DR SUSAN M GOOBIE (Orcid ID : 0000-0001-8697-089X)

Article type : Special Interest Article (review)

Accepted Article
Handling Section Editor: Prof Francis Veyckemans

Society for the Advancement of Blood Management Administrative and

Clinical Standards for Patient Blood Management Programs. 4th Edition
(Pediatric Version).

Running head: SABM Pediatric PBM Guidelines.

Article Category: Special interest article.

Susan M. Goobie1, Trudi Gallagher2, Irwin Gross3, Aryeh Shander4

1
Department of Anaesthesiology, Critical Care and Pain Medicine, Harvard
Medical School, Boston, MA, USA.
2
Patient Blood Management Division, Washington State Hospital Association,
Seattle, WA, USA.
3
Patient Blood Management Division, Accumen Inc at Eastern Maine Medical
Center, Bangor, ME, USA.
4
Department of Anesthesiology and Bloodless Medicine, Englewood Hospital
and Medical Center, NJ, USA.

Correspondence:
Susan M. Goobie, MD, FRCPC
Department of Anesthesiology, Perioperative & Pain Medicine
Boston Children’s Hospital
300 Longwood Avenue, Boston, MA. 02115
Phone: 617 355 7737
Fax: 617 730 0894
E-Mail: [email protected]
ORID ID https://orcid.org/0000-0001-8697-089X

Key words: Patient Blood Management, PBM, transfusion, indicators,

guidelines, standards, anemia, iron deficiency, preoperative assessment.

This article has been accepted for publication and undergone full peer review but has not
been through the copyediting, typesetting, pagination and proofreading process, which may
lead to differences between this version and the Version of Record. Please cite this article as
doi: 10.1111/pan.13574
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 What is already known: Multimodal patient blood management strategies
are recommended by international organizations, including the World Health
Organization, as a means to best manage blood loss and limit blood
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transfusion.

What this article adds: This article provides Pediatric Patient Blood
Management Standards, per the Society for the Advancement of Blood
Management, to guide clinicians, and as a resource for hospitals caring for
pediatric patients to implement a comprehensive pediatric PBM program.

WC 3195

SUMMARY

Patient Blood Management is the timely application of evidence-based

medical and surgical concepts designed to maintain hemoglobin concentration,
optimize hemostasis and minimize blood loss to improve patient outcomes.
Conceptually similar to a “bundle” strategy, it is designed to improve clinical
care by using comprehensive evidence-based treatment strategies to manage
patients with potential or ongoing critical bleeding, bleeding diathesis, critical
anemia and/ or a coagulopathy.
Patient Blood Management includes multimodal strategies to screen,
diagnose and properly treat anemia, coagulopathies and minimize bleeding,
using goal-directed therapy and leverages a patient’s physiologic ability to
adapt to anemia while definitive treatment is undertaken. Allogeneic blood
component transfusion is one traditional therapeutic modality out of many for
managing blood loss and anemia and, while it may be the best choice in
certain situations, other effective and more appropriate options are available
and should be used in conjunction or alone. Therefore, comprehensive Patient
Blood Management is the new standard of care to prevent and manage
anemia and optimize hemostasis and has been recommended by the World

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 Health Organization, the American Society of Anesthesiologists, the European
Society of Anaesthesiology and the Australian National Blood Authority.
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While there is a plethora of expert consensus and good practice guidelines
published for blood component transfusion from multiple professional
organizations and societies, there remains a need for more comprehensive
and broader standards of patient medical management to proactively reduce
the risk of exposure to allogeneic transfusions. In 2010, the Society for
Advancement of Blood Management published the first comprehensive
standards to address the administrative and clinical components of an
effective, patient-centered Patient Blood Management program. Recognizing
the need to reduce inappropriate transfusions, some professional
organizations have placed their emphasis on transfusion guidelines. In
contrast, the focus of the Society for Advancement of Blood Management
Standard is on the centrality of the patient and the full spectrum of
therapeutic strategies needed to improve clinical outcomes in patients at risk
for blood loss or anemia, thereby reducing avoidable transfusions as well. The
Standards are meant not to replace, but to complement transfusion guidelines
by more completely addressing the need for a multi-modal clinical approach
with the goal to improve patient outcomes.
Compared to adult programs, Pediatric Patient Blood Management programs
are currently not commonly accepted as standard of care for pediatric
patients. This is partly due the fact that, until recently, there was a paucity of
robust evidence based literature and expert consensus guidelines on pediatric
patient blood management. Managing pediatric bleeding and blood product
transfusion presents a unique set of challenges. The main goal of transfusion is
to correct or avoid imminent inadequate oxygen carrying capacity caused by
inadequate red blood cell mass. Determining when, what and how much to

