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Adverse events Adverse events Side effects of blood donation by apheresis Side effects of blood donation by apheresis Adverse events of blood collections Whole blood collections Apheresis collections Hans Vrielink, MD, PhD

  1. Adverse events Adverse events Side effects of blood donation by apheresis Side effects of blood donation by apheresis Adverse events of “blood collections” • Whole blood collections • Apheresis collections Hans Vrielink, MD, PhD • Donors Department of Transfusion Medicine • Adverse events can be local and / or systemic or both • Events must be registered 2 Donor side effects after WB Donor side effects after WB-donation donation Donor complications after WB-donation Donor complications after WB donation 1000 random donors interview ed 3 w eeks post donation (WB; 500 mL) Adverse Events Incidence % • 36% donors had one or more A E Local / Systemic • Female : men = 2:1 (48 vs 23%) • FD > RD (47 vs 36%) Bruise / Hematoma 25 • Race affects bruising Arm pain 10 • Spontaneous reported < solicited rates • Rates differ w ith interview er and used questions Burning Numbness Tingling 1 Fatigue 8 Vasovagal symptoms 5 Nausea vomiting 1 3 4 Newman B, et al. Transfusion 2003 Newman B, et al. Transfusion 2003 Effect Adverse Events on Return Rates (RR) Effect Adverse Events on Return Rates (RR) Effect Adverse Events on Return Rates (RR) Effect Adverse Events on Return Rates (RR) 1000 interview ed random WB-donors number return visits (follow -up 9-21 Adverse Events % decrease months) Hematoma (incidence 15%) 0 (n.s.) Pain in arm (7%) 2 (n.s.) Estimated overall effect various A E on subsequent donation in general blood donor population = 6% reduction Fatigue (5%) 20 Donor reaction (4%) 34 •Greatest impact Vasovagal symptoms •Combinations: synergistic reducing effect (pain + fatigue: 65 instead 22) Donor reaction + pain arm 35 Pain arm + fatigue 65 Donor reaction + fatigue 66 Donor reaction + fatigue + pain arm 85 Estimated RR without AE: 1.32 visits / yr 5 6 Newman B, et al. Transfusion 2006 Newman B, et al. Transfusion 2006 1

  2. “Donors who react may not come back Donors who react may not come back” Adverse Events WB Adverse Events WB vs vs Apheresis (%) Apheresis (%) •Whole blood donors (n=89,587) A merican Red Cross Blood Services WB Apheresis •Analyzed repeat donation vs. vasovagal reaction McLeod AE 11 - 21 2.18 Despotis AE 0.81 • one-year follow -up:  moderate & severe vasovagal reaction: 50% overall reduction FD 1.09 RD 0.77  mild vasovagal reaction (97%): 20% reduction FD, 33% RD Winters Hematoma or pain 9 - 6 1.15 Citrate toxicity 0.4 Mild vasovagal 2 - 5 0.05 Vasovagal + syncope 0.1 - 0.3 0.08 Vasov. + syncope + injury 0.013 7 8 France et al. TRASCI 2005 Vasovagal reaction Vasovagal reaction Vasovagal Vasovagal reaction reaction • A reflex of the parasympatic nervous system The body overreacts to certain triggers: • Affects the heart: bradycardia •Stress • Affects the nerves to the blood vessels in the legs  dilatation. •Stress related to painful or unpleasant stimuli • As a result: hypotension • Trauma • The brain is deprived of oxygen  fainting • Watching / experiencing medical procedures (e.g. venipuncture) • Hypocalcaemia • Anxiety •Extreme emotional distress •Lack of sleep •Dehydration •Hunger •etc 9 10 Vasovagal Vasovagal Reaction: symptoms Reaction: symptoms Vasovagal Reaction: actions Vasovagal Reaction: actions  bradycardia • Trendelenburg’s position  restoring the blood flow to the brain  hypotension • Stop donation / procedure  dizziness, pallor and sw eating • Control pulse and RR  nausea, anxiousness • Trust giving attitude  unconsciousness 10-15% develop syncope after leaving the donation site 11 12 2

  3. Strategies to decrease Strategies to decrease Vasovagal Vasovagal Reactions Reactions Hypotension Hypotension a. Attention to donor & “keep their minds busy” Can be seen in donors (and patients) during apheresis. • Vasovagal reactions b. Effect of drinking w ater • Anaphylaxis  w ithout: 8/22 presyncope, w ith: 1/22 presyncope  mediated by increased peripheral vascular resistance Lu, Circulation 2003 RCT high school (+ FD) WB-donors  473 ml w ater (after medical acceptance for donation):  21% reduction Vasovagal reaction rate (men 27% vs w omen 15%) Newman Transfusion 2005 and 2007 Hanson Transfusion 2004  500 ml: 28% reduction Newman Transfusion 2006 13 14 Hypotension Hypotension Hemodynamic changes in apheresis donors Hemodynamic changes in apheresis donors Can be seen in donors (and patients) during apheresis. • Hypovolemia • Vasovagal reactions • Plasmapheresis • Anaphylaxis • Cytapheresis • Hypovolemia • Plateletapheresis • WBC collections • RBC collections 15 16 Standards Standards Guide (standards) Guide (standards) In any combined collection of plasma, platelets and/or red cells in one apheresis procedure, the total volume of donated plasma, platelets and red cells must not exceed 16% of total blood volume w ith a maximum of 750 mL (exclusive of anticoagulant) unless fluid replacement is undertaken. The total blood volume must be calculated on the basis of gender, height and w eight. 3

