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ORIGINAL ARTICLE  
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Adherence to low volume massive hemorrhage protocol: Experience from an urban level 1 trauma center


1 Department of Transfusion Medicine, Jai Prakash Narayan Apex Trauma Centre, All India Institute of Medical Sciences, New Delhi, India
2 Department of Surgery, Jai Prakash Narayan Apex Trauma Centre, All India Institute of Medical Sciences, New Delhi, India
3 Department of Critical and Intensive Care, Jai Prakash Narayan Apex Trauma Centre, All India Institute of Medical Sciences, New Delhi, India
4 Department of Emergency Medicine, Jai Prakash Narayan Apex Trauma Centre, All India Institute of Medical Sciences, New Delhi, India
5 Department of Laboratory Medicine, Jai Prakash Narayan Apex Trauma Centre, All India Institute of Medical Sciences, New Delhi, India

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Date of Submission16-Jun-2022
Date of Decision02-Aug-2022
Date of Acceptance28-Aug-2022
Date of Web Publication12-Dec-2022
 

   Abstract 

BACKGROUND AND OBJECTIVES: Adherence to the massive hemorrhage protocol (MHP) is essential for its successful implementation. An indigenous low-volume MHP was designed in accordance with the institutional needs. Adherence to various components of the designed MHP components was assessed.
MATERIALS AND METHODS: Retrospective analysis of all MHP activations for 1-year duration was performed. Patient demographics, injury details, and baseline vitals were collected along with details of transfusion. Adherence to critical steps such as activation criteria, timing of delivery of the blood components, pack size and ratios of blood components, and endpoints were assessed, followed by calculation of adherence scores.
RESULTS: MHP was activated in 1.1% of patients presenting to the emergency. Massive transfusions were required for 76%. Adherence scores of ≥50% were achieved in 77% of MHP activations. Timely issue of the first transfusion pack was achieved in all cases, whereas the demand for the red blood cell (RBC) components exceeded the predefined number of units, thus affecting the desired ratio of blood components. Hemorrhagic deaths within 24 h were observed in 13 patients and were not affected by the overall adherence scores.
CONCLUSION: Adherence to prepared MHP was moderate for most patients. Adherence can be improved significantly by increasing the number of compatible blood components after the first transfusion pack in case of limited inventory. In addition, reducing the delivery time for the subsequent transfusion packs, incorporation of hemostatic adjuncts, and point-of-care tests in the MHP should be considered on a priority basis.

Keywords: Blood components, massive hemorrhage, trauma


How to cite this URL:
Chaurasia R, Kumar A, Chaudhary N, Soni KD, Sinha TP, Chopra S, Aggarwal R, Subramanian A. Adherence to low volume massive hemorrhage protocol: Experience from an urban level 1 trauma center. Asian J Transfus Sci [Epub ahead of print] [cited 2023 Jan 28]. Available from: https://www.ajts.org/preprintarticle.asp?id=363239



   Introduction Top


Severe injuries have a high propensity of uncontrolled hemorrhage and subsequent hypovolemic shock. Approximately one-fourth of the trauma patients, have preexisting coagulopathy, which increases the risk of significant hemorrhage and affects patient outcomes.[1] After the presentation to the emergency department (ED), the first few hours are critical for resuscitation, as most hemorrhagic deaths have been reported within are reported within 3 h of presentation.[2]

Massive hemorrhage protocol (MHP) is a proactive and multidisciplinary approach aimed toward providing blood components in a predetermined and timely fashioned manner in patients with uncontrolled hemorrhage. It includes early identification and activation of MHP, coordinated communication, and response to activation, involvement of laboratory testing, use of hemostatic agents, prevention and management of hypothermia and termination, once bleeding is controlled.

For adequate and timely delivery of blood components, massive hemorrhage packs containing predefined numbers and ratios of blood components, so that it can be issued without any delay.[3] Transfusion packs for the first and subsequent issue are generally designed to include 4–6 units of RBC, along with equivalent units of fresh frozen plasma (FFP), and platelets with or without cryoprecipitate (CRYO). Number of blood components that are included in these packs vary across different institutions/settings, depending on the patient characteristics, availability of laboratory tests, availability of blood component, and distance between transfusion services and clinical areas.