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 transfuse can be difficult. Neonates, infants, children and adolescents each
have specific considerations based on age, weight, physiology and
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pharmacology.
In this edition of Pediatric Anaesthesia we provide, in abbreviated format,
the 4th edition of the Administrative and Clinical Standards for Patient Blood
Management; Pediatric Version, first published in 2010 with the addition of a
new Pediatric section in 2016. These Standards provide guidance for
implementing a comprehensive Pediatric Patient Blood Management program
at both pediatric and adult medical institutions.
While every hospital may not be equipped to have a dedicated Pediatric
Patient Blood Management program, this document highlights important
universal clinical strategies that can be implemented to optimize pediatric
bleeding management and minimize allogeneic blood product exposure
through the use of multi-modal therapeutic strategies that have their central
emphasis on the patient rather than the transfusion. Important strategies
include: treatment of preoperative anemia, standardized transfusion
algorithms, the use of restrictive transfusion thresholds, goal-directed therapy
based on point of care and viscoelastic testing, antifibrinolytics, and avoidance
of hemodilution and hypothermia as supported by evidence. For the full
version, please go to https://www.sabm.org/publications.

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 INTRODUCTION
The Society for the Advancement of Blood Management® (SABM®) is a not-
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for-profit professional organization composed of a multidisciplinary team of
health care providers that educates caregivers on the clinical issues associated
with blood transfusion and their impact on patient outcomes. This is achieved
through an understanding of Patient Blood Management (PBM), defined by
SABM as the timely application of evidence-based medical and surgical
concepts designed to maintain hemoglobin concentration, optimize hemostasis
and minimize blood loss to improve patient outcome (Figure).
Recognizing that transfusion of allogeneic blood and its components has
long been an integral and necessary part of healthcare delivery throughout the
world, it is also associated with a significant cost and a safety burden. While
evidence-based criteria and expert consensus guidelines for clinically
appropriate transfusion have been published, practitioners continue to
transfuse patients outside these recommended criteria and best practice
guidelines without sufficient demonstration of benefit to the recipient. The
implementation of a comprehensive PBM program has been shown to
decrease blood transfusion, decrease morbidity and mortality and decrease
hospital costs.
Therefore, comprehensive multimodal PBM is the new standard of care to
manage anemia and hemostasis and has been recommended by the World
Health Organization, the American Society of Anesthesiologists, the European
Society of Anaesthesiology and the Australian National Blood Authority.
Management of pediatric bleeding and blood product transfusion presents
distinctive considerations. Blood volumes and normal hemoglobin
concentrations vary per age and weight, with neonates and infants having
higher blood volumes per weight but a lower tolerance to losses. The pediatric

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 patient is more vulnerable to blood loss; for example a 10 kg infant’s blood
volume is 80 mL/kg; and a loss of > 20% total blood volume (>160 mL) may
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cause significant hypotension and end organ under perfusion if not managed
expeditiously and appropriately. Furthermore, blood losses of small but
significant volumes can be under-recognized and under-estimated and
therefore mismanaged. Twelve percent of all pediatric cardiac arrests are
secondary to hypovolemia associated with blood loss. Although
improvements in hemovigilance have significantly reduced the risk of
transfusion-related infections, reports of pediatric non-infectious transfusion-
associated complications have increased. Transfusion related acute lung
injury, transfusion related acute circulatory overload and hemolytic
transfusion reactions are the main culprits with mortality rates as high as 15-
30%. Allogeneic red blood cell transfusion is associated with an increased
incidence of 30-day mortality and complications in children. In order to
decrease the risks associated with transfusion of blood products, a concerted
effort must be made by all hospitals and health care workers to avoid
unnecessary and inappropriate transfusions as well as over-transfusion.
Management of critical pediatric bleeding using massive hemorrhage
guidelines complements Massive Transfusion Protocols; the focus being
managing a patient’s critical bleeding in addition to appropriately managing
blood product transfusion. Hospitals caring for pediatric patients should have
written Massive Hemorrhage Guidelines incorporating Massive Transfusion
Protocols which are based on age and weight readily accessible and available
(for a specific example see Supplementary Material which incorporates expert
consensus and SABM pediatric PBM guidelines).