  4. Hypotension Hypotension ACE ACE-Inhibitors Inhibitors Can be seen in donors (and patients) during apheresis. Possible causes: • Decreased ability to inactivate bradykinin • Vasovagal reactions • Negatively charged plastic (disposables) or albumin • Anaphylaxis • flushing, hypotension, bradycardia, and dyspnea • Hypovolemia • Angiotensin converting enzyme (A CE) inhibitors 19 20 Hypotension Hypotension Citrate Citrate Can be seen in donors (and patients) during apheresis. Possible causes: • Trisodiumcitrate • Vasovagal reactions • Flavoring and buffering agent in drinks / food • Anaphylaxis • Prevention of blood clotting in disposable / machine • Hypovolemia • Laxans • Angiotensin converting enzyme (A CE) inhibitors • WHO “oral rehydration solution” • Citrate toxicity 21 FXII FXIIa Citrate handling during apheresis procedures Citrate handling during apheresis procedures FXI FXIa Tissue factor • Tri-sodiumcitrate is added to w hole blood donor in procedure specific ratio Ca 2+ • Citrate resolves completely in plasma FIX FIXa FVIIa FVII • Citrate chelates free Calcium • Citrate returns to donor w ith plasma containing components Ca 2+ Ca 2+ FIXa-FVIIIa Tissue factor-FVIIa FX Ca 2+ FVIII FVIIIa Tissue factor FXa Ca 2 + FV FVa FXa-FVa Ca 2+ prothrombin thrombin fibrinogen fibrin 23 4

  5. Calcium metabolism Calcium metabolism Calcium metabolism Calcium metabolism • Active intake in intestines • Excretion via Kidney: • 250 mmol/day in pre-urine • Reabsorption of 245 mmol/day • Exchange blood – bone  parathyroid hormone (PTH) http://www.en.wikipedia.org Serum calcium & citrate infusion Serum calcium & citrate infusion Serum PTH, Serum PTH, iCa iCa and citrate during and citrate during plt plt apheresis apheresis McLeod BC, Szczepiorkowski ZM, Weinstein R, Winters JL, eds; Apheresis: Principles and Practice, KURZ 2001 3rd edition; Bethesda, MD: AABB Press, 2010 Function of Calcium Function of Calcium Citrate Reactions Citrate Reactions • Structural function  bones • Decrease in ionized calcium results in increased excitability of neurons to the • Signaling function  messenger for some hormones point of spontaneous depolarization. • Enzymatic function  co-enzyme for clotting factors • Function in transmission of nerve impulse • Function in the contraction of muscles 30 5

  6. Citrate → Hypomagnesemia Symptoms of Citrate reactions Symptoms of Citrate reactions Citrate Hypomagnesemia 1. Minor : metallic taste and (peri-oral) tingling • Mg 2+ also bound by citrate Actions: Slow rate of infusion, return speed ↓ / Increase the blood to • During plateletapheresis: 30% drop in magnesium levels citrate ratio • Steeper decrease and recovers more slow ly than calcium 2. Moderate: complains persist despite measures + nausea, shivering, • Muscle spasms & w eakness light-headedness, paraesthesia and tremors, hypotension • Decreased vascular tonus (blood pressure) + abnormal cardiac Actions: stop, keep needle in situ, calcium tablets contractibility • Interference w ith potassium and calcium homeostasis 3. Severe: Carpopedal spasm , muscle cramps + laryngeal spasm, sw allow complains, Chvostek’s and Trousseau’s sign positive, arrhythmia (prolongation QT interval) Actions: stop, keep needle in situ: 10 mL calcium i.v. Long term effects? Dettk e J . Cli n Ap he resi s 2 00 3 Comparison bone density of 45 donors >100 PLT-apheresis w ith 40 donors <50 procedures. 31 32 35% of >100 procedures donors show ed significant osteoporosis. Local Adverse Events Local Adverse Events Cubital Cubital fossa fossa • Good access  sufficient blood flow Contents • Several veins (e.g. median cubital vein, cephalic vein, and basilic vein) • Brachial artery • Biceps brachii tendon • Radial nerve • Medial nerve 33 Ganfyd & Wikipedia Frequent venous variations Frequent venous variations Hematoma Hematoma 35 36 6

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