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 Table of Contents  
REVIEW ARTICLE
Year : 2022  |  Volume : 42  |  Issue : 2  |  Page : 57-63

Practice algorithm of rotational thromboelastometry-guided bleeding management in trauma and orthopedic surgery


1 Department of Orthopedic Surgery, National Defense Medical Center and Tri-Service General Hospital, Taipei; Department of Orthopedic Surgery, Hualien Armed Forces General Hospital, Hualien, Taiwan
2 Department of Orthopedic Surgery, National Defense Medical Center and Tri-Service General Hospital, Taipei, Taiwan
3 Department of Anesthesiology, National Defense Medical Center and Tri-Service General Hospital, Taipei, Taiwan

Date of Submission13-Apr-2021
Date of Acceptance14-May-2021
Date of Web Publication30-Mar-2022

Correspondence Address:
Dr. Chueng-He Lu
Department of Anesthesiology, Tri-Service General Hospital, #325, Section 2, Chenggung Road, Neihu 114, Taipei
Taiwan
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/jmedsci.jmedsci_122_21

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  Abstract 


Severe traumatic injury continues to present challenges to health-care systems worldwide, and posttraumatic bleeding remains a leading cause of potentially preventable death among injured patients. Rotational thromboelastometry (ROTEM) is a point-of-care viscoelastic method and enables to assess viscoelastic profiles of whole blood in various clinical settings. ROTEM-guided patient blood management has been shown to be effective in reducing bleeding, transfusion requirements, complication rates, and health-care costs. Accordingly, several randomized-controlled trials, meta-analyses, and health technology assessments provided evidence that using ROTEM-guided algorithms in bleeding patients resulted in improved patient's safety and outcomes including perioperative morbidity and mortality. This document aims to provide practice algorithm on the management of major bleeding and coagulopathy following traumatic injury and encourages adaptation of the guiding principles described here to individual institutional circumstances and resources.

Keywords: Hemostasis, trauma, orthopedic surgery, rotational thromboelastometry


How to cite this article:
Zheng ZH, Yeh TT, Yeh CC, Lu CH. Practice algorithm of rotational thromboelastometry-guided bleeding management in trauma and orthopedic surgery. J Med Sci 2022;42:57-63

How to cite this URL:
Zheng ZH, Yeh TT, Yeh CC, Lu CH. Practice algorithm of rotational thromboelastometry-guided bleeding management in trauma and orthopedic surgery. J Med Sci [serial online] 2022 [cited 2022 May 27];42:57-63. Available from: https://www.jmedscindmc.com/text.asp?2022/42/2/57/323753




  Introduction Top


Severe trauma is a major global public health issue, contributing to about 1 in 10 mortalities and resulting in the annual worldwide death of more than 5.8 million people.[1] Uncontrolled posttraumatic bleeding is still the leading cause of potentially preventable death among injured patients[2],[3] and one-third of all bleeding trauma patients show signs of coagulopathy at hospital admission.[4],[5],[6],[7],[8],[9] These patients develop multiple organ failure and experience death more frequently than patients with similar injury patterns in the absence of coagulopathy.[5],[6],[7],[10],[11 The early acute coagulopathy associated with traumatic injury has recently been recognized as a multifactorial primary condition that results from a combination of bleeding-induced shock, tissue injury-related thrombomodulin upregulation, thrombin-thrombomodulin-complex generation, and the activation of anticoagulant and fibrinolytic pathways.[3],[4],[6],[7],[8],[12],[13],[14],[15] The severity of the coagulation disorder is influenced by environmental and therapeutic factors that result in acidemia, hypothermia, dilution, hypoperfusion, and consumption of coagulation factors.[4],[7],[14],[16],[18],[19],[20] Moreover, the coagulopathy is modified by trauma-related factors such as brain injury[21] and individual patient-related factors that include age, genetic background, comorbidities, inflammation and medication administered before becoming injured, especially oral anticoagulants, and prehospital fluid administration.[17],[22] Prophylactic and/or inappropriate plasma and platelet transfusion does not prevent bleeding and transfusion and is associated with worse outcomes including mortality.[23],[24],[25] Furthermore, two-thirds of transfusion-related mortality is based on transfusion-related acute lung injury, transfusion-associated circulatory overload, and transfusion-related immunomodulation with hospital-acquired infections.[26]

