2 Minute Medicine Rewind October 12, 2020

Tranexamic Acid During Prehospital Transport in Patients at Risk for Hemorrhage After Injury: A Double-blind, Placebo-Controlled, Randomized Clinical Trial

1. In trauma patients at risk for hemorrhage, pre-hospital administration of tranexamic acid did not significantly improve 30-day mortality compared to a placebo.

2. 30-day mortality outcomes were higher in the treatment group, when tranexamic acid was administered within 1 hour of injury, when the patient underwent severe shock, or when 2 g of tranexamic acid were administered within 8 hours of hospital arrival.

Evidence Rating Level: 1 (Excellent)

In the treatment of trauma patients at risk for hemorrhage, administering tranexamic acid during hospital care has shown improved mortality outcomes, since it is an antifibrinolytic medication that promotes blood clotting. However, current guidelines also suggest tranexamic acid be administered in a prehospital setting, despite a lack of evidence on the effectiveness and safety of this practice. The current study is a double-blind, randomized controlled trial that assessed the all-cause 30-day mortality outcomes between patients treated with tranexamic acid versus a saline placebo. During hospital care for the intervention group, patients were further subdivided in receiving 0, 1, or 2 g of additional tranexamic acid within 8 hours of arrival. The study population consisted of 903 patients (447 in the treatment group) and was conducted at four level 1 trauma centres in the US, between 2015 and 2019. The mean ±SD age was 42±18 years, and 74% were male. Overall, the study found no significant difference in 30-day mortality, with 36 deaths in the intervention and 45 deaths in the placebo (hazard ratio 0.81, 95% CI 0.59 to 1.11, p = 0.18). With regards to safety, there was no difference in arterial thrombotic complications and myocardial infarction, although 8 adverse events occurred in the treatment group, compared to 21 in the placebo group. In some cases, 30-day mortality was lowered in the treatment compared to the placebo, such as when 2 g of additional tranexamic acid was administered (mortality difference -2.7%, 95% CI -5.0 to -0.4%, p = 0.4), when tranexamic acid was administered within an hour of injury (difference -3.0%, 95% CI -5.7% to -0.3%, p < 0.002), and for patients in severe shock, defined as a systolic blood pressure lower than 70 mm Hg (difference -17%, 95% CI -25.8% to -8.1%, p < 0.003). Altogether, this study demonstrates a need to modify current guidelines on pre-hospital tranexamic acid administration for trauma.


Fifteen year quality of life outcomes in men with localized prostate cancer: population based Australian prospective study

1. Men diagnosed with localized prostate cancer have lower self-reported quality of life outcomes, particularly sexual function in those who underwent radical prostatectomy.

2. Mental well-being was similar between men without prostate cancer and men who underwent active surveillance/watchful waiting or low dose rate brachytherapy, as their primary treatment for prostate cancer.

Evidence Rating Level: 2 (Good)

Prostate cancer is the second most prevalent form of cancer among men and fourth most out of all types, with 1.3 million diagnoses in 2018 globally. For the most part however, prostate cancers are diagnosed in first world countries when they are still localized, which have survival rates of 100%, 98%, and 96%, at 5, 10, and 15 years respectively. Although quality of life outcomes in the short-term have been extensively studied for various treatment options, research on long-term outcomes has been lacking. The current longitudinal cohort study, based out of New South Wales, Australia, compared 15 year self-reported quality of life outcomes for men with prostate cancer, compared to age matched controls without prostate cancer. At baseline, the sample consisted of 1642 patients with localized prostate cancer and 495 controls, although after 15 years, 487 patients and 103 controls remained, due to loss of follow-up and death. The study analyzed each patient’s primary treatment options, which included nerve sparing radical prostatectomy (NSRP), non-nerve sparing radical prostatectomy (non-NSRP), androgen deprivation therapy, low dose rate brachytherapy, and active surveillance/watchful waiting. The quality of life outcomes measured related to sexual, urinary, and bowel function. The results showed that for all treatments after 15 years, higher prevalence of erectile dysfunction was reported compared to controls, ranging from 62.3% for the active surveillance/watchful waiting group, to 83.0% in the non-NSRP surgery group (control group prevalence was 42.7%). Additionally, patients in the NSRP or non-NSRP surgery group had the highest rates of urinary incontinence at 15 years compared to controls (NSRP: adjusted mean difference -12.6, 95% CI -16.6 to -8.7; non-NSRP: adjusted mean difference -14.1, 95% CI -18.2 to -10.0). For bowel problems, those who underwent androgen deprivation therapy had the highest prevalence after 15 years (17.8%) compared to the controls (1.9%). Finally, mental well-being was similar to the controls for the active surveillance/watchful waiting and low dose rate brachytherapy groups. Overall, this study demonstrates the importance of considering long-term health outcomes for treating localized prostate cancer, to better inform patient-doctor decision making when weighing the likelihood of survival versus the aggressiveness of treatment.


Impact of COVID-19 Pandemic on the Incidence and Management of Out of Hospital Cardiac Arrest in Patients Presenting with Acute Myocardial Infarction in England

1. The proportion of out of hospital cardiac arrests (OHCAs) within all acute myocardial infarction (AMI) hospital admissions was higher at the start of the COVID-19 pandemic compared to before, by a difference of 2.0%.

