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8. Impact of time to start of tranexamic acid treatment on rebleed risk and outcome in aneurysmal subarachnoid hemorrhage

Author

Neurologen, Brain, Circulatory Health, UMC Utrecht, Germans, Menno R., Tjerkstra, Maud A., Post, René, Brenner, Amy, Vergouwen, Mervyn D.I., Rinkel, Gabriël J.E., Roos, Yvo B.W.E.M., van den Berg, René, Coert, Bert A., Vandertop, W. Peter, Verbaan, Dagmar, Neurologen, Brain, Circulatory Health, UMC Utrecht, Germans, Menno R., Tjerkstra, Maud A., Post, René, Brenner, Amy, Vergouwen, Mervyn D.I., Rinkel, Gabriël J.E., Roos, Yvo B.W.E.M., van den Berg, René, Coert, Bert A., Vandertop, W. Peter, and Verbaan, Dagmar

Published
2024

9. Impact of time to start of tranexamic acid treatment on rebleed risk and outcome in aneurysmal subarachnoid hemorrhage

Author

Germans, Menno R; https://orcid.org/0000-0003-2185-4526, Tjerkstra, Maud A; https://orcid.org/0000-0001-9060-3435, Post, René; https://orcid.org/0000-0001-7844-6262, Brenner, Amy, Vergouwen, Mervyn DI; https://orcid.org/0000-0002-6823-1628, Rinkel, Gabriël Je, Roos, Yvo Bwem; https://orcid.org/0000-0001-9205-5882, van den Berg, René, Coert, Bert A, Vandertop, W Peter; https://orcid.org/0000-0001-5417-0265, Verbaan, Dagmar; https://orcid.org/0000-0002-9212-5470, Germans, Menno R; https://orcid.org/0000-0003-2185-4526, Tjerkstra, Maud A; https://orcid.org/0000-0001-9060-3435, Post, René; https://orcid.org/0000-0001-7844-6262, Brenner, Amy, Vergouwen, Mervyn DI; https://orcid.org/0000-0002-6823-1628, Rinkel, Gabriël Je, Roos, Yvo Bwem; https://orcid.org/0000-0001-9205-5882, van den Berg, René, Coert, Bert A, Vandertop, W Peter; https://orcid.org/0000-0001-5417-0265, and Verbaan, Dagmar; https://orcid.org/0000-0002-9212-5470

Abstract

INTRODUCTION: The ULTRA-trial investigated effectiveness of ultra-early administration of tranexamic acid (TXA) in subarachnoid hemorrhage (SAH) and showed that TXA reduces the risk of rebleeding without concurrent improvement in clinical outcome. Previous trials in bleeding conditions, distinct from SAH, have shown that time to start of antifibrinolytic treatment influences outcome. This post-hoc analysis of the ULTRA-trial investigates whether the interval between hemorrhage and start of TXA impacts the effect of TXA on rebleeding and functional outcome following aneurysmal SAH. PATIENTS AND METHODS: A post-hoc comparative analysis was conducted between aneurysmal SAH patients of the ULTRA-trial, receiving TXA and usual care to those receiving usual care only. We assessed confounders, hazard ratio (HR) of rebleeding and odds ratio (OR) of good outcome (modified Rankin Scale 0-3) at 6 months, and investigated the impact of time between hemorrhage and start of TXA on the treatment effect, stratified into time categories (0-3, 3-6 and >6 h). RESULTS: Sixty-four of 394 patients (16.2%) in the TXA group experienced a rebleeding, compared to 83 of 413 patients (19.9%) with usual care only (HR 0.86, 95% confidence interval (CI): 0.62-1.19). Time to start of TXA modifies the effect of TXA on rebleeding rate (p < 0.001), with a clinically non-relevant reduction observed only when TXA was initiated after 6 h (absolute rate reduction 1.4%). Tranexamic acid treatment showed no effect on good outcome (OR 0.96, 95% CI: 0.72-1.27) with no evidence of effect modification on the time to start of TXA (p = 0.53). DISCUSSION AND CONCLUSIONS: This study suggests that the effect of TXA on rebleeding is modified by time to treatment, providing a protective, albeit clinically non-relevant, effect only when started after 6 h. No difference in functional outcome was seen. Routine TXA treatment in the aneurysmal SAH population, even within a specified time frame, is not recommended to impro

