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Gelens, Frank ; Äijälä, Juho ; Komatsu, Misako ; Uran, Cem ; Jensen, Michael A. ; Miller, Kai J. ; Ince, Robin A. A. ; Vinck, Martin ; Canales-Johnson, Andres
An important question concerning inter-areal communication in the cortex is whether these interactions are synergistic, i.e. convey information beyond what can be performed by isolated signals. In other words, any two signals can either share common information (redundancy) or they can encode complementary information that is only available when both signals are considered together (synergy). Here, we dissociated cortical interactions sharing common information from those encoding complementary information during prediction error processing. To this end, we computed co-information, an information-theoretical measure that distinguishes redundant from synergistic information among brain signals. We analyzed auditory and frontal electrocorticography (ECoG) signals in five common awake marmosets performing two distinct auditory oddball tasks, and investigated to what extent event-related potentials (ERP) and broadband (BB) dynamics exhibit redundancy and synergy for auditory prediction error signals. We observed multiple patterns of redundancy and synergy across the entire cortical hierarchy with distinct dynamics. The information conveyed by ERPs and BB signals was highly synergistic even at lower stages of the hierarchy in the auditory cortex, as well as between lower and higher areas in the frontal cortex. These results indicate that the distributed representations of prediction error signals across the cortical hierarchy can be highly synergistic.
Gelens, Frank ; Äijälä, Juho ; Roberts, Louis ; Komatsu, Misako ; Uran, Cem ; Jensen, Michael A. ; Miller, Kai J. ; Ince, Robin A. A. ; Garagnani, Max ; Vinck, Martin ; Canales-Johnson, Andres
An important question concerning inter-areal communication in the cortex is whether these interactions are synergistic, i.e. brain signals can either share common information (redundancy) or they can encode complementary information that is only available when both signals are considered together (synergy). Here, we dissociated cortical interactions sharing common information from those encoding complementary information during prediction error processing. To this end, we computed co-information, an information-theoretical measure that distinguishes redundant from synergistic information among brain signals. We analyzed auditory and frontal electrocorticography (ECoG) signals in five common awake marmosets performing two distinct auditory oddball tasks and investigated to what extent event-related potentials (ERP) and broadband (BB) dynamics encoded redundant and synergistic information during auditory prediction error processing. In both tasks, we observed multiple patterns of synergy across the entire cortical hierarchy with distinct dynamics. The information conveyed by ERPs and BB signals was highly synergistic even at lower stages of the hierarchy in the auditory cortex, as well as between auditory and frontal regions. Using a brain-constrained neural network, we simulated the spatio-temporal patterns of synergy and redundancy observed in the experimental results and further demonstrated that the emergence of synergy between auditory and frontal regions requires the presence of strong, long-distance, feedback and feedforward connections. These results indicate that the distributed representations of prediction error signals across the cortical hierarchy can be highly synergistic.
Gelens, Frank ; Äijälä, Juho ; Komatsu, Misako ; Uran, Cem ; Jensen, Michael A. ; Miller, Kai J. ; Ince, Robin A. A. ; Vinck, Martin ; Canales-Johnson, Andres
An important question concerning inter-areal communication in the cortex is whether these interactions are synergistic, i.e. convey information beyond what can be performed by isolated signals. Here, we dissociated cortical interactions sharing common information from those encoding complementary information during prediction error processing. To this end, we computed co-information, an information-theoretical measure that distinguishes redundant from synergistic information among brain signals. We analyzed auditory and frontal electrocorticography (ECoG) signals in three common awake marmosets and investigated to what extent event-related-potentials (ERP) and broadband (BB) dynamics exhibit redundancy and synergy for auditory prediction error signals. We observed multiple patterns of redundancy and synergy across the entire cortical hierarchy with distinct dynamics. The information conveyed by ERPs and BB signals was highly synergistic even at lower stages of the hierarchy in the auditory cortex, as well as between lower and higher areas in the frontal cortex. These results indicate that the distributed representations of prediction error signals across the cortical hierarchy can be highly synergistic.
