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1. Population Pharmacokinetics of Intra-articular and Intravenous Administration of Tranexamic Acid in Patients Undergoing Total Knee Replacement

Author

Ma José Martínez-Zapata, Xavier Aguilera Roig, Aránzazu González Osuna, Francesc Pla-Junca, Luisa Fernanda Rojas, Marta Valle, Sebastián Videla, and C. Lamas

Subjects
Antifibrinolytic, Dose, medicine.drug_class, medicine.medical_treatment, Population, Blood Loss, Surgical, Renal function, Injections, Intra-Articular, Pharmacokinetics, Fibrinolysis, Humans, Medicine, Blood Transfusion, Pharmacology (medical), Arthroplasty, Replacement, Knee, Adverse effect, education, Aged, Pharmacology, education.field_of_study, business.industry, Antifibrinolytic Agents, Tranexamic Acid, Anesthesia, Administration, Intravenous, Female, business, Tranexamic acid, medicine.drug
Abstract

Tranexamic acid (TXA), an antifibrinolytic drug, is usually administered intravenously; however, intra-articular administration has recently been proven to be as effective as intravenous administration. Limited information regarding the pharmacokinetics (PK) of TXA after intra-articular administration has been reported. The aim of this study was to develop a population PK model of TXA administered as a single intra-articular dose and as two intravenous doses, and to study the sources of interindividual variability (IIV) in the PK processes of TXA. The developed model was used to simulate PK profiles of TXA at different dosage regimens and in patients with renal impairment. Patients who underwent primary unilateral total knee replacement (TKR) received 1 g/10 mL (concentration of 100 mg/mL) of TXA applied directly to the surgical field before wound closure, or 2 g (two doses of 1 g) of intravenous TXA. A population PK model was developed using a nonlinear mixed-effects approach and sources of IIV, such as sex, age, body weight, height, body mass index (BMI), preoperative haemoglobin, preoperative haematocrit, and creatinine clearance. Twenty-four patients were included, 12 in each group. Twenty patients were female, mean age (standard deviation) was 73.7 years (5.6). The disposition of TXA was best described as a two-compartment model with clearance dependent on creatinine clearance. Bootstrap results indicated that the model was stable and robust. The estimated bioavailability for intra-articular administration was 81%. Simulations indicated that 100% of patients would have plasma concentrations associated with partial fibrinolysis at 8 h post-administration with the dosages and routes of administration used in the present study. Intra-articular administration would produce complete inhibition of fibrinolysis in only 12% of patients compared with 72.5% with intravenous administration. No adverse events were reported. This population PK model demonstrated that a single dose of high-concentration, low-volume intra-articular TXA can achieve antifibrinolytic plasma concentrations of the drug for 8 h, providing both local and systemic effects in patients undergoing TKR. TXA administration to the surgical field could be an alternative to the intravenous; route for patients undergoing TKR; however, clinical studies are needed to assess the toxic local effects of TXA. Spanish Clinical Studies Registry Number: 2017-004059-22. Date of registration: 12 April 2018.

Published
2021
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2. Accelerated surgery versus standard care in hip fracture (HIP ATTACK): an international, randomised, controlled trial

