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Tongporn Wannatoop, M.D.*, Janejira Kittivorapart, M.D. Ph.D.**, Kulvara Kittisares, M.D.**, Warit Werawatakul,
M.D.*, eera Ruchutrakool, M.D.***, Parichart Permpikul, M.D.**, Sunanta Chobpluk, B.Sc.**
*Division of Trauma Surgery, Department of Surgery, **Department of Transfusion Medicine, ***Division of Hematology, Department of Medicine,
Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok 10700, ailand.
Implementation of Viscoelastic Hemostatic
Assay-guided Therapy to Evaluate and Manage
Trauma-related Bleeding: A Pilot Study from
a Level 1 Trauma Center in Bangkok, Thailand
ABSTRACT
Objective: To evaluate the eectiveness of viscoelastic hemostatic assay (VHA)-guided therapy for assessing and
managing trauma-related bleeding using a multidisciplinary team approach at a level 1 trauma center.
Materials and Methods: is retrospective pilot study included trauma-related hemorrhagic patients who underwent
rotational thromboelastometry (ROTEM) during September 2019-May 2020. ROTEM trace results were compared
with those of conventional coagulation tests (CCT).
Results: irteen patients (median age: 29.1 years; male: 76.92%) were included. e median (range) days of
ventilator support, ICU length of stay, and hospital length of stay was 4 [0-65], 5 [1-65], and 6 [1-83], respectively.
ROTEM-guided therapy was applied 26 times, and was repeated in 7 cases. Of those, four cases were repeated to
correct coagulopathy. e median time-to-conrmed hemostasis for ROTEM was substantially shorter than for
CCT (92 minutes [70-110] vs. 287 minutes [204-354], respectively). e coagulation results from 26 ROTEM tests
were also compared between those requiring and not requiring a massive transfusion protocol (MTP). MTP with
ROTEM-guided therapy was activated in 6/13 cases. Following the resuscitation endpoints in traumatic shock, four
of those had their median serum lactate levels decreased from 10.9 d/L (2.1-16.8) to 3.9 d/L (1.7-17.7). ROTEM
traces detected cases with low brinogen that only required cryoprecipitate transfusion, and red blood cell and
fresh frozen plasma use was less in ROTEM than in conventional MTP.
Conclusion: VHA-guided therapy was shown to eectively facilitate goal-directed hemostatic resuscitation and
ecient blood product use during resuscitation, denitive treatment, and postoperative intensive care.
Keywords: Implementation; viscoelastic hemostatic assay-guided therapy; trauma-related bleeding; rotational
thromboelastometry; trauma-induced coagulopathy (Siriraj Med J 2022; 74: 294-304)
Corresponding author: Tongporn Wannatoop
E-mail: tongporn.wan@mahidol.ac.th
Received 27 November 2021 Revised 31 December 2021 Accepted 4 January 2022
ORCID ID: https://orcid.org/0000-0002-9331-9218
http://dx.doi.org/10.33192/Smj.2022.36
All material is licensed under terms of
the Creative Commons Attribution 4.0
International (CC-BY-NC-ND 4.0)
license unless otherwise stated.
INTRODUCTION
Preventable death due to exsanguination is a leading
cause of death in trauma patients. This means that
improvements in patient care can improve patient survival.
1
Consistent with this premise, advancements in damage
control resuscitation (DCR), including improvements
in methods for assessing and managing trauma-related
bleeding, have been adopted and implemented with very
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favorable results.
2,3
e DCR concept comprises three
aspects, including balanced resuscitation, hemostatic
resuscitation, and bleeding control. Hemostatic resuscitation
requires advanced understanding of trauma-induced
coagulopathy (TIC) that is guided by a goal-directed
resuscitation approach.
4-8
is is essentially important
because several previous studies reported TIC to be
associated with 4- to 6-fold higher mortality.
4,9-13
Another important death-related factor in hemorrhaging
patients is time, including time to hemostasis, time-to-
treat, and time to activation of a massive transfusion
protocol (MTP).
14
erefore, a rapid and reliable method
is needed that can detect and correct TIC during eorts to
achieve surgical control at the bleeding site.
10,15
In a trauma
setting, conventional coagulation tests (CCT), such as
prothrombin time (PT), activated partial thromboplastin
time (APTT), international normalized ratio (INR),
platelet count, and brinogen level, have limited ability
to evaluate for TIC due to their ability to accurately
reect the real physiologic dynamic changes that occur
during the coagulation process.
