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European Haemovigilance Seminar London 2005

European Haemovigilance Seminar London 2005. “Haemovigilance Relating to Donors” Jan Jørgensen, Jorge Condeco, Ludo Muylle, Antony Keller, and Pierre Robillard. ISBT Working Party on Haemovigilance Meeting July 2004 (Edinburgh). Workgroup on Definition of complications related to donation

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European Haemovigilance Seminar London 2005

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  1. European Haemovigilance Seminar London 2005 “Haemovigilance Relating to Donors” Jan Jørgensen, Jorge Condeco, Ludo Muylle, Antony Keller, and Pierre Robillard

  2. 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

  3. 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

  4. 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

  5. Donor Complications (DOCO)Haemovigilance: HOW? First step: Haemovigilance Events / Complications Categories Definitions Occurrence Report form

  6. Donor Complications (DOCO)How should categories be defined? Theory: Based on aetiology Same treatment and prophylaxis Practice (Liz Caffrey)

  7. Donor Complications (DOCO)How should categories be defined? Practice (Liz Caffrey): Should be objective Easy to understand Simple to record

  8. Donor Complications (DOCO)Haemovigilance: HOW? Second step: Medical information Symptoms Treatment Complications Prophylaxis

  9. 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”

  10. 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

  11. Donor Complications (DOCO) Status report from the EHN workgroup on ‘Donor Events and Reactions’ in collaboration with the ISBT workgroupon ‘Definition of complications related to donation’ JJ February 2005

  12. 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

  13. 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 Donor Complications (DOCO)

  14. 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 Donor Complications (DOCO)

  15. 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 Donor Complications (DOCO)

  16. 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 Donor Complications (DOCO)

  17. 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 Donor Complications (DOCO)

  18. 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 Donor Complications (DOCO)

  19. 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 Donor Complications (DOCO)

  20. 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 Donor Complications (DOCO)

  21. 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

  22. 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).

  23. 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 <4 minutes). Bright red colour of the collected blood. Pulsating needle. Complications: Haematoma. Brachial artery pseudo aneurysm. Arteriovenous fistula. Compartment syndrome.

  24. 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.

  25. 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.

  26. 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.

  27. 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.

  28. 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.

  29. 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 Donor Complications (DOCO)

  30. 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.

  31. 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 Donor Complications (DOCO)

  32. 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

  33. 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 Donor Complications (DOCO)

  34. 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 (>15 minutes).

  35. 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 .

  36. 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 Donor Complications (DOCO)

  37. 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.

  38. 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 Donor Complications (DOCO)

  39. 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.

  40. 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 Donor Complications (DOCO)

  41. 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 Donor Complications (DOCO)

  42. 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.

  43. 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.

  44. 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 Donor Complications (DOCO)

  45. 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

  46. 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.

  47. 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.

  48. 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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