating pain, with occasional loss of strength In a study, s ixty-six cases of blood donation-related neurologic needle injury were identified during a 2-year collection period involving 419,000 whole blood donations Blood donation-related neurologic needle injury: evaluation of 2 years’ worth of data from a large blood center B.H. NEWMAANN D D.A. WAXMAN Total recovery occurs in over 90% but it can take a prolonged time.

Nerve injury:

Nerve injury Nerve injuries may be unavoidable because nerves cannot be palpated. In 40% of cases of nerve injuries, phlebotomy was performed without any difficulty Treatment : Early identification and referral Reduced use of the arm Arm slings

Tendon injury :

Tendon injury Injury of a tendon by the needle. Symptoms : V ery severe local non-radiating pain initiating immediately when the needle is inserted Treatment : Rest for the muscle involved Referral if needed

Thrombosis :

Thrombosis Thrombosis can also develop in the phlebotomized vein. Almost always superficial. Rarely deep vein thrombosis may occur. Symptoms : Pain Antecubital fossa tenderness Swelling of the arm Prominent, palpable, cord-like thickening of the thrombosed vein Treatment : Topical heparin

Infection :

Infection Phlebotomy site can become infected Signs : Red streaks from the site Warmth Redness Tenderness Lymphadenopathy in the axilla May lead to abscess formation or septic phlebitis. Treatment : Early application of warm compresses, Oral anti-inflammatory agents Antibiotics when indicated

Allergy (local):

Allergy (local) Allergic type skin reaction at the venipuncture site may be caused by Allergens in solutions used for disinfection of the arm Due to the use of adhesive tape at the phlebotomy site after donation. Symptoms : Rash Swelling Itching at venipuncture site Less common but may be hindrance in retention of a donor

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Bajpai M, Gupta S, Chatterjee K. Are medicated adhesive bands at the phlebotomy site useful? Indian J Hematol Blood Transfus 2009;25:86-87

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Bajpai et al recommended that post donation hemostasis can be achieved by applying a pressure dressing using a sterile swab rather than adhesive tape to reduce the risk of allergic contact dermatitis Ind J of Haematol Blood Transfus 2009;25:86-87 Sometimes preexisting skin lesions like atopic dermatitis, psoriasis, etc. may be the source of infection to both the donor and the donated blood.

Prevention of local complications:

Prevention of local complications Needle insertion techniques: Always move the needle forward in a slow ongoing movement. If the needle is not inserted in the vein at the first attempt, it is not advisable to do a second try by moving the needle a little bit backwards, change direction, and then move forward again in a new direction, as this will increase the risk of injuries and occurrence of hematoma, and thereby the risk of a severe complication. Never try to insert the needle twice, using the same puncture site. Try instead the other arm. Jorgensen J & Sorensen BS, (2008). Donor vigilance. ISBT Science Series, 3(1), 48-52

Vasovagal reactions :

Vasovagal reactions Important predictors for VVR include : Young age Low weight D onation status (first time vs. repeat donor ). Female sex Low body mass index, Small estimated blood volume R apid pulse Low systolic and/or diastolic blood pressure before donation A calculated blood volume of less than 3500 mL was an independent risk factor with the greatest predictive value for an adverse reaction . Can be classified into Mild Moderate Severe

Vasovagal Reactions:

Vasovagal Reactions Mild reactions are defined as any of the following: Pallor, Faintness, dizziness Mild nausea Feeling warm or chilled Hyperventilation Restlessness, anxiety Cold/clammy extremities Perspiration Small or Short decrease in blood pressure and/or heart rate Tingling/numbness Loss of consciousness for one minute or less.

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Moderate reactions may include one or more mild reaction symptoms and at least one of the following: Large or sustained decrease in heart rate; Severe nausea or vomiting Loss of bowel or bladder control Loss of consciousness for more than one minute Prolonged recovery time (longer than 30 min). Severe reactions may include one or more mild or moderate symptoms and at least one of the following: Large or sustained decrease in blood pressure Chest pain Rigidity or tremors Cyanosis Convulsions. C.R. France et al. / Transfusion and Apheresis Science 33 (2005) 99–106

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Pathophysiology of vasovagal reaction Vasovagal syncope is a biphasic process The presyncopal phase:

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The syncopal phase:

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Loss of consciousness occurs when brain perfusion is substantially diminished A systolic blood pressure below 75 mm Hg is sufficient to cause syncope. The vasovagal attack appears to be a hypothalamic response mediated by either a central neural pathway or a peripheral pathway associated with the baroreceptors . Vasovagal syncope is largely dependent on the donor’s peripheral baroreceptor sensitivity, which is influenced by age, emotional stress, and the percentage of the blood volume that is removed.