3,16
Moreover, these tests
consume too much of the ‘golden hour’ that is so crucial
to patient survival in a trauma setting.
17
To remedy these treatment-related concerns,
technological innovations for detecting coagulopathy
were introduced to improve advanced resuscitation.
Viscoelastic hemostatic assay (VHA), such as rotational
thromboelastometry (ROTEM) (TEM Innovations GmbH,
Munich, Germany) and thromboelastography (TEG)
(Haemonetics Corp, Niles, IN, USA), is a tool that has the
ability to detect and report global hemostasis, including
all stages of the coagulation cascade from initiation of clot
formation to clot lysis.
3,18
Several clinical trials, reported
signicant advantages of VHA-guided MTP in trauma
patients relative to both decreased mortality and reduced
use of blood components during resuscitation.
19-23
e VHA technique was rst introduced by Hellmut
Hartert in 1948.
24
During the early period, VHA was used
during liver transplantation and cardiac surgery.
3,25-27
It was rst applied in trauma care in 1997 to study its
ability to detect and improve the management of TIC.
28
VHA-guided MTP was then evaluated their superior
benet than standard MTP for use in trauma patients
in 2013.
29
e VHA instrument that is available at our
center is a ROTEM sigma machine (TEM Innovations
GmbH, Munich, Germany), so this study evaluated the
eectiveness of this device compared to conventional
MTP. This cartridge-based device delivers dynamic
run-through coagulation information in trace, including
clot initiation, clot propagation, clot rmness, and clot
lysis.
Even though the management of trauma patients
in ailand continues to improve and evolve, certain
factors, such as TIC, continue to delay treatment, which
reduces the likelihood of a favorable outcome. Moreover,
genetic variations may exert variable inuence on the
pathophysiology of TIC, and data specic to this condition
in ai population remains scarce. Accordingly, the
aim of this pilot study was to evaluate the eectiveness
of VHA-guided therapy for assessing and managing
trauma-related bleeding using a multidisciplinary team
approach at our level 1 trauma center, which is a major
university-based medical center.
MATERIALS AND METHODS
Study design and patients
is retrospective pilot study included trauma-related
hemorrhagic patients who underwent ROTEM testing
during September 2019 to May 2020. Patients with trauma-
related bleeding caused by penetrating injury or blunt
force injury, and patients who required blood transfusion
were eligible for inclusion. Our institution’s massive
transfusion protocol with rotational thrombolelastometry
(ROTEM)-guided coagulation management algorithm
(Fig 1) was designed and implemented by hematologists
and blood bank specialists. ROTEM trace results were
compared with those of CCT and interpreted by trained
personnel in a multidisciplinary team that included the
trauma surgeons, hematologists, and the transfusion
team. e primary outcome was 24-hour survival. e
secondary outcomes were the number of ventilator days,
the number of hospital days, the number of intensive care
days, and clinical progression until hospital discharge.
Time-to-conrmed hemostasis in this study was dened
as the duration from the drawing of the initial blood
sample to be sent to the ROTEM machine and the
laboratory with subsequent correction of any reported
coagulopathy to the time point when repeat results
reported the achievement of hemostasis aer receiving
guided-therapy. e protocol for this study was approved
by our center’s institutional review board, and written
informed consent was not obtained due to our study’s
anonymous retrospective design.
Brief overview of the use and function of the ROTEM
sigma VHA
e ROTEM sigma system is a reagent cartridge-
based fully automated system. Blood is added into a cup
that is xed, and a pin is moved by a counterspring (Fig
2). e pin is stabilized by a ball bearing avoid artifacts
caused by shock and vibration, which facilitates mobile
use of the device. With increasing viscoelastic forces due
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Fig 1. Siriraj massive transfusion protocol with rotational thrombolelastometry (ROTEM)-guided coagulation management algorithm.
A5
EX
, clot amplitude 5 min aer CT on EXTEM assay; CT
FIB
, clotting time (CT) on FIBTEM assay; ML, maximum lysis; A5
FIB
, clot amplitude
5 min aer CT on FIBTEM assay; CT
EX
, CT on EXTEM assay; FFP, fresh frozen plasma.