Published
2024

10. Tranexamic acid by the intramuscular or intravenous route for the prevention of postpartum haemorrhage in women at increased risk: a randomised placebo-controlled trial (I’M WOMAN)

Author

Brenner, Amy Charlotte, primary, Shakur-Still, Haleema, additional, Chaudhri, Rizwana, additional, Muganyizi, Projestine, additional, Olayemi, Oladapo, additional, Arribas, Monica, additional, Kayani, Aasia, additional, Javaid, Kiran, additional, Bello, Folasade Adenike, additional, Roberts, Ian, additional, and Group, I'M WOMAN Trial Collaborative, additional

Published
2023
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12. Tranexamic acid for acute gastrointestinal bleeding (the HALT-IT trial): statistical analysis plan for an international, randomised, double-blind, placebo-controlled trial

Author

Brenner, Amy, Afolabi, Adefemi, Ahmad, Syed Masroor, Arribas, Monica, Chaudhri, Rizwana, Coats, Timothy, Cuzick, Jack, Gilmore, Ian, Hawkey, Christopher, Jairath, Vipul, Javaid, Kiran, Kayani, Aasia, Mutti, Muttiullah, Nadeem, Muhammad Arif, Shakur-Still, Haleema, Stanworth, Simon, Veitch, Andrew, Roberts, Ian, and HALT-IT Trial Collaborators

Published
2019
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17. PRISMA-P checklist

Author

Ker, Katharine, Shakur-Still, Haleema, Sentilhes, Loic, Pacheco, Luis, Saade, George, Deneux-Tharaux, Catherine, Brenner, Amy, Mansukhani, Raoul, Ageron, Francois-Xavier, Prowse, Danielle, Chaudhri, Rizwana, Olayemi, Oladapo, and Roberts, Ian

Abstract

PRISMA-P checklist for 'Tranexamic acid for the prevention of postpartum bleeding: Protocol for a systematic review and individual patient data meta-analysis'.

Published
2022
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19. Postpartum Haemorrhage in Anaemic Women: Assessing Outcome Measures for Clinical Trials

Author

Brenner, Amy Charlotte, primary, Roberts, Ian, additional, Balogun, Eni, additional, Bello, Folasade Adenike, additional, Chaudhri, Rizwana, additional, Fleming, Charlotte, additional, Javaid, Kiran, additional, Kayani, Aasia, additional, Lubeya, Mwansa Ketty, additional, Mansukhani, Raoul, additional, Olayemi, Oladapo, additional, Prowse, Danielle, additional, Vwalika, Bellington, additional, and Shakur-Still, Haleema, additional

Published
2021
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20. A high-dose 24-hour tranexamic acid infusion for the treatment of significant gastrointestinal bleeding: HALT-IT RCT

Author

Roberts, Ian, primary, Shakur-Still, Haleema, additional, Afolabi, Adefemi, additional, Akere, Adegboyega, additional, Arribas, Monica, additional, Austin, Emma, additional, Bal, Kiran, additional, Bazeer, Nuha, additional, Beaumont, Danielle, additional, Brenner, Amy, additional, Carrington, Laura, additional, Chaudhri, Rizwana, additional, Coats, Timothy, additional, Gilmore, Ian, additional, Halligan, Kenneth, additional, Hussain, Irshad, additional, Jairath, Vipul, additional, Javaid, Kiran, additional, Kayani, Aasia, additional, Lisman, Ton, additional, Mansukhani, Raoul, additional, Miners, Alec, additional, Mutti, Muttiullah, additional, Nadeem, Muhammad Arif, additional, Pollok, Richard, additional, Prowse, Danielle, additional, Simmons, Jonathan, additional, Stanworth, Simon, additional, Veitch, Andrew, additional, and Williams, Jack, additional

Published
2021
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21. Development of a patient reported outcome questionnaire to measure the impact of postpartum blood loss in women with moderate and severe anaemia: A study using a multi-faceted approach

Author

Miller, Lori, primary, Chaudhri, Shahana, additional, Beaumont, Danielle, additional, Kayani, Aasia, additional, Javid, Kiran, additional, Chaudhri, Rizwana, additional, Edwards, Phil, additional, Brenner, Amy, additional, Roberts, Ian, additional, and Shakur-Still, Haleema, additional

