scholarly journals Protocol for a multicentre prehospital randomised controlled trial investigating tranexamic acid in severe trauma: the PATCH-Trauma trial

BMJ Open ◽  
2021 ◽  
Vol 11 (3) ◽  
pp. e046522
Author(s):  
Biswadev Mitra ◽  
Stephen Bernard ◽  
Dashiell Gantner ◽  
Brian Burns ◽  
Michael C Reade ◽  
...  
Keyword(s):  
New Zealand ◽  
Tranexamic Acid ◽  
Controlled Trial ◽  
South Australia ◽  
Severe Trauma ◽  
Ethics Committee ◽  
Trauma Systems ◽  
Acute Traumatic Coagulopathy ◽  
Trauma Deaths ◽  
Traumatic Coagulopathy

IntroductionHaemorrhage causes most preventable prehospital trauma deaths and about a third of in-hospital trauma deaths. Tranexamic acid (TXA), administered soon after hospital arrival in certain trauma systems, is an effective therapy in preventing or managing acute traumatic coagulopathy. However, delayed administration of TXA appears to be ineffective or harmful. The effectiveness of prehospital TXA, incidence of thrombotic complications, benefit versus risk in advanced trauma systems and the mechanism of benefit remain uncertain.Methods and analysisThe Pre-hospital Anti-fibrinolytics for Traumatic Coagulopathy and Haemorrhage (The PATCH-Trauma study) is comparing TXA, initiated prehospital and continued in hospital over 8 hours, with placebo in patients with severe trauma at risk of acute traumatic coagulopathy. We present the trial protocol and an overview of the statistical analysis plan. There will be 1316 patients recruited by prehospital clinicians in Australia, New Zealand and Germany. The primary outcome will be the eight-level Glasgow Outcome Scale Extended (GOSE) at 6 months after injury, dichotomised to favourable (GOSE 5–8) and unfavourable (GOSE 1–4) outcomes, analysed using an intention-to-treat (ITT) approach. Secondary outcomes will include mortality at hospital discharge and at 6 months, blood product usage, quality of life and the incidence of predefined adverse events.Ethics and disseminationThe study was approved by The Alfred Hospital Research and Ethics Committee in Victoria and also approved in New South Wales, Queensland, South Australia, Tasmania and the Northern Territory. In New Zealand, Northern A Health and Disability Ethics Committee provided approval. In Germany, Witten/Herdecke University has provided ethics approval. The PATCH-Trauma study aims to provide definitive evidence of the effectiveness of prehospital TXA, when used in conjunction with current advanced trauma care, in improving outcomes after severe injury.Trial registration numberNCT02187120.

scholarly journals Tranexamic acid in trauma-induced coagulopathy

2021 ◽  
Vol 26 (80) ◽  
pp. 126-147
Author(s):  
Sanja Ratković ◽  
Adi Hadžibegović ◽  
Isidora Jovanović ◽  
Marija Rajković ◽  
Aleksandar Jovanović ◽  
...  
Keyword(s):  
At Risk ◽  
Tranexamic Acid ◽  
Cause Of Death ◽  
Severe Trauma ◽  
Massive Bleeding ◽  
Acute Traumatic Coagulopathy ◽  
Trauma Induced Coagulopathy ◽  
The Subject ◽  
Hemostatic Disorder ◽  
Traumatic Coagulopathy

Trauma is still the leading cause of death in the world among the population under the age of 45 and bleeding is the dominant cause of early mortality in one third of all injured. Coagulopathy in trauma is directly related to the outcome and is considered to be the most significant preventable cause of death. Trauma-induced coagulopathy is a complex, multifactorial disorder that can be roughly divided into three phases. The entity of acute traumatic coagulopathy is characterized as an endogenous hemostatic disorder that occurs in the first few minutes of injury associated with tissue damage caused by severe trauma and hemorrhagic shock, regardless of external factors. The pathogenesis of trauma-induced coagulopathy is not fully known and is still the subject of research. According to the latest recommendations of the European Guide for the Management of Massive Bleeding and Coagulopathy in Trauma, tranexamic acid should be used as soon as possible, and no later than three hours after the injury in a patient who is bleeding or at risk of significant bleeding. Its prehospital application should be considered. In the light of new knowledge, the question of the justification and safety of the free use of tranexamic acid in trauma has been raised. The use of tranexamic acid in trauma-induced coagulopathy is a simple and affordable therapeutic approach that should be used in the prehospital period in those patients who are bleeding or at risk of significant bleeding. The implementation of this therapy in our country has not yet come to life.

Acute traumatic coagulopathy decreased actual survival rate when compared with predicted survival rate in severe trauma

2011 ◽  
Vol 29 (11) ◽  
pp. 906-910 ◽  
Author(s):  
Su Jin Kim ◽  
Sung Woo Lee ◽  
Gap Su Han ◽  
Sung Woo Moon ◽  
Sung Hyuck Choi ◽  
...  
Keyword(s):  
Survival Rate ◽  
Severe Trauma ◽  
Acute Traumatic Coagulopathy ◽  
Actual Survival ◽  
Traumatic Coagulopathy

scholarly journals Effect of tranexamic acid administration on acute traumatic coagulopathy in rats with polytrauma and hemorrhage