Fig 2. Operational principle of rotational thromboelastometry (ROTEM). (Le image) e ROTEM sigma system is a reagent cartridge-
based fully automated system. Blood that is pre-warmed to 37°C is added into a cup that is xed, and a pin is moved by a counterspring.
e pin is stabilized by a ball bearing avoid artifacts caused by shock and vibration, which facilitates mobile use of the device. With increasing
viscoelastic forces due to brin polymerization and brin-platelet interaction, the movement of the pin is reduced, which is detected contact-
free by an LED light-mirror-optical detector system. e ROTEM soware transforms this signal to a graphical result/signature waveform
called a temogram. (Right image) e ROTEM sigma machine. (Figure provided courtesy of TEM Innovations GmbH, Munich, Germany)
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to brin polymerization and brin-platelet interaction,
the movement of the pin is reduced, which is detected
contact-free by an LED light-mirror-optical detector
system. e ROTEM soware transforms this signal to a
graphical result/signature waveform called a temogram
(Fig 3). Clot initiation, propagation, strength, and lysis
are displayed in time tracing patterns. e essential initial
results for correcting TIC are brinolysis, brinogen
level, platelet quantity, and platelet function because
these factors inuence initiation and propagation of
blood clotting. ROTEM output data can be reliable
interpreted within 5 minutes aer clotting time (CT)
(A5 = amplitude of clot rmness 5 minutes aer CT)
for brinogen polymerization and clot formation. ese
ndings help to determine the stage of the dynamic
process of coagulopathy, and facilitate correction via
goal-directed therapy.
23,30-32
Statistical analysis
Descriptive statistics were used to summarize patient
demographic and clinical characteristics. Microsoft
Excel® spreadsheet and data analysis soware was used
to manage and analyze the data. e data are presented
as number and percentage for categorical variables, and
as median and range for continuous data.
RESULTS
Patient characteristics
A total of 13 patients with trauma-related bleeding
were included. e median age of patients was 29.1 years
(range: 15-75), most were men (10/13, 76.92%), and most
had sustained blunt force trauma (11/13, 84.6%). One of
the two patients with a penetrating injury was referred
to our center with cardiac tamponade and clinically
compensated shock at 4 hours aer the injury. ree
Fig 3. ROTEM traces 4 main clot parameters. 1. Clot initiation: Coagulation time (CT) is dened as the time from initiation of clot formation
to brin aggregation 2. Clot propagation: Clot formation time (CFT) and alpha-angle are used to determine the speed of growth in clot
rmness due to brin polymerization and brin-platelet interaction. 3. Clot strength: Amplitude (A) 5 minutes (A5) and 10 minutes (A10)
aer CT and maximal clot rmness (MCF) result from brinogen and platelet contribution. We normally used the amplitude at 5 minutes
aer CT (A5) brinogen trace (ROTEM – FIBTEM) as POC for early correction of brinogen concentration during resuscitation. [27-29]
4. Clot lysis: Maximal lysis (ML) and clot lysis index at 30 and 60 minutes aer CT (LI30 and LI60, respectively) are related to brinolysis.
If hyperbrinolysis is present, antibrinolytic agents, such as tranexamic acid (TXA) will be administered to correct this pathology that is
commonly associated with TIC. [7, 13, 15] (Figure provided courtesy of Dr. Klaus Görlinger, Munich, Germany)
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patients were on heparinization, antiplatelet therapy
or anticoagulants for post-injury related conditions.
Among all cases, the median Injury Severity Score (ISS)
was 26 (range: 10-43), and the Revised Trauma Score
(RTS) was 7.84 (range: 0-7.84).
Two patients were diagnosed with severe traumatic
brain injury (TBI), which was dened as a Glasgow
Coma Scale (GCS) score <8, and a head Abbreviated
Injury Scale (AIS) score >2. Among all patients, the
median systolic blood pressure (SBP) was 118 mmHg
(range: 0-154), and the heart rate (HR) was 110 beats
per minute (range: 0-158). Patient body temperature
data was not recorded in all cases, so that information
is not presented here. During critical stage assessment,
the median base decit (BD) was -8.2 mEq/L (range:
-16 to 0), and the serum lactate level was 6.5 d/L (range:
1.1-16.8). Aer VHA-guided therapy, seven patients
underwent immediate further surgery in the operating
room, and the remaining patients were transferred to the
intensive care unit (ICU) (Table 1). In our study group,
ve cases were transported directly to our trauma center
(not transferred from another hospital), and tranexamic
acid (TXA) was administrated aer drawing the blood
sample.