Treatment :

Treatment Stop the donation immediately. Loosen any tight clothing Improve ventilation Raise the donor’s feet by 45º Apply cold packs to the back of neck and forehead Ask donor to breathe in a closed bag if there is hyperventilation. If loss of consciousness or convulsions occur, Ensure adequate airway Administer 95% O 2 + 5% CO 2 Gently restrain to prevent the donor from injuring himself Make the donor lie in lateral position to prevent any aspiration

Prevention strategies :

Prevention strategies Muscle tension: When a donor makes repeated and rhythmic contractions with the major muscle groups in his arms and legs, the blood flow to the brain can be increased in order to prevent fainting. Distracting the donor during the bleeding procedure. Watching a movie/hearing fm radio could reduce stress in a donor Water or caffeine loading. Several studies have reported fewer complications when donors drink water or coffee before their donation.

Tetany :

Tetany Incidence 1 in 1000 Due to hyperventilation. Manifestations : Carpopedal spasm, Laryngismus Stridulus Positive Chvostek’s sign. Treatment : Rebreathing from a paper bag or Inhaling 5% CO2 from a cylinder.

Long term adverse effects:

Long term adverse effects Iron deficiency is common among regular whole blood donors. Each donation causes a loss of 213 to 236 mg of iron, leading to a continuous depletion of body iron stores. An increase in donation frequency was accompanied by a significant decrease in serum ferritin ; values<15 μg /l were found in 21 and 46 per cent of male and female donors respectively who donated once per year, in 29 and 27 per cent in those who donated twice per year and in 49 and 100 per cent in those who donated thrice per year.

Iron deficiency:

Iron deficiency Risk factors : Donation frequency Lower weight Female gender. Besides iron deficiency anaemia , iron loss can lead to fatigue, decreased physical and job performance and cognitive changes Iron deficiency has additionally been found to be a cause of restless legs syndrome (RLS). Lack of dopamine is thought to be a cause for RLS and iron is an essential cofactor for the production of dopamine. The reported prevalence of RLS in blood donors is 14%–25%

Apheresis-related adverse events:

Apheresis -related adverse events K. Amrein et al. / Blood Reviews 26 (2012) 33–42


FREQUENCY OF ADVERSE EVENTS IN PLATELETPHERESIS DONORS IN REGIONAL TRANSFUSION CENTRE IN NORTH INDIA Gopal K Patidar , R R Sharma, Jyotdeep Kaur 1 , N Marwaha Thesis by Dr.Gopal . (Unpublished Data) The study included 500 healthy, first-time (n=301) and repeat (n=199) plateletpheresis donors after informed consent. The plateletpheresis procedures were performed on Trima Accel (5.1 version, GAMBRO BCT) and Amicus (3.2 version FENWAL) cell separators.

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Type of Adverse events Number 1. Hypocalcemic reactions 45 (9%) 2. Needle insertion related reactions 37 (7.4%) 3. Vasovagal reactions, 4 (0.8%) 4. Other reactions (kit related) 4(0.8%) Total 90(18%) Table 1: Categorization and frequency of adverse events during plateletpheresis donations

Citrate toxicity:

Citrate toxicity Citrate is used as the primary anticoagulant in donor apheresis procedures. The anticoagulant effect of citrate results from its ability to chelate calcium ions resulting in the calcium ions being unavailable to participate in the coagulation cascade. Within the apheresis instrument, plasma citrate concentrations reach 15 to 24 mmol /l, lowering the calcium ion concentration below 0.2 to 0.3 mmol /L, the level necessary for clotting to occur.  Normal  ionized calcium  level in the human body 1.1-1.4  mmol /L


Pathophysiology Compensatory mechanisms to citrate infusion: When blood returns from the apheresis instrument to the donor, the citrate present in the blood is diluted throughout total extracellular fluid, not just the intravascular space. Liver, kidneys, and muscles rapidly metabolize citrate, releasing the bound calcium. increasing parathyroid hormone levels with mobilization of calcium from skeletal stores as well as increased absorption by the kidneys. mobilization of ionized calcium bound to serum albumin Average fall in ionized calcium of 33% from baseline Excitability of nerve membranes increases to the point where spontaneous depolarization can occur.

Factors influencing citrate reactions:

Factors influencing citrate reactions Alkalosis due to hyperventilation, Type of anticoagulant solution used Rate of infusion of the anticoagulant solution, Amount of citrate infused Donor’s serum albumin level prior to the start of the collection procedure

Manifestations :

Manifestations Perioral paresthesias , Acral paresthesias , Shivering, Light-headedness, Twitching, Tremors, Nausea and vomiting. May progress to carpopedal spasm, Tetany , Seizure, Hypotension. Prolongation of the qt interval on electrocardiogram

Treatment :

Treatment Slowing the re-infusion rate, Increasing donor blood to citrate ratio to decrease the amount of citrate infused, Oral calcium in the form of calcium antacids Intravenous calcium (calcium gluconate 8.5% 5ml over 5 min or 3 to 7 ml/hour) Administration of 2 g of calcium carbonate was associated with a statistically significant reduction in the severity of paresthesias Bolan CD, Wesley RA, Yau YY, Cecco SA, Starling J, Oblitas JM, et al. Randomized placebo-controlled study of oral calcium carbonate administration in plateletpheresis:Transfusion 2003;43:1403–1413.


