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Adverse events Side effects of donation by Adverse events of “blood collections” • collections Hans Vrielink, MD, PhD • Apheresis collections Department of • Donors

• Adverse events c an be local and / or systemic or both • Events must be registered

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Donor side effects 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 • Female : men = 2:1 (48 vs 23%) Local / Systemic • FD > RD (47 vs 36%) Bruis e / Hematoma 25 • Race affects bruising • Spontaneous reported < solic ited rates Arm pain 10 • Rates differ w ith interview er and used questions Burning Numbness Tingling 1

Fatigue 8 Vasovagal sy mptoms 5 Nausea 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)

1000 interview ed random WB-donors number return v isits (follow -up 9-21 Adverse Events % decrease months) Hematoma (inc idence 15%) 0 (n.s.) Estimated overall effect various A E on s ubsequent donation in general Pain in arm (7%) 2 (n.s.) blood donor population = 6% reduction Fatigue (5%) 20

•Greatest impact Vas ovagal sy mptoms Donor reaction (4%) 34 •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 “Donors who react may not come back” Adverse Events WB vs Apheresis (%)

•Whole blood donors (n=89,587) A merican Red Cross Blood Serv ices WB Apheresis •Analyzed repeat donation vs. vasovagal reaction McLeod AE 11 - 21 2.18

• one-year follow -up: Despotis AE 0.81  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 vas ovagal 2 - 5 0.05 Vasovagal + 0.1 - 0.3 0.08 Vasov. + syncope + injury 0.013

7 8 France et al. TRASCI 2005

Vasovagal reaction Vasovagal reaction

• A reflex of the parasy mpatic nervous system The body overreacts to certain triggers: • Affects the : bradycardia •Stress • Affects the nerves to the blood v essels in the legs  dilatation. •Stress related to painful or unpleasant stimuli • As a result: hypotension • The brain is deprived of  fainting • Trauma • Watc hing / experiencing medical procedures (e.g. ) • Hypocalcaemia • Anxiety •Extreme emotional distress •Lack of sleep • •Hunger •etc

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Vasovagal Reaction: symptoms Vasovagal Reaction: actions

 bradycardia • Trendelenburg’s position  restoring the  hypotension blood flow to the brain  dizziness, pallor and sw eating • Stop donation / procedure  naus ea, anxiousness • Control and RR  unconsciousness • Trust giv ing attitude

10-15% develop syncope after leaving the donation site

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2 Strategies to decrease Vasovagal Reactions Hypotension

a. Attention to donor & “keep their minds busy” Can be seen in donors (and patients) during apheres is. • Vasovagal reactions b. Effect of drinking w ater • Anaphy laxis w ithout: 8/22 presyncope, w ith: 1/22 presyncope mediated by increased peripheral vascular res istanc e Lu, Circulation 2003

RCT high school (+ FD) WB-donors 473 ml w ater (after medical acceptanc e 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 Hemodynamic changes in apheresis donors

Can be seen in donors (and patients) during apheres is. • • Vasovagal reactions • Plas mapheresis • Anaphy laxis • Cytapheresis • Hypovolemia • Plateletapheresis • WBC collections • RBC collections

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Standards Guide (standards)

In any combined collection of plas ma, and/or red c ells in one apheresis procedure, the total volume of donated plas ma, platelets and red cells must not exceed 16% of total w ith a max imum of 750 mL (exclusive of ) unless is undertaken.

The total blood volume must be calculated on the bas is of gender, height and w eight.

3 Hypotension ACE-Inhibitors

Can be seen in donors (and patients) during apheres is. Possible causes: • Decreased ability to inactivate bradykinin • Vasovagal reactions • Negatively charged plastic (disposables) or • Anaphy laxis • , hy potension, bradycardia, and dyspnea • Hypovolemia • Angiotensin c onverting enzy me (A CE) inhibitors

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Hypotension Citrate

Can be seen in donors (and patients) during apheres is. Possible causes: • Tris odiumcitrate • Vasovagal reactions • Flavoring and buffering agent in / • Anaphy laxis • Prevention of blood c lotting in dispos able / mac hine • Hypovolemia • Laxans • Angiotensin c onverting enzy me (A CE) inhibitors • WHO “oral rehydration solution” • Citrate toxicity