Twelve of 13 patients survived to at least 24 hours
aer treatment for a survival rate of 92.3%. e one patient
who did not survive had sustained an unsurvivable TBI,
and also had preexisting terminal cancer. e median
number of days of ventilatory support, ICU admission,
and length of hospital stay was 4 (range: 0-65), 5 (range:
1-65), and 6 (range: 1-83), respectively.
ROTEM-guided therapy
A total of 26 ROTEM tests were performed among
the 13 study participants. e indications for ROTEM
activation were, as follows: (1) MTP activation (13 tests
in 6 patients), (2) evaluation of clinical correlation (4
tests in 3 patients), and (3) evaluation of eorts to achieve
hemostasis (9 tests in 4 patients). ese ROTEM tests
were performed during hemorrhagic shock in 12 patients.
e locations where the decision was made to employ
ROTEM-guided therapy were, as follows: resuscitation
room (6 cases), ICU (13 cases), and the perioperative care
unit (7 cases). Due to the limited number of cartridges
available at the beginning of implementation, ROTEM
testing was applied more than once in only 7 cases. Of
those, four cases had repeat ROTEM testing immediately
aer blood component transfusion to correct coagulopathy.
TABLE 1. Patient characteristics on admission or during initiation of viscoelastic hemostatic assay (VHA)-guided
therapy and patient outcomes (N=13).
Parameters n (%) or median [range]
Age (years) 29.1 [15-75]
Gender (male) 10 (76.92%)
Type of injury: Blunt force trauma 11 (84.62%)
Severe traumatic brain injury (cases) 2 (15.38%)
Injury Severity Score (ISS) 26 [10-43]
Revised Trauma Score (RTS) 7.84 [0-7.84]
Systolic blood pressure (mmHg) 118 [0-154]
Heart rate (beats per minute) 110 [0-158]
Base decit (mEq/L) -8.2 [-16 to 0]
Serum lactate (d/L) 6.5 [1.1-16.8]
Survival rate after 24-hour 12 (92.31%)
Intensive care unit outcomes
Duration of ventilatory support (days) 4 [0-65]
Intensive care unit admission (days) 5 [1-65]
Length of hospital stay (days) 6 [1-83]
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e median time-to-conrmed hemostasis was markedly
shorter in the ROTEM group (92 minutes; range: 70-110)
than in the CCT group (287 minutes; range: 204-354).
ROTEM trace results and conventional coagulation
test results compared between the massive transfusion
protocol (MTP) and non-MTP groups are shown in
Table 2. An initial study in three cases found normal
coagulation status. One case had no further resuscitation
plan aer a family discussion due to non-survivable TBI
with pre-coexisting terminal cancer. e other two cases
were reassessed in the ICU aer resuscitation, and both
were found to have achieved hemostasis. Four cases that
were treated according to the ROTEM-guided coagulation
management algorithm, demonstrated good response
to resuscitation with a median decrease in serum lactate
level from 10.9 d/L (range: 2.1-16.8) to 3.9 d/L (range:
1.7-17.7).
Blood and blood component utilization
MTP with ROTEM-guided coagulation management
algorithm was activated in 6 of 13 cases (Table 2). Our
institutional conventional MTP comprises 3 dierent
sets of blood and blood components. e rst set, which
is transfused into patients with an unknown ABO blood
group, consists of 4 units of group ‘O’ RBCs, and two
units of group “AB” fresh frozen plasma (FFP). is set
was transfused into ve patients. e second set consists
of 4 units of RBCs, 4 units of FFP, and 1 adult dose
of platelets. e third set consists of 4 units of RBCs,
4 units of FFP, and 12 units of cryoprecipitate. ere
were 4 patients who required set 2, and only 1 patient
received set 3. e blood package was no longer used
aer ROTEM results were reported.
is study analyzed the blood and blood components
used within 6 hours pre- and post-ROTEM application
by categorizing their use into following 3 phases: (1) pre-
ROTEM, which was dened as 6 to 1 hour before testing;
(2) peri-ROTEM, which was dened as 1 hour before
testing to 3 hours aer testing; and, (3) post-ROTEM,
which was dened as 3 hours to 6 hours aer testing.
is description of the distribution of blood and blood
products makes clearer the benet of ROTEM testing
data and the types of blood products needed during
dierent phases of treatment (Fig 4).
TABLE 2. Indications for rotational thromboelastometry (ROTEM) activation, and ROTEM trace results and
conventional coagulation test results compared between the massive transfusion protocol (MTP) and non-MTP groups.
