European Haemovigilance Seminar London 2005

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European Haemovigilance Seminar London 2005

• Haemovigilance Relating to Donors
• Jan Jørgensen,
• Jorge Condeco, Ludo Muylle,
• Antony Keller, and Pierre Robillard

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ISBT Working Party on HaemovigilanceMeeting July
2004 (Edinburgh)

• Workgroup on
• Definition of complications related to donation
• Jan Jørgensen (chair)
• Anthony Keller
• With the aim to
• Collect data
• Make a list of complications
• Make definitions

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European Haemovigilance NetworkExecutive meeting
July 2004 (Edinburgh)

• Workgroup on
• Donor Events and Reactions
• Ludo Muylle (chair)
• Jorge Condeco
• Jan Jørgensen
• Pierre Robillard
• With the aim to
• Organize the work
• Coordinate the work with the ISBT workgroup

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Donor Complications (DOCO)Haemovigilance WHY?

• To know about the risk
• To give realistic information to the blood
  donor
• To reduce the number of
• Complications
• Long lasting symptoms
• So, we can increase the safety of the donor,
• and make the donor continue as a regular donor

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Donor Complications (DOCO)Haemovigilance HOW?

• First step Haemovigilance
• Events / Complications
• Categories
• Definitions
• Occurrence Report form

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Donor Complications (DOCO)How should categories
be defined?

• Theory
• Based on aetiology
• Same treatment and prophylaxis
• Practice (Liz Caffrey)

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Donor Complications (DOCO)How should categories
be defined?

• Practice (Liz Caffrey)
• Should be objective
• Easy to understand
• Simple to record

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Donor Complications (DOCO)Haemovigilance HOW?

• Second step Medical information
• Symptoms
• Treatment
• Complications
• Prophylaxis

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Donor Complications (DOCO) Haemovigilance
workgroups Status 25.02.05

• The following is a primary draft
• of the very first proposal of
• Categories of complications
• related to blood donation

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Donor Complications (DOCO)Haemovigilance Status

• The proposal is a status report
• from the workgroup
• It is the result of the work
• of a few members of the groups
• in the last 3-4 months
• The proposal has not yet been seen by all members
  of the workgroups

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Donor Complications (DOCO)

• Status report from the EHN workgroup on
• Donor Events and Reactions
• in collaboration with the ISBT workgroup on
• Definition of complications
• related to donation
• JJ February 2005

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Donor Complications (DOCO)Main Categories

• Arm injury
• Vasovagal event
• Hyperventilation
• Epileptic crisis
• Cardiovascular event
• Allergic reaction
• Haemolytic reaction
• Air embolus
• Citrate toxicity
• Chill and/or rigor

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Donor Complications (DOCO)

• 1. Arm injury
• 1.1. Vessel injury
• 1.2. Nerve injury
• 1.3. Local allergy
• 2. Vasovagal event
• 2.1. Vasovagal reaction
• 2.2. Vasovagal syncope
• 3. Hyperventilation
• 4. Epileptic crisis

• 5. Cardiovascular event
• 5.1. Angina
• 5.2. Myocardial infarction
• 5.3. Stroke
• 6. Allergic reaction
• 6.1. Mild allergic reaction
• 6.2. Anaphylactic reaction
• 7. Haemolytic reaction
• 8. Air embolus
• 9. Citrate toxicity
• 10. Chills and /or rigors

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Donor Complications (DOCO)

• 1. Arm injury
• 1.1. Vessel injury
• 1.2. Nerve injury
• 1.3. Local allergy
• 2. Vasovagal event
• 2.1. Vasovagal reaction
• 2.2. Vasovagal syncope
• 3. Hyperventilation
• 4. Epileptic crisis

• 5. Cardiovascular event
• 5.1. Angina
• 5.2. Myocardial infarction
• 5.3. Stroke
• 6. Allergic reaction
• 6.1. Mild allergic reaction
• 6.2. Anaphylactic reaction
• 7. Haemolytic reaction
• 8. Air embolus
• 9. Citrate toxicity
• 10. Chills and /or rigors

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Donor Complications (DOCO)

• 1. Arm injury
• 1.1. Vessel injury
• 1.2. Nerve injury
• 1.3. Local allergy
• 2. Vasovagal event
• 2.1. Vasovagal reaction
• 2.2. Vasovagal syncope
• 3. Hyperventilation
• 4. Epileptic crisis