Author

Flavia K Borges, Mohit Bhandari, Ernesto Guerra-Farfan, Ameen Patel, Alben Sigamani, Masood Umer, Maria E Tiboni, Maria del Mar Villar-Casares, Vikas Tandon, Jordi Tomas-Hernandez, Jordi Teixidor-Serra, Victoria RA Avram, Mitchell Winemaker, Mmampapatla T Ramokgopa, Wojciech Szczeklik, Giovanni Landoni, Chew Yin Wang, Dilshad Begum, John D Neary, Anthony Adili, Parag K Sancheti, Abdel-Rahman Lawendy, Mariano Balaguer-Castro, Paweł Ślęczka, Richard J Jenkinson, Aamer Nabi Nur, Gavin CA Wood, Robert J Feibel, Stephen J McMahon, Alen Sigamani, Ekaterine Popova, Bruce M Biccard, Iain K Moppett, Patrice Forget, Paul Landais, Michael H McGillion, Jessica Vincent, Kumar Balasubramanian, Valerie Harvey, Yaiza Garcia-Sanchez, Shirley M Pettit, Leslie P Gauthier, Gordon H Guyatt, David Conen, Amit X Garg, Shrikant I Bangdiwala, Emilie P Belley-Cote, Maura Marcucci, Andre Lamy, Richard Whitlock, Yannick Le Manach, Dean A Fergusson, Salim Yusuf, PJ Devereaux, Laurent Veevaete, Bernard le Polain de Waroux, Patricia Lavand'homme, Olivier Cornu, Karim Tribak, Jean Cyr Yombi, Nassim Touil, Maike Reul, Jigme Tshering Bhutia, Carol Clinckaert, Dirk De Clippeleir, Justin de Beer, Diane L Simpson, Andrew Worster, Kim A Alvarado, Krysten K Gregus, Kelly H Lawrence, Darryl P Leong, Philip G Joseph, Patrick Magloire, Benjamin Deheshi, Stuart Bisland, Thomas J Wood, Daniel M Tushinski, David AJ Wilson, Clive Kearon, David D Cowan, Vickas Khanna, Amna Zaki, Janet C Farrell, Anne Marie MacDonald, Steven CW Wong, Arsha Karbassi, Douglas Steven Wright, Harsha Shanthanna, Ryan Coughlin, Moin Khan, Spencer Wikkerink, Faraaz A Quraishi, Waleed Kishta, Emil Schemitsch, Timothy Carey, Mark D Macleod, David W Sanders, Edward Vasarhelyi, Debra Bartley, George K Dresser, Christina Tieszer, Steven Shadowitz, Jacques S Lee, Stephen Choi, Hans J Kreder, Markku Nousiainen, Monica R Kunz, Ravianne Tuazon, Mopina Shrikumar, Bheeshma Ravi, David Wasserstein, David JG Stephen, Diane Nam, Patrick DG Henry, Stephen M Mann, Melanie T Jaeger, Marco LA Sivilotti, Christopher A Smith, Christopher C Frank, Heather Grant, Leone Ploeg, Jeff D Yach, Mark M Harrison, Aaron R Campbell, Ryan T Bicknell, Davide D Bardana, Katie McIlquham, Catherine Gallant, Samantha Halman, Venkatesh Thiruganasambandamoorth, Sara Ruggiero, William J Hadden, Brian P-J Chen, Stephanie A Coupal, Lisa M McLean, Hemant R Shirali, Syed Y Haider, Crystal A Smith, Evan Watts, David J Santone, Kevin Koo, Allan J Yee, Ademilola N Oyenubi, Aaron Nauth, Emil H Schemitsch, Timothy R Daniels, Sarah E Ward, Jeremy A Hall, Henry Ahn, Daniel B Whelan, Amit Atrey, Amir Khoshbin, David Puskas, Kurt Droll, Claude Cullinan, Jubin Payendeh, Tina Lefrancois, Lise Mozzon, Travis Marion, Michael J Jacka, James Greene, Matthew Menon, Robert Stiegelmahr, Derek Dillane, Marleen Irwin, Lauren Beaupre, Chad P Coles, Kelly Trask, Shelley MacDonald, J Andrew I Trenholm, William Oxner, C Glen Richardson, Niloofar Dehghan, Mehdi Sadoughi, Achal Sharma, Neil J White, Loretta Olivieri, Stephen B Hunt, Thomas R Turgeon, Eric R Bohm, Sarah Tran, Stephen M Giilck, Tom Hupel, Pierre Guy, Peter J