N=13 cases, 26 tests
Indications for ROTEM activation
Massive transfusion protocol, n 6
Clinical correlation, n 3
Evaluation of efforts to achieve hemostasis, n 4
MTP Non-MTP
(n=6, 13 tests) (n=7, 13 tests)
ROTEM trace results
Low brinogen 6 1
Low coagulation factor 3 4
Poor platelet 1 1
Hyperbrinolysis 0 1
Normal study 0 3
Conventional coagulation tests when ROTEM was run
(data presented as median)
Fibrinogen level (mg/dL) 186.13 229.64
Platelets (/μL) 171,667 162,667
Prothrombin time (seconds) 16.02 15.08
Activated partial thromboplastin time (seconds) 35.05 28.94
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e total number of units of transfused blood products
among the 13 patients in this study were, as follows: RBCs
102 units, FFP 103 units, platelets 100 units (25 adult
doses), and cryoprecipitate 140 units. A patient who
had multiple active conditions, including reoperation
for laparotomy and thoracotomy with extracorporeal
membrane oxygenation (ECMO) support received a
blood transfusion during ROTEM testing that included
the following products: RBC 12 units, FFP 14 units,
platelet 2 doses, and cryoprecipitate 54 units. Of the four
products, RBCs, FFP, and platelets were mainly used
during the pre-ROTEM phase for a phase total of 65, 58,
and 52 units, respectively. e ratio of MT during the
resuscitation phase before applying ROTEM was 1 to 0.9
to 1.12 for FFP, platelets, and RBCs. Cryoprecipitate was
given either as part of the 3
rd
blood product combination
MTP set or as needed according to the result of ROTEM
testing. e number of units of cryoprecipitate used in
the pre-, peri-, and post-ROTEM phases was 40, 80, and
20 units, respectively.
To non-statistically evaluate the benet of ROTEM-
guided therapy as a point-of-care testing (POCT) modality,
we evaluated 6 cases that were included in this study
that met the activation criteria for conventional MTP.
at analysis revealed that we administered 24 units of
RBCs and 20 units of FFP less than the number called
for using the conventional MTP protocol.
Wannatoop et al.
Fig 4. Flow diagram dening the time of evaluation for the before, during, and aer phases of rotational thromboelastometry (ROTEM)
application (A). Units of blood products given during the before, during, and aer phases of ROTEM application among the 13 study
patients (B).
Abbreviations: RBC; red blood cell product, FFP; fresh frozen plasma, CRYO; cryoprecipitate
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DISCUSSION
Trauma resuscitation in an actively hemorrhagic
patient is a challenge, especially in patients with a non-
compressible torso hemorrhage (NCTH) because these
patients require more time to stabilize, and surgical
interventions are commonly needed to control the bleeding.
Improved understanding of the pathophysiology of
TIC has improved DCR in trauma patients.
2,4-6,9,10,19
e incidence of TIC was reported to range from 25%
to 35% in civilian and military trauma-related bleeding
patients.
4,9
Prior to the introduction of VHA-guided therapy,
CCT was used for coagulation-guided therapy in patients
with TIC; however, these tests are time-consuming
and they are limited in their ability to dynamically
assess the coagulation cascade.
3,19,28
VHA as a POCT
for coagulation assessment was implemented in many
countries to overcome these limitations.
5,6,8,10,33,34
Even
though there is limited evidence and varied outcomes
among studies, several studies reported the benet of
VHA-guided therapy for the management of bleeding
in trauma, liver transplantation, cardiothoracic surgery,
and obstetric patients.
3,5,8,22,34-36
Moreover, this technology continues to rapidly
evolve and improve. From recent study, the fastest reliable
result for the FIBTEM assay was the 5-minute result (the
A5 FIBTEM).
30-32
e benets of VHA are essential in trauma care,
especially during resuscitation and the critical phase,
which is associated with many factors that can cause or
contribute to TIC. Previous studies that investigated
the ecacy of VHA applied in trauma care reported a
decrease in mortality from as high as 36% to as low as
17%.
5,18,19,22,23
In the present study, the median ISS among
our study subjects was 26, and our 24-hour survival rate
was 92.3%. e only death occurred in a patient with
non-survivable TBI with coexisting terminal cancer.