Kennedy, Eamonn ; Vadlamani, Shashank ; Lindsey, Hannah M. ; Lei, Pui-Wa ; Jo-Pugh, Mary ; Adamson, Maheen ; Alda, Martin ; Alonso-Lana, Silvia ; Ambrogi, Sonia ; Anderson, Tim J. ; Arango, Celso ; Asarnow, Robert F. ; Avram, Mihai ; Ayesa-Arriola, Rosa ; Babikian, Talin ; Banaj, Nerisa ; Bird, Laura J. ; Borgwardt, Stefan ; Brodtmann, Amy ; Brosch, Katharina ; Caeyenberghs, Karen ; Calhoun, Vince D. ; Chiaravalloti, Nancy D. ; Cifu, David X. ; Crespo-Facorro, Benedicto ; Dalrymple-Alford, John C. ; Dams-O’Connor, Kristen ; Dannlowski, Udo ; Darby, David ; Davenport, Nicholas ; DeLuca, John ; Díaz-Caneja, Covadonga M. ; Disner, Seth G. ; Dobryakova, Ekaterina ; Ehrlich, Stefan ; Esopenko, Carrie ; Ferrarelli, Fabio ; Frank, Lea E. ; Franz, Carol ; Fuentes-Claramonte, Paola ; Genova, Helen ; Giza, Christopher C. ; Goltermann, Janik ; Grotegerd, Dominik ; Gruber, Marius ; Gutiérrez-Zotes, Alfonso ; Ha, Minji ; Haavik, Jan ; Hinkin, Charles ; Hoskinson, Kristen R. ; Hubl, Daniela ; Irimia, Andrei ; Jansen, Andreas ; Kaess, Michael ; Kang, Xiaojian ; Kenney, Kimbra ; Keřková, Barbora ; Khlif, Mohamed Salah ; Kim, Minah ; Kindler, Jochen ; Kircher, Tilo ; Knı́žková, Karolina ; Kolskår, Knut K. ; Krch, Denise ; Kremen, William S. ; Kuhn, Taylor ; Kumari, Veena ; Kwon, Jun Soo ; Langella, Roberto ; Laskowitz, Sarah ; Lee, Jungha ; Lengenfelder, Jean ; Liebel, Spencer W. ; Liou-Johnson, Victoria ; Lippa, Sara M. ; Løvstad, Marianne ; Lundervold, Astri ; Marotta, Cassandra ; Marquardt, Craig A. ; Mattos, Paulo ; Mayeli, Ahmad ; McDonald, Carrie R. ; Meinert, Susanne ; Melzer, Tracy R. ; Merchán Naranjo, Jessica ; Michel, Chantal ; Morey, Rajendra A. ; Mwangi, Benson ; Myall, Daniel J. ; Nenadić, Igor ; Newsome, Mary R. ; Nunes, Abraham ; O’Brien, Terence J. ; Oertel, Viola ; Ollinger, John ; Olsen, Alexander ; Ortiz Garcı́a de la Foz, Victor ; Ozmen, Mustafa ; Pardoe, Heath ; Parent, Marise ; Piras, Fabrizio ; Piras, Federica ; Pomarol-Clotet, Edith ; Repple, Jonathan ; Richard, Geneviève ; Rodriguez, Jonathan ; Rodriguez, Mabel ; Rootes-Murdy, Kelly ; Rowland, Jared ; Ryan, Nicholas P. ; Salvador, Raymond ; Sanders, Anne-Marthe ; Schmidt, André ; Soares, Jair C. ; Spalleta, Gianfranco ; Španiel, Filip ; Stasenko, Alena ; Stein, Frederike ; Straube, Benjamin ; Thames, April ; Thomas-Odenthal, Florian ; Thomopoulos, Sophia I. ; Tone, Erin ; Torres, Ivan ; Troyanskaya, Maya ; Turner, Jessica A. ; Ulrichsen, Kristine M. ; Umpierrez, Guillermo ; Vilella, Elisabet ; Vivash, Lucy ; Walker, William C. ; Werden, Emilio ; Westlye, Lars T. ; Wild, Krista ; Wroblewski, Adrian ; Wu, Mon-Ju ; Wylie, Glenn R. ; Yatham, Lakshmi N. ; Zunta-Soares, Giovana B. ; Thompson, Paul M. ; Tate, David F. ; Hillary, Frank G. ; Dennis, Emily L. ; Wilde, Elisabeth A.