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Citrate handling during apheresis procedures FXII FXIIa FXI FXIa factor • Tri-sodiumcitrate is added to w hole blood donor in procedure s pecific ratio 2+ • Citrate resolves completely in plas ma Ca FIX FIXa FVIIa FVII • Citrate chelates free Calc ium • Citrate returns to donor w ith plas ma containing components Ca2+ FIXa-FVIIIa Tissue factor-FVIIa Ca2+ FX FVIII FVIIIa Ca2+ Tissue factor FXa Ca2+ FV FVa FXa-FVa Ca2+ prothrombin thrombin

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4 Calcium metabolism

• Active intake in intestines • via : • 250 mmol/day in pre- • Reabs orption of 245 mmol/day • Exc hange blood – bone  parathyroid (PTH)

http://www.en.wikipedia.org

Serum calcium & citrate infusion PTH, iCa and citrate during plt 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 Citrate Reactions

• Structural function  bones • Decrease in ioniz ed calcium results in • Signaling function  messenger for some increased excitability of neurons to the point of spontaneous depolarization. • Enzy matic function  co-enzy me for clotting factors • Function in trans mission of nerve impulse • Function in the contraction of muscles

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5 Symptoms of Citrate reactions Citrate → Hypomagnesemia

1. : metallic and (peri-oral) tingling • Mg2+ also bound by citrate Actions: Slow rate of infusion, return speed↓ / Increase the blood to • During plateletapheresis: 30% drop in magnesium lev els citrate ratio • Steeper decrease and recovers more slow ly than calcium 2. Moderate: complains persist despite measures + nausea, shivering, • Muscle spas ms & w eakness light-headedness, paraesthesia and tremors, hypotension • Decreased vascular tonus () + abnormal cardiac Actions: stop, keep needle in situ, c alcium tablets contractibility • Interference w ith potassium and calcium 3. Severe: Carpopedal spas m, muscle cramps + laryngeal spas m, sw allow complains, Chvostek’s and Trousseau’s sign positive, arrhythmia (prolongation QT interval) Actions: stop, keep needle in situ: 10 mL calc ium i.v.

Long term effects? Dettk e J . Cli n Ap he resi s 2 00 3 Comparis on bone density of 45 donors >100 PLT-apheres is w ith 40 donors <50 procedures. 35% of >100 procedures donors show ed significant osteoporos is. 31 32

Local Adverse Events Cubital fossa

• Good access  sufficient blood flow Contents • Several (e.g. median cubital , c ephalic vein, and bas ilic vein) • Brachial • Biceps brachii tendon • Radial nerve • Medial nerve

33 Ganfyd & Wikipedia

Frequent venous variations Hematoma

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6 Hematomas in multicomponent apheresis Hematomas in multicomponent apheresis

Related factors Related factors

1375 donors, retrospective 5177 procedures, A micus / Trima Hematoma • Correlated to:  170 (3,3%) hematoma • Race • Correlated to: less bruising in Afro-A meric an donors (p<0.05) • Experience operator (<500 proc edures) • Prior donations (1st versus 16th, arm movements) • Vena Bas ilica > Cephalica, Mediana • Low blood pressure: more frequent hematoma • No correlation to prior hematoma, age, gender

37 38 Bueno et al, Transfusion 2006 Newman et al, Transfusion 2003

Nervus cutaneus antebrachii Cubital fossa

Superficial veins and nerves • In general: “veins overlie nerves” • Exc eption: medial antebrachial cutaneous nerve • 7 randomly chosen cadavers: 14 fossa cubiti dissections

6 out of 14: nerves w ere superficial to and overlay veins many intertw ines betw een superficial veins and cutaneous nerves frequent contact needle and nerve. Injuries are rare.

39 Horowitz Transfusion 2000 Wikipedia

Venipuncture-induced causalgia Phlebitis

Superficial veins and nerves • Inflammation vein • 24 patients w ith causalgia after venipuncture: 22 immediate pain, 2 after 12 to 18 hours, 16 hematoma  1,5 to13 years follow up • Slow onset of a painful, red area 3 improved s pontaneously • Long thin red area along the vein 6 no change: persisting burning, numbness, hyperpathia (hard, w arm, sw ollen and cord- 15 w orsened pain or numbness (11 developed dystrophy) like).

Horowitz Transfusion 2000

• 1:6300 blood donors, 56 of 66 follow up: 52 full recovery, 4 mild residual numbness. Newman Transfusion 1996

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7 Rare side effects & apheresis In summary

• Citrate effect • Kinks • Venipuncture related problems • Vasovagal reactions • Air embolus • Side effects from blood components • • Registration is needed

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