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 SABM has developed this abbreviated Pediatric version of the SABM
Administrative and Clinical Standards for Patient Blood Management
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Programs© fourth edition, 2016. Full-length version of this document can be
found at https://www.sabm.org/publications. These SABM Standards address
clinical activities related to pediatric patient blood management and are
intended to optimize clinical outcomes, improve patient safety and decrease
health care costs. The listed indicators provide the reader with a very useful
template of required items that must be collectively addressed in the care of
the pediatric patient to minimize iatrogenic anemia as well as to limit
allogeneic blood component transfusion exposure. These Standards are not
intended to provide strict indications, contraindications or other criteria for the
practice of clinical medicine and surgery. Clinical decisions, should be based on
locally accepted practices and on the individual pediatric patient’s clinical
status.

STANDARD 13 Patient Blood Management for Pediatric Patients for

hospitals that treat pediatric patients.

There are age-appropriate evidence-based patient blood management

clinical strategies, policies and procedures in place. Patient Blood Management
is available to all pediatric patients.

GUIDANCE
Neonates, infants and children are physiologically distinct from adults.
Normal blood volume and red cell mass varies by age and weight from birth to
adolescence and is different from that of adults. Metabolic rate and baseline
oxygen demands may be greater than in adults. However, otherwise healthy

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 pediatric age patients (excluding neonates for which there is a paucity of data)
may be more tolerant of severe anemia if they have normal cardiopulmonary
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function and may tolerate lower hemoglobin transfusion thresholds,
particularly when anemia develops slowly.
Preoperative anemia is prevalent with ~ 40% incidence in children worldwide
and a 15-20% prevalence in children in industrialized countries; 1% having
severe anemia. The main etiology is iron deficiency. The impact of
preoperative anemia on postoperative patient outcomes has been reported.
Preoperative anemia is independently associated with increasing the risk of
requiring a blood transfusion and increasing postoperative morbidity and
mortality in surgical and critically ill pediatric patients. Given that preoperative
anemia is a significant health problem and that it has a strong independent
association with mortality in neonates, infants and children, outcomes may be
improved by timely preoperative screening, diagnosis, prevention and
appropriate monitoring and treatment.
Restrictive hemoglobin thresholds have been shown to be indicated and
safe in infants, children and adolescents. Current expert consensus guidelines
recommend taking into consideration the individual patient’s clinical status
along with an optimum hemoglobin target. In general, recommendations for
pediatric patients (excluding neonates) suggests that a hemoglobin threshold
transfusion target of 7 g/dL (70 g/L) is appropriate in a hemodynamically stable
well compensated patient and that, in general, a hemoglobin concentration >9
g/dL (90 g/L) red blood cell transfusion is unnecessary and inappropriate.
Neonates, are physiologically quite distinct from infants and young children
and require a specific and different set of hemoglobin thresholds and
transfusion guidelines. This is confounded by the fact that they have varying
hemoglobin levels and types, and potentially a limited inability to tolerate

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 physiologic stress, and a weak immune response. Furthermore physicians
caring for neonates have the challenge of determining and assessing clinical
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symptoms and physiological markers of critical anemia. Current evidence
regarding optimum hemoglobin thresholds in neonates is controversial and
evolving. Most evidence based sources recommend a restrictive hemoglobin
threshold in term neonates given that no significant differences in short term
outcomes have been found in comparing a restrictive to a liberal strategy.
These guidelines take into account the age and the respiratory status (i.e. if
ventilated or not and the oxygen requirement). Preterm neonates account for
the highest transfusion rate and are the most challenging to determine the risk
benefit ratio of blood transfusion. Expert opinion favoring a more liberal
approach in preterm neonates, suggests that liberal transfusion thresholds
may favor improved neurodevelopmental outcomes. Until safety can be
concluded by recent ongoing trials (clinical trials.gov NCT01702805 and
NCT01393496) the indications for transfusion in the premature and low birth
weight neonate remain challenging. Specific strategies to optimize peri-partum
red cell mass, such as cord clamping, and minimizing phlebotomy to prevent
hospital acquired anemia, are important in pre-term neonates. Given that a
neonates’ total blood volume can often be less than 100 mL (90ml/kg), blood
sampling for diagnostic laboratory testing can quickly lead to significant
iatrogenic anemia; and measures should be taken to minimize both sample
volume and testing frequency. Initial laboratory testing may be performed on a
cord blood sample as one strategy to decrease phlebotomy blood losses Red
blood cell transfusions when indicated should be single donor, leukocyte
depleted, irradiated and fresh.