Published
2021
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23. Tranexamic acid to reduce head injury death in people with traumatic brain injury: the CRASH-3 international RCT

Author

Roberts, Ian, primary, Shakur-Still, Haleema, additional, Aeron-Thomas, Amy, additional, Beaumont, Danielle, additional, Belli, Antonio, additional, Brenner, Amy, additional, Cargill, Madeleine, additional, Chaudhri, Rizwana, additional, Douglas, Nicolas, additional, Frimley, Lauren, additional, Gilliam, Catherine, additional, Geer, Amber, additional, Jamal, Zahra, additional, Jooma, Rashid, additional, Mansukhani, Raoul, additional, Miners, Alec, additional, Pott, Jason, additional, Prowse, Danielle, additional, Shokunbi, Temitayo, additional, and Williams, Jack, additional

Published
2021
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24. Additional file 1 of Understanding the neuroprotective effect of tranexamic acid: an exploratory analysis of the CRASH-3 randomised trial

Author

Brenner, Amy, Belli, Antonio, Rizwana Chaudhri, Coats, Timothy, Frimley, Lauren, Sabariah Faizah Jamaluddin, Jooma, Rashid, Mansukhani, Raoul, Sandercock, Peter, Shakur-Still, Haleema, Temitayo Shokunbi, and Roberts, Ian

Abstract

Supplementary Table 1. Effect of tranexamic acid on all-cause mortality within 24 hours of injury, after 24 hours and at 28 days stratified by severity and country income in patients randomised within 3 hours of injury. Supplementary Table 2. Effect of tranexamic acid on head injury death within 24 hours, after 24 hours and at 28 days by severity and country income in patients randomised within 3 hours of injury, excluding those with GCS 3 or bilateral unreactive pupils. Supplementary Table 3. Effect of tranexamic acid on head injury death within 24 hours, after 24 hours and at 28 days by severity and country income in patients randomised within 3 hours of injury.

Published
2020
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25. Parents' and children's perspectives of a children's hospice bereavement program

Author

Davies, Betty, Collins, John, Steele, Rose, Cook, Karen, Distler, Vivian, and Brenner, Amy

Subjects
Children -- Management, Children -- Research, Bereavement in children -- Management, Bereavement in children -- Research, Hospice care -- Research, Self-help groups -- Services, Company business management, Health, Health care industry, Social sciences
Published
2007

26. Children's perspectives of a pediatric hospice hospital

Author

Davies, Betty, Collins, John B., Steele, Rose, Cook, Karen, Brenner, Amy, and Smith, Stephany

Subjects
Children's hospitals -- Research, Palliative treatment -- Research, Children -- Health aspects, Children -- Research, Health, Health care industry, Social sciences
Published
2005

27. Effects of a high-dose 24-h infusion of tranexamic acid on death and thromboembolic events in patients with acute gastrointestinal bleeding (HALT-IT): an international randomised, double-blind, placebo-controlled trial