• 5. Cardiovascular event
• 5.1. Angina
• 5.2. Myocardial infarction
• 5.3. Stroke
• 6. Allergic reaction
• 6.1. Mild allergic reaction
• 6.2. Anaphylactic reaction
• 7. Haemolytic reaction
• 8. Air embolus
• 9. Citrate toxicity
• 10. Chills and /or rigors

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Donor Complications (DOCO)

• 1. Arm injury
• 1.1. Vessel injury
• 1.2. Nerve injury
• 1.3. Local allergy
• 2. Vasovagal event
• 2.1. Vasovagal reaction
• 2.2. Vasovagal syncope
• 3. Hyperventilation
• 4. Epileptic crisis

• 5. Cardiovascular event
• 5.1. Angina
• 5.2. Myocardial infarction
• 5.3. Stroke
• 6. Allergic reaction
• 6.1. Mild allergic reaction
• 6.2. Anaphylactic reaction
• 7. Haemolytic reaction
• 8. Air embolus
• 9. Citrate toxicity
• 10. Chills and /or rigors

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Donor Complications (DOCO)

• 1. Arm injury
• 1.1. Vessel injury
• 1.2. Nerve injury
• 1.3. Local allergy
• 2. Vasovagal event
• 2.1. Vasovagal reaction
• 2.2. Vasovagal syncope
• 3. Hyperventilation
• 4. Epileptic crisis

• 5. Cardiovascular event
• 5.1. Angina
• 5.2. Myocardial infarction
• 5.3. Stroke
• 6. Allergic reaction
• 6.1. Mild allergic reaction
• 6.2. Anaphylactic reaction
• 7. Haemolytic reaction
• 8. Air embolus
• 9. Citrate toxicity
• 10. Chills and /or rigors

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Donor Complications (DOCO)

• 1. Arm injury
• 1.1. Vessel injury
• 1.2. Nerve injury
• 1.3. Local allergy
• 2. Vasovagal event
• 2.1. Vasovagal reaction
• 2.2. Vasovagal syncope
• 3. Hyperventilation
• 4. Epileptic crisis

• 5. Cardiovascular event
• 5.1. Angina
• 5.2. Myocardial infarction
• 5.3. Stroke
• 6. Allergic reaction
• 6.1. Mild allergic reaction
• 6.2. Anaphylactic reaction
• 7. Haemolytic reaction
• 8. Air embolus
• 9. Citrate toxicity
• 10. Chills and /or rigors

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Donor Complications (DOCO)

• 1. Arm injury
• 1.1. Vessel injury
• 1.2. Nerve injury
• 1.3. Local allergy
• 2. Vasovagal event
• 2.1. Vasovagal reaction
• 2.2. Vasovagal syncope
• 3. Hyperventilation
• 4. Epileptic crisis

• 5. Cardiovascular event
• 5.1. Angina
• 5.2. Myocardial infarction
• 5.3. Stroke
• 6. Allergic reaction
• 6.1. Mild allergic reaction
• 6.2. Anaphylactic reaction
• 7. Haemolytic reaction
• 8. Air embolus
• 9. Citrate toxicity
• 10. Chills and /or rigors

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Donor Complications (DOCO)

• 1. Arm injury
• 1.1. Vessel injury
• 1.2. Nerve injury
• 1.3. Local allergy
• 2. Vasovagal event
• 2.1. Vasovagal reaction
• 2.2. Vasovagal syncope
• 3. Hyperventilation
• 4. Epileptic crisis

• 5. Cardiovascular event
• 5.1. Angina
• 5.2. Myocardial infarction
• 5.3. Stroke
• 6. Allergic reaction
• 6.1. Mild allergic reaction
• 6.2. Anaphylactic reaction
• 7. Haemolytic reaction
• 8. Air embolus
• 9. Citrate toxicity
• 10. Chills and /or rigors

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Donor Complications (DOCO)1. Arm Injury 1.1.
Vessel Injury

• Haematoma (bruise)
• Arterial puncture
• Brachial artery pseudoaneurysm
• Arteriovenous fistula
• Compartment syndrome
• Trombophlebitis (superficial)
• Deep venous thrombosis

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Donor Complications (DOCO)1. Arm Injury 1.1.
Vessel Injury1.1.1. Haematoma

• Definition
• An abnormal, localized collection of blood
• under the skin.
• Signs and symptoms
• Colour change in the skin.
• (Bruise, if no other signs.)
• Swelling.
• Pain or tenderness at the venipuncture site.
• Complications
• Nerve irritation (see 1.2).

