Donor vigilance:

an international perspective

Johanna (Jo) Wiersum-Osselton

ISBT working party on haemovigilance

International Haemovigilance Network

Sanquin Blood Supply

TRIP Hemovigilance and biovigilance

Landsteiner

Photo WBDD

EU voluntary reporting: very basic (2013) data

on serious donor reactions

Donor (hemo)vigilance

Donor hemovigilance is the systematic

monitoring of adverse reactions and incidents in

the whole chain of blood donor care, with a view

to improving quality and safety for blood donors.

From Haemovigilance: an effective tool for

improving transfusion practice, RRP de Vries, P

Robillard and JC Faber (eds), Wiley, 2012.

• International reporting

• Advances in knowledge

• Interventions

• Challenges

International reporting

• EU

• Notify Library: didactic examples

• ISTARE

EU Notify ISTARE

What Serious

Reactions

And events

Didactic

examples

All levels of

severity and

imputability

Denominators Yes No Yes

Status Reported to HV

system; country

aggregate data

Documented

in HV system or

published

Reported to HV

system;

aggregate data

Recommend-

ations

No No No

www.notifylibrary.org

Adding hemovigilance to Notify

• Commonalities

• Human origin

• Guiding principles-> protection of donors and recipients

• Organisations and professionals

• Didactic

• Assisting countries in creating their systems

NEXT STEPS

• Who will be the users?

• Align taxonomy to hemovigilance and donor vigilance

definitions

• Editorial group members and topic expert subgroups

• Contributor network

Definitions!

International Haemovigilance Network with

International Society for Blood Transfusion and

AABB Blood and Tissues

December 2014 publication of revised classification for

surveillance of complications of blood donation

Publicly available on IHN/ISBT websites www.isbtweb.org->working parties->haemovigilance->definitions

Endorsement

• Alliance of Blood Operators

• European Blood Alliance

International Haemovigilance Network

International Surveillance database for Transfusion Adverse Reactions and Events

in donors and recipients of blood components (ISTARE)

Working Group C. Politis, Ph. Renaudier,

C. Richardson, P. Robillard, J. Wiersum

Aggregate data from national HV systems

• By blood component

• Severity

• Imputability

Online data entry since 2010

0

2

4

6

8

10

12

14

16

18

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

2006 2007 2008 2009 2010 2011 2012 2013

Co

un

trie

s

Donor complications

Other

Local

VVR

Countries

Total N = 107 million donations

721063 donation complications = 0.67%

2013: data collection in

progress

(2011)

Donation complications, 2012 data (n= 121436)

Analysis by type N Total

Rate

per 100,000 N serious

%

severe

Haematoma 31376 111 888 4.2%

Arterial puncture 242 1 9 3.7%

Delayed bleeding 286 1 3 1.0%

Painful arm 4771 25 366 7.7%

Localised infection 46 0.2 30 65%

Thrombophlebitis 47 0.2 22 47%

VVR Immediate type 85075 441 1161 1.4% VVR Immediate type, accident 688 4 253 37%

VVR Delayed type 4648 24 436 9.4%

VVR Delayed, accident 229 1 80 35%

Citrate reaction 1979 10 218 11% Haemolysis 0

Generalised allergic R 16 0.1 9 56%

Air embolism 2 0.01 1 50% Other 2235 11 266 13%

Severe donor complications, 2012

• Variation in rates

• Variation in severity assessment

• Not all countries can break down between complications of whole blood donation and apheresis

• Shows up rare complications and serious complications

• Limited analyses possible

Summary

“In view of the increasing general interest in blood

banks, it is hoped that this report may be of some

value to those concerned with the organisation of

such blood banks and may aid in anticipating some

of the problems which may arise from time to time

in the care and maintenance of such projects.

The first consideration of the Blood Donor Service

has been the care and protection of the donor; the

second has been the care and prevention of spoilage

of the blood obtained.”

3,500,000 donations

• Distinguished local vs systemic complications

• Subgroup case-control study of risk factors for vasovagal

reactions –> young, first-time, female, low body weight,

previous reaction, lower blood pressure, white-collar

workers, stress

• Risks to donors from

• ammonia as a restorative: 6 cases where solution went

into eye

• use of local anaesthetic

• Study of deaths and non-fatal cardiovascular events within

48 hours revealed cases of undeclared donor morbidity

Ask your donors!

• 3 premedical students and 1 volunteer

• 1000 donors (55% female, 17% first time,

median age 42)

• Telephone interview 3 weeks after WB

donation

• “Did you have any general symptoms during or

after your blood donation?”

• “Did you have any arm problems after your blood

donation?”

• Questions about specific symptoms/complications

AEs (%) in whole-blood donors

and subgroups

All AE Bruise/

hema-

toma

Sore arm Fatigue

Vasovagal

reactions

All

donors 1000 36.1 22.7 10.0 7.8 5.3

Men 447 23.3 13.2 6.9 4.0 3.1

Women 553 48.0 30.6 12.5 11.1 7.1

Repeat 834 35.6 22.4 9.1 6.6 3.8

First-

time 166 47.0 24.7 14.5 14.5 10.8

Newman BH et al.,

Transfusion 2003;43:598-603

Range between interviewers: 30-43%

Complications of blood donation

• Complications

Rates highly dependent on ascertainment method

variation between centres, even with identical SOPs

• ->reduced

donor return

*needle-related complications,

failed stab or flow problems Experience at 1st whole blood

donation (2010; n=28819),

Return within 1 year

Needle-related complications

Sorensen BS et al, Vox Sanguinis 2008; 94;132-137: moderate and severe complications (1997 to 2003)

Sorensen BS et al, Vox Sanguinis 2015: early view: • 152 donors (4-6 per 100,000) moderate to severe arm pain (2000-2009)

• FU questionnaire 12m – 10y after donation: 88 responders

• 61 (78%) had persistent symptoms, 17 (19%) impact on daily life

Risk factors: fainting

Trouern-Trend et al.,

Transfusion 1999; 39:316-320.