Author

Roberts, Ian, primary, Shakur-Still, Haleema, additional, Afolabi, Adefemi, additional, Akere, Adegboyega, additional, Arribas, Monica, additional, Brenner, Amy, additional, Chaudhri, Rizwana, additional, Gilmore, Ian, additional, Halligan, Kenneth, additional, Hussain, Irshad, additional, Jairath, Vipul, additional, Javaid, Kiran, additional, Kayani, Aasia, additional, Lisman, Ton, additional, Mansukhani, Raoul, additional, Mutti, Muttiullah, additional, Arif Nadeem, Muhammad, additional, Pollok, Richard, additional, Simmons, Jonathan, additional, Soomro, Majid, additional, Stanworth, Simon, additional, Veitch, Andrew, additional, Hawkey, Christopher, additional, Cuzick, Jack, additional, Henry, David, additional, Metcalfe, Chris, additional, Roberts, Ian, additional, Gray, Richard, additional, Barkun, Alan, additional, David, Suresh, additional, Devereaux, Philip, additional, Brady, Tony, additional, Coats, Timothy, additional, Edwards, Phil, additional, Ker, Katharine, additional, Manno, Daniela, additional, Austin, Emma, additional, Bal, Kiran, additional, Balogun, Eni, additional, Barrow, Collette, additional, Beaumont, Danielle, additional, Benyahia, Myriam, additional, Brooks, Imogen, additional, Cargill, Madeleine, additional, Carrington, Laura, additional, Frimley, Lauren, additional, Geer, Amber, additional, Gilbert, Daniel, additional, Gilliam, Catherine, additional, Gil Onandia, Julio, additional, Golfi, Nayia, additional, Hetherington, Daniel, additional, Howe, Courtenay, additional, Hughes, Carolyn, additional, I'anson, David, additional, Jackson, Rob, additional, Joshi, Miland, additional, Kansagra, Sneha, additional, Kawahara, Taemi, additional, Kostrov, Sergey, additional, Miah, Hakim, additional, Ndungu, Bernard, additional, Needham, Kelly, additional, Outtandy, Aroudra, additional, Pearson, Daniel, additional, Pepple, Tracey, additional, Prowse, Danielle, additional, Quashi, Nigel, additional, Quinn, Anna, additional, Ramos, Maria, additional, Ranopa, Laura, additional, Reid, Mia, additional, Roukas, Chris, additional, Squires, Chelci, additional, Tanner, Jemma, additional, Thayne, Andrew, additional, Uddin, Ruhama, additional, Fawole, Bukola, additional, Bello, Folasade Adenike, additional, Olayemi, Oladapo, additional, Okunade, Olujide, additional, Adetayo, Olusade, additional, Khamis, Hussein, additional, Shukri Bin Jahit, Mohammad, additional, Gogichaishvili, Tamar, additional, Mateescu, Radu Bogdan, additional, Adhikaree, Ajay, additional, Abdo, Abdelmounem Eltayeib, additional, Zaher, Mohammad, additional, Deasy, Conor, additional, Alvarez Gregori, Joaquin, additional, Wellsh, Bobby, additional, Lawton, Luke, additional, Kamath, Raghavendra, additional, Barry, Adrian, additional, Carpio, Racquel, additional, Finney, Kay, additional, Maguire, Holly, additional, James, Martin, additional, Coffey, Frank, additional, Gough, Chris, additional, Sawers, Lisa, additional, Thi, Aye-Aye, additional, Burnett, Claire, additional, Jacques, Nicola, additional, Murray, Victoria, additional, Jarman, Heather, additional, Lambe, Christine, additional, Rounding, Sarah, additional, Tucker, Simon, additional, Al-Idari, Romaih, additional, Guest, Samuel, additional, Stoddard, Emma, additional, Yeo, David, additional, Bergin, Colin, additional, Hardy, Elaine, additional, Thunder, Joanne, additional, Jhalli, Paul, additional, Hartley, Edward, additional, Jarvis, Catherine, additional, Swann, Carly, additional, Reed, Matthew, additional, Gallagher, Bernadette, additional, Grahamslaw, Julia, additional, O'Brien, Rachel, additional, Harris, Timothy, additional, Bellhouse, Geoffrey, additional, Boulton, Olivia, additional, Skene, Imogen, additional, Stanley, Adrian, additional, Johnstone, Janet, additional, Maguire, Donogh, additional, Thornton, Susan, additional, Banks, Matthew, additional, Bercades, Georgia, additional, Marks, Daniel, additional, Ryu, Jung, additional, Dowty, Claire, additional, Pott, Jason, additional, East, James, additional, Bailey, Adam, additional, Beer, Sally, additional, Davies, Sian, additional, Appelboam, Andrew, additional, Mackle, Daisy, additional, Small, Jennifer, additional, Vorwerk, Christiane, additional, Atkins, Rachel, additional, Bradbury, Isobel, additional, Bryceland, Catriona, additional, McClelland, Lisa, additional, Thomas, Martin, additional, Clayton, Kate, additional