Hypomagnesemia Signs and symptoms similar to hypocalcemia Muscle spasms, Muscle weakness, Decreased vascular tone, Impaired cardiac contractility Hypomagnesemia can also impair calcium and potassium homeostasis, inhibiting the release of parathyroid hormone when markedly decreased Signs and symptoms of citrate toxicity may occur due to hypomagnesemia and not hypocalcemia . These symptoms may be unresponsive to the administration of calcium supplementation


HYPOTENSIVE REACTIONS Hypotension during apheresis collections can result from Intravascular volume depletion, Vasovagal reactions, Citrate reactions, Severe allergic reactions, Air embolism. Treatment : The procedure should be temporarily interrupted and a fluid bolus should be infused. If the reaction is due to hypovolemia , the blood pressure should increase and the pulse rate should decrease in response to this intervention. If the reaction is due to a vasovagal reaction, this may not occur.

Air embolism:

Air embolism Rare complication of apheresis Results when more than 3 to 8 ml/kg of air enters the venous system through either a leak in the hemapheresis instrument or the venous access Characteristics: Dyspnoea, Tachypnoea , Cyanosis, Tachycardia, Hypotension


Due to improper installation of apheresis kit or a defect in the kit itself or use of incorrect fluids Monitor donor plasma throughout the procedure If hemolysis is detected, stop the procedure immediately Set up of machine should always be double checked and use of correct fluids be ensured Haemolysis

Allergic reactions:

Allergic reactions Among platelet and plasma donors, reactions to ethylene oxide used to sterilize the disposable sets have been described. Ethylene oxide present in the plastic binds to proteins in the plasma with these serving as carrier molecules. The ethylene oxide becomes a hapten resulting in an immune response to the ethylene oxide bound to the serum protein and production of IgE antibodies

Adverse effects associated with Granulocyte donations:

Adverse effects associated with Granulocyte donations Granulocyte donors are pretreated with either G-CSF alone or a combination of G-CSF and steroids. G-CSF related adverse effects Bone and muscle pain (37– 68%), Headache (15–26%), Fatigue (0–21%), Nausea (3–6%) Insomnia Restlessness, dizziness, sweating, and hunger. Steroid –related: Posterior subcapsular cataracts Karin amrein , angelika valentin , gerhard lanzer , camilla drexler blood reviews 26 (2012) 33–42

Adverse effects associated with Peripheral blood stem cell donation:

Adverse effects associated with Peripheral blood stem cell donation Bone pain (81–98%) Headache (28– 40%) Flu-like symptoms (8.7–20%) Spleen enlargement, rarely splenic rupture. Very rare reported events include Intracranial haemorrhage due to cerebrovascular malformation ,myocardial infarction, pulmonary embolism ,deep venous thrombosis, severe hypertension ,capillary leak syndrome ,acute lung injury ,G-CSF-related pseudo gout, hyperthyroidism, severe thrombocytopenia Karin amrein , angelika valentin , gerhard lanzer , camilla drexler blood reviews 26 (2012) 33–42

Long term adverse effects of apheresis donation:

Long term adverse effects of apheresis donation Immune suppression due to long-term apheresis donation Thrombocytopenia with repeat platelet donation Iron deficiency Exposure to plasticizers (DEHP) Protein loss Altered bone metabolism Significant osteopenia , decreased bone mineral density Rare Acute myocardial infarction and stroke

Grading of complications:

Grading of complications Severity is graded in two main levels severe and non-severe. Severe complications Conditions which define a case as severe are: Hospitalization : If it was attributable to the complication. Intervention : To preclude permanent damage or impairment of a body function to prevent death (life- threatening) Symptoms : Causing significant disability or incapacity following a complication of blood donation and persisted for more than a year after the donation (Long term morbidity) Death : If it follows a complication of blood donation and the death was possibly, probably or definitely related to the donation. Non-severe complications The non-severe complications are complications which do not satisfy any of the requirements for being severe.

Grading of Imputability:

Grading of Imputability The strength of relation between donation and complication is Definite or certain : when there is conclusive evidence beyond reasonable doubt for the relation Probable or likely : when the evidence is clearly in favor of a relation Possible : when the evidence is indeterminate for attributing the complication to the donation or an alternative cause Unlikely or doubtful : when the evidence is clearly in favor of attributing the complication to other causes Excluded : when there is conclusive evidence beyond reasonable doubt that the complication can be attributed to causes other than the donation. It is recommended that for international comparison of data on complications related to blood donation only cases with imputability of possible, probable or definite be captured.