O'Brien, Andrew W Duncan, Gordon A Crawford, Junlin Zhou, Yanrui Zhao, Yang Liu, Lei Shan, Anshi Wu, Juan Manuel Muñoz, Philippe Chaudier, Marion Douplat, Michel Henri Fessy, Vincent Piriou, Lucie Louboutin, Jean Stephane David, Arnaud Friggeri, Sebastien Beroud, Jean Marie Fayet, Frankie Ka Li Leung, Christian Xinshuo Fang, Dennis King Hang Yee, Parag Kantilal Sancheti, Chetan Vijay Pradhan, Atul Ashok Patil, Chetan Prabhakar Puram, Madhav Pandurang Borate, Kiran Bhalchandra Kudrimoti, Bharati Anil Adhye, Himanshu Vijaykumar Dongre, Bobby John, Valsamma Abraham, Ritesh Arvind Pandey, Arti Rajkumar, Preetha Elizabeth George, Manesh Stephen, Nitheesh Chandran, Mohammed Ashraf, AM Georgekutty, Ahamad Shaheel Sulthan, S Adinarayanan, Deep Sharma, Satish Prasad Barnawal, Srinivasan Swaminathan, Prasanna Udupi Bidkar, Sandeep Kumar Mishra, Jagdish Menon, Niranjan M, Varghese Zachariah K, Santosh Angad Hiremath, Madhusudhan NC, Abhijit Jawali, Kingsly Robert Gnanadurai, Carolin Elizabeth George, Tatarao Maddipati, Mary KP KP, Vijay Sharma, Kamran Farooque, Rajesh Malhotra, Samarth Mittal, Chavi Sawhney, Babita Gupta, Purva Mathur, Shivanand Gamangati, Vijaylaxmi Tripathy, Prem Haridas Menon, Mandeep S Dhillon, Devendra K Chouhan, Sharanu Patil, Ravi Narayan, Purushotham Lal, Prashanth Nabhirajappa Bilchod, Surya Udai Singh, Uttam Vaidya Gattu, Ravi Prabhakar Dashputra, Prashant Vitthal Rahate, Maurizio Turiel, Giuseppe De Blasio, Riccardo Accetta, Paolo Perazzo, Daniele Stella, Marika Bonadies, Chiara Colombo, Stefania Fozzato, Fabio Pino, Ilaria Morelli, Eleonora Colnaghi, Vincenzo Salini, Giuseppe Denaro, Luigi Beretta, Giacomo Placella, Giuseppe Giardina, Mirko Binda, Anna Marcato, Luca Guzzetti, Fabio Piccirillo, Maurizio Cecconi, HM Khor, Hou Yee Lai, CS Kumar, KH Chee, PS Loh, Kit Mun Tan, Simmrat Singh, Li Lian Foo, Komella Prakasam, Sook Hui Chaw, Meng-Li Lee, Joanne HL Ngim, Huck Wee Boon, Im Im Chin, Ydo V Kleinlugtenbelt, Ellie BM Landman, Elvira R Flikweert, Herbert W Roerdink, Roy B.G. Brokelman, Hannie F Elskamp-Meijerman, Maarten R Horst, Jan-Hein MG Cobben, Anila Anjum, Pervaiz Mehmood Hashmi, Tashfeen Ahmed, Haroon Ur Rashid, Mujahid Jamil Khattak, Rizwan Haroon Rashid, Riaz Hussain Lakdawala, Shahryar Noordin, Naveed Muhammed Juman, Robyna Irshad Khan, Muhammad Mehmood Riaz, Syedah Saira Bokhari, Ayesha Almas, Hussain Wahab, Arif Ali, Hammad Naqi Khan, Eraj Khurshid Khan, Kholood Abid Janjua, Sajjad Hassan Orakzai, Abdus Salam Khan, Khawaja Junaid Mustafa, Mian Amjad Sohail, Muhammad Umar, Siddra Ahmed Khan, Muhammad Ashraf, Muhammad Kashif Khan, Muhammad Shiraz, Ahmad Furgan, Piotr Dąbek, Adam Kumoń, Wojciech Satora, Wojciech Ambroży, Mariusz Święch, Jacek Rycombel, Adrian Grzelak, Jaroslaw Gucwa, Waldemar Machala, Mmampapatla Thomas Ramokgopa, Gregory Bodley Firth, Mwalimu Karera, Maria Fourtounas, Virsen Singh, Anna Biscardi, Muhammad Nasir Iqbal, Ryan Jonathan Campbell, Matimba Lenny Maluleke, Carien Moller, Lerato Nhlapo, Sithombo Maqungo, Margot Flint, Marcin B Nejthardt, Sean Chetty, Rubendren Naidoo, Miriam Garrido Clua, Vicente Molero-Garcia, Joan Minguell-Monyart, Jordi