Investigators in the cognitive neurosciences have turned to Big Data to address persistent replication and reliability issues by increasing sample sizes, statistical power, and representativeness of data. While there is tremendous potential to advance science through open data sharing, these efforts unveil a host of new questions about how to integrate data arising from distinct sources and instruments. We focus on the most frequently assessed area of cognition - memory testing - and demonstrate a process for reliable data harmonization across three common measures. We aggregated raw data from 53 studies from around the world which measured at least one of three distinct verbal learning tasks, totaling N = 10,505 healthy and brain-injured individuals. A mega analysis was conducted using empirical bayes harmonization to isolate and remove site effects, followed by linear models which adjusted for common covariates. After corrections, a continuous item response theory (IRT) model estimated each individual subject’s latent verbal learning ability while accounting for item difficulties. Harmonization significantly reduced inter-site variance by 37% while preserving covariate effects. The effects of age, sex, and education on scores were found to be highly consistent across memory tests. IRT methods for equating scores across AVLTs agreed with held-out data of dually-administered tests, and these tools are made available for free online. This work demonstrates that large-scale data sharing and harmonization initiatives can offer opportunities to address reproducibility and integration challenges across the behavioral sciences.
Gelens, Frank ; Äijälä, Juho ; Roberts, Louis ; Komatsu, Misako ; Uran, Cem ; Jensen, Michael A. ; Miller, Kai J. ; Ince, Robin A. A. ; Garagnani, Max ; Vinck, Martin ; Canales-Johnson, Andres
An important question concerning inter-areal communication in the cortex is whether these interactions are synergistic, i.e. brain signals can either share common information (redundancy) or they can encode complementary information that is only available when both signals are considered together (synergy). Here, we dissociated cortical interactions sharing common information from those encoding complementary information during prediction error processing. To this end, we computed co-information, an information-theoretical measure that distinguishes redundant from synergistic information among brain signals. We analyzed auditory and frontal electrocorticography (ECoG) signals in five common awake marmosets performing two distinct auditory oddball tasks and investigated to what extent event-related potentials (ERP) and broadband (BB) dynamics encoded redundant and synergistic information during auditory prediction error processing. In both tasks, we observed multiple patterns of synergy across the entire cortical hierarchy with distinct dynamics. The information conveyed by ERPs and BB signals was highly synergistic even at lower stages of the hierarchy in the auditory cortex, as well as between auditory and frontal regions. Using a brain-constrained neural network, we simulated the spatio-temporal patterns of synergy and redundancy observed in the experimental results and further demonstrated that the emergence of synergy between auditory and frontal regions requires the presence of strong, long-distance, feedback and feedforward connections. These results indicate that the distributed representations of prediction error signals across the cortical hierarchy can be highly synergistic.
Sens, Alena ; Rischke, Samuel ; Hahnefeld, Lisa Katharina ; Dorochow, Erika ; Schäfer, Stephan Martin Gastón Helmut Johannes ; Thomas, Dominique Jeanette ; Köhm, Michaela ; Geisslinger, Gerd ; Behrens, Frank ; Gurke, Robert
The emerging disciplines of lipidomics and metabolomics show great potential for the discovery of diagnostic biomarkers, but appropriate pre-analytical sample-handling procedures are critical because several analytes are prone to ex vivo distortions during sample collection. To test how the intermediate storage temperature and storage period of plasma samples from K3EDTA whole-blood collection tubes affect analyte concentrations, we assessed samples from non-fasting healthy volunteers (n = 9) for a broad spectrum of metabolites, including lipids and lipid mediators, using a well-established LC-MS-based platform. We used a fold change-based approach as a relative measure of analyte stability to evaluate 489 analytes, employing a combination of targeted LC-MS/MS and LC-HRMS screening. The concentrations of many analytes were found to be reliable, often justifying less strict sample handling; however, certain analytes were unstable, supporting the need for meticulous processing. We make four data-driven recommendations for sample-handling protocols with varying degrees of stringency, based on the maximum number of analytes and the feasibility of routine clinical implementation. These protocols also enable the simple evaluation of biomarker candidates based on their analyte-specific vulnerability to ex vivo distortions. In summary, pre-analytical sample handling has a major effect on the suitability of certain metabolites as biomarkers, including several lipids and lipid mediators. Our sample-handling recommendations will increase the reliability and quality of samples when such metabolites are necessary for routine clinical diagnosis.
