ACS TQIP MASSIVE TRANSFUSION IN TRAUMA GUIDELINES

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ACS TQIP MASSIVE TRANSFUSION IN TRAUMA GUIDELINES
ACS TQIP
MASSIVE
TRANSFUSION
IN TRAUMA
GUIDELINES

         Released October 2014
ACS TQIP MASSIVE TRANSFUSION IN TRAUMA GUIDELINES
Table of Contents
    Introduction............................................................................................................................................... 3

    Development of a Massive Transfusion Protocol:
    Engagement and Scope........................................................................................................................ 3

    Triggers for Initiating Massive Transfusion...................................................................................... 4

    Blood Product Resuscitation in the Trauma Bay,
    Operating Room, and Angiography Suite....................................................................................... 5

    Massive Transfusion in the Intensive Care Unit ............................................................................ 6

    Operational Aspects of the Transfusion Service/Blood Bank................................................... 6

    Endpoints of Transfusion....................................................................................................................... 8

    Therapeutic Adjuncts in Massive Transfusion..............................................................................10

    Monitoring System Performance in Massive Transfusion........................................................ 11

    Bibliography............................................................................................................................................ 13

    Expert Panel............................................................................................................................................. 15

    Disclaimer..................................................................................................................................................16

2
ACS TQIP MASSIVE TRANSFUSION IN TRAUMA GUIDELINES
Introduction                                   Development of a
Hemorrhage is the most common cause            Massive Transfusion
of death within the first hour of arrival to   Protocol: Engagement
a trauma center. More than 80 percent
of deaths in the operating room (OR)
                                               and Scope
and nearly 50 percent of deaths in the         An MTP should be a written document,
first 24 hours after injury are due to         accessible to all, and adopted by the
exsanguination and coagulopathy. While         center. All staff should be familiar
only 3 percent of civilian trauma patients     with the procedures. Initial training
will receive a massive transfusion (>10        and subsequent regular drills are
units red blood cells [RBC] in 24 hours),      recommended to maintain competency.
these patients consume 70 percent of           This process is especially important in
all blood transfused at a trauma center.       trauma centers where MTP initiations are
Because massive transfusions are               rare, for example, smaller centers. The
unplanned and require the processing           content of MT protocols should be based
and delivery of large amounts of blood         on the principles of damage control
products rapidly for a sustained period        resuscitation. As such, they should
of time, significant preplanning and           provide for ratio-based blood products
coordination between the blood bank,           that are empirically delivered (hemostatic
the emergency department, the OR,              resuscitation) and have a process for
and delivery personnel is required. The        the immediate availability of RBC,
development and implementation of              plasma, and platelets. Protocols should
massive transfusion protocols (MTPs)           also include standardization of the
have been associated with a reduction          assessment of coagulopathy and include
in mortality and overall blood product         assessment and treatment of acidosis,
use in trauma centers. The purpose of          hypothermia, and hypocalcemia.
the following guidelines is to identify
the necessary components of an MTP             Massive transfusion protocols should
and address key issues involved in             be developed by a multidisciplinary
developing an MTP for trauma.                  committee that includes, at a
                                               minimum, representatives from:

                                                zz Transfusion service/blood bank

                                               zz Emergency department

                                               zz Anesthesia

                                               zz Trauma service

                                                                                            3
ACS TQIP MASSIVE TRANSFUSION IN TRAUMA GUIDELINES
The massive transfusion protocol            respectively, with specificities that range
    should address:                             between 80 percent and 90 percent.
                                                One well-validated scoring system is
    zz Triggers for initiating massive
                                                the Assessment of Blood Consumption
       transfusion in trauma
                                                (ABC) score. The ABC score consists
    zz Resuscitation in the trauma              of four variables (pulse >120, SBP
ACS TQIP MASSIVE TRANSFUSION IN TRAUMA GUIDELINES
zz Transfuse universal RBC and plasma
Blood Product                                  in a ratio between 1:1 and 1:2 (plasma
                                               to RBC).
Resuscitation in the
Trauma Bay, Operating                       zz Transfuse one single donor apheresis
                                               or random donor platelet pool for
Room, and Angiography                          each six units of RBC.
Suite                                       zz Blood products should be
Universally compatible RBC (O Rh-              automatically sent by the transfusion
negative and O Rh-positive) and                service in established ratios.
thawed plasma should be immediately
                                            zz Subsequent coolers should be
available and ideally stored in the
                                               delivered at 15-minute intervals until
emergency department (ED). Centers
                                               the MTP has been terminated.
that have used thawed plasma early
in resuscitation have seen reductions       zz The goal is to keep at least one MTP
in blood product utilization and               cooler ahead for the duration of the
product wastage. In areas where the            MTP activation.
transfusion service is unable to provide
                                           When the patient is moved from the
adequate stores of AB plasma, low
                                           resuscitation suite to the operating
(anti-B) titer A plasma may be utilized.
                                           room or the angiography suite it is
For maximum effectiveness, damage          important that this is communicated to
control resuscitation (DCR) principles     the Transfusion Service so that blood
suggest that RBC and plasma should         product delivery can continue to the site
be delivered by a rapid transfuser and     of patient care. During the procedure
through a blood warmer. Initial rate of    rapid delivery and transfusion of
transfusion should restore perfusion but   products should continue in appropriate
allow for permissive hypotension until     ratios and at a rate to keep maintain
the operation or angioembolization to      adequate blood volume while the patient
stop the bleeding has begun. Platelets     is actively bleeding. Once major bleeding
and cryoprecipitate should not be          has been controlled and the rate of
administered through a blood warmer.       transfusion has slowed it is appropriate
                                           to switch to a laboratory-or point of
 zz Universal blood products should be
                                           care (POCT)-based transfusion. For
    immediately available on patient
                                           performance improvement purposes the
    arrival to support ratio-based
                                           ratio of blood product transfusion should
    transfusion.
                                           be assessed at the time of bleeding
If MTP triggers are met:                   cessation and not necessarily at a specific
                                           time point or at the end of an operation
 zz Begin universal blood product          or angioembolization.
    infusion rather than crystalloid or
    colloid solutions.

                                                                                         5
ACS TQIP MASSIVE TRANSFUSION IN TRAUMA GUIDELINES
 Ionized calcium
    Massive Transfusion in                              Blood gas analysis, including
    the Intensive Care Unit                               base deficit

    Trauma patients for whom a massive            zz Use of empiric fixed ratios of blood
    transfusion protocol is activated most           products should be followed in the
    frequently require intensive care.               ICU until bleeding is controlled and/
    Arrival of these patients to the intensive       or specific laboratory and POCT data
    care unit (ICU) marks an important               are available. These products should
    checkpoint, including a systematic               be delivered in a ratio between 1:1
    review of the patient’s prior resuscitative      and 1:2 (plasma:RBC).
    efforts. The ICU accepting team should
                                                  zz Once laboratory data are available,
    anticipate arrival of these patients with
                                                     resuscitation should be goal directed
    the necessary equipment to continue
                                                     based on the laboratory findings
    rapidly infusing blood products.
                                                     and clinical evidence of ongoing
    Attention should be paid to correcting
                                                     bleeding.
    factors that exacerbate coagulopathy,
    including hypothermia, acidosis, and
    hypocalcemia. If massive ongoing
    bleeding persists, the patient may require    Operational Aspects of
    prompt return to the operating room,
    particularly if the coagulation status has    the Transfusion Service/
    been normalized.                              Blood Bank
    An appropriate ICU-driven algorithm           A designated trauma center should
    should be optimized to use blood              have an on-site transfusion service
    components for goal-directed therapy.         that operates 24 hours a day, seven
                                                  days a week and has specific operating
     zz Upon arrival in the ICU, baseline
                                                  procedures for the rapid early and
        laboratory measures should be
                                                  continued delivery of blood components
        obtained and then repeated as
                                                  as dictated by an MTP. The MTP must
        needed or at least hourly:
                                                  allow adherence to current, standard
           INR                                  safe practices for transfusion. During
                                                  massive transfusion, timely and precise
           aPTT                                 communication between the trauma
           Fibrinogen level                     team, the ED, the operating room,
                                                  anesthesia, and the transfusion service
           Hemoglobin or hematocrit             regarding availability and need for
                                                  transfusion products is imperative.
           Platelet count