TIC incidence
ROTEM analysis of 6 unstable trauma patients
upon arrival revealed TIC in all patients (incidence
100%). When comparing between MTP and non-MTP
patients, we found a far higher number of patients with
low brinogen in the MTP group (85.7% vs. 16.67%,
respectively), which was dened as a brinogen level
<200 mg/dL or A5 FIBTEM <9 mm. (Table 2). ese
results are consistent with the known mechanisms of TIC,
especially the importance of brinogen concentration,
which strongly inuences the initial phase of the coagulation
cascade. Base on the principle of early brinogen and
coagulation factor deciency in TIC, the evolution of
VHA as a POCT was developed to deliver faster results
so that the speed of care could be accelerated in this
vulnerable patient population. ese advantages encourage
hospitals to provide both VHA-guided therapy and
specic coagulation therapy (brinogen concentration,
prothrombin complex concentrate) to improve patient
care to the level currently being provided in several
countries around the world.
3,5,8,20,21,37,38
Interestingly, no patients in the MTP group showed
hyperbrinolysis as a result of ROTEM testing. However,
it is possible that cases that were transferred to our trauma
center from other hospitals could have received TXA
prior to transfer. At present, the CRASH-2 trial and many
clinical practice guidelines recommend administration
of tranexamic acid (TXA), which is an antibrinolytic
drug, for patients with trauma-related bleeding to correct
hyperbrinolysis in TIC.
4,33,39,40
Our pilot data suggests this
as a potentially important topic of further study because
TXA administration may help to improve trauma care
in developing countries.
ROTEM-related clinical considerations
In addition to the benets of faster point-of-care testing
to determine hemodynamic status, bleeding status, and
lactate acidosis or base excess, ROTEM-guided test data
also helped us dierentiate between medically controllable
bleeding and bleeding that required surgical intervention.
Two cases that required extensive resuscitation had their
treatment plan changed to surgical intervention aer
our review of ROTEM test results. One patient in our
cohort presented with clinically profound shock and was
unresponsiveness to resuscitation. Hemorrhagic shock
was excluded in that patient aer negative result from
evaluation by both clinical examination and full-body
computed tomography scan. e ROTEM result was
also normal, so further investigation revealed a non-
survivable TBI with neurogenic shock and no additional
strategies for correcting the patient’s condition. We also
used VHA to evaluate the coagulation status of 3 patients
who were on heparinization, antiplatelet therapy or
anticoagulants for post-injury related conditions. e
rst case was on ECMO support for post-traumatic acute
respiratory distress syndrome (ARDS), the second had
post-vascular bypass with prosthetic gra, and the third
was on anticoagulant to treat thrombosis.
Transfusion of blood components
Blood transfusion is one of the mainstay treatments
for hemorrhagic trauma patients, especially in those
requiring massive transfusion (MT). ere are several
denitions of MT. MT was dened as a requirement for
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more than 4 RBC units or death within the rst hour
aer injury.
5,6
In this study, there were 6 patients who
received MT therapy.
Early initiation of blood and blood component
transfusion combined with close monitoring of hemostasis
is needed to correct TIC. In this study, we evaluated the
use of blood and blood components before, during, and
aer ROTEM measurement. A target MTP ratio of 1:1:1
or 1:1:2 is achieved during the resuscitation process
before applying ROTEM. We observed that the use of
RBCs, FFP, and platelets was decreased during and aer
ROTEM testing compared to the pre-ROTEM phase.
A previous randomized controlled trial also reported
less use of plasma and platelets, but not RBC units, in
patients who received MT in the VHA arm.
19
Since the
rst and second sets of MTP consist of RBC, FFP, and
platelet, the higher numbers of blood products used
before the application of ROTEM than the post-ROTEM
period possibly account for the component consisting
in the conventional MTP and a requirement of volume
resuscitation in an initial phase. Aer administration of
ROTEM, blood and components would be transfused
based on the ROTEM results. is result is in agreement
with what we observed that in the VHA arm, the total
of 24 units of RBC and 20 units of FFP was spared when
compared with the conventional MTP.
In contrast, cryoprecipitate was the only component
that was increasingly transfused during the peri-and
post-ROTEM phases. e increasing requirement for
cryoprecipitate aer ROTEM testing suggests that ROTEM
is an eective tool for identifying hypobrinogenemia,
and that brinogen is an important factor in hemorrhagic
trauma patients. is result strongly correlates with the
pathophysiology of massive bleeding condition.