Selga Marsa, Juan A Porcel-Vazquez, Jose-Vicente Andres-Peiro, Marc Aguilar, Jaume Mestre-Torres, Maria J Colomina, Patricia Guilabert, M Luisa Paños Gozalo, Luis Abarca, Nuria Martin, Gemma Usua, Pedro Martinez-Ripol, MA Gonzalez Posada, Pilar Lalueza-Broto, Judith Sanchez-Raya, Jorge Nuñez Camarena, Antoni Fraguas-Castany, Pere Torner, Monsant Jornet-Gibert, Jorge Serrano-Sanz, Jaume Cámara-Cabrera, Mònica Salomó-Domènech, Christian Yela-Verdú, Anna Peig-Font, Laura Ricol, Anna Carreras-Castañer, Luis Martínez-Sañudo, Susana Herranz, Carlos Feijoo-Massó, Mònica Sianes-Gallén, Pablo Castillón, Martí Bernaus, Saioa Quintas, Olga Gómez, Jordi Salvador, Javiera Abarca, Cristina Estrada, Marga Novellas, Mercè Torra, Alfred Dealbert, Oscar Macho, Alexia Ivanov, Esther Valldosera, Marta Arroyo, Borja Pey, Antoni Yuste, Llorenç Mateo, Julio De Caso, Rafael Anaya, JL Higa-Sansone, Angelica Millan, Victoria Baños, Sergio Herrera-Mateo, Hector J Aguado, Gonzalo Martinez-Municio, Ricardo León, Silvia Santiago-Maniega, Ana Zabalza, Gregorio Labrador, Enrique Guerado, Encarnacion Cruz, Juan Ramon Cano, Jose Manuel Bogallo, Paphon Sa-ngasoongsong, Noratep Kulachote, Norachart Sirisreetreerux, Nachapan Pengrung, Theerawat Chalacheewa, Vanlapa Arnuntasupakul, Teerapat Yingchoncharoen, Bundit Naratreekoon, Miriam Adel Kadry, Surendini Thayaparan, Ihab Abdlaziz, Arash Aframian, Arjuna Imbuldeniya, Souad Bentoumi, Sherif Omran, Marcela Paola Vizcaychipi, Patricia Correia, Shashank Patil, Kevin Haire, Amy SE Mayor, Sally Dillingham, Laura Nicholson, Mohamed Elnaggar, Joby John, Shashi Kumar Nanjayan, Martyn J Parker, Susan O'Sullivan, Meir T Marmor, Amir Matityahu, Robert Trigg McClellan, Curt Comstock, Anthony Ding, Paul Toogood, Gerard Slobogean, Katherine Joseph, Robert O'Toole, Marcus Sciadini, Scott P Ryan, Molly E Clark, Charles Cassidy, Konstantin Balonov, Sergio D Bergese, Laura S Phieffer, Alicia A Gonzalez Zacarias, Andrew J Marcantonio, Sanela Dragic-Taylor, Chelsea Maxwell, Sarah Molnar, Jennifer R Wells, Sandra N Ofori, Stephen S Yang, Michael K Wang, Emmanuelle Duceppe, Jessica Spence, Javiera P Vasquez, Francesc Marcano-Fernández, Hyungjoo Ham, Carlos Prada, Terence CH Yung, Isidro Sanz Pérez, Michael J Bosch, Michael R Prystajecky, Chinmoy Chowdhury, James S Khan, Steffan F Stella, Behrouz Heidary, Allen Tran, Katarzyna Wawrzycka-Adamczyk, Yu Chiao Peter Chen, Aránzazu González-Osuna, Grzegorz Biedroń, Anna Wludarczyk, Marco Lefebvre, Jaclyn A Ernst, Bas Staffhorst, Jason D Woodfine, Emad M Alwafi, Marko Mrkobrada, Simon Parlow, Robin Roberts, Finlay McAlister, David Sackett, James Wright, (HIP ATTACK, Investigators), Landoni, G., Faculty of Medicine and Pharmacy, Orthopaedics - Traumatology, Supporting clinical sciences, Emergency Medicine, UCL - SSS/IONS - Institute of NeuroScience, UCL - SSS/IONS/CEMO - Pôle Cellulaire et moléculaire, UCL - SSS/IREC/NMSK - Neuro-musculo-skeletal Lab, UCL - SSS/IREC/SLUC - Pôle St.-Luc, UCL - (SLuc) Service d'anesthésiologie, UCL - (SLuc) Service d'orthopédie et de traumatologie de l'appareil locomoteur, and UCL - (SLuc) Service de médecine interne générale