, Michael, Angiy, additional, Haig, Stephen, additional, Al-Nahhas, Saif, additional, Godfrey, Tim, additional, Boger, Philip, additional, Comer, Rachel, additional, Watkins, Barbara, additional, Afolabi, Ola, additional, Afzal, Shazad, additional, Cowton, Amanda, additional, Everett, Simon, additional, Fazakerley, Ruth, additional, Onoviran, Felicia, additional, Snook, Jonathon, additional, Berry, Jackie, additional, Simpson, Diane, additional, Keep, Jeff, additional, Cotton, Hannah, additional, Helyar, Sinead, additional, Rutter, Matthew, additional, Johnston, Tracey, additional, O'Rourke, Laura, additional, Chan, Louisa, additional, Tambellini, Joanna, additional, Trodd, Dawn, additional, Shutt, James, additional, Moreton, Sarah, additional, Oglesby, Abby, additional, Boyle, Adrian, additional, Haeger, Nicola, additional, Hardwick, Susie, additional, Kendall, Jason, additional, Faulkner, Beverley, additional, Worner, Ruth, additional, Hearnshaw, Sarah, additional, Doona, Mary, additional, Price, Maria, additional, Hunter, Laura, additional, Bell, Maggie, additional, Loureiro, Vania, additional, Kehoe, Anthony, additional, Jefferey, Alison, additional, Squire, Rosalyn, additional, Hartin, David, additional, Bell, Stephanie, additional, Newman, Alexandra, additional, Gagg, James, additional, Foot, Jayne, additional, Wakeford, Sue, additional, May, Gabrielle, additional, Bartram, Thomas, additional, Cumpstay, Paul, additional, Parker, Lucy, additional, Das, Rita, additional, Pahary, Sheik, additional, Wright, Gavin, additional, Butt, Georgina, additional, Christmas, Natasha, additional, Wilson, Sarah, additional, Ashfaq, Mohammed, additional, Chandler, Louise, additional, Demetriou, Carrie, additional, Kaye, Philip, additional, Carley, Simon, additional, Brown, Andrew, additional, Jones, Lucy, additional, Whileman, Amanda, additional, Greenaway, John, additional, Tregonning, Julie, additional, Kuhrt, Avril, additional, Goodacre, Steve, additional, Jones, John, additional, Owen, Charlotte, additional, Mitra, Anu, additional, Harper-Payne, Abby, additional, Trudgill, Nigel, additional, Hayes, Anne, additional, Butt, Faheem, additional, Clifford, Gayle, additional, Kinnon, Andrew, additional, Fowler, Susan, additional, Pillay, Kris, additional, Gidwani, Shweta, additional, McNair, Alistair, additional, Omer, Omer, additional, de Weymarn, Tanya, additional, Amin, Adnan, additional, Martin, Jane, additional, Mathieu, Nick, additional, Barnes, Simon, additional, Turvill, James, additional, Sweeting, Helen, additional, Draegebo, Morten, additional, McNaught, Marion, additional, Grocutt, Mandy, additional, Margalef, Jordi, additional, Humphrey, Julian, additional, Jackson, Richard, additional, Bellis, Fionn, additional, Hunt, Jane, additional, Stevenson, Alastair, additional, Watson, Nicholas, additional, Barden, Steven, additional, Paterson, Stuart, additional, Macdonald, Chris, additional, Hobday, David, additional, Orugun, Olu, additional, Allison, Andrew, additional, Dyer, Tristan, additional, McBride, Samuel, additional, Sawicki, Wojciech, additional, Rayner, Ben, additional, Flowerdew, Lynsey, additional, Barbour, Jamie, additional, Klein, Jason, additional, Hood, Stephen, additional, Palmer, Nicola, additional, de Wolff, Jacob, additional, Shenoy, Achuth, additional, Swallow, Peter, additional, Srirajaskanthan, Rajaventhan, additional, Arshad, Hamza, additional, Aslam, Naeem, additional, Bangash, Anam, additional, Qamar, Muhammad, additional, Zahoor, Haroon, additional, Arshad, Saba, additional, ain Ghalib, Quratul, additional, Hameed, Tehseen, additional, Saif, Tayyaba, additional, Shafi, Wajahat, additional, Ali, Abid, additional, Khan, Shehroze, additional, Muaaz, Muhammad, additional, Taj, Ahmad, additional, Ghafoor, Aamir, additional, Afridi, Aamir, additional, Ahmad, Mansoor, additional, Aslam, Mujahid, additional, Kumar, Sandeep, additional, Ali, Mohsin, additional, Bughio, Ubedullah, additional, Chang, Adil, additional, Shaikh, Sana, additional, Ahmad, Syed, additional, Ali, Zeeshan, additional, Waqar, Marium, additional, Mushir, Aiman, additional, Sattar, Sadaf, additional, Goraya, Saifullah, additional, Aslam, Sharmeen, additional, Fatima, Nighat, additional, Noreen, Saadia, additional, Saleem, Sheraz, additional, Rahman, Fazal, additional, Iqbal, Nadeem, additional, Khalid, Mohammad, additional, Riaz, Umar, additional, Umar, Muhammad, additional, Akhter, Tayyab, additional, Khan, Javaria, additional, Misbah, Noureen, additional, Afzal, Muhammad, additional, Kayani, Mobeen, additional, Shah, Syed, additional, Tarar, Shahida, additional, Khan, Sherbat, additional, Iqbal, Yasir, additional, Khan, Essa, additional, Reki, Maqbool, additional, Hussain, Tanveer, additional, Iqbal, Shafqat, additional, Khurram, Muhammad, additional, Shafi, Muhammad, additional, Shaikh, Abrar, additional, Ahmed, Aijaz, additional, Kumar, Ameet, additional, Sachdev, Pinkey, additional, Nasir, Khalid