5,37,38,41
ese
results emphasize the importance of brinogen level and
plasma replacement in an early phase of resuscitation.
Time-to-conrmed hemostasis of coagulation assessment
Time-to-conrmed hemostasis depends on the
consistency of VHA-guided initiation, institutional protocol,
and team activation. Time-to-conrmed hemostasis in
this study was dened as outlined in the Methods section,
and included the turnaround time (TAT) duration,
which was dened as the time from the blood draw to the
reporting of the results. e current European guideline
for the management of major bleeding and coagulopathy
following trauma states that VHA as a POCT can reduce
the TAT by 30-60 minutes when compared to CCT.
5
A multicenter study reported the median TAT in CCT
to be 88 minutes with a maximum TAT of up to 235
minutes.
17
e our study found a markedly decreased
time-to-conrmed hemostasis between ROTEM and
CCT (92 minutes [70-110] vs. 287 minutes [204-354],
respectively). Moreover, we are condent that the time-
to-conrmed hemostasis by ROTEM can be further
decreased once an institutional protocol is established,
learned, and rened.
Limitations
is study has some limitations that need to be
addresses. First, the inherent weaknesses of the retrospective
study design include missing and/or incomplete data, a
tendency towards certain types of biases, and an inability
to prove causation. For example, body temperature data
was not available in all cases, so that data could not be
reported in this study. Second, the size of our study
population was small because this is a newly implemented
technique at our center, and we set forth in this study to
evaluate its eectiveness since its introduction. ird,
the small number of cases in each group limited our
ability to perform sophisticated statistical analyses.
However, we analyzed and compared several important
related parameters to assess the performance of ROTEM
testing compared to non-VHA-guided therapy, and
we found marked improvement between techniques
for all evaluated parameters. Fourth, since this is a new
technique at our center, no standard protocol has been
established, which means that heterogeneity in practice
management should be assumed. Fih, since we were
limited by the number of available cartridges for VHA
testing, repeat ROTEM testing was only performed in
7 of 13 patients. e results of this study suggest the
value of full implementation of ROTEM testing in this
trauma setting, and that an established ROTEM practice
protocol be established within a multidisciplinary team
framework. From the beginning of full implementation, a
pilot study should be conducted to conrm the results of
this study. Our patients and our center will benet from
the improvements in patient survival and more ecient
use of blood products that were both demonstrated in
this study.
CONCLUSION
e ndings of this pilot study strongly suggest
the value of VHA-guided therapy for facilitating goal-
directed hemostatic resuscitation and ecient blood
product use during resuscitation, denitive treatment,
and postoperative intensive care. e median time-to-
conrmed hemostasis for ROTEM was markedly shorter
than for CCT. Among the 6 cases that had MTP activated
via ROTEM-guided therapy, four who adhere the protocol
had their median lactate levels substantially decreased.
Wannatoop et al.
Volume 74, No.5: 2022 Siriraj Medical Journal
https://he02.tci-thaijo.org/index.php/sirirajmedj/index
303
Original Article
SMJ
Regarding blood product use, ROTEM detected cases
with low brinogen that only required cryoprecipitate
transfusion, and red blood cell and fresh frozen plasma
use was less in ROTEM than in conventional MTP.
is point-of-care test platform reduces the time to
treat trauma-induced coagulopathy in patients with
trauma-related bleeding resulting in improved survival
outcome. ese results support full implementation of
this technique in ailand to improve survival among
patients with trauma-related bleeding.
Funding disclosure
is was an unfunded study.
Authors’ contributions
TW and JK conceived and designed the study,
performed the literature review, collected the data, analyzed
and interpreted the data, and draed the article. KK
designed the study and critically reviewed the manuscript.
WW and SC collected, analyzed, and interpreted the
data. PR and TR critically reviewed the manuscript for
important intellectual content. All authors have read
and approved the version of the manuscript submitted
for journal publication.
ACKNOWLEDGEMENTS
e authors thank Dr. Klaus Görlinger for his review
and providing knowledge of viscoelastic-hemostatic assays
(VHA) and rotational thromboelastometry (ROTEM).
Conict of interest declaration
All authors declare no personal or professional
conicts of interest, and no nancial support from the
companies that produce and/or distribute the drugs,
devices, or materials described in this report. However,
it is herewith declared that laboratory reagents were
provided free of charge by TEM International GmbH
during the early phase of VHA implementation at our
center.
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