However, the turnaround time of standard laboratory coagulation tests (SLCTs) is too long (30–90 min) to guide clinical decisions.[27],[28] In contrast, point-of-care (POC) Rotational thromboelastometry (ROTEM) provides test results within 10–15 min, as shown in [Figure 1]. Here, early amplitudes of clot firmness at 5 and 10 min (A5 and A10) after the time to initiate clotting (coagulation time [CT]) correlate very well with maximum clot firmness, plasma fibrinogen concentration and platelet count and are essential for a short turnaround time of ROTEM analysis [Table 1].[29],[30],[31],[32],[33] POC ROTEM testing does not only enable a shorter turnaround time compared to SLCTs, but these assays (such as FIBTEM) are also superior to SLCTs (such as plasma fibrinogen concentration) to predict bleeding and transfusion in trauma and orthopedic surgery.[12],[34],[35]
Figure 1: Rotational thromboelastometry trace displaying the clinically most important parameters and their informative value

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Table 1: ROTEM delta assays

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Implementation of ROTEM-guided bleeding management algorithms resulted in significant reduction in bleeding, transfusion requirements, complication rates, and hospital costs in trauma and orthopedic surgery.[26],[36],[37],[38],[39],[40],[41],[42],[43],[44] The Cochrane analysis published in 2016[36] demonstrated a risk ratio (RR) for mortality in trials using ROTEM of 0.44. The Cochrane analysis also confirmed the significant reduction in transfusion requirements and in acute kidney injury with the need for dialysis (RR, 0.46). Two large multi-center cohort studies confirmed that the implementation of a patient blood management (PBM) program including ROTEM-guided bleeding management resulted in reduced blood product utilization, blood product-related cost savings, and improved patient outcomes.[45],[46] In a meta-analysis assessing the efficacy of implementing a multimodal PBM program addressing each of the three PBM pillars including 17 studies comprising 235,779 surgical patients, transfusion rate was reduced by 39%, hospital length of stay was reduced in mean by 0.45 days, total number of complications was reduced by 20%, and mortality rate was reduced by 11%.[47] Accordingly, European and American perioperative bleeding management, trauma and PBM guidelines recommend to implement PBM including POC-guided bleeding management algorithms.[48],[49],[50],[51]

We believe that this clinical practice guideline has the potential to ensure a uniform standard of care in Taiwan and beyond and better outcomes for the severely bleeding trauma patient, as has indeed be found in three recent studies.[38],[44],[52]


  Evidence-Based Rotational Thromboelastometry-Guided Algorithm in Trauma and Orthopedic Surgery Top


The aim of algorithm includes administering the right hemostatic intervention(s), in the right dose [fibrinogen dose calculation, [Table 2]], at the right time, and in the right sequence. The trauma and orthopedic surgery ROTEM A5 algorithm is presented in [Figure 2]. The first step is always the presence or absence of clinically relevant bleeding and the potential need for blood transfusion. The second step deals with fibrinolysis management. The next two steps take care for clot firmness management (fibrinogen and platelet transfusion). A fibrinogen deficiency is most often associated with a prolonged CT in EXTEM assay (CTEX). Therefore, only if FIBTEM clot amplitude in early 5 min tracing (A5FIB) is adequate, CTEX values can be interpreted adequately. In other words, ROTEM results should be interpreted in a reasonable sequence (A5FIB prior to CTEX) as given by the algorithm. The reason is that fibrinogen concentration drop down first in severe bleeding, before thrombin generation is affected. Cutoff or trigger values used in ROTEM algorithm to guide clinical decision-making are determined in trauma and orthopedic surgery observational studies by receiver operating characteristics curve analysis or multivariate regression analysis.[12],[34],[35]
Figure 2: Evidence-based algorithm for A5 Rotational thromboelastometry-guided bleeding management in trauma and orthopedic surgery. 1. Fibrinogen dose calculation [stepwise approach; see [Table 2]]: Fibrinogen dose (g) = targeted increase in A5FIB (mm) × body weight (kg)/160, 10 U Cryoprecipitate ~1.25 g fibrinogen concentrate. 2. Consider compensation by increased A5FIB ≥12 mm. Consider TXA (25 mg/kg) and/or desmopressin (DDAVP; 0.3 μg/kg) in patients with dual antiplatelet therapy. 3. 45–90 μg rFVIIa/kg bw (if patient is normothermic and pH >7.3 and Cai2+ >1 mmol/L and A5EX ≥35 mm and A5FIB ≥9 mm but FFP is not effective to decrease CTEX ≤80 s and CTHEP ≤240s). Consider acquired hemophilia A in early severe bleeding, EXTEM and FIBTEM are normal but CTIN and CTHEP are significantly prolonged. Therapy: rFVIIa. 4. Endogenous HLE might occur in severe trauma and shock