           Point-of-care testing/
             thromboelastometry and
             rotational thromboelastography,
             if available

6
ACS TQIP MASSIVE TRANSFUSION IN TRAUMA GUIDELINES
The most efficient way to immediately          of RBC with short storage times to the
initiate an MTP is to have a blood             trauma patient at the expense of other
refrigerator containing universal donor        patients. The RECESS and ABLE studies
products in the resuscitation bay. Rapid       that are underway in the U.S. and Canada
delivery of subsequent blood coolers           may give further guidance in the future.
from the transfusion service to the
                                               For an MTP to be effective, universal
resuscitation bay is best accomplished
                                               thawed plasma should be immediately
by the assignment of a dedicated
                                               available. This step can be accomplished
runner. A process must be in place to
                                               by storing thawed or liquid (never frozen)
rapidly deliver a group and screen to
                                               plasma. The ideal universal plasma is AB
the transfusion service laboratory to
                                               plasma, but unfortunately it is in short
facilitate the availability of crossmatched
                                               supply, as only 4 percent of donors have
RBC. Uncrossmatched (O Rh negative or
                                               this blood type. As a result of increased
O Rh positive RBC) should be available
                                               use of AB plasma in resuscitation,
immediately. Group O Rh negative
                                               shortages of plasma may occur for
RBC should be reserved for women of
                                               patients with AB blood type. However, 40
child-bearing potential (younger than
                                               percent of donors are type A and many
45 to 50 years old). Patients should
                                               of them have low titers of anti-B; this low
be switched to crossmatched RBC as
                                               titer plasma can be safely given to almost
soon as it is available, which should be
                                               everyone. In order to avoid overuse
achievable within one hour for most
                                               or wastage of AB plasma, transfusion
patients (about 97 percent). For a small
                                               services may utilize group A plasma with
number of patients who have a positive
                                               low anti-B titers. This process requires
antibody screen, obtaining crossmatched
                                               determining anti-B titer at the time of
RBC may take hours. Staffing the
                                               donation. Patients should be switched
transfusion service with technologists
                                               to group-specific plasma as soon as
trained in antibody investigations is
                                               the blood group has been determined,
instrumental for providing these patients
                                               which usually takes about 10 minutes.
with compatible RBC. A transfusion
                                               The transfusion service should maintain
medicine specialist should be available to
                                               a sufficient quantity of platelets to
consult with the trauma team regarding
                                               support ratio-based massive transfusion.
compatibility and other issues related to
                                               Additional platelets may be needed to
massive transfusion.
                                               support patients with bleeding disorders
Currently RBC can be safely stored for up      or those on antiplatelet therapy. Blood
to six weeks and are released using a first-   products should be transported and
in, first-out system to minimize wastage.      stored appropriately. RBC and plasma
While there is concern that transfusion of     should be delivered and kept in
RBC with longer storage times in trauma        temperature-controlled coolers. Platelets
may increase complications, there is no        and cryoprecipitate should not be placed
current justification to prioritize the use    in coolers. Upon termination of MTP, all
                                               remaining blood products and coolers
                                               should be returned to the transfusion
                                               service promptly.