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 Massive Transfusion Protocols (MTPs) are indicated for patients with imminent
or ongoing massive bleeding and, when activated, provide rapid preparation
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and availability of red cells and plasma components in a 1:1:1 ratio. The goal of
MTPs is to avoid coagulopathy as a consequence of platelet and clotting factor
depletion secondary to transfusion restricted to red blood cells. While
evidence regarding the utility, feasibility and improvement in patient outcomes
when Pediatric Massive Transfusion Protocols are employed is weak and
extrapolated from adult MTP’s, hospitals should have weight and age based
standardized pediatric MTP’s available.
Uniquely challenging settings are those of cardiopulmonary bypass,
extracorporeal membrane oxygenation or exchange transfusion; situations
analogous to a massive transfusion. Due to the small blood volume of
neonates and infants, multiple blood components are usually indicated.
Prematurity and immaturity contribute to sub-optimal coagulation in many
patients. Multimodal PBM techniques incorporating massive hemorrhage
guidelines, as well as massive transfusion protocols, focus the goal on best
managing a patient’s critical bleeding and hemostatic derangement in addition
to appropriately managing blood transfusion (see Supplementary Material).
Intraoperative cell collection and re-administration (autologous cell salvage)
has been limited by the minimum cell volume needed for efficient washing, but
smaller bowls and new technologies are extending the use of this strategy to
patients with a body weight less than 10 kg. Pharmacologic agents to reduce
bleeding and blood loss, such as antifibrinolytics, and to treat anemia, such as
iron and erythropoietin, play a similar role in pediatric PBM as they do in
adults, but selection and dosing should be based on age and weight and
current expert guidelines. Goal directed transfusion algorithms using point of
care technology, such as viscoelastic testing, are helpful to target specific

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 hemostatic derangements and therefore guide transfusion of appropriate
products in the appropriate quantities. Strategies should be employed
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regarding avoidance of hemodilution, hypothermia, hyperkalemia, acidosis,
hypotension and maintaining adequate tissue perfusion and oxygenation.
Adolescents can often be managed in a manner very similar to adults. Like
adults, patient autonomy with regard to transfusion decisions should be
respected and policies in place to address the needs and concerns of pediatric
patients who have not reached the age of majority but who refuse transfusion
for religious or other reasons.
In summary, while there are considerable areas of overlap, pediatric patient
blood management presents a unique set of challenges that should be
explicitly addressed in hospitals with or without a formal patient blood
management program, both dedicated pediatric hospitals and hospitals that
treat both adults and pediatric patients. While there is less published evidence
in pediatric patient blood management strategies and outcomes compared to
the adult literature, enough published data are available along with reasonable
extrapolation from the adult literature to develop a robust PBM program that
should decrease the exposure to and risks of transfusion, achieve better
patient outcomes while decreasing associated costs.

INDICATORS

13.1 There are clearly defined and accepted definitions for neonates, infants,
children and adolescent patients based on age and weight that delineate
categories within neonatology and pediatrics for the purposes of patient
blood management. Caregivers and hospitals should reach a consensus

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 on these definitions prior to the establishment of specific age and
weight related guidelines.
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13.2 Transfusion guidelines for all blood components should be weight and
age appropriate, based on both laboratory and physiologic/clinical
criteria, and use restrictive transfusion thresholds for allogeneic red
blood cell transfusion when supported by published evidence and expert
consensus.
13.3 The Transfusion Service has policies and procedures that limit donor
exposure in patients who require transfusion, limit the risk of infection,
and limit the risk of transfusion associated graft versus host disease.
13.4 The Transfusion Service has policies and procedures to ensure fresh or
washed packed red blood cells are available and administered to
patients weighing less than 10 kg or age less than 1 year with expected
massive transfusion to prevent hyperkalemic cardiac arrest.
13.5 Written guidelines for monitoring and managing perioperative bleeding
are established, based on evidence and expert consensus and are weight
and age appropriate.
13.6 Specific measures to reduce blood loss and improve hemoglobin
concentration in the pediatric population should be employed when
possible. Preoperative screening for anemia is recommended in patients
at high risk for blood loss, at least three to four weeks prior to surgery,
to allow sufficient time to diagnose and manage anemia; unless the
surgery is of an urgent nature or must be performed sooner.
Specifically pertaining to the neonate, delayed cord clamping and
placental blood sampling for initial laboratory studies should be
considered at delivery.

