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Efficacy and safety of the second in-hospital dose of tranexamic acid after receiving the prehospital dose: double-blind randomized controlled clinical trial in a level 1 trauma center
El-Menyar A, Ahmed K, Hakim S, Kanbar A, Mathradikkal S, Siddiqui T, Jogol H, Younis B, Taha I, Mahmood I, et al
European journal of trauma and emergency surgery : official publication of the European Trauma Society. 2021
Abstract
BACKGROUND Prehospital administration of tranexamic acid (TXA) to injured patients is increasing worldwide. However, optimal TXA dose and need of a second infusion on hospital arrival remain undetermined. We investigated the efficacy and safety of the second in-hospital dose of TXA in injured patients receiving 1 g of TXA in the prehospital setting. We hypothesized that a second in-hospital dose of TXA improves survival of trauma patients. METHODS A prospective, double-blind, placebo-controlled randomized, clinical trial included adult trauma patients receiving 1 g of TXA in the prehospital settings. Patients were then blindly randomized to Group I (second 1-g TXA) and Group II (placebo) on hospital arrival. The primary outcome was 24-h (early) and 28-day (late) mortality. Secondary outcomes were thromboembolic events, blood transfusions, hospital length of stay (HLOS) and organs failure (MOF). RESULTS A total of 220 patients were enrolled, 110 in each group. The TXA and placebo groups had a similar early [OR 1.000 (0.062-16.192); p = 0.47] and late mortality [OR 0.476 (95% CI 0.157-1.442), p = 0.18].The cause of death (n = 15) was traumatic brain injury (TBI) in 12 patients and MOF in 3 patients. The need for blood transfusions in the first 24 h, number of transfused blood units, HLOS, thromboembolic events and multiorgan failure were comparable in the TXA and placebo groups. In seriously injured patients (injury severity score > 24), the MTP activation was higher in the placebo group (31.3% vs 11.10%, p = 0.13), whereas pulmonary embolism (6.9% vs 2.9%, p = 0.44) and late mortality (27.6% vs 14.3%, p = 0.17) were higher in the TXA group but did not reach statistical significance. CONCLUSION The second TXA dose did not change the mortality rate, need for blood transfusion, thromboembolic complications, organ failure and HLOS compared to a single prehospital dose and thus its routine administration should be revisited in larger and multicenter studies. TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT03846973.
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The effect of massive transfusion protocol implementation on the survival of trauma patients: a systematic review and meta-analysis
Consunji R, Elseed A, El-Menyar A, Sathian B, Rizoli S, Al-Thani H, Peralta R
Blood transfusion = Trasfusione del sangue. 2020
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Abstract
BACKGROUND Massive transfusion protocol (MTP) has been widely adopted for the care of bleeding trauma patients but its actual effectiveness is unclear. An earlier meta-analysis on the implementation of MTP for injured patients from 1990 to 2013 reported that only 2 out of 8 studies showed statistical improvement in survival. This study aimed to conduct an updated systematic review and meta-analysis to evaluate the effect of implementing an MTP on the mortality of trauma patients. MATERIALS AND METHODS MEDLINE, PubMed, Cochrane Library and Google scholar databases were systematically searched for relevant studies published from 1(st) January 2008 to 30(th) September 2019 using a combination of keywords and additional manual searching of reference lists. Inclusion criteria were: original study in English, study population including trauma patients, and comparison of mortality outcomes before and after institutional implementation of an MTP. Primary outcomes were 24-hour, 30-day, and overall mortality. RESULTS Fourteen studies met inclusion criteria, analysing outcomes from 3,201 trauma patients. There was a wide range of outcomes, patient populations, and process indicators utilised by the different authors. MTP significantly reduced the overall mortality for trauma patients (OR 0.71 [0.56-0.90]). No significant reduction was seen in either the 24-hour mortality (OR 0.81 [0.57-1.14]) or the 30-day mortality (OR 0.73 [0.46-1.16]). However, when mortality timing was unspecified, mortality was statistically reduced (OR 0.69 [0.55-0.86]). DISCUSSION The present study found a significant reduction in mortality following MTP implementation and thus it should be recommended to all institutions managing acutely injured patients. To better identify which elements of an MTP contribute to this effect, we encourage the use of standard nomenclature, indicators, protocols and patient populations in all future MTP studies.