                                                                                             7
ACS TQIP MASSIVE TRANSFUSION IN TRAUMA GUIDELINES
In multicasualty situations, especially        zz Special consideration for universal
    when patients are poorly identified, the          product use should be given only in
    transfusion service should be notified            multicasualty situations
    immediately, and consideration should
    be given to exclusive use of universal
    donor blood products until stable
    identities or aliases can be established.     Endpoints of Transfusion
    A designated trauma center or its             To ensure that the MTP protocol does not
    supporting transfusion service                needlessly waste scarce resources, it is
    should have on hand and available             important to determine the criteria and
    for immediate release the following:          process for termination of the protocol.
                                                  Based on guidelines for enrollment in the
           At least eight units of universal    current Pragmatic, Randomized Optimal
             donor, uncrossmatched RBC            Platelets and Plasma Ratios (PROPPR)
             (for example, four units of O Rh     study, criteria for stopping the MTP
             negative RBC and four units of       should include both anatomic (control
             O Rh positive RBC)                   of bleeding) and physiologic criteria
           At least eight units of thawed       (normalizing hemodynamic status). The
             group AB or low titer anti-B group   decision to stop should be made by the
             A plasma. Additional plasma          trauma surgeon in conjunction with the
             should be obtainable from the        anesthesiologist, if the patient is still in
             transfusion service within 15        the operating room, or the intensivist/
             minutes of MTP activation.           trauma surgeon if in the ICU.

     zz Uncrossmatched blood products             In addition, the exact laboratory value
        should be delivered until group-          endpoints that should be used to guide
        matched products are available.           further blood product use should
                                                  be based on published data and the
           Once the transfusion service has     extensive clinical experience of those
             received a blood specimen for        who are caring for the patient.
             group matching, group-matched
             products should be available          zz The ratio-driven massive transfusion
             within 10 minutes.                       may be discontinued or downgraded
                                                      to goal-directed transfusion based
           Crossmatched RBC should                  on the laboratory findings if surgical
             be available within one hour             bleeding has been controlled by the
             for most patients. Notable               surgeon in the operating room OR
             rare exceptions include RBC              there is radiographic and physiologic
             alloantibody, rare blood group,          evidence of bleeding control after
             and so on.                               angioembolization.

8
ACS TQIP MASSIVE TRANSFUSION IN TRAUMA GUIDELINES
zz The MTP should be discontinued         If rapid TEG is available, the following
   when there is recognition that         cut-points for transfusion triggers may
   further resuscitation is futile.       also be used:

zz The following should be used as        zz Plasma for ACT >128 seconds
   guides to cease therapy with blood
                                          zz Plasma and/or cryoprecipitate
   and blood components in a patient
                                             (fibrinogen concentrate) for k-time
   who is (1) not actively bleeding and
                                             >2.5 minutes
   (2) still in the acute resuscitation
   phase:                                 zz Cryoprecipitate (fibrinogen
                                             concentrate) and/or plasma for
zz RBC transfusions for hemoglobin
                                             α-angle 230seconds
zz Cryoprecipitate or fibrinogen
   concentrate for fibrinogen level       zz Cryoprecipitate (fibrinogen
   >180 g/L                                  concentrate) and/or plasma for MCF
                                             fibTEM15
zz Plasma for r-value >9 minutes             percent
zz Plasma and/or cryoprecipitate
   (fibrinogen concentrate) for
   k-time >4 minutes

