Tranexamic acid for hyperacute primary IntraCerebral Haemorrhage (TICH-2): an international randomised, placebo-controlled, phase 3 superiority trial

BackgroundTranexamic acid (TXA) reduces death due to bleeding after trauma and post-partum haemorrhage. The aim was to assess if tranexamic acid reduces haematoma expansion and improves outcome in adults with stroke due to intracerebral 6 haemorrhage (ICH). MethodsWe undertook an international, randomised placebo-controlled trial in adults with intracerebral haemorrhage. Participants received 1g intravenous tranexamic acid bolus followed by an 8 hour 1g infusion, or matching placebo, within 8 hours of symptom onset. The primary outcome was functional status at day 90, measured by shift in the modified Rankin Scale (mRS), using ordinal logistic regression, with adjustment for stratification and minimisation criteria. All analyses were performed on an intention to treat basis. This trial is registered as ISRCTN93732214.FindingsWe recruited 2,325 participants (TXA 1161, placebo 1164) from 124 hospitals in 12 countries between 2013 and 2017. Treatment groups were well balanced at baseline. The primary outcome was determined for 2307 (99·2%) participants. There was no statistically significant difference between the groups for the primary outcome of functional status at day 90 (adjusted odds ratio [aOR] 0·88, 95% CI 0·76-1·03, p=0·11). Although there were fewer deaths by day 7 in the TXA group (aOR 0·73, 95% CI 0·53-0·99, p=0·0406), there was no difference in case fatality at 90 days (adjusted hazard ratio 0·92, 95% CI 0·77 to 1·10, p =0·37). There were fewer serious adverse events after TXA vs. placebo by days 2 (p=0·0272), 7 (p=0·0200) and 90 (p=0·0393).InterpretationThere was no significant difference in functional status 90 days after intracerebral haemorrhage with tranexamic acid, despite a reduction in early deaths and serious adverse events. Larger randomised trials are needed to confirm or refute a clinically significant treatment effect

sj-pdf-1-eso-10.1177_23969873231186863 – Supplemental material for Anticoagulation in acute ischemic stroke patients with mechanical heart valves: To bridge or not with heparin. The ESTREM study

Supplemental material, sj-pdf-1-eso-10.1177_23969873231186863 for Anticoagulation in acute ischemic stroke patients with mechanical heart valves: To bridge or not with heparin. The ESTREM study by Maurizio Paciaroni, Valeria Caso, Michele Romoli, Cecilia Becattini, Alexander Salerno, Costanza Rapillo, Fanny Simonnet, Davide Strambo, Isabella Canavero, Marialuisa Zedde, Rosario Pascarella, Sung-Il Sohn, Simona Sacco, Raffaele Ornello, Kristian Barlinn, Daniela Schoene, Jan Rahmig, Maria Giulia Mosconi, Ilaria Leone De Magistris, Andrea Alberti, Michele Venti, Giorgio Silvestrelli, Alfonso Ciccone, Marina Padroni, Michele Laudisi, Andrea Zini, Luana Gentile, Odysseas Kargiotis, Georgios Tsivgoulis, Rossana Tassi, Francesca Guideri, Maurizio Acampa, Luca Masotti, Elisa Grifoni, Alessandro Rocco, Marina Diomedi, Theodore Karapanayiotides, Stefan T Engelter, Alexandros A Polymeris, Annaelle Zietz, Fabio Bandini, Pietro Caliandro, Giuseppe Reale, Marco Moci, Aurelia Zauli, Manuel Cappellari, Andrea Emiliani, Antonio Gasparro, Valeria Terruso, Marina Mannino, Elisa Giorli, Danilo Toni, Marco Andrighetti, Anne Falcou, Lina Palaiodimou, George Ntaios, Dimitrios Sagris, Efstathia Karagkiozi, Anastasia Adamou, Panagiotis Halvatsiotis, Yuriy Flomin, Umberto Scoditti, Antonio Genovese, Nemanja Popovic, Leonardo Pantoni, Francesco Mele, Nicola Molitierno, Piergiorgio Lochner, Alessandro Pezzini, Massimo Del Sette, Davide Sassos, Sotirios Giannopoulos, Maria Kosmidou, Evangelos Ntais, Enrico Maria Lotti, Vincenzo Mastrangelo, Alberto Chiti, Andrea Naldi, Peter Vanacker, Mario Ferrante, Vera Volodina, Michelangelo Mancuso, Nicola Giannini, Marco Baldini, Kostantinos Vadikolias, Sofia Kitmeridou, Carlo Emanuele Saggese, Tiziana Tassinari, Valentina Saia and Patrik Michel in European Stroke Journal</p