PLoS ONE ◽  
2019 ◽  
Vol 14 (10) ◽  
pp. e0223406 ◽  
Author(s):  
Xiaowu Wu ◽  
Avi Benov ◽  
Daniel N. Darlington ◽  
Jeffrey D. Keesee ◽  
Bin Liu ◽  
...  
Keyword(s):  
Tranexamic Acid ◽  
Acute Traumatic Coagulopathy ◽  
Acid Administration ◽  
Traumatic Coagulopathy

An in vitro study of the effects of t-PA and tranexamic acid on whole blood coagulation and fibrinolysis

2016 ◽  
Vol 70 (2) ◽  
pp. 154-161 ◽  
Author(s):  
Anne Godier ◽  
Kiran Parmar ◽  
Karuna Manandhar ◽  
Beverley J Hunt
Keyword(s):  
Tranexamic Acid ◽  
Whole Blood ◽  
In Vitro Study ◽  
Factor V ◽  
Acute Traumatic Coagulopathy ◽  
Clot Strength ◽  
20 Nm ◽  
Coagulation And Fibrinolysis ◽  
Traumatic Coagulopathy

AimsAcute traumatic coagulopathy is characterised by fibrinolysis and low fibrinogen. It is unclear how much fibrinogenolysis contributes to reduce fibrinogen levels. The study aim was to: investigate in vitro the effects of tissue-plasminogen activator (t-PA) and tranexamic acid (TXA) on coagulation and fibrinolysis.MethodsWhole blood was spiked with varying t-PA concentrations. Clauss fibrinogen levels and thrombelastography (TEG, Haemonetics) were performed, including functional fibrinogen level (FLEV). TXA effects were assessed using four TXA concentrations. Recorded parameters from kaolin activated TEG included maximal amplitude (MA), clot strength (G), percentage lysis (LY). Plasmin–antiplasmin complex (PAP), endogenous thrombin potential (ETP), prothrombin fragment 1+2 (PF1+2), factor V and factor VIII levels were all measured.Resultst-PA induced fibrinolysis: it increased PAP and LY, but decreased MA and G. t-PA induced fibrinogenolysis, with a concentration-dependant decrease in fibrinogen from 2.7 (2.6–3.1) to 0.8 (0.8–0.9) g/L with 60 nM t-PA. FLEV and fibrinogen levels were well correlated. High t-PA doses increased PF1+2, decreased ETP of 19% and FVIII of 63% but not FV. TXA had no effect on plasmin generation as evidenced by no change in PAP. It corrected LY, MA and G and partly protected fibrinogen against fibrinogenolysis: 0.03 mg/mL TXA reduced the fibrinogen fall induced by t-PA 20 nM from 43% to 14%. TXA halved the FVIII fall and increased ETP.Conclusionst-PA induced plasminogen activation and fibrinogenolysis in a concentration-dependant manner. TXA did not affect plasmin activation but reduced fibrinogenolysis. These results suggest that TXA given early in bleeding patients may prevent fibrinogenolysis.

scholarly journals Computerised cognitive training to improve cognition including delirium following coronary artery bypass grafting surgery: protocol for a blinded randomised controlled trial

BMJ Open ◽  
2020 ◽  
Vol 10 (2) ◽  
pp. e034551 ◽  
Author(s):  
Danielle Greaves ◽  
Peter J Psaltis ◽  
Amit Lampit ◽  
Daniel H J Davis ◽  
Ashleigh E Smith ◽  
...  
Keyword(s):  
Cognitive Decline ◽  
Cognitive Training ◽  
Controlled Trial ◽  
Artery Bypass ◽  
Intervention Group ◽  
South Australia ◽  
Ethics Committee ◽  
Significant Decline ◽  
Bypass Grafting ◽  
Registration Number

IntroductionCoronary artery bypass grafting (CABG) surgery is known to improve vascular function and cardiac-related mortality rates; however, it is associated with high rates of postoperative cognitive decline and delirium. Previous attempts to prevent post-CABG cognitive decline using pharmacological and surgical approaches have been largely unsuccessful. Cognitive prehabilitation and rehabilitation are a viable yet untested option for CABG patients. We aim to investigate the effects of preoperative cognitive training on delirium incidence, and preoperative and postoperative cognitive training on cognitive decline at 4 months post-CABG.Methods and analysisThis study is a randomised, single-blinded, controlled trial investigating the use of computerised cognitive training (CCT) both pre-CABG and post-CABG (intervention group) compared with usual care (control group) in older adults undergoing CABG in Adelaide, South Australia. Those in the intervention group will complete 1–2 weeks of CCT preoperatively (45–60 min sessions, 3.5 sessions/week) and 12 weeks of CCT postoperatively (commencing 1 month following surgery, 45–60 min sessions, 3 sessions/week). All participants will undergo cognitive testing preoperatively, over their hospital stay including delirium, and postoperatively for up to 1 year. The primary delirium outcome variable will be delirium incidence (presence vs absence); the primary cognitive decline variable will be at 4 months (significant decline vs no significant decline/improvement from baseline). Logistic regression modelling will be used, with age and gender as covariates. Secondary outcomes include cognitive decline from baseline to discharge, and at 6 months and 1 year post-CABG.Ethics and disseminationEthics approval was obtained from the Central Adelaide Local Health Network Human Research Ethics Committee (South Australia, Australia) and the University of South Australia Human Ethics Committee, with original approval obtained on 13 December 2017. It is anticipated that approximately two to four publications and multiple conference presentations (national and international) will result from this research.Trial registration numberThis clinical trial is registered with the Australian New Zealand Clinical Trials Registry and relates to the pre-results stage. Registration number: ACTRN12618000799257.

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