zz Cryoprecipitate (or fibrinogen
   concentrate) and/or plasma for
   α-angle
For the purposes of reporting and
     documentation in registry and                 Therapeutic Adjuncts in
     databases, hemorrhage control/
     hemostasis can be declared when               Massive Transfusion
     both of the following have been met:          There are several adjuncts available for
     zz The surgeon declares hemostasis            massive transfusion. Antifibrinolytic
        based on the absence of bleeding           medications, such as tranexemic acid
        requiring intervention in the surgical     (TXA) or aminocaproic acid, inhibit
        field OR resolution of blush after         plasminogen activation and plasmin
        angioembolization.                         activity thus stabilizing the clot.
                                                   Although available and widely used for
     zz The surgeon and/or anesthesiologists       many years, it was not until the Clinical
        agree that the patient is adequately       Randomization of an Antifibrinolytic in
        resuscitated based on the following        Significant Hemorrhage-2 (CRASH-2)
        criteria, if available:                    trial that the use of TXA in trauma
                                                   was examined. Tranexemic acid
           Stable or increasing
                                                   has been shown to be effective in a
             blood pressure, or
                                                   variety of surgical settings, including
           Stable or decreasing heart rate, or   cardiovascular surgery, orthopaedic
           Stable or increasing                  surgery, postpartum hemorrhage, and
             urine output, or                      trauma. In trauma, antifibrinolytic agents
                                                   can be used empirically or in response to
           Decreasing requirement for
                                                   findings of increased fibrinolytic activity
             vasopressors to maintain a stable
                                                   on POCT.
             blood pressure
     Frequent communication between                Recombinant activated factor VIIa was
     the members of the resuscitation              initially developed for the treatment of
     and surgical teams cannot be                  hemophilia with inhibitors and is only
     overemphasized to guide the                   licensed by the U.S. Food and Drug
     resuscitation, plan for continued need        Administration (FDA) for this indication.
     for blood products and adjuncts, and          However, over the last decade, it has
     determination of when to move toward          been studied and has been used in
     data-based resuscitation and when to          the setting of traumatic coagulopathy
     end active resuscitation.                     as well as reversal of warfarin-induced
                                                   anticoagulation in serious bleeding. At
                                                   this time, the role of factor VIIa is unclear.
                                                   It certainly appears to reduce transfusion
                                                   requirement, but lack of long-term
                                                   mortality benefit and potential increases
                                                   in morbidity have placed its position
                                                   in the MTP in doubt.

10
A variety of prothrombin complex
concentrates are currently available.           Monitoring System
These concentrates contain either
three (II, IX and X) or four (II, VII, IX and   Performance in Massive
X) clotting factors. Although widely            Transfusion
available in Europe and elsewhere for
years, the first FDA-approved four-factor       Acute hemorrhage associated with
PCC has just been released in the United        traumatic injury places the patient
States. This product is licensed for urgent     at risk for a myriad of complications.
reversal of warfarin but is sometimes           Review of hemorrhage- and transfusion-
used off-label for management of                related complications, along with
trauma-induced coagulopathy in Europe.          monitoring of the availability and
                                                management of blood products during
 zz TXA 1 gram intravenous over 10              massive transfusion, can help identify
    minutes followed by infusion                opportunities for improvement in the MT
    of 1 gram over eight hours is               process.
    recommended in all injured patients
    who are actively bleeding and are           The trauma center should review
    within three hours of injury.               cases of massive transfusion with the
                                                following complications:
 zz PCC is currently only approved for
    correction of warfarin-induced              zz Coagulopathy
    coagulopathy in bleeding patients.          zz Thrombotic complications
    As such, the American College of
    Chest Physicians Guidelines,                zz ARDS
    9th Edition, recommends use of
                                                zz Other transfusion reactions, including
    PCC over FFP for warfarin reversal in
                                                   TACO (transfusion-associated volume
    the setting of major bleeding.
                                                   overload), TRALI (transfusion-related
 zz Recombinant VIIa is generally not              acute lung injury), and hemolytic
    recommended for management of                  transfusion reaction
    refractory hemorrhage in trauma.
                                                zz Over-transfusion of RBC

                                                zz Death

                                                                                            11
Performance indicators for the process
     of massive transfusion should include:

     zz Time from calling MTP to infusion of
        first unit RBC

     zz Time from calling MTP to infusion of
        first unit plasma

     zz Adherence to a predetermined ratio
        or goal between one to two hours
        after initiation of the MTP

     zz Informing the transfusion service that
        MTP has been terminated within one
        hour of termination

     zz Wastage rates for blood products

12
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                                                                     activated Factor VII in the management of refractory
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     Flegel WA. A practical strategy to reduce the risk of passive
     hemolysis by screening plateletpheresis donors for high-        Thomas GO, Dutton RP, Hemlock B, et al.
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     Ratios (PROPPR). Available at: http://clinicaltrials.gov/
     show/NCT01545232. Accessed March 28, 2013.

