scholarly journals CRASH-2 Study of Tranexamic Acid to Treat Bleeding in Trauma Patients: A Controversy Fueled by Science and Social Media

2015 ◽  
Vol 2015 ◽  
pp. 1-12 ◽  
Author(s):  
Sophia Binz ◽  
Jonathon McCollester ◽  
Scott Thomas ◽  
Joseph Miller ◽  
Timothy Pohlman ◽  
...  
Keyword(s):  
Social Media ◽  
Tranexamic Acid ◽  
Communication Technology ◽  
Low Income ◽  
Controlled Trial ◽  
Low Income Countries ◽  
Trauma Patients ◽  
Randomized Controlled ◽  
Cast Doubt ◽  
Trauma Networks

This paper reviews the application of tranexamic acid, an antifibrinolytic, to trauma. CRASH-2, a large randomized controlled trial, was the first to show a reduction in mortality and recommend tranexamic acid use in bleeding trauma patients. However, this paper was not without controversy. Its patient recruitment, methodology, and conductance in moderate-to-low income countries cast doubt on its ability to be applied to trauma protocols in countries with mature trauma networks. In addition to traditional vetting in scientific, peer-reviewed journals, CRASH-2 came about at a time when advances in communication technology allowed debate and influence to be leveraged in new forms, specifically through the use of multimedia campaigns, social media, and Internet blogs. This paper presents a comprehensive view of tranexamic acid utilization in trauma from peer-reviewed evidence to novel multimedia influences.

Reducing Mortality Among Bleeding Trauma Patients with Tranexamic Acid

2018 ◽  
pp. 241-247
Author(s):  
Haytham M. A. Kaafarani
Keyword(s):  
Randomized Controlled Trial ◽  
Tranexamic Acid ◽  
Hemorrhagic Shock ◽  
Low Income ◽  
Controlled Trial ◽  
Low Income Countries ◽  
Trauma Patients ◽  
Thromboembolic Events ◽  
The World ◽  
The Impact

The CRASH-2 trial is a randomized controlled trial performed in more than 270 hospitals across the world and aimed at studying the impact of tranexamic acid (TXA), an anti-fibrinolytic agent, on mortality in trauma patients presenting with hemorrhagic shock. With more than 20,000 patients, CRASH-2 showed a small but statistically significant decrease in mortality from 16% to 14.5% (p < 0.05), without any increase in thromboembolic events, in patients who received TXA versus placebo. Subset analyses suggested that the benefit was only present if TXA was administered within 3 h from injury. Two main criticisms of the study are (1) TXA reduced mortality but not the number of blood products used or the percentage of patients who needed transfusion, raising questions regarding the mechanism by which the drug worked; (2) the conductance of the study in moderate- to low-income countries, limiting its generalizability to high-income countries with advanced trauma systems.

The Future of Telemedicine in Europe and Methods for the Evaluation of Health Services

2012 ◽  
Vol 1 (3) ◽  
pp. 20-26 ◽  
Author(s):  
Paola Di Giacomo
Keyword(s):  
Low Income ◽  
New Technologies ◽  
Controlled Trial ◽  
Evaluation Methods ◽  
Low Income Countries ◽  
Middle Income ◽  
Middle Income Countries ◽  
Randomized Controlled ◽  
Analytical Work ◽  
The One

Despite the accumulation of evidence for the effects of approaches to chronic illness, methodological and analytical work is still needed to develop widely accepted evaluation methods that are scientifically sound and also practicable in routine settings. Given all the diversity and variability of disease management, a key issue for this work concerns the difficulties in establishing a useful “comparator” in settings where it is not practical or possible to execute an evaluation as a randomized controlled trial (RCT). This is indeed an important task because evaluation methods are a precondition to select efficient and effective programs, or components within a program that can address the growing burden of chronic and more in general health conditions. This is evident, in particular, when it comes to new technologies in medicine and implementation and evaluation, in the healthcare sectors, distinguishing low-income countries, on the one-hand, and those in other middle income countries.

scholarly journals A study protocol for a Pilot Masked, Randomized Controlled Trial Evaluating Locally-applied Gentamicin versus Saline in Open Tibia Fractures (pGO-Tibia) in Dar es Salaam, Tanzania

2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Ericka P. von Kaeppler ◽  
Claire Donnelley ◽  
Syed H. Ali ◽  
Heather J. Roberts ◽  
John M. Ibrahim ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Low Income ◽  
Low Cost ◽  
Controlled Trial ◽  
Dar Es Salaam ◽  
Tibial Fractures ◽  
Low Income Countries ◽  
Open Tibial Fractures ◽  
Randomized Controlled ◽  
Tibia Fractures