Since there is a lack of information regarding the implementation of MHP in trauma settings in India, a MHP was designed to facilitate adequate and timely provision of blood components for trauma patients in shock with severe hemorrhagic shock after discussions with all stakeholders involved in early management of severely bleeding trauma patients. Transfusion packs were prepared based on the consensus decision, as outlined in [Figure 1]. The protocol was then implemented and adherence to critical components of the designed protocol was assessed. We also analyzed the blood utilization, outcome, and associated risk factors.
Figure 1: Massive hemorrhage protocol designed for our center

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   Materials and Methods Top


Study design

A retrospective analysis of the MHP activations for the 1-year duration (February 2019 to January 2020) was conducted after approval by the Institutional Ethics Committee (IEC-1183/December 04, 2020). All trauma patients ≥18 years of age, for whom MHP was activated were included in the data analysis. Patients with isolated brain injury, referred cases, those transfused elsewhere for the current injuries, transferred out, and patients who left against medical advice were excluded from the study.

Patient details were collected from patient records, including the demographics (age and gender), and injury details such as time to admission after injury, site, and mechanism of injury. Various injury scores such as Abbreviated injury score (AIS), Injury severity score (ISS), Revised Trauma Scores (RTS), Trauma and injury severity score (TRISS), and Glasgow Coma Scores (GCS) were calculated. Clinical details included baseline vitals (pulse rate, blood pressure and respiratory rate, SpO2), extended focused assessment with sonography in trauma (E-FAST), intubation at presentation, and volume of intravenous (IV) fluids infused before transfusion. Laboratory values for hemoglobin (Hb), platelet count, prothrombin time (PT), activated partial thromboplastin time (aPTT), and blood grouping were also collected. Details of transfusion collected, included timing, number, and type of blood components such as red blood cells (RBCs), whole blood-derived platelet concentrates (WB-PC), FFP, and CRYO that were transfused or returned to the transfusion services.

Data collected were coded, entered, and managed using SPSS version 20.0 (Armonk, NY, USA: IBM Corporation). Descriptive analysis was performed for demographic, injury details, baseline vitals, and blood utilization. Adherence to the predefined criteria of the MHP [Figure 1], such as activation criteria, the timing of delivery of transfusion packs, adherence to subsequent pack sizes, the ratio of blood components (1:1:1 ratio for RBC: FFP: Platelets), and endpoints achieved were scored as 1 and nonadherence was graded as 0. Patients were then classified into low (≤4), medium (5–6), and high scores (≥7). Patient outcome was assessed as, length of hospital stay and all-cause mortality and compared with TRISS scores calculated at the time of admission.


   Results Top


A total of 5416 patients were admitted to red area in the ED during the study period, wherein uncross-matched Group O RBCs were requested for 195 patients, this included 73 patients with MHP activations. Of these 58 (1.1%) patients were included for data analysis, whereas 15 patients who received transfusion before presenting to our center were excluded. Majority of included patients (86.2%) were males, with a mean age of 35.4 ± 12.6 (range 18–70) years. The most common age group was 26–35 years with 36.2% of patients, followed by 18–25 years (24.1%), >45 years (20.7%), and finally, 36–45 years with 19% of patients. The median time to admission after trauma was 142 min (interquartile range [IQR] 97–254 min).