Case-control study

1860 allogeneic donors &

control group from

random donor population

Risk factors (2)

faints and prefaints

Overall rate 1.43% of which 37% “moderate” or “severe”

Blood volume

Interventions Theme Method Remarks

Preventing vasovagal

reactions

Water drink (or isotonic)

Applied muscle tension

Social support

Donor information

Reduced collection volume

for at-risk donors

Newman 2007 and others

France 2010, Ditto 2009

Hanson 2009

France 2010

Eder, 2011

Needle injury !! Avoid needle manipulation Need of evidence-based

treatment methods

Monitoring donor iron status - Ferritin

- Zinc protoporphyrin

Replacement therapy

Adjusting interval

Magnussen, Goldman and others

Baart 2013

Controversial!

Baart 2011

Campaign for modification

of apheresis connectors

(preventing mix-up of saline

and citrate)

Collaboration between

stakeholder organisations

“Managed convergence”

(European Blood Alliance and

other organisations)

Iron depletion

• Regular whole blood donation depletes iron stores

• Regular donation by apheresis also has an impact

• Deferral for low Hb is the most frequent reason for donor deferral

• Deferral reduces donor return

Bryant et al. Transfusion 2012; 52:1566-1575

Low Hb group (age >18y) (

Magnussen et al. Transfusion 2015 early view

-Capital region of Denmark (192,288 donations) -Central department handling iron investigation and supplementation

-GP referral if health history suspect (no systematic follow-up; 4 donors

notified centre of leukemia, 2 bowel cancer, 1 SLE)

-Tailored iron supplements for Hb-deferred donors after FBC/ferritin

-including 20 tablets at supplement donations

“increase in Hb concentration

and a reduction in the

proportion of donors with low

Hb concentration”

M. Baart, Transfusion 2015

early view

Hb previous

donation /visit,

mmol/L*

n (%)

Prevalence of

Hb deferral,

n (%)

(total)

Prevalence of Hb deferral, n (%)

(per time interval )

Interval

< 3 months

Interval

3-6 months

Men (n=112,491)

8.6 95,210 (84.6) 1,799 (1.9) 1,079 (3.0) 454 (1.6) 165 (1.0) 101 (0.7)

Women (n=108,455)

8.0 80,600 (74.3) 3,057 (3.8) 82 (7.4) 2,171 (4.7) 489 (2.7) 315 (2.1)

Ongoing study:

effect of pre-

emptive

adjustment of

donation interval

based on

predonation Hb

WHO decision, January 2015

The Executive Board, having considered the report by the Secretariat on blood and

other medical products of human origin (MPHO),

• noted that several medical products of human origin, which are intended for human

clinical application, have significant commonalities in terms of sharing some

characteristics inherent in their human origin;

• recognized that protection of the donor is a prerequisite in order to meet the needs

of patients for access to safe medical products of human origin

• … safety issues for donors and recipients;

• … protect the fundamental human rights of donors;

• …standards to guarantee quality and safety of medical products of human origin and

to ensure traceability, vigilance, surveillance and equitable access to these products

REQUESTED that the Director-General convene consultations with Member States and

international partners, to support the development of global consensus on guiding

ethical principles for the donation and management of the mentioned medical products

of human origin; good governance mechanisms; and common tools to ensure quality,

safety and traceability, as well as equitable access and availability, as applicable, to

result in a document to be submitted to the Seventieth World Health Assembly for its

consideration

Why do we need donor

vigilance?

“The goals of management of young blood donors are

to

• provide an excellent experience for the donor at

every step in the donation process

• minimize the duration of the total donation process

• minimize vasovagal reaction/complication rates

• protect against donor injury in those who sustain a

reaction

• maximize donor retention.” B. Newman Management of young blood donors

Transfus Med Hemother 2014;41:284–295

Many unanswered questions

o Lower iron stores associated with reduced cardiovascular

events or is it the healthy donor effect?

o Health consequences of low iron stores

o Frequent automated donation – demineralisation?

o Question from donors – do frequent donations weaken

my immunity?

o Repeated vaccination (off label use)

o Stem cell donation – donor follow up

o Living organ donation

Increasing focus on donors

Increasing focus on donors

A vision

• Capture of complication data according to common

definitions and minimum set of parameters

• Denominator data

• Comparisons between blood centres

• Comparisons between countries

• Developing and evaluating interventions

• Improvements for donors

• Don’t wait for the perfect definitions and data!

Acknowledgements

All blood donors

ISTARE Working group Constantina Politis, Clive Richardson, Philippe Renaudier, Pierre

Robillard, Jan Jorgensen (retired) , Danielle Rebibo (retired)

IHN Peter Tomasulo, Jean-Claude Faber, Erica Wood, all board

members

Sanquin Tanneke Marijt, Arlinke Bokhorst, Wim de Kort, all colleagues

ISBT Mindy Goldman, Kevin Land, Barbee Whitaker

Haemovigilance working party donor subgroup