Mahmood, additional, Chaudhry, Zafar Iqbal, additional, Zubair, Muhammad, additional, Tayyab, Ghias, additional, Mushtaq, Junaid, additional, Nasir, Muhammad, additional, Khan, Amir, additional, Ali, Amjad, additional, Ali, Sajjad, additional, Uddin, Wasim, additional, Ahmed, Sohaib, additional, Kazmi, Tazaeen, additional, Channa, Saleh, additional, Aman, Adeeqa, additional, Shaikh, Mouzam, additional, Rizvi, Tahir, additional, Hussain, Amjad, additional, Baqai, Haider Zaigham, additional, Rasheed, Zakawat, additional, Khan, Abdus, additional, Irfan, Adeela, additional, Husain, Aamir, additional, Aslam, Asifa, additional, Yahya, Khalid, additional, Azhar, Salman, additional, Ul Haq, Mansoor, additional, Afzal, Adeel, additional, Imran, Muhammad, additional, Saeed, Iram, additional, Yusuf, Aasim, additional, Hassan, Mariam, additional, Marwat, Mumtaz, additional, Ishfaq, Muhammad, additional, Bashir, Tahir, additional, Kumar, Santosh, additional, Yaqoob, Sajjad, additional, Wahid, Abdul, additional, Fakoya, Tinuola, additional, Oke, Temitope, additional, Tejan, Edries, additional, Olaomi, Oluwole, additional, Badejo, Olawale, additional, Nnaemaka, Okafor, additional, Ukwu, Nancy, additional, Arowolo, Olukayode, additional, Aderounmu, Adewale, additional, Wuraola, Funmilola, additional, Ugiagbe, Rose, additional, Atiri, Alexander, additional, Eghaghe, Enadeghe, additional, Adekoya, Adeleke, additional, Tade, Adedayo Oluyomi, additional, Shonoiki, Olatunji, additional, Olatoke, Samuel, additional, Raji, Toafiq, additional, Ekwunife, Christopher, additional, Onyekpere, Chigozirim, additional, Ahmed, Adamu, additional, Muhammad, Daniyan, additional, Odeghe, Emuobor, additional, Lesi, Olufunmilayo, additional, Osueni, Azeberoje, additional, Samaila, Adamu, additional, Nahuche, Aminu, additional, Ajayi, Akande, additional, Dongo, Andrew, additional, Ijoma, Uchenna, additional, Adebanjo, Ademola Tolulope, additional, Igetei, Rufina, additional, Yilkudi, Monday, additional, Osisanya, Kehinde, additional, Okeke, Edith Nonyelum, additional, Enwere, Oguamanam Okezie, additional, Esmat, Serag, additional, Ashoush, Omar, additional, Naga, Mazen, additional, Nagy, Fady, additional, Saiid, Mostafa, additional, Shaker, Ahmed, additional, Helmy, Ashraf, additional, Saafan, Saafan, additional, Abdel Monem, Mohammed, additional, Din, Jiffre, additional, Azis, Khairul, additional, Brukan, Muhyuddin, additional, Singh, Sanjay, additional, Zakaria, Andee, additional, Farid, Shaik, additional, Hashim, Nizam, additional, Mafauzy, Masykurin, additional, Najmi, Wan, additional, Amri, Nil, additional, Yi, Xin, additional, Hisyam, Mohammad, additional, Ng, Elaine, additional, Ramli, Zuhrirahimi, additional, Yee Lim, Shyang, additional, Voon, Kelvin, additional, Young Yam, Sir, additional, Jahit, Mohammad, additional, Joon, Lee, additional, Melikidze, Besik, additional, Kazaishvili, Davit, additional, Grubelashvili, Nino, additional, Mosidze, Baadur, additional, Tomadze, Gia, additional, Megreladze, Avto, additional, Oprita, Ruxandra, additional, Pestroiu Calescu, Dorina, additional, Chioncel, Camelia, additional, Ragea, Andrei, additional, Mateescu, Bogdan, additional, Busuioc, Bogdan, additional, Voiosu, Andrei, additional, Cotirlet, Adrian, additional, Pintilie, Iulia, additional, Jinga, Mariana, additional, Balaban, Daniel, additional, Tanău, Marcel, additional, Negreanu, Lucian, additional, Bataga, Simona, additional, Priya, Khushboo, additional, Baral, Shankar, additional, K.C., Anuj, additional, Sah, Vijay, additional, Yadav, Vijay, additional, Abdo, Abdelmounem, additional, Ahmed, Dalia, additional, Al Anazi, Marzouqah, additional, Al Balkhi, Areej, additional, Álvarez Gregori, Joaquín, additional, Fornieles Pérez, Helio, additional, and Beqiri, Arben, additional