2. The in-hospital mortality rate for OHCAs during COVID-19 was higher than before, by a difference of 9.9%.

Evidence Rating Level: 2 (Good)

During the COVID-19 pandemic, it was observed that hospitalizations for acute myocardial infarction (AMI) were reduced, whereas out of hospital cardiac arrests (OHCAs) were increased. For instance, research from Italy found a 50% decrease in AMI hospitalizations, and a separate study found a 58% increase in OHCAs during the outbreak. This may perhaps be due to increased public concern about visiting the hospital, for fear of contracting COVID-19. However, there is potentially an increased risk for death from OHCAs due to a delay in reperfusion treatment and other interventions. The current study compared the characteristics and outcomes of OHCA-related AMI hospital admissions, both prior to and during COVID-19. This study examined nationwide acute coronary syndrome data and percutaneous coronary intervention data from the UK. The population consisted of adults diagnosed with AMI from February to May 2019 (for the pre-COVID group) and from February to May 2020 (for the COVID group). Overall, the study found that 5.6% of all AMI hospital admissions were related to OHCA during the pandemic, whereas 3.6% of were OHCA-related in the pre-COVID group. There were significantly more AMI hospital admissions in the pre-COVID period, with 20,310 admissions compared to 9,235. In terms of outcomes, the COVID group had higher in-hospital mortality (27.8% vs 37.7%, p < 0.001), took longer to initiate reperfusion treatment (mean 2.1 hours vs 1.1 hours, p = 0.05), and were less likely to have an invasive coronary angiography investigation (58.4% vs 71.6%, p < 0.001). Altogether, this study demonstrates the increase in proportion of OHCA-related hospital admissions, and worse outcomes for these admissions, which underlies the need to promote public awareness and improve access to cardiac care during the ongoing pandemic.


Midwifery continuity of care versus standard maternity care for women at increased risk of preterm birth: A hybrid implementation–effectiveness, randomised controlled pilot trial in the UK

1. A midwifery continuity of care model, involving maternal care before, during, and after birth, yielded no improved clinical outcomes compared to a standard model of care.

Evidence Rating Level: 1 (Excellent)

Around the world, 10% of infants are born preterm and over 1 million die from preterm birth (PTB) complications annually. A systematic review found that the only health system intervention correlated with lower PTBs and higher perinatal survival was midwifery continuity of care. This involves one midwife, or a team of midwives, providing care maternal care before, during, and after the birth. Although past research has shown reductions in PTBs for individuals at low and mixed risk, provided with this care model, research on those at high risk for PTBs is lacking. The current study was a randomized controlled pilot trial comparing clinical outcomes for women at high risk for PTBs, provided with the midwifery continuity of care model, versus the standard maternity care model. This study took place at an inner-city maternity service in London, UK, and consisted of 331 women with 168 randomly assigned to the midwifery continuous care group (also known as the POPPIE group). The primary outcome measured was the initiation and appropriate timing of interventions to prevent/manage PTBs, such as administering antibiotics for UTIs, transvaginal scan assessments, and fetal fibronectin tests. Overall, the study found no significant difference in this outcome, with 83.3% and 84.7% receiving appropriate initiation of PTB interventions in the POPPIE and standard care groups respectively (risk ratio 0.98, 95% CI 0.90-1.08, p = 0.742). Furthermore, the prevalence of complications were similar in both groups, such as pre-eclampsia (7.7% in the POPPIE group, 7.4% in the standard group, effect size 1.05 with a 95% CI 0.49-2.24). There was also no difference in PTBs between groups (18.5% in POPPIE and 11.7% in the standard group, effect size 1.58 with a 95% CI of 0.93-2.69). However, it was found that those in the POPPIE group had a greater likelihood of breastfeeding right after birth and at hospital discharge, as well as initiating skin-to-skin contact after birth. Overall, this study demonstrated the feasibility of implementing a midwifery continuity of care model for mothers at risk of PTBS, although it did not show improved outcomes compared to a standard care model.


Association between prehospital time and outcome of trauma patients in 4 Asian countries: A cross-national, multicenter cohort study

1. Longer pre-hospital times for trauma patients were not associated with 30-day mortality.

2. A 10-minute delay in pre-hospital time for trauma patients was associated with a 6% increased odds of a poor functional outcome upon discharge.

Evidence Rating Level: 2 (Good)

Each year, trauma comprises 0.5% of deaths worldwide. Historically, it has been thought that the time taken to respond to a trauma and transport a patient to the hospital was critical. However, interventions done by paramedics at the scene of trauma may delay transport to hospital. Overall, research has been inconsistent on whether shorter prehospital time is associated with positive health outcomes. The current retrospective study examined the correlation between prehospital time and outcomes such as 30-day mortality and functional status upon discharge. The study population consisted of 24,365 patients from Japan, Korea, Malaysia, and Taiwan. Prehospital time was split into 3 categories: response time (RT), scene to hospital time (SH), and total prehospital time (TPT). As well, the associations were adjusted for age, sex, injury severity, and prehospital interventions. Overall, there was no association of prehospital time with 30-day mortality. Specifically, for each 10-minute delay, the adjusted odds ratios were 0.99 (95% CI 0.92-1.06, p = 0.740), 1.08 (95% CI 1.00-1.17, p = 0.065), and 1.03 (95% CI 0.98-1.09, p = 0.236), for RT, SH, and TPT respectively. However, there was a 6% increased odds of poor functional outcome for every 10-minute delay in prehospital time. The adjusted ORs were 1.06 (95% CI 1.04-1.08, p < 0.001), 1.05 (95% Ci 1.01-1.08, p = 0.007), and 1.06 (95% CI 1.04-1.08, p < 0.001) for RT, SH, and TPT respectively. Altogether, this study showed that longer prehospital times may not be critical for short-term survival, but are significantly associated with severe disability upon discharge. The results from this study may have implications on the training of paramedics and first responders at the scene of trauma, as well as influence policies on facilitating quicker transportation of trauma patients to hospitals.

Image: PD

©2020 2 Minute Medicine, Inc. All rights reserved. No works may be reproduced without expressed written consent from 2 Minute Medicine, Inc. Inquire about licensing here. No article should be construed as medical advice and is not intended as such by the authors or by 2 Minute Medicine, Inc.