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 13.7 Strategies are routinely applied to maintain hemostasis include by
avoiding hemodilution, avoiding hypothermia, avoid acidosis, prevent
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and treat metabolic derangements, careful blood pressure control to
avoid unplanned hypotension and maintaining adequate tissue
perfusion and oxygenation.
13.8 Topical hemostatic agents coupled with using meticulous surgical
techniques should be considered in neonatal and pediatric surgical
patients as an adjuvant to control bleeding.
13.9 The use of antifibrinolytics and intraoperative cell salvage collection and
re-administration should be considered for all pediatric patients
undergoing high blood loss surgery including, but not limited to, cardiac
surgery with cardiopulmonary bypass, craniofacial surgery, and
scoliosis/orthopedic surgery.
13.10 Prothrombin complex concentrates may be considered in neonatal and
pediatric patients undergoing urgent surgery who are receiving vitamin K
antagonists.
13.11 Policies and procedures are in place and followed that minimize the
frequency and volume of blood sampling for diagnostic laboratory
testing, facilitate earliest possible removal of sampling lines and provide
for the safe return of discard or void volumes.
13.12 Non-invasive techniques are used for monitoring of blood gases,
hemoglobin and other analytes whenever possible.
13.13 Point of care test-guided transfusion algorithms for pediatric surgical and
critically ill patients are available and used to guide blood component
therapy when time permits.
13.14 Retrograde autologous priming, miniature circuits, microplegia,
ultrafiltration, vacuum assisted venous drainage, and surface modified

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 bypass circuits are for extracorporeal circulation where clinically
practical and appropriate.
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13.15 In pediatric patients, especially those less than 20 kg, blood volume,
allowable blood loss and red cell transfusion volume (mL) should be
calculated based on weight and the target change in hemoglobin
increment.
13.16 The decision to transfuse platelets should be based on the platelet count
and function, the etiology of the patient’s thrombocytopenia and the
patient’s clinical status. Platelet transfusion volume should be calculated
based on weight and desired increase in platelet increment.
13.17 The decision to transfuse fresh frozen plasma should be based on
laboratory studies, including point of care viscoelastic testing if available,
and take into consideration the patient’s clinical status and the etiology
of the patient’s coagulopathy. Fresh frozen plasma transfusion volume
should be calculated based on weight and desired improvement in
coagulation indices.
13.18 The decision to transfuse cryoprecipitate should be based on laboratory
studies, including point of care viscoelastic testing if available, fibrinogen
concentration, the patient’s clinical status and the etiology of the
patient’s coagulopathy. Cryoprecipitate transfusion volume should be
calculated based on weight and desired increase in fibrinogen
concentration and improvement in coagulations indices. Fibrinogen
concentrate may alternatively be considered.
13.19 Guidelines are established for the use of erythropoiesis stimulating
agents, intravenous and/or oral iron, folate and vitamin B12 in all
pediatric patients, including extremely low birth weight and very low

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 birth weight neonates to prevent or mitigate pre-existing or hospital
acquired anemia.
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13.20 Children and adolescents with sickle cell disease should be assessed for
stroke risk and transfused with red blood cells, based on current
evidence-based guidelines, to prevent stroke.
13.21 Pediatric massive hemorrhage guidelines incorporating a massive
transfusion protocol based on age/weight should be readily accessible
and available.

Figure: Patient Blood Management Organizational Chart per the Society for the
Advancement of Blood Management.

Supplementary Material: An example of Massive Hemorrhage Management

Guidelines. These guidelines were designed by the author (SMG) based the
Society for the Advancement of Blood Management’s Pediatric Patient Blood
Management Standards and incorporates pediatric blood management expert
consensus recommendations (Ref 31).

DISCLOSURES OR CONFLICTS OF INTEREST:

Ethics: Ethical approvals not indicated.
Funding: The study was funded internally by the Society for the
Advancement of Blood Management.
Disclosures: SMG, TG and IG and AS: No COI to declare pertaining to this
work.
SMG is a section editor for Pediatric Anesthesia.

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 STANDARD 13 REFERENCES (PEDIATRICS)
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Management. Practice Guidelines For Perioperative Blood Management:
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 Transfusion and Anemia Expertise Initiative. Pediatr Crit Care Med. 2018
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33.National Blood Authority, 2016 © Patient Blood Management
Accepted Article
Guidelines: Module 6 Neonatal and Pediatrics. Published by the
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 42.Wang YC, Chan OW, Chiang MC, et al. Red Blood Cell Transfusion and
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Accepted Article
43.World Health Organization (WHO) 63rd World Health Assembly.
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2010

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Accepted Article

This article is protected by copyright. All rights reserved.