At baseline, 43(74.1%) patients had systolic blood pressure ≤90 mmHg, whereas 34(58.6%) patients had abnormal heart rate i.e. <60 or >120 bpm. Clinical and injury details are outlined in [Table 1]. E-FAST was positive in 32 (55.2%) patients, whereas 9 (15.5%) patients were intubated during the initial assessment. An average of 1.0 L IV crystalloid was infused before blood transfusion. Tranexamic acid was administered in 18 (31%) patients. Baseline Hb, platelet count, and PT/aPTT were available for 50 (86.2%) patients; mean values for the available results are shown in [Table 2]. Results of blood grouping showed Group O (24; 41.4%) as the commonest group, followed Group B (29.3%), Group A (22.4%), and only 6.9% of patients with Group AB. Rh (D) positivity, was 94.8%.
Table 1: Demographic and injury details of the patients for whom massive hemorrhage protocol was activated (n=58)

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Table 2: Baseline laboratory

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Blood transfusion

During the study period, a total of 1625 blood components (596 RBC, 504 WB-PC, 405 FFP, and 120 CRYO units) were transfused to these patients. RBCs were transfused in all cases, whereas WB-PC, FFP, and CRYO were transfused to 45, 44, and 12 patients, respectively. Of total, 92.3% RBC, 73.4% WB-PC, 72.8% FFP, and 83.3% CRYO were transfused during initial 24 h. The cumulative average of the blood components transfused during the initial 24 h is shown in [Figure 2]. Blood components were returned to transfusion services for six patients, this included two patients with surgical hemostasis, whereas in four cases, patients expired. A total of 44 (75.9%) patients were classified as massive transfusions, defined as transfusion of ≥10 RBC during an initial 24 h or transfusion of ≥4 units of RBC with an ongoing requirement.
Figure 2: Cumulative average of the blood components transfused per patient. RBC = Red blood cell, WB-PC = Whole blood-derived platelet concentrates, FFP = Fresh frozen plasma, CRYO = Cryoprecipitate

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Adherence to massive hemorrhage protocol

Most MHP activations 47 (81%) were done telephonically, while in other cases, manual request forms were sent for MHP activations. For 14 (24.1%) patients, blood components were issued, even before the patient was registered at the hospital. Adherence to the various critical components of the MHP is shown in [Table 3]. Majority of the patients (65.5%) had moderate adherence scores (5–6) and 7 (12.1%) patients had higher adherence scores (≥7), whereas 22.4% of patients had low scores (≤4) [Figure 3].
Table 3: Adherence to the massive hemorrhage protocol components

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Figure 3: Frequency distribution of the overall adherence scores

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Patient outcome

The expected mortality using TRISS scores was 14.3%, against the observed mortality was 44.8% (26 patients). This included 13 deaths due to uncontrolled hemorrhage, eight deaths from septic shock, three deaths due to cardiac arrest, and two deaths following severe head injury. All hemorrhagic deaths occurred within 24 h of admission, with a median time of 12 (IQR 6–12) h. Hemorrhagic deaths were significantly associated with poor ISSs (RTS and TRISS), lack of tranexamic acid administration, and coagulopathy (high PT and aPTT values) [Table 4]. No significant associations were observed due to differences in the adherence scores, 3 (23.1%) deaths in the low adherence group, 8 (21.1%) deaths in the medium adherence group, and 2 (28.6%) deaths in patients with higher adherence scores (P = 0.906).
Table 4: Comparison of clinical characteristics in patients with hemorrhagic deaths and others

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   Discussion Top


Adherence to the prepared MHP is critical to its successful implementation. In this study, we evaluated steps related to the issue of blood components, as its assessment will help in further shaping or modifying the MHP. In our study, MHP was activated in 1.1% of all the cases presenting to ED. Compared to the 3%–5% incidence of massive transfusion in civilian settings, lower rates in our study could be due to conservative activation of MHP as uncross-matched Group O RBC were also issued for many in the ED.[4],[5]

The identification of bleeding patients and then activating the MHP is the most critical and foremost step of MHP. While underactivation of MHP can delay transfusion, leading to adverse effect on clinical outcomes, overactivation may lead to overzealous transfusion and wastage of blood components.[6],[7] In this study, we observed that three-fourth of the MHP activation were in accordance with the definitions of massive transfusions. Although some overactivations were observed in 8 (13.8%) cases where 2 or less transfusion packs were transfused. Overzealous transfusion and the wastage of blood components were largely avoided due to the limited number of blood components in the transfusion packs.