Published
2020
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28. Additional file 1 of Tranexamic acid for acute gastrointestinal bleeding (the HALT-IT trial): statistical analysis plan for an international, randomised, double-blind, placebo-controlled trial

Author

Brenner, Amy, Adefemi Afolabi, Ahmad, Syed, Arribas, Monica, Rizwana Chaudhri, Coats, Timothy, Cuzick, Jack, Gilmore, Ian, Hawkey, Christopher, Jairath, Vipul, Javaid, Kiran, Aasia Kayani, Muttiullah Mutti, Nadeem, Muhammad, Shakur-Still, Haleema, Stanworth, Simon, Veitch, Andrew, and Roberts, Ian

Abstract

Figure S1 Trial profile. Figure S2 Cumulative percentage of death due to bleeding in the tranexamic acid and placebo groups. Figure S3 Distribution of cause of death by days since randomisation. Table S1 Baseline characteristics of participants prior to randomisation. Table S2 Death due to bleeding and rebleeding. Table S3 Other causes of death and all-cause mortality. Table S4 Death due to bleeding by subgroups. Table S5 Need for surgical, endoscopic and radiological interventions and blood transfusion. Table S6 Thromboembolic events, complications and self-care capacity. Table S7 Adverse events. (DOC 355 kb)

Published
2019
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29. Tranexamic acid for significant traumatic brain injury (The CRASH-3 trial): Statistical analysis plan for an international, randomised, double-blind, placebo-controlled trial

Author

Roberts, Ian, Belli, Antonio, Brenner, Amy, Chaudhri, Rizwana, Fawole, Bukola, Harris, Tim, Jooma, Rashid, Mahmood, Abda, Shokunbi, Temitayo, Shakur, Haleema, and CRASH-3 trial collaborators

Abstract

Background: Worldwide, traumatic brain injury (TBI) kills or hospitalises over 10 million people each year. Early intracranial bleeding is common after TBI, increasing the risk of death and disability. Tranexamic acid reduces blood loss in surgery and death due to bleeding in trauma patients with extra-cranial injury. Early administration of tranexamic acid in TBI patients might limit intracranial bleeding, reducing death and disability. The CRASH-3 trial aims to provide evidence on the effect of tranexamic acid on death and disability in TBI patients. We will randomly allocate about 13,000 TBI patients (approximately 10,000 within 3 hours of injury) to an intravenous infusion of tranexamic acid or matching placebo in addition to usual care. This paper presents a protocol update (version 2.1) and statistical analysis plan for the CRASH-3 trial. Results: The primary outcome is head injury death in hospital within 28 days of injury for patients treated within 3 hours of injury (deaths in patients treated after 3 hours will also be reported). Because there are reasons to expect that tranexamic acid will be most effective in patients treated immediately after injury and less effective with increasing delay, the effect in patients treated within one hour of injury is of particular interest. Secondary outcomes are all-cause and cause-specific mortality, vascular occlusive events, disability based on the Disability Rating Scale and measures suggested by patient representatives, seizures, neurosurgical intervention, neurosurgical blood loss, days in intensive care and adverse events. Sub-group analyses will examine the effect of tranexamic acid on head injury death stratified by time to treatment, severity of TBI and baseline risk. Conclusion: The CRASH-3 trial will provide reliable evidence of the effectiveness and safety of tranexamic acid in patients with acute TBI. Registration: International Standard Randomised Controlled Trials registry ( ISRCTN15088122) 19/07/2011, and ClinicalTrials.gov ( NCT01402882) 25/07/2011.

