Systematic review: tranexamic acid for upper gastrointestinal bleeding

IntroductionThe management of acute upper gastrointestinal bleeding (UGIB) is challenging in patients with cirrhosis, as it is responsible for severe complications and high mortality rates. Tranexamic acid (TXA) may help control the bleeding by counterbalancing cirrhosis-related hyperfibrinolysis. Still, there is a lack of unbiased data to conclude on its efficacy. The aim of this study is to evaluate the efficacy of TXA in the early treatment of acute UGIB in patients with cirrhosis.Methods and analysisThis study is a multicentre, randomised, double-blind, placebo-controlled trial, for adult patients with cirrhosis presenting with an acute UGIB and allocated to one of two arms: TXA or placebo (saline). Physicians from emergency mobile services, emergency departments (EDs) or intensive care units (ICUs) can include patients. Besides study intervention, standard care for UGIB will be performed as recommended. Intervention will consist an intravenous infusion of 10 mL of TXA (1 g) or saline, immediately followed by three identical intravenous infusions over 8 hours each (total dose of 4 g of TXA or 40 mL of placebo over 24 hours). Main analyses will be conducted in intention to treat on every patient included, then in modified intention to treat on patients with underlying lesion of portal hypertension visualised by endoscopy. The main objective is to show efficacy of TXA until day 5 on a composite criterion (bleeding control, rebleeding episodes and mortality). Secondary objectives aim at showing the efficacy of TXA on each individual component of the main outcome measure and others at 6 weeks and later (transjugular intrahepatic portosystemic shunt procedure, cirrhosis-specific complications, length of stay in ICU and in hospital, safety and tolerance of TXA, liver transplantation). Included patients will be followed up to 1 year after inclusion.500 patients will be necessary to show a reduction in the prevalence of the primary outcome from 30% to 18% with a bilateral alpha risk of 5% and a power of 80%.Ethics and disseminationEthical approval has been obtained from the Comité de Protection des Personnes Ile-de-France 1 (CPP-IDF1). Results will be disseminated via publications in peer-review medical journals and scientific forums.Protocol versionThis protocol is based on the latest version, as established on 11 October 2017 and validated by the IRB CPP Ile-de-France 1.Trial registration numberNCT03023189.

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Use of hemostatic powder in treatment of upper gastrointestinal bleeding: a systematic review and meta-analysis

Endoscopy International Open ◽

10.1055/a-0977-2897 ◽

2019 ◽

Vol 07 (12) ◽

pp. E1704-E1713 ◽

Cited By ~ 4

Author(s):

Daniel Tavares de Rezende ◽

Vitor Ottoboni Brunaldi ◽

Wanderley Marques Bernardo ◽

Igor Braga Ribeiro ◽

Raquel Cristina Lins Mota ◽

...

Keyword(s):

Systematic Review ◽

Gastrointestinal Bleeding ◽

Latin American ◽

Upper Gastrointestinal Bleeding ◽

Rescue Therapy ◽

Meta Analysis ◽

Secondary Outcome ◽

Primary Hemostasis ◽

Hemostatic Powder ◽

Upper Gastrointestinal

Abstract Background and study aims TC-325 is a novel mineral hemostatic powder that creates a mechanical barrier by absorbing blood components and promoting clotting. Recently approved for use in humans, it has shown promise for treatment of upper gastrointestinal bleeding (UGIB). However, because there have been no large studies of TC-325, its true efficacy and safety profile remain unknown. We performed a systematic review and meta-analysis to determine the safety and efficacy of TC-325 in treating UGIB, based on rates of initial hemostasis, rebleeding, and adverse events (AEs). Methods We searched the MEDLINE/PubMed, EMBASE, CENTRAL, Latin-American and Caribbean Health Sciences Literature databases, as well as the gray literature, to identify articles describing use of TC-325 up to October 2018. Primary outcomes were initial hemostasis and rebleeding. AEs were described as a secondary outcome. Risk of bias was assessed with international scores. Results We identified 2077 records after removal of duplicates. We included 50 studies, involving a collective total of 1445 patients, in the quantitative synthesis. Primary hemostasis and rebleeding rates were 90.7 % and 26.1 %, respectively. Subgroup analyses showed similar results. Only eight AEs were reported. Conclusions TC-325 appears to be a safe, effective treatment for UGIB. The overall rate of initial hemostasis after TC-325 use is high, regardless of etiology of bleeding or whether TC-325 is used as a primary or rescue therapy. Although it is also associated with high rebleeding rates, rates of AEs and equipment failure after TC-325 use are extremely low.

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