For optimum activation of MHPs, various scoring systems have been used in trauma settings; however, its role has been far from optimal.[8] In our study, clinical gestalt was used for MHP activation, which was adhered in 74% of the cases. Lack of complete adherence to trigger could be due to the underlying need for surgical exploration/intervention which may have necessitated early availability of blood components. Thus, details of surgical intervention/exploration need to be analyzed and incorporated as a criterion for activation of MHP.

Most MHP protocols recommend, O Rh(D) negative RBC for immediate transfusion, when samples for blood grouping are not available, or the test is not completed. In our study, we reserved O Rh(D) negative RBCs only for female patients under 45 years of age as the prevalence of Rh(D) negative populations in our country ranges between 5% and 6%, which is in contrast with 12% and 18% Rh (D) negative population of European ancestry and 8% among African Americans.[9] The blood group of the required blood components was in accordance with the outlined MHP for >80% of the patients. Nonadherence was observed in four instances where O Rh(D) positive RBC units were issued to females under the age of 45 years, likewise, six male patients were issued O Rh(D) negative RBC units. This can be attributed to the availability of O Rh(D) negative RBCs at the time of issue.

Timings to the delivery of blood component are essential to MHP. American College of Surgeons Trauma Quality Improvement Best Practices recommends a time limit of 15 min for delivery of transfusion packs.[10] Meyer et al., in their multicentric randomized trial, reported increased mortality for delayed activation of MHP and delivery of transfusion packs.[11] In this study, the mean time to issue of first transfusion pack was 10 min, with 100% adherence. However, adherence for second and third packs was relatively lower, i.e., 48% and 22%, respectively. Decreased adherence to timings could be due to delay in sending the porter from the clinical area to the transfusion services for collection of blood components since patients are often shifted to different locations (DSA suite, operation theater, etc.) from the resuscitation bay, from where transfusion requests were initially made. Dedicating a porter specifically for the transportation of blood components, samples, and requisition forms will aid in adhering to the set timelines for the issue of blood components.

MHP transfusion packs are generally designed to include 4–6 units of RBC, along with equivalent units of FFP, platelets with or without CRYO, the volume/size of the transfusion packs in our study was quite low.[12],[13],[14],[15] Since we are a hospital associated transfusion services, and have limited inventory of group O RBC, issuing 4–6 units of O group RBC empirically for such patients can lead to imbalances in the inventory. Before designing the MHP, a consensus was formed that the initial pack would consist of 2 units of Group O RBCs, after which group specific/compatible RBCs will be issued. We observed 63.8% adherence to size for 1st transfusion pack whereas it was 50% and 3.4% adherence for the 2nd and 3rd packs, respectively. Increased demand for only RBC components from the clinical area, during the successive issue times for operative intervention or resuscitation, was the major reason for nonadherence. This increased demand for RBC components also affected the adherence to the predefined ratio of blood components, where a 1:1:1 ratio of RBC, plasma, and platelets, were achieved in 12% of patients at 1 h. Timings and monitoring of the ratio of the blood components in MHP have been controversial, with many authors recommending different ratios. Higher RBC: FFP ratios were recommended by earlier studies, however growing evidence for increased usage of plasma and platelet early during resuscitation. Early use of the equivalent amount of plasma, platelets, and RBC in a 1:1:1 ratio has been recommended for the treatment and prevention of trauma-associated coagulopathy.[3],[16],[17],[18],[19] In our study, adherence to blood component ratios were not as expected, as there was increased RBC transfusions and/or fewer number of FFP transfusions. Regular audits for pack size may help justify the increase in the number and ratio of blood components.