PICO Summary
Population
Trauma patients (14 studies, n= 3201).
Intervention
Implementation of a massive transfusion protocol (MTP) on the mortality of trauma patients.
Comparison
Outcome
There was a wide range of outcomes, patient populations, and process indicators utilised by the different authors. MTP significantly reduced the overall mortality for trauma patients. No significant reduction was seen in either the 24-hour mortality or the 30-day mortality. However, when mortality timing was unspecified, mortality was statistically reduced.
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Review of Existing Scoring Systems For Massive Blood Transfusion in Trauma Patients: Where Do We Stand?
El-Menyar A, Mekkodathil A, Abdelrahman H, Latifi R, Galwankar S, Al-Thani H, Rizoli S
Shock (Augusta, Ga.). 2019
Abstract
BACKGROUND Uncontrolled bleeding is the main cause of the potential preventable death in trauma patients. Accordingly, we reviewed all the existing scores for massive transfusion posttraumatic hemorrhage and summarized their characteristics, thus making it easier for the reader to have a global view of these scores - how they were created, their accuracy and to which population they apply. METHODS A narrative review with a systematic search method to retrieve the journal articles on the predictive scores or models for massive transfusion was carried out. A literature search using PubMed, SCOPUS and Google scholar was performed using relevant keywords in different combinations. The keywords used were "massive transfusion", "score", "model", "trauma" and "hemorrhage" in different combinations. The search was limited for full-text articles published in English language, human species and for the duration from 01 January, 1998 to 30 November, 2018. RESULTS The database search yielded 295 articles. The search was then restricted to the inclusion criteria which retrieved 241 articles. Duplicates were removed and full-texts were assessed for the eligibility to include in the review which resulted in inclusion of 24 articles. These articles identified 24 scoring systems including modified or revised scores. Different models and scores for identifying patients requiring massive transfusion in military and civilian settings have been described. Many of these scorings were complex with difficult calculation, while some were simple and easy to remember. CONCLUSIONS The current prevailing practice that is best described as institutional or provider centered should be supplemented with score based protocol with auditing and monitoring tools to refine it. This review summarizes the current scoring models in predicting the need for MT in civilian and military trauma. Several questions remain open; i.e., do we need to develop new score, merge scores, modify scores or adopt existing score for certain trauma setting?
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Efficacy of prehospital administration of tranexamic acid in trauma patients: A meta-analysis of the randomized controlled trials
El-Menyar A, Sathian B, Asim M, Latifi R, Al-Thani H
The American Journal of Emergency Medicine. 2018;36((6):):1079-1087
Abstract
OBJECTIVE Antifibrinolytic agent tranexamic acid (TXA) has a potential clinical benefit for in-hospital patients with severe bleeding but its effectiveness in pre-hospital settings remains unclear. We conducted a systematic review and meta-analysis to evaluate whether pre-hospital administration of TXA compared to placebo improve patients' outcomes? METHODS PubMed, MEDLINE, Cochrane Library, WHO International Clinical Trials Registry Platform, Cochrane Central Register of Controlled Trials (CENTRAL), Scopus, clinicaltrials.gov and Google scholar databases were searched for a retrospective, prospective and randomized (RCT) or quasi-RCT studies that assessed the effect of prehospital administration of TXA versus placebo on the outcomes of trauma patients with significant hemorrhage. The main outcomes of interest were 24hour 30-day mortality and in-hospital thromboembolic complications. Two authors independently abstracted the data using a data collection form. Results from different studies were pooled for the analysis, when appropriate. RESULTS Out of 92 references identified through the search, two analytical studies met the inclusion criteria. The effect of TXA on 24-hour mortality had a pooled odds ratio (OR) of 0.49 (95% CI 0.28-0.85), 30-day mortality OR of 0.86 (95% CI, 0.56-1.32), and thromboembolic events OR of 0.74 (95% CI, 0.27-2.07). CONCLUSION Prehospital TXA appears to reduce early mortality in trauma patients. The pooled analysis also shows a trend toward lower 30-day mortality and reduced risk of thromboembolic events. Additional randomized controlled clinical trials are needed to determine the significance of these trends.