Abstract Background Open tibia fractures are a major source of disability in low- and middle-income countries (LMICs) due to the high incidence of complications, particularly infection and chronic osteomyelitis. One proposed adjunctive measure to reduce infection is prophylactic local antibiotic delivery, which can achieve much higher concentrations at the surgical site than can safely be achieved with systemic administration. Animal studies and retrospective clinical studies support the use of gentamicin for this purpose, but no high-quality clinical trials have been conducted to date in high- or low-income settings. Methods We describe a protocol for a pilot study conducted in Dar es Salaam, Tanzania, to assess the feasibility of a single-center masked randomized controlled trial to compare the efficacy of locally applied gentamicin to placebo for the prevention of fracture-related infection in open tibial shaft fractures. Discussion The results of this study will inform the design and feasibility of a definitive trial to address the use of local gentamicin in open tibial fractures. If proven effective, local gentamicin would be a low-cost strategy to reduce complications and disability from open tibial fractures that could impact care in both high- and low-income countries. Trial registration ClinicalTrials.gov, Registration # NCT03559400; Registered June 18, 2018.

scholarly journals POSTPARTUM HEMORRHAGE;

2012 ◽  
Vol 19 (03) ◽  
pp. 360-364
Author(s):  
ROBINA ALI ◽  
FARZANA HINA
Keyword(s):  
Blood Loss ◽  
Cesarean Section ◽  
Low Income ◽  
Controlled Trial ◽  
Cost Effective ◽  
Uterine Atony ◽  
Low Income Countries ◽  
Trial Duration ◽  
Standard Size ◽  
Randomized Controlled

Introduction: Worldwide PPH remains one of the most common cause of maternal mortality and is largely preventable maternaldeaths mainly in low income countries. 80% of it occurs due to uterine atony and uterotonics can decrease the risk of uterine atony. Misoprostolhas powerful uterotonic effect because it is well absorbed and has potential to be used more widely than would be possible with injectableuterotonics alone. Objective: The objective of this study is to compare efficacy of misoprostol with ergometrine in cesarean delivery formanagement of PPH. Study Design: Randomized controlled trial. Duration of study: The duration of study was six months from 1/1/2010 to30th/6/2010. Setting: Department of Gynae and obstetrics, DHQ hospital, Faisalabad. Subjects and methods: All patients fulfilling inclusioncriteria were included in study and before cesarean section Hb was carried out and Patients were divided into two groups, GP , and GP . GP 1 2 1was given 800 ug MP per rectal just before starting cesarean Section and GP was given intravenous ergometrine at delivery of head or anterior 2shoulder. Blood loss was measured objectively after delivery of the baby with help of standard size kidney tray of 500cc and post operative Hbwas Carried out on 3rd post operative day. Results: 187 Patients were randomly allocated in GP and GP each. In GP , misoprostol was given 1 2 1800 μg per rectal just before starting cesarean section and 13 patients (7%) out of 187 have blood loss more than 500ml measured by standardsize kidney tray while in GP intravenous ergometrine was given at delivery of the head and in this group 25 patients (13.5%) out of 187 had 2blood loss more than 500ml, so misoprostol was found to be a better uterotonic than ergometrine for prevention of PPH. On the third postoperative day Hb was carried out and in GP 13 patients (7%) out of 187 had their Hb less than 9 g/dl while in GP 25 patients (13.5%) had Hb less 1 2than 9 g/d1. Conclusions: Mp is stable, cost effective and easily administrable drug and was found to be comparatively more powerfuluterotonic than ergometrine for preventing uterine atony.

scholarly journals The ASHA (Hope) Project: Testing an Integrated Depression Treatment and Economic Strengthening Intervention in Rural Bangladesh: A Pilot Randomized Controlled Trial

2021 ◽  
Vol 18 (1) ◽  
pp. 279
Author(s):  
Alison Karasz ◽  
Shabnam Anne ◽  
Jena Derakhshani Hamadani ◽  
Fahmida Tofail
Keyword(s):  
Randomized Controlled Trial ◽  
Low Income ◽  
Controlled Trial ◽  
Cash Transfer ◽  
Depression Treatment ◽  
Rural Bangladesh ◽  
Randomized Controlled ◽  
Low Income Women ◽  
Economic Strengthening ◽  
Pilot Randomized Controlled Trial

Depression, a debilitating disorder, is highly prevalent among low-income women in low- and middle-income countries. Standard psychotherapeutic approaches may be helpful, but low treatment uptake, low retention, and transient treatment effects reduce the benefit of therapy. This pilot randomized controlled trial examined the effectiveness and feasibility of an integrated depression treatment/economic strengthening intervention. The study took place in two villages in the Sirajganj district in rural Bangladesh. Forty-eight low-income women with depressive symptoms (Patient Health Questionnaire (PHQ-9) score ≥ 10) were recruited and randomized to intervention or control arms. The intervention included a six-month group-based, fortnightly depression management and financial literacy intervention, which was followed by a cash-transfer of $186 (equivalent to the cost of two goats) at 12 months’ follow-up. The cash transfer could be used to purchase a productive asset (e.g., agricultural animals). The control arm received no intervention. Findings showed significant reduction in depression scores in the intervention group. The mean PHQ-9 score decreased from 14.5 to 5.5 (B ± SE, −9.2 ± 0.8 95% CI −10.9, −7.5, p < 0.01) compared to no change in the control group. Most other psycho-social outcomes, including tension, self-esteem, hope, social-support, and participation in household economic decision-making, also improved with intervention. An integrated depression treatment and financial empowerment intervention was found to be highly effective among rural low-income women with depression. Next steps involve formal testing of the model in a larger trial.

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