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Table 2: FIBTEM-guided fibrinogen substitution

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In trauma, a previous randomized controlled trial (CRASH-2 trial) postulated that tranexamic acid (TXA) should be given to all trauma patients with significant hemorrhage within 3 h after injury, since TXA administration was associated with a RR for death of 0.91 in this study.[53] Accordingly, TXA should only be started later than 3 h after injury if signs of trauma-induced coagulopathy (A5EX <35 mm or FIBTEM flat-line [CTFIB >600 s]) or hyperfibrinolysis (EXTEM or FIBTEM maximum lysis [ML] ≥5% within 60 min) are present.[54],[55],[56]

Acute traumatic coagulopathy (ATC) is functional characterized by a reduction in ROTEM clot firmness amplitude.[28],[57] With a cutoff value of A5EX ≤35 mm, ROTEM can identify ATC at 5 min after CT and predict the need for massive transfusion. In patients with A5EX >35 mm transfusion requirements were below 2U red blood cell (RBC)/12 h and 1U fresh-frozen plasma (FFP)/12 h. For A5EX <35 mm transfusion requirements for RBCs and FFP increase significantly. This allows for initiation and termination of massive transfusion protocols in hemorrhaging trauma patients.[58],[59]

FIBTEM is the most sensitive assay for fibrinolysis.[60] Schöchl et al.[34] showed that FIBTEM (A5FIB) provided early prediction of massive transfusion (≥10U RBCs within 24 h of admission). Furthermore, the crucial factor of fibrinogen for the hemostatic competence in trauma has been confirmed by Hagemo et al.,[13] who detected a dramatic increase in 28-day mortality in trauma patients if admission fibrinogen concentration was below a critical value of 2.29 g/L. These results have been confirmed by an international prospective validation study including 808 trauma patients.[12] An A5EX cutoff value of ≤37 mm had a detection rate of 66.3% for ATC. An A5EX threshold value of ≤40 mm predicted massive transfusion in 72.7%. An A5FIB cutoff value of ≤8 mm detected ATC in 67.5% and an A5FIB cut-off value ≤9 mm predicted massive transfusion in 77.5%. Accordingly, an A5EX and A5FIB cutoff value of 35 mm and 9 mm has been selected for fibrinogen substitution and platelet transfusion in our trauma algorithm. This is also in line with the FIBTEM cutoff values published by Na et al.[35] to predict massive bleeding in total hip replacement arthroplasty.

Impaired thrombin generation with the need for plasma transfusion or four-factor PCC administration is considered in our trauma algorithm if CTEX >80 s and A5FIB ≥9 mm according to the consensus group on viscoelastic test-based transfusion guidelines for early trauma resuscitation.[48] In severe traumatic hemorrhage, fixed-ratio RBC and plasma transfusion is not effective to treat ATC and to reduce mortality.[61],[62],[63],[64]

Endogenous heparinization with a heparin-like effect (HLE) detected by viscoelastic testing (CTIN/CTHEP-ratio) has been reported in 5% of patients with severe trauma and seems to be linked to endothelial glycocalyx degradation.[65]

Finally, thrombosis is a big issue in trauma and orthopedic surgery, and overtreatment should definitively be avoided by implementing the ROTEM-guided bleeding management. This also includes the timely start of thromboprophylaxis in the postoperative period.[38],[66],[67]


  Conclusion Top


We believe that the greatest outcome improvement can be achieved through education and the establishment of local clinical management guidelines or algorithms. If incorporated into local practice, this clinical practice guideline has the potential to ensure a uniform standard of care in Taiwan and beyond and better outcomes for the severely bleeding trauma patient.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.



 
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    Figures

  [Figure 1], [Figure 2]
 
 
    Tables

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