Post donation care:

Post donation care Donors should be seated for sometime after donation Should be offered refreshments No donor should leave the venue until collection personnel feel confident that he/she is well enough to do so Pressure should be applied on the venepuncture site for sometime Venepuncture dressing should be kept in place for rest of the day Strenuous exercise should be avoided for the next 24 hrs Plenty of fluids should be taken Heavy weights should not be lifted using the arm in which venepuncture was performed

Post Donation advice:

Post Donation advice Prolonged standing should be avoided for rest of the day In the event of feeling faint, the donor should quickly sit down and lower his /her head Any illness within 2 weeks of donation should be reported to the transfusion service Avoid smoking and alcohol for 24 hours following donation. Refrain from heavy work. Those involved in work which may be a danger to others like pilots, drivers and surgeons should avoid work on the day.



Donor notification and counseling :

Donor notification and counseling Objectives : (a) protects the health of the donor , and prevents secondary transmission of infectious diseases to sexual partners and offspring ; ( b) protects the safety of the blood supply by conveying the message that the individual should refrain from future blood donations (c ) provides feedback about the effectiveness of donor selection procedures such as pre-donation education, medical history and confidential unit exclusion (d ) fulfills ethical requirements of disclosure .

Donor notification and counseling :

Donor notification and counseling Prior to 2004, government policy stated that blood banks discard human immunodeficiency virus (HIV)- seropositive blood without informing donors about their status in order to maintain donor confidentiality and avoid stigmatizing those with HIV/AIDS. The National Blood Transfusion Council now advocates the disclosure of results of TTI to blood donors. Blood banks are now required to obtain written consent at the time of donation from the donors as to whether they wish to be informed about a reactive test result. They are required to refer donors who tested HIV reactive to the designated Voluntary Counseling & Testing Centres for disclosure, counseling and referral. All donors reactive to hepatitis B or hepatitis C need to be informed and then referred to a gastroenterologist for further management

Donor notification and counseling :

Donor notification and counseling

Revised NACO Blood Policy 2007:

Revised NACO Blood Policy 2007 Sero -reactive blood donors may be called to the blood bank concerned for their counselling and confirmatory HIV test to defer their referral to the counselling and testing centres in the vicinity. The major blood banks are to be equipped with facilities for counselling and HIV test confirmation in sero -reactive donors. Blood banks collecting blood through organized camps to send their sero -reactive samples to government-recognized HIV testing laboratories for confirmatory HIV tests. An HIV/AIDS counselor would be placed at all major blood banks, who would provide the pre- and post-test counselling to the HIV sero -reactive blood donors and adequate referral to RNTCP/ART /STI. Blood banks collecting less than 3000 units of blood per annum would not require any counsellor due to the low work load. In this context, adequate linkage needs to be established between these blood banks and the nearest major blood bank/voluntary counselling centre for referring the sero -reactive blood donors for HIV/AIDS counselling and confirmation of their HIV status.

Pre-donation counseling:

Pre-donation counseling Comprehensive pre-donation risk assessment It also introduces TTI and the screening tests that are performed. Questions aimed to elicit specific sexual risk factors and history of jaundice are also included. The questionnaire helps the donors to self-defer if they have any risk factors. The importance of being aware of a reactive test result is conveyed to the donor, i.e. to start early treatment, and take preventive measures for self and others in family. A written consent and their contact address and telephone numbers are noted on the donor form. They are made aware that they will be informed of a reactive result either via a letter, phone call or email. Confidentiality of the test results is assured.

Confidential unit exclusion ::

Confidential unit exclusion : CUE provides donors with a mechanism to indicate in a confidential manner whether or not the blood collected should be released for transfusion . This procedure is no longer used as it is associated with errors in the selection of CUE options by donors and the loss of large numbers of safe donors .

Notification and counseling of donors with positive results for HIV:

Notification and counseling of donors with positive results for HIV On the first session, the donor is made aware of the findings and is offered repeat testing to confirm the results. Risk review and extensive discussion Written information should also be provided A return visit for follow-up test results and counseling is usually scheduled a week later. This second visit allows Review of test results Solidification of counseling information, Discussion about counseling of sexual partners Referral to a physician or clinic for further follow-up. Information about support groups. It is critical to remind these individuals throughout the counseling process that they should never donate blood or tissues because of risk of transmission of HIV to recipients.

Benefits of donor counseling:

Benefits of donor counseling Benefits to the blood center and community Prevents transmission of infectious diseases, Protects the safety of the blood supply Prevents wastage of resources. Benefits to the donor Early diagnosis and treatment. Preventive interventions for self and family.

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