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Donor Complications (DOCO)1. Arm Injury 1.1.
Vessel Injury1.1.2. Arterial Puncture

• Definition
• Accidental puncture of an artery.
• Signs and symptoms
• High blood flow rate (blood unit lt4 minutes).
• Bright red colour of the collected blood.
• Pulsating needle.
• Complications
• Haematoma.
• Brachial artery pseudo aneurysm.
• Arteriovenous fistula.
• Compartment syndrome.

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Donor Complications (DOCO)1. Arm Injury 1.1.
Vessel Injury1.1.3. Brachial artery
pseudoaneurysm

• Definition
• Accidental puncture of the brachial artery
  followed by leaking of blood and formation of a
  collection of blood that, on an arteriogram,
  appears to be aneurysm but without a vascular
  wall.
• Signs and symptoms
• Bruise, haematoma, swelling, tenderness, and
• pain of the arm, sensory changes
• Waxing and waning of the symptoms over an
  extended period of time (2 weeks to 2 months)
• Eventually, development of a pulsatile mass at
  the point of leakage.

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Donor Complications (DOCO)1. Arm Injury 1.1.
Vessel Injury 1.1.4. Arteriovenous fistula

• Definition
• Formation of a channel
• between a vein and an artery
• following laceration of the vessels
• by the penetrating needle.
• Signs and symptoms
• Bruise, haematoma, stiffness, swelling, pain in
  the arm.
• Distal veins dilated and pulsate.
• Pulsating mass with a continuous murmur and
  palpable thrill.

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Donor Complications (DOCO)1. Arm Injury 1.1.
Vessel Injury 1.1.5. Compartment syndrome

• Definition
• Accidental puncture of an artery, and
• leaking of blood into a closed cavity,
• leading to an increased intracompartmental
  pressure, causing vascular ischemia, nerve- and
  muscle tissue necrosis.
• Signs and symptoms
• Tense swollen fascial compartment.
• Pain when the arm is moved.
• Nerve injury (paresthesias, sensory changes),
  partial paralysis.

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Donor Complications (DOCO)1. Arm Injury 1.1.
Vessel Injury 1.1.6. Thrombophlebitis
(superficial)

• Definition
• Formation of a blood clot in the punctured
  superficial vein associated with an inflammatory
  reaction of the vein.
• Signs and symptoms
• Tenderness and hardness of the vein.
• Redness of the overlying skin.

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Donor Complications (DOCO)1. Arm Injury 1.1.
Vessel Injury 1.1.7. Deep venous thrombosis

• Definition
• Formation of a blood clot in a deep vein with
• very little reaction in the vein wall.
• Signs and symptoms
• May be asymptomatic (bruise, haematoma).
• Swelling of the arm.
• Discoloration of the arm.
• Antecubital tenderness.
• Increasing arm pain (arm, neck, and shoulder).
• Venous distention of the arm.
• Complications
• Pulmonary embolus.

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Donor Complications (DOCO)

• 1. Arm injury
• 1.1. Vessel injury
• 1.2. Nerve injury
• 1.3. Local allergy
• 2. Vasovagal event
• 2.1. Vasovagal reaction
• 2.2. Vasovagal syncope
• 3. Hyperventilation
• 4. Epileptic crisis

• 5. Cardiovascular event
• 5.1. Angina
• 5.2. Myocardial infarction
• 5.3. Stroke
• 6. Allergic reaction
• 6.1. Mild allergic reaction
• 6.2. Anaphylactic reaction
• 7. Haemolytic reaction
• 8. Air embolus
• 9. Citrate toxicity
• 10. Chills and /or rigors

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Donor Complications (DOCO)1. Arm Injury 1.2.
Nerve Injury

• Definition
• Injury of a nerve by the needle or by a
  haematoma
• Signs and symptoms
• Sensory changes (numbness, tingling).
• Excessive/burning/ radiating pain in the arm.
• Loss of arm or hand strength.
• Complications
• Temporary or permanent residual local numbness.
• Pain in the arm for many years.
• Permanent disability.