Published
2018

31. Tranexamic acid for acute gastrointestinal bleeding (The HALT-IT trial): Statistical analysis plan for an international, randomised, double blind, placebo-controlled trial

Author

Brenner, Amy Charlotte, primary, Afolabi, Adefemi, additional, Ahmad, Syed Masroor, additional, Arribas, Monica, additional, Chaudhri, Rizwana, additional, Coats, Timothy, additional, Cuzick, Jack, additional, Gilmore, Ian, additional, Hawkey, Christopher, additional, Jairath, Vipul, additional, Javaid, Kiran, additional, Kayani, Aasia, additional, Mutti, Muttiullah, additional, Nadeem, Muhammad Arif, additional, Shakur-Still, Haleema, additional, Stanworth, Simon, additional, Veitch, Andrew, additional, and Roberts, Ian, additional

Published
2019
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32. Development of a patient reported outcome questionnaire to measure the impact of postpartum blood loss in women with moderate and severe anaemia: A study using a multi-faceted approach

Author

Miller, Lori, primary, Chaudhri, Shahana, additional, Beaumont, Danielle, additional, Kayani, Aasia, additional, Javid, Kiran, additional, Chaudhri, Rizwana, additional, Edwards, Phil, additional, Brenner, Amy, additional, Roberts, Ian, additional, and Shakur-Still, Haleema, additional

Published
2019
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33. The clinical effectiveness of different surveillance strategies to prevent colorectal cancer in people with intermediate-grade colorectal adenomas: a retrospective cohort analysis, and psychological and economic evaluations

Author

Atkin, Wendy, primary, Brenner, Amy, additional, Martin, Jessica, additional, Wooldrage, Katherine, additional, Shah, Urvi, additional, Lucas, Fiona, additional, Greliak, Paul, additional, Pack, Kevin, additional, Kralj-Hans, Ines, additional, Thomson, Ann, additional, Perera, Sajith, additional, Wood, Jill, additional, Miles, Anne, additional, Wardle, Jane, additional, Kearns, Benjamin, additional, Tappenden, Paul, additional, Myles, Jonathan, additional, Veitch, Andrew, additional, and Duffy, Stephen W, additional

Published
2017
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35. Mo1981 Sensitivity of Annual Faecal Immunochemical Tests for Haemoglobin (FIT) for Detecting Advanced Neoplasia in Patients Undergoing Three-Yearly Surveillance Colonoscopy - The FIT for Follow-Up Study

Author

MacRae, Eilidh, primary, Howe, Rosemary, additional, Brenner, Amy, additional, Pearson, Sheena, additional, Piggott, Carolyn J., additional, von Wagner, Christian, additional, Wardle, Jane, additional, Halloran, Stephen P., additional, and Atkin, Wendy, additional

Published
2015
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42. Understanding the neuroprotective effect of tranexamic acid: an exploratory analysis of the CRASH-3 randomised trial.

Author

Brenner, Amy, Belli, Antonio, Chaudhri, Rizwana, Coats, Timothy, Frimley, Lauren, Jamaluddin, Sabariah Faizah, Jooma, Rashid, Mansukhani, Raoul, Sandercock, Peter, Shakur-Still, Haleema, Shokunbi, Temitayo, Roberts, Ian, On behalf of the CRASH-3 trial collaborators, Aeron-Thomas, Amy, Chaudary, Muhammad Anwar, Jamaluddin, Sabariah Faizah Bt, Javaid, Kiran, Kayani, Aasia, Leech, Caroline, and Mahmood, Khalid

Abstract