Subjects
Postoperative Complications/epidemiology, Male, Internationality, Femoral Neck Fractures/epidemiology, Arthroplasty, Replacement, Hip, Myocardial Ischemia, Comorbidity, Time-to-Treatment/statistics & numerical data, 030204 cardiovascular system & hematology, law.invention, Fracture Fixation, Internal, Postoperative Complications, 0302 clinical medicine, Randomized controlled trial, Residence Characteristics, law, Activities of Daily Living, Fracture fixation, Risk of mortality, Medicine and Health Sciences, Fracture Fixation, Internal/methods, Sepsis/epidemiology, 030212 general & internal medicine, Cardiovascular Diseases/mortality, Stroke, Aged, 80 and over, Hip fracture, Residence Characteristics/statistics & numerical data, Infections/epidemiology, General Medicine, Middle Aged, Open Fracture Reduction, Treatment Outcome, Cardiovascular Diseases, Diabetes Mellitus/epidemiology, Female, medicine.medical_specialty, Hip Fractures/epidemiology, Postoperative Hemorrhage, Infections, Early Medical Intervention/methods, Time-to-Treatment, 03 medical and health sciences, Arthroplasty, Replacement, Hip/methods, Early Medical Intervention, Sepsis, Diabetes Mellitus, medicine, Humans, Mortality, Myocardial Ischemia/epidemiology, Aged, Proportional Hazards Models, Postoperative Hemorrhage/epidemiology, Hip Fractures, Proportional hazards model, business.industry, Hemiarthroplasty/methods, Dementia/epidemiology, Delirium, Delirium/epidemiology, medicine.disease, Femoral Neck Fractures, Nursing Homes, Surgery, Open Fracture Reduction/methods, Dementia, Observational study, Hemiarthroplasty, business
Abstract

© 2020 Elsevier Ltd Background: Observational studies have suggested that accelerated surgery is associated with improved outcomes in patients with a hip fracture. The HIP ATTACK trial assessed whether accelerated surgery could reduce mortality and major complications. Methods: HIP ATTACK was an international, randomised, controlled trial done at 69 hospitals in 17 countries. Patients with a hip fracture that required surgery and were aged 45 years or older were eligible. Research personnel randomly assigned patients (1:1) through a central computerised randomisation system using randomly varying block sizes to either accelerated surgery (goal of surgery within 6 h of diagnosis) or standard care. The coprimary outcomes were mortality and a composite of major complications (ie, mortality and non-fatal myocardial infarction, stroke, venous thromboembolism, sepsis, pneumonia, life-threatening bleeding, and major bleeding) at 90 days after randomisation. Patients, health-care providers, and study staff were aware of treatment assignment, but outcome adjudicators were masked to treatment allocation. Patients were analysed according to the intention-to-treat principle. This study is registered at ClinicalTrials.gov (NCT02027896). Findings: Between March 14, 2014, and May 24, 2019, 27 701 patients were screened, of whom 7780 were eligible. 2970 of these were enrolled and randomly assigned to receive accelerated surgery (n=1487) or standard care (n=1483). The median time from hip fracture diagnosis to surgery was 6 h (IQR 4–9) in the accelerated-surgery group and 24 h (10–42) in the standard-care group (p

Published
2020

3. Dabigatran in patients with myocardial injury after non-cardiac surgery (MANAGE) : an international, randomised, placebo-controlled trial

Author

P J Devereaux, Emmanuelle Duceppe, Gordon Guyatt, Vikas Tandon, Reitze Rodseth, Bruce M Biccard, Denis Xavier, Wojciech Szczeklik, Christian S Meyhoff, Jessica Vincent, Maria Grazia Franzosi, Sadeesh K Srinathan, Jason Erb, Patrick Magloire, John Neary, Mangala Rao, Prashant V Rahate, Navneet K Chaudhry, Bongani Mayosi, Miriam de Nadal, Pilar Paniagua Iglesias, Otavio Berwanger, Juan Carlos Villar, Fernando Botto, John W Eikelboom, Daniel I Sessler, Clive Kearon, Shirley Pettit, Mukul Sharma, Stuart J Connolly, Shrikant I Bangdiwala, Purnima Rao-Melacini, Andreas Hoeft, Salim Yusuf, P.J. Devereaux, Shrikant I. Bangdiwala, Stuart Connolly, John Eikelboom, Janice Pogue, Daniel I. Sessler, Sara Di Diodato, Zora Gasic, Louise J. Mastrangelo, Sarah H. Molnar, Jennifer L. Swanson, Makayla L. Tosh, Jennifer R. Wells, Rafael Diaz, Clara K. Chow, Beatriz Gonzales, Skarlet Vásquez, Petr Jansky, Radovan Dušek, Christian S. Meyhoff, Pierre Coriat, Maria Wittmann, Gerald Yonga, Nandini Mathur, Elena Seletti, German Malaga, Bernadette A. Tumanan-Mendoza, Maria Pamela A. Tagle, Bruce M. Biccard, Pablo Alonso-Coello, Ekaterine Popova, Martin Shields, Yannick Le Manach, Paul Moayyedi, Sander van Zanten, Edith Fleischmann, Amit Garg, Kamilu Karaye, Edward McFalls, Alben Sigamani, Emilie Belley-Côté, Grzegorz Biedroń, Flavia Borges, Steffan Frosi Stella, Christian Haarmark Nielsen, Darryl P. Leong, Jessica Spence, Allen Tran, Katarzyna Wawrzycka-Adamczyk, Stephen S. Yang, Terence Yung, D. George Wyse, Davy Cheng, David E. Johnstone, George A. Wells, Philip Joseph, Ameen Patel, Krysten Gregus, Kelly Lawrence, Lindsay Doharris, David Conen, Jason Cheung, Jim Douketis, Douglas Wright, Spencer Wikkerink, William Dechert, Mohamed Panju, Khalid Azzam, Theodore Rapanos, Tomas Van Helder, Anjali Shroff, Jacqueline Hare, Biniam Kidane, Thang Nguyen, Larissa Leydier, Vanessa Bayaraa, Joel Parlow, Deborah A. DuMerton, Amar Thakrar, Jessica Shelley, Benoit Deligne, Roberta Daila Carling, Marko Mrkobrada, George K. Dresser, Michael J. Jacka, David Hornstein, Gerrit B. Winkelaar, Zoeb Hussain Haider, Pravina Prashant Lanjewar, Valsamma Varughese, Rajneesh Calton, Hemani Ahuja, Preetha George, Ambika Sharma, Keyur Sureshchandra Bhatt, Dhaval Odhavajibhai Mangukiya, Karshan Vira Nandaniya, Viral Vasantrai Parekh, Ashok Bhaskaran Pillai, Vidya P. Menon, Sanjay Channappa Desai, Ravinder Singh Sidhu, Sandeep Kumar Gupta, Robbie K. George, T.R. Gurunath, Leanne W. Drummond, Alexandra M. Torborg, Belinda S. Küsel, Prebashini Naidoo, Datshana P. Naidoo, Chantal Rajah, Zane Farina, Richard Peter von Rahden, Simphiwe Gumede, Chishala Chishala, Ettienne Coetzee, Robert A. Dyer, Johan Diedericks, Piotr Bielański, Bogusz Kaczmarek, Dorota Studzińska, Maciej Zaniewski, Marek Józef Libura, Tomasz Mikołaj Zacharias-Nalichowski, Aurelia A.S. Sega, Jakub Salwa, Mateusz Kózka, Jacek Górka, Anna Wludarczyk, Ilona Nowak-Kózka, Paweł Szczepan Grudzień, Jaroslaw W. Gucwa, Michał Piotr Słowiaczek, Paweł P.D. Dobosz, Ismail Gögenur, Jens Ravn Eriksen, Tine Borup, Tove Kirkegaard, Dan Isbye, Asger Sonne, Lars S. Rasmussen, Sofie Pedersen, Hannibal Troensegaard, Camilla L. Duus, Benedikte M. Halle, Ossian N. Gundel, Katrine F. Bernholm, Kristian Rønsholt Martinsen, Søren Pedersen, Theis S. Itenov, Elena Camio, Carles Vázquez, Silvia Matarin, Esther Cano, Jesús Álvarez-García, Inmaculada India, Aránzazu González-Osuna, Marc Vives, Elena Rosselló, Ana B. Serrano, Maurizio Turiel, Lorenzo Drago, Chiara Colombo, Federica Marra, Lucio Mos, Franco Arteni, Rosalba Lembo, Alessandro Ortalda, Simonetta Passarani, Zhirajr Mokini, Estevao Lanna Figueiredo, Gustavo Fonseca Werner, Joao Luiz Petriz, Lilia Nigro Maia, Ricardo R. Bergo, Dalton Bertolim Precoma, José Francisco Kerr Saraiva, Oscar Gomez Vilamajo, Eduardo Allegrini, Mariano Benzadón, Maria Leonor Parody, Ernesto A. Duronto, Adrián C. Ingaramo, Gustavo Adolfo Parra, Danny Novoa, Scott A. Miller, Sabu Thomas, Sudhakar P. Karlapudi, Mohamad H. Bourji, Subhash Banerjee, Anita Gupta, Isaac O. Opole, Michal Fischer, Victor Lecaros Mendoza, Eugenio Borja Reyes, Richard J. Pierson, Martin O. Shields, Vincent Piriou, Kai Zacharowski, Aida Rotta-Rotta, Main Paper, Sadeesh K. Srinathan, Prashant Rahate, Navneet Chaudhry, Bogani Mayosi, and Mike Sharma

Subjects
Male, medicine.medical_specialty, Myocardial Infarction, Placebo-controlled study, Hemorrhage, 030204 cardiovascular system & hematology, Placebo, Antithrombins, Dabigatran, law.invention, Peripheral Arterial Disease, 03 medical and health sciences, 0302 clinical medicine, Randomized controlled trial, 030202 anesthesiology, law, Internal medicine, medicine, Humans, Perioperative Period, Stroke, Aged, Aged, 80 and over, business.industry, Hazard ratio, Proton Pump Inhibitors, Thrombosis, Venous Thromboembolism, General Medicine, Perioperative, Placebo Effect, medicine.disease, Troponin, Clinical trial, Treatment Outcome, Female, business, Omeprazole, medicine.drug
Abstract

Summary Background Myocardial injury after non-cardiac surgery (MINS) increases the risk of cardiovascular events and deaths, which anticoagulation therapy could prevent. Dabigatran prevents perioperative venous thromboembolism, but whether this drug can prevent a broader range of vascular complications in patients with MINS is unknown. The MANAGE trial assessed the potential of dabigatran to prevent major vascular complications among such patients. Methods In this international, randomised, placebo-controlled trial, we recruited patients from 84 hospitals in 19 countries. Eligible patients were aged at least 45 years, had undergone non-cardiac surgery, and were within 35 days of MINS. Patients were randomly assigned (1:1) to receive dabigatran 110 mg orally twice daily or matched placebo for a maximum of 2 years or until termination of the trial and, using a partial 2-by-2 factorial design, patients not taking a proton-pump inhibitor were also randomly assigned (1:1) to omeprazole 20 mg once daily, for which results will be reported elsewhere, or matched placebo to measure its effect on major upper gastrointestinal complications. Research personnel randomised patients through a central 24 h computerised randomisation system using block randomisation, stratified by centre. Patients, health-care providers, data collectors, and outcome adjudicators were masked to treatment allocation. The primary efficacy outcome was the occurrence of a major vascular complication, a composite of vascular mortality and non-fatal myocardial infarction, non-haemorrhagic stroke, peripheral arterial thrombosis, amputation, and symptomatic venous thromboembolism. The primary safety outcome was a composite of life-threatening, major, and critical organ bleeding. Analyses were done according to the intention-to-treat principle. This trial is registered with ClinicalTrials.gov, number NCT01661101. Findings Between Jan 10, 2013, and July 17, 2017, we randomly assigned 1754 patients to receive dabigatran (n=877) or placebo (n=877); 556 patients were also randomised in the omeprazole partial factorial component. Study drug was permanently discontinued in 401 (46%) of 877 patients allocated to dabigatran and 380 (43%) of 877 patients allocated to placebo. The composite primary efficacy outcome occurred in fewer patients randomised to dabigatran than placebo (97 [11%] of 877 patients assigned to dabigatran vs 133 [15%] of 877 patients assigned to placebo; hazard ratio [HR] 0·72, 95% CI 0·55–0·93; p=0·0115). The primary safety composite outcome occurred in 29 patients (3%) randomised to dabigatran and 31 patients (4%) randomised to placebo (HR 0·92, 95% CI 0·55–1·53; p=0·76). Interpretation Among patients who had MINS, dabigatran 110 mg twice daily lowered the risk of major vascular complications, with no significant increase in major bleeding. Patients with MINS have a poor prognosis; dabigatran 110 mg twice daily has the potential to help many of the 8 million adults globally who have MINS to reduce their risk of a major vascular complication. Funding Boehringer Ingelheim and Canadian Institutes of Health Research.

Published
2018

4. Evaluation of grip strength in hook of hamate fractures treated with osteosynthesis. Is this surgical treatment necessary?

Author

Claudia Lamas-Gómez, Laura Velasco-González, Aranzazu González-Osuna, Marta Almenara-Fernández, Luis Trigo-Lahoz, and Xavier Aguilera-Roig

Subjects
Orthopedic surgery, RD701-811
Abstract

Objective: The aim of this study was to evaluate the outcomes of open reduction and internal fixation (ORIF) in hamate hook fractures and review the literature on this surgical procedure. Methods: We report the outcomes of ORIF of hamate hook fractures in 13 consecutive patients (12 men and 1 woman; mean age: 32 years (range, 22–48 years)). In eight patients (61%) the fracture was associated with ulnar nerve neuritis in Guyon's canal. We assessed the following clinical data: age, sex, mechanism of injury, side of the injured hand and associated lesions, fracture classification, average time from injury to correct diagnosis, surgical technique, complications, and length of follow-up.All patients underwent radiological imaging, including standard radiographs in two planes (anteroposterior and lateral projections), and a CT study. Functional outcomes evaluated were pain, range of motion, grip strength, Disabilities of the arm, shoulder and hand (DASH) and Mayo wrist score. Results: The mean follow-up was 36 months (range, 12–144 months). All 13 cases were treated with ORIF of the hook of the hamate. Mean VAS pain score was 5 preoperatively (4–9) and 1 (0–2) postoperatively. All patients returned to pre-injury level and only one patient felt pain on activity. Preoperative modified Mayo wrist score was 51 and the postoperative value was 94. All outcomes scores improved significantly from preoperative values. The patients who participated in sports postoperatively were able to do so at or near pre-injury levels. Postoperative average range of wrist motion was 76° in extension, 71° in flexion, 14° in ulnar deviation, and 21° in radial deviation.Mean grip strength in the hand with the hook fracture was 58 kg compared with 53 Kg in the unaffected hand. All patients returned to their pre-injury level of functioning after 10–12 weeks and there were no complications. Analysis of grip strength revealed values comparable with the unaffected hand. Conclusion: ORIF of hamate hook fractures is a safe and effective technique to restore normal grip strength and return to pre-injury level. In cases of ulnar nerve neuritis, neurolysis of the deep palmar branch is mandatory. Level of evidence: Level IV, Therapeutic study. Keywords: Guyon's canal, Hamate fracture, Hook of the hamate neuritis, Ulnar nerve

Published
2019
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