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Donor Complications (DOCO)

• 1. Arm injury
• 1.1. Vessel injury
• 1.2. Nerve injury
• 1.3. Local allergy
• 2. Vasovagal event
• 2.1. Vasovagal reaction
• 2.2. Vasovagal syncope
• 3. Hyperventilation
• 4. Epileptic crisis

• 5. Cardiovascular event
• 5.1. Angina
• 5.2. Myocardial infarction
• 5.3. Stroke
• 6. Allergic reaction
• 6.1. Mild allergic reaction
• 6.2. Anaphylactic reaction
• 7. Haemolytic reaction
• 8. Air embolus
• 9. Citrate toxicity
• 10. Chills and /or rigors

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Donor Complications (DOCO)1. Arm Injury 1.3.
Local allergy

• Definition
• Allergic reaction to an adhesive tape or skin
  preparation solution.
• Signs and symptoms
• Erythema, pruritus

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Donor Complications (DOCO)

• 1. Arm injury
• 1.1. Vessel injury
• 1.2. Nerve injury
• 1.3. Local allergy
• 2. Vasovagal event
• 2.1. Vasovagal reaction
• 2.2. Vasovagal syncope
• 3. Hyperventilation
• 4. Epileptic crisis

• 5. Cardiovascular event
• 5.1. Angina
• 5.2. Myocardial infarction
• 5.3. Stroke
• 6. Allergic reaction
• 6.1. Mild allergic reaction
• 6.2. Anaphylactic reaction
• 7. Haemolytic reaction
• 8. Air embolus
• 9. Citrate toxicity
• 10. Chills and /or rigors

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Donor Complications (DOCO)2. Vasovagal event
2.1. Vasovagal reaction

• Definition
• A feeling of discomfort just before, during, or
  shortly after blood donation.
• Signs and symptoms
• Pallor, weakness, dizziness, sweating, anxiety,
  nausea, vomiting, hypotension, and bradycardia.
• Complication
• Syncope (see 2.2).
• Long recovery period (gt15 minutes).

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Donor Complications (DOCO)2. Vasovagal event
2.2. Vasovagal syncope

• Definition
• Donor unconscious for a short period of time.
  Cannot remember all what happened.
• A syncope may occur after the donor left the
  collection site.
• Signs and symptoms
• Symptoms of a vasovagal reaction (see 2.1) Loss
  of consciousness.
• Incontinence. Convulsions.
• Complication
• Injury caused by a fall .

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Donor Complications (DOCO)

• 1. Arm injury
• 1.1. Vessel injury
• 1.2. Nerve injury
• 1.3. Local allergy
• 2. Vasovagal event
• 2.1. Vasovagal reaction
• 2.2. Vasovagal syncope
• 3. Hyperventilation
• 4. Epileptic crisis

• 5. Cardiovascular event
• 5.1. Angina
• 5.2. Myocardial infarction
• 5.3. Stroke
• 6. Allergic reaction
• 6.1. Mild allergic reaction
• 6.2. Anaphylactic reaction
• 7. Haemolytic reaction
• 8. Air embolus
• 9. Citrate toxicity
• 10. Chills and /or rigors

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Donor Complications (DOCO)3. Hyperventilation

• Definition
• Faster and deeper breathing resulting in
  exhaling excessive amounts of carbon dioxide.
  This causes a decreased blood carbon dioxide
  level and increased pH level.
• Both can cause cerebrovascular constriction.
• Signs and symptoms
• Paresthesias/tingling, twitching
• Muscular spasm (carpopedal/fascial spasm)
• Anxiety, sensation of suffocation.

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Donor Complications (DOCO)

• 1. Arm injury
• 1.1. Vessel injury
• 1.2. Nerve injury
• 1.3. Local allergy
• 2. Vasovagal event
• 2.1. Vasovagal reaction
• 2.2. Vasovagal syncope
• 3. Hyperventilation
• 4. Epileptic crisis

• 5. Cardiovascular event
• 5.1. Angina
• 5.2. Myocardial infarction
• 5.3. Stroke
• 6. Allergic reaction
• 6.1. Mild allergic reaction
• 6.2. Anaphylactic reaction
• 7. Haemolytic reaction
• 8. Air embolus
• 9. Citrate toxicity
• 10. Chills and /or rigors

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Donor Complications (DOCO)4. Epileptic crisis

• Definition
• Sudden attack of loss of consciousness or
• awareness associated with abnormal movements or
  confusion.
• Signs and symptoms
• Sudden onset.
• Loss of consciousness.
• Tonic-convulsive movements. Upturning eyes.
• Complications
• Injury from falling.