     Holcomb JB, Minei KM, Scerbo ML, Radwan ZA, Wade CE,
     Kozar RA, Gill BS, Albarado R, McNutt MK, McCarthy JJ,
     Cotton BA. Admission rapid thrombelastography (r-TEG) can

14
Expert Panel
H. Gill Cryer, MD, FACS (Chair)                           Rosemary Kozar, MD, FACS
Professor of Surgery, Trauma/Emergency Surgery            Professor of Surgery and Chief of Trauma, Memorial
and Critical Care Program, UCLA, Los Angeles, CA          Hermann Hospital, Houston, TX

Avery B. Nathens, MD, FACS                                Joseph Minei, MD, FACS
Professor of Surgery, University of Toronto, Surgeon      Professor of Surgery and Chief, Division of Burn,
in Chief of Department of Surgery, Sunnybrook             Trauma, and Critical Care, University of Texas
Hospital, Toronto, ON                                     Southwestern Medical Center, Dallas, TX

Eileen M. Bulger, MD, FACS                                Katerina Pavenski, MD, FRCPC
Professor of Surgery and Chief of Trauma, University of   Assistant Professor, Departments of Medicine and
Washington, Harborview Medical Center, Seattle, WA        Laboratory Medicine and Pathology, University of
                                                          Toronto, Toronto, ON
J. Forrest Calland, MD, FACS
Assistant Professor of Surgery, University of Virginia    Martin Schreiber, MD, FACS
Health System, Charlotte, VA                              Professor of Surgery and Director of Trauma, Oregon
                                                          Health & Science University, Portland, OR
Mitchell J. Cohen, MD, FACS
Assistant Professor of Surgery, Division of General       Philip C. Spinella, MD, FCCM
Surgery, University of California, San Francisco, CA      Associate Professor of Pediatrics and Director, Critical
                                                          Care Translational Research Program, Washington
Bryan A. Cotton, MD, FACS, MPH                            University, St. Louis, MO
Associate Professor of Surgery, Division of Acute Care
Surgery Department of Surgery, University of Texas,       Angela M. Ingraham, MD
Houston, TX                                               Critical Care Medicine Fellow, University of
                                                          Pittsburgh, PA
Matthew L. Davis, MD, FACS
Assistant Professor of Surgery, Texas A&M COM,            Hunter B. Moore, MD
Trauma Program Director, Scott and White                  Integrated Research Fellow, University of Colorado
Healthcare System, Temple, TX                             RAS Liason to ACS Committee on Trauma

Mark R. Hemmila, MD, FACS
Associate Professor of Surgery, University of
Michigan Health Systems, Ann Arbor, MI

John R. Hess, MD, MPH, FACP, FAAAS
Professor of Laboratory Medicine, University of
Washington, Seattle, WA

Randeep Jawa, MD, FACS, FCCM
Visiting Associate Professor of Surgery, Division of
Trauma, Emergency Surgery, and Surgical Critical
Care, Stony Brook University School of Medicine,
Stony Brook, NY

                                                                                                                     15
The intent of the ACS TQIP Best Practices Guidelines is to provide health care professionals
     with evidence-based recommendations regarding care of the trauma patient. The Best
     Practices Guidelines do not include all potential options for prevention, diagnosis, and
     treatment and are not intended as a substitute for the provider’s clinical judgment and
     experience. The responsible provider must make all treatment decisions based upon his or
     her independent judgment and the patient’s individual clinical presentation. The ACS shall
     not be liable for any direct, indirect, special, incidental, or consequential damages related
     to the use of the information contained herein. The ACS may modify the TQIP Best Practices
     Guidelines at any time without notice.

16
Notes

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