In this study, laboratory endpoints were achieved in only 25 (43%) cases, as the decision for stopping transfusion was mainly based on the clinical gestalt (including parameters such as mean arterial pressure and urine output). Clinical endpoints were the key driving factors for necessitating transfusion, due to increased turnaround times for laboratory testing. Point-of-care testing devices such as TEG/ROTEM have been recommended for guiding transfusion therapy in massively bleeding cases.[10],[20],[21] Thus, it can be used as a criterion for termination of MHP, to help reduce the wastage of blood components.[22],[23]

Although MHP has been actively advocated to improve the early and or late survival among trauma patients, several studies have reported equivocal responses to implemented MHPs.[12],[24],[25],[26] Suboptimal responses to MHP implementation could be related to clinical characteristics of a subset of trauma patients or lack of adherence to defined protocols or lack of audit/monitoring of the key performance indicators. Studies evaluating MHP have reported median adherence rates ranging from 60% to 80%, wherein failure to send a complete hemorrhage panel from the trauma bay and repeat monitoring are the most common factors for nonadherence.[27],[28] In this study, adherence scores were comparatively lower, (adherence score of ≥5 was achieved in 77.6% of patients). The inability to keep up with the demand of blood components and their ratios are common causes of nonadherence in our study.

Observed mortality in our study was significantly higher than the expected mortality from TRISS scores in our study. Higher than expected mortality could have resulted from the unstable physiological condition, variable time to hospital presentation, or adherence to the MHP. Adherence to the MHP has been reported to improve the overall outcome of the patients.[27],[28] In our study, we observed a significant association of the hemorrhagic deaths with the HR, coagulation parameters (PT and aPTT), along with the RTS and TRISS values, suggesting poor physiological status of patients with hemorrhagic deaths. However, no such association was identified with regard to time to hospital presentation or adherence scores, which might be due to the smaller number of patients with higher adherence scores. Our study was also limited by the fact that the role of clinical and/or surgical interventions such as support of inotropes, and presurgical intubation were not taken into consideration.


   Conclusion Top


This study represented a preliminary step toward monitoring and improving transfusion management of severely injured trauma patients in our country. The overall adherence to designed MHP was moderate for most patients. Increasing the number of group-compatible blood components with the second and subsequent packs will improve adherence. Improving communication and dedicated porters for transportation will facilitate the timely delivery of blood components. Hemostatic adjuncts such as tranexamic acid and point-of-care tests for laboratory parameters should also be incorporated into the MHP.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.



 
   References Top

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Riccio LM, Oviedo RJ. Standardized massive transfusion protocol decreases blood product wastage and improves transfusion ratios: Results from a rural, level II trauma center. J Am Coll Surg 2019;229:e242.  Back to cited text no. 7
    
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El-Menyar A, Mekkodathil A, Abdelrahman H, Latifi R, Galwankar S, Al-Thani H, et al. Review of existing scoring systems for massive blood transfusion in trauma patients: Where do we stand? Shock 2019;52:288-99.  Back to cited text no. 8
    
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Meyer DE, Vincent LE, Fox EE, O'Keeffe T, Inaba K, Bulger E, et al. Every minute counts: Time to delivery of initial massive transfusion cooler and its impact on mortality. J Trauma Acute Care Surg 2017;83:19-24.  Back to cited text no. 11
    
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Dente CJ, Shaz BH, Nicholas JM, Harris RS, Wyrzykowski AD, Patel S, et al. Improvements in early mortality and coagulopathy are sustained better in patients with blunt trauma after institution of a massive transfusion protocol in a civilian level I trauma center. J Trauma 2009;66:1616-24.  Back to cited text no. 12
    
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Nunez TC, Young PP, Holcomb JB, Cotton BA. Creation, implementation, and maturation of a massive transfusion protocol for the exsanguinating trauma patient. J Trauma 2010;68:1498-505.  Back to cited text no. 13
    
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Riskin DJ, Tsai TC, Riskin L, Hernandez-Boussard T, Purtill M, Maggio PM, et al. Massive transfusion protocols: The role of aggressive resuscitation versus product ratio in mortality reduction. J Am Coll Surg 2009;209:198-205.  Back to cited text no. 14
    
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Correspondence Address:
Rahul Chaurasia,
Department of Transfusion Medicine, Jai Prakash Narayan Apex Trauma Centre, All India Institute of Medical Sciences, New Delhi
India
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Source of Support: None, Conflict of Interest: None

DOI: 10.4103/ajts.ajts_76_22



    Figures

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