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Donor Complications (DOCO)

• 1. Arm injury
• 1.1. Vessel injury
• 1.2. Nerve injury
• 1.3. Local allergy
• 2. Vasovagal event
• 2.1. Vasovagal reaction
• 2.2. Vasovagal syncope
• 3. Hyperventilation
• 4. Epileptic crisis

• 5. Cardiovascular event
• 5.1. Angina
• 5.2. Myocardial infarction
• 5.3. Stroke
• 6. Allergic reaction
• 6.1. Mild allergic reaction
• 6.2. Anaphylactic reaction
• 7. Haemolytic reaction
• 8. Air embolus
• 9. Citrate toxicity
• 10. Chills and /or rigors

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Donor Complications (DOCO)

• 1. Arm injury
• 1.1. Vessel injury
• 1.2. Nerve injury
• 1.3. Local allergy
• 2. Vasovagal event
• 2.1. Vasovagal reaction
• 2.2. Vasovagal syncope
• 3. Hyperventilation
• 4. Epileptic crisis

• 5. Cardiovascular event
• 5.1. Angina
• 5.2. Myocardial infarction
• 5.3. Stroke
• 6. Allergic reaction
• 6.1. Mild allergic reaction
• 6.2. Anaphylactic reaction
• 7. Haemolytic reaction
• 8. Air embolus
• 9. Citrate toxicity
• 10. Chills and /or rigors

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Donor Complications (DOCO)6. Allergic reaction
6.1. Mild allergic reaction

• Definition
• An allergic reaction to a substance that is
  transfused to the donor during an apheresis
  procedure.
• Signs and symptoms
• Pruritus, rash, urticaria.

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Donor Complications (DOCO)6. Allergic reaction
6.2. Anaphylactic reaction

• Definition
• Immediate severe hypersensitivity reaction to a
  substance that is transfused to the donor during
  an apheresis procedure.
• Signs and symptoms
• Erythema, urticaria,
• laryngeal, pharyngeal and facial oedema,
  bronchospasm, respiratory distress,
• hypotension, shock.

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Donor Complications (DOCO)

• 1. Arm injury
• 1.1. Vessel injury
• 1.2. Nerve injury
• 1.3. Local allergy
• 2. Vasovagal event
• 2.1. Vasovagal reaction
• 2.2. Vasovagal syncope
• 3. Hyperventilation
• 4. Epileptic crisis

• 5. Cardiovascular event
• 5.1. Angina
• 5.2. Myocardial infarction
• 5.3. Stroke
• 6. Allergic reaction
• 6.1. Mild allergic reaction
• 6.2. Anaphylactic reaction
• 7. Haemolytic reaction
• 8. Air embolus
• 9. Citrate toxicity
• 10. Chills and /or rigors

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Donor Complications (DOCO)7. Haemolytic
reaction

• Definition
• Return of haemolysed blood (mechanical) or
  haemolytic reaction in the donor following
  accidental infusion of a hypotonic solution
  during an apheresis procedure
• Signs and symptoms
• Haemoglobinuria, haemolysed plasma
• Renal dysfunction
• Hypotension, DIC and fever

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Donor Complications (DOCO)8. Air embolus

• Definition
• Fast infusion of a large air bubble into a donor
  during an aphaeresis procedure.
• Signs and symptoms
• Abrupt onset, cough, dyspnoea, cyanosis
  Hypotension.
• Cardiac arrhythmia.

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Donor Complications (DOCO)9. Citrate toxicity

• Definition
• Citrate infusion during an apheresis procedure
• causing reduced free calcium and associated
  symptoms.
• Subsides with reduction of the blood flow.
• Signs and symptoms
• Paresthesia/tingling
• Nausea, vomiting
• Arrhythmia.

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Donor Complications (DOCO)10. Chills and/or rigor

• Definition
• Return of cold blood during an apheresis
  procedure may cause a cold feeling.
• Signs and symptoms
• Chills, rigor.

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