Gelens, Frank ; Komatsu, Misako ; Uran, Cem ; Jensen, Michael A. ; Miller, Kai J. ; Ince, Robin A. A. ; Vinck, Martin ; Canales-Johnson, Andres
An important question concerning inter-areal communication in the cortex, is whether these interactions are synergistic, i.e. convey information beyond what can be performed by isolated signals. Here, we dissociated cortical interactions sharing common information from those encoding complementary information during prediction error processing. To this end, we computed co-information, an information-theoretical measure that distinguishes redundant from synergistic information among brain signals. We analyzed auditory and frontal electrocorticography (ECoG) signals in three common awake marmosets and investigated to what extent event-related-potentials (ERP) and broadband (BB) dynamics exhibit redundancy and synergy in auditory prediction error signals. We observed multiple patterns of redundancy and synergy across the entire cortical hierarchy with distinct dynamics. The information conveyed by ERPs and BB signals was highly synergistic even at lower stages of the hierarchy in the auditory cortex, as well as between lower and higher areas in the frontal cortex. These results indicate that the distributed representations of prediction error signals across the cortical hierarchy can be highly synergistic.
Abdulhamid, Muhammad Ibrahim ; Aboona, Bassam ; Adam, Jaroslav ; Adams, Joseph ; Agakishiev, Geydar ; Aggarwal, Ishu ; Aggarwal, Madan ; Ahammed, Zubayer ; Aitbaev, Alisher ; Alekseev, Igor ; Anderson, Derek ; Aparin, Alexey ; Aslam, Sameer ; Atchison, Joseph ; Averichev, Georgy ; Bairathi, Vipul ; Baker, William ; Ball Cap, Jonathan Gonzalo ; Barish, Kenneth ; Bhagat, Pratibha ; Bhasin, Anju ; Bhatta, Somadutta ; Bordyuzhin, Igor G. ; Brandenburg, James ; Brandin, Andrei ; Cai, Xiang-Zhou ; Caines, Helen ; Calderon de la Barca Sanchez, Manuel ; Cebra, Daniel ; Ceska, Jakub ; Chakaberia, Irakli ; Chan, Brian ; Chang, Zilong ; Chatterjee, Arghya ; Chen, Ding ; Chen, J. ; Chen, J.H. ; Chen, Zhenyu ; Cheng, Jianping ; Cheng, Yunshan ; Choudhury, Subikash ; Christie, Bill ; Christie, William ; Chu, Xiaoxuan ; Crawford, Henry J. ; Dale-Gau, Gabriel ; Das, Ayanabha ; Daugherity, Michael ; Dedovich, Tatiana ; Deppner, Ingo Martin ; Derevschikov, Anatoly ; Dhamija, Arushi ; Di Carlo, Launa ; Dixit, Prabhupada ; Dong, Xin ; Drachenberg, James ; Duckworth, Eddie ; Dunlop, James ; Engelage, Jack ; Eppley, Geary ; Esumi, ShinIchi ; Evdokimov, Olga ; Ewigleben, Annika ; Eyser, Kjeld Oleg ; Fatemi, Renee ; Fazio, Salvatore ; Feng, Chan-Jui ; Feng, Yicheng ; Finch, Evan ; Fisyak, Yuri V. ; Flor, Fernando Antonio ; Fu, Chuan ; Gao, Taoya ; Geurts, Frank ; Ghimire, Navagyan ; Gibson, Adam ; Gopal, Krishan ; Gou, Xingrui ; Grosnick, David ; Gupta, Anik ; Hamed, Ahmed ; Han, Yiding ; Harasty, Matthew ; Harris, John W. ; Harrison-Smith, Hannah ; He, Wanbing ; He, Xionghong ; He, Yang ; Hu, Chenlu ; Hu, Qiang ; Hu, Y. ; Huang, H. ; Huang, H.Z. ; Huang, Shengli ; Huang, Te-Chuan ; Huang, Xinjie ; Huang, Y. ; Huang, Y. ; Humanic, Thomas J. ; Isenhower, Donald ; Isshiki, Moe ; Jacobs, William ; Jalotra, Ashish ; Jena, Chitrasen ; Ji, Yuanjing ; Jia, Jiangyong ; Jin, Chenliang ; Ju, Xinyue ; Judd, Eleanor ; Kabana, Sonia ; Kabir, Md Latiful ; Kalinkin, Dmitry ; Kang, Kejun ; Kapukchyan, David ; Kauder, Kolja ; Keane, Declan ; Kechechyan, Armen ; Kelsey, Matthew ; Kimelman, Benjamin ; Kiselev, Alexander ; Knospe, Anders ; Ko, Ho San ; Kochenda, Leonid ; Korobitsin, Artem ; Kravtsov, Petr ; Kumar, Lokesh ; Kumar, Shyam ; Kunnawalkam Elayavalli, Raghav ; Lacey, Roy Alphanso ; Landgraf, Jeffery ; Lebedev, Alexei ; Lednicky, Richard ; Lee, Jeong-Hun ; Leung, Yue-Hang ; Lewis, Nicole ; Li, Changfeng ; Li, Wei ; Li, Xiujun ; Li, Y. ; Li, Y. ; Li, Ziyang ; Liang, Xilin ; Liang, Yue ; Lin, Ting ; Liu, Chengyang ; Liu, Feng ; Liu, Guoming ; Liu, H. ; Liu, H. ; Liu, Li-ke ; Liu, Tong ; Liu, Xiaoyu ; Liu, Yanfang ; Liu, Zuowen ; Ljubicic, Tonko ; Llope, William Joseph ; Lomicky, Ondrej ; Longacre, Ronald S. ; Loyd, E.M. ; Lu, Tan ; Lukow, Nicholas ; Luo, Xiaofeng ; Luong, V.B. ; Ma, Long ; Ma, Rongrong ; Ma, Yu-Gang ; Magdy Abdelwahab Abdelrahman, Niseem ; Mallick, Dukhishyam ; Margetis, Spiros ; Matis, Howard ; Mazer, Joel Anthony ; McNamara, Grant ; Mi, K. ; Minaev, Nikolai ; Mohanty, Bedanga ; Mondal, Mriganka ; Mooney, Isaac A. ; Morozov, Dmitry ; Mudrokh, Aleksandr ; Nagy, Marton ; Nain, Ankita ; Nam, J.D. ; Nasim, M. ; Neff, Dylan ; Nelson, John M. ; Nemes, Daniel ; Nie, Maowu ; Nigmatkulov, Grigory ; Niida, Takafumi ; Nishitani, Risa ; Nogach, Larisa ; Nonaka, Toshihiro ; Odyniec, Grazyna ; Ogawa, Akio ; Oh, Saehanseul ; Okorokov, Vitaly A. ; Okubo, Kosuke ; Page, Brian ; Pak, Robert ; Pan, Jinjin ; Pandav, Ashish ; Pandey, Ashutosh ; Panebratsev, Yuri ; Pani, Tanmay ; Parfenov, Petr ; Paul, Ananya ; Perkins, Chris ; Pokhrel, B.R. ; Posik, Matthew ; Protzman, Tristan ; Pruthi, Navneet Kumar ; Putschke, Joern ; Qin, Zhi ; Qiu, Hao ; Quintero, Amilkar ; Racz, Cameron ; Radhakrishnan, Sooraj ; Raha, Nandita ; Ray, Lanny ; Ritter, Hans Georg ; Robertson, Charles ; Rogachevskiy, Oleg ; Rosales Aguilar, Manuel ; Roy, Diptanil ; Ruan, Lijuan ; Sahoo, Aswini ; Sahoo, Nihar Ranjan ; Sako, Hiroyuki ; Salur, Sevil ; Samigullin, Edward ; Sato, Susumu ; Schmidke, William B. ; Schmitz, Norbert ; Seger, Janet ; Seto, Richard ; Seyboth, Peter ; Shah, Neha ; Shahaliev, Ehtiram ; Shanmuganathan, Prashanth V. ; Shao, Tianhao ; Sharma, Mahima ; Sharma, Natasha ; Sharma, Rishabh ; Sharma, Sharang Rav ; Sheikh, Ashik Ikbal ; Shen, D. ; Shen, D.Y. ; Shen, Kaifeng ; Shi, Shusu ; Shi, Yingying ; Shou, Qi-Ye ; Si, Fan ; Singh, Jagbir ; Singha, Subhash ; Sinha, Priyanshi ; Skoby, Michael ; Soehngen, Yannick ; Song, Youqi ; Srivastava, Brijesh ; Stanislaus, Shirvel ; Stewart, David ; Strikhanov, Mikhail ; Stringfellow, Blair ; Su, Yuan ; Sun, Chuan ; Sun, X. ; Sun, Y. ; Sun, Y. ; Surrow, Bernd ; Svirida, Dmitry ; Sweger, Zachary ; Tamis, Andrew ; Tang, Aihong ; Tang, Zebo ; Taranenko, Arkadiy ; Tarnowsky, Terry ; Thomas, James H. ; Tlusty, David ; Todoroki, Takahito ; Tokarev, Michael ; Tomkiel, Catherine ; Trentalange, Steven ; Tribble, Robert ; Tribedy, Prithwish ; Tsai, Oleg D. ; Tsang, Chun Yuen ; Tu, Zhoudunming ; Tyler, Jace ; Ullrich, Thomas ; Underwood, David G. ; Upsal, Isaac ; Van Buren, Gene ; Vasiliev, Alexander ; Verkest, Veronica ; Videbæk, Flemming ; Vokal, Stanislav ; Voloshin, Sergei ; Wang, Fuqiang ; Wang, Gang ; Wang, J.S. ; Wang, J. ; Wang, Xiaofeng ; Wang, Y. ; Wang, Y. ; Wang, Y. ; Wang, Zhen ; Webb, Jason ; Weidenkaff, Philipp ; Westfall, Gary D. ; Wieman, Howard ; Wilks, Gavin ; Wissink, Scott ; Wu, J. ; Wu, J. ; Wu, X. ; Wu, X. ; Wu, Yang ; Xi, Baoshan ; Xiao, Zhigang ; Xie, Guannan ; Xie, Wei ; Xu, Haojie ; Xu, N. ; Xu, Qinghua ; Xu, Y. ; Xu, Y. ; Xu, Z. ; Xu, Z. ; Yan, Gaoguo ; Yan, Zhengxi ; Yang, Chi ; Yang, Qian ; Yang, Shuai ; Yang, Y. ; Ye, Z. ; Ye, Z. ; Yi, L. ; Yip, Kin ; Yu, Y. ; Zha, Wangmei ; Zhang, ChunJian ; Zhang, Dingwei ; Zhang, Jinlong ; Zhang, Shenghui ; Zhang, Wei ; Zhang, Xin ; Zhang, Y. ; Zhang, Y. ; Zhang, Y. ; Zhang, Y. ; Zhang, Z.J. ; Zhang, Z. ; Zhang, Z. ; Zhao, Fengyi ; Zhao, Jie ; Zhao, Minghui ; Zhou, Chensheng ; Zhou, Jian ; Zhou, Shuai ; Zhou, Yingjie ; Zhu, Xianglei ; Zurek, Maria ; Zyzak, Maksym
The polarization of Λ and Λ¯ hyperons along the beam direction has been measured relative to the second and third harmonic event planes in isobar Ru+Ru and Zr+Zr collisions at √sNN = 200 GeV. This is the first experimental evidence of the hyperon polarization by the triangular flow originating from the initial density fluctuations. The amplitudes of the sine modulation for the second and third harmonic results are comparable in magnitude, increase from central to peripheral collisions, and show a mild pT dependence. The azimuthal angle dependence of the polarization follows the vorticity pattern expected due to elliptic and triangular anisotropic flow, and qualitatively disagree with most hydrodynamic model calculations based on thermal vorticity and shear induced contributions. The model results based on one of existing implementations of the shear contribution lead to a correct azimuthal angle dependence, but predict centrality and pT dependence that still disagree with experimental measurements. Thus, our results provide stringent constraints on the thermal vorticity and shear-induced contributions to hyperon polarization. Comparison to previous measurements at RHIC and the LHC for the second-order harmonic results shows little dependence on the collision system size and collision energy.
Palma, Clementina Duran ; Mamba, Musawenkosi ; Geldenhuys, Johan ; Fadahun, Oluwafolajimi ; Rossaint, Rolf ; Zacharowski, Kai ; Brand, Martin ; Díaz-Cambronero, Óscar ; Belda, Javier ; Westphal, Martin ; Brauer, Ute ; Dormann, Dirk ; Dehnhardt, Tamara ; Hernandez-Gonzalez, Martin ; Schmier, Sonja ; Korte, Dianne de ; Plani, Frank ; Buhre, Wolfgang Friedrich
Background: Trauma may be associated with significant to life-threatening blood loss, which in turn may increase the risk of complications and death, particularly in the absence of adequate treatment. Hydroxyethyl starch (HES) solutions are used for volume therapy to treat hypovolemia due to acute blood loss to maintain or re-establish hemodynamic stability with the ultimate goal to avoid organ hypoperfusion and cardiovascular collapse. The current study compares a 6% HES 130 solution (Volulyte 6%) versus an electrolyte solution (Ionolyte) for volume replacement therapy in adult patients with traumatic injuries, as requested by the European Medicines Agency to gain more insights into the safety and efficacy of HES in the setting of trauma care.
Methods: TETHYS is a pragmatic, prospective, randomized, controlled, double-blind, multicenter, multinational trial performed in two parallel groups. Eligible consenting adults ≥ 18 years, with an estimated blood loss of ≥ 500 ml, and in whom initial surgery is deemed necessary within 24 h after blunt or penetrating trauma, will be randomized to receive intravenous treatment at an individualized dose with either a 6% HES 130, or an electrolyte solution, for a maximum of 24 h or until reaching the maximum daily dose of 30 ml/kg body weight, whatever occurs first. Sample size is estimated as 175 patients per group, 350 patients total (α = 0.025 one-tailed, power 1–β = 0.8). Composite primary endpoint evaluated in an exploratory manner will be 90-day mortality and 90-day renal failure, defined as AKIN stage ≥ 2, RIFLE injury/failure stage, or use of renal replacement therapy (RRT) during the first 3 months. Secondary efficacy and safety endpoints are fluid administration and balance, changes in vital signs and hemodynamic status, changes in laboratory parameters including renal function, coagulation, and inflammation biomarkers, incidence of adverse events during treatment period, hospital, and intensive care unit (ICU) length of stay, fitness for ICU or hospital discharge, and duration of mechanical ventilation and/or RRT.
Discussion: This pragmatic study will increase the evidence on safety and efficacy of 6% HES 130 for treatment of hypovolemia secondary to acute blood loss in trauma patients.
Trial registration:Registered in EudraCT, No.: 2016-002176-27 (21 April 2017) and ClinicalTrials.gov, ID: NCT03338218 (09 November 2017).
Walaszczyk, Ireneusz ; Čech, Stanislav ; Crampton, James S. ; Dubicka, Zofia ; Ifrim, Christina ; Jarvis, Ian ; Kennedy, William James ; Lees, Jackie A. ; Lodowski, Damian ; Pearce, Martin ; Peryt, Danuta ; Sageman, Bradley B. ; Schiøler, Poul ; Todes, Jordan ; Uličný, David ; Voigt, Silke ; Wiese, Frank ; Linnert, Christian ; Püttmann, Tobias ; Toshimitsu, Seiichi
Following votes in the Coniacian Working Group, the Cretaceous Subcommission and the International Commission on Stratigraphy, on May 1st, 2021, the International Union of Geological Sciences voted unanimously to ratify the Global Stratotype Section and Point (GSSP) proposal for the base of the Coniacian Stage of the Upper Cretaceous Series and Cretaceous System. The lower boundary of the Coniacian Stage is placed at the base of Bed 46 of the Salzgitter-Salder section in northern Germany. The boundary is defined by the first appearance of the inoceramid bivalve species Cremnoceramus deformis erectus (Meek) and complemented by the Navigation carbon isotope event. Additional data include the bivalve genus Didymotis, foraminifera, ammonite, nannofossil and organic-walled dinoflagellate cyst events. Three auxiliary sections (Słupia Nadbrzeżna, central Poland; Střeleč, Czech Republic; El Rosario, NE Mexico) supplement the details of the boundary record in various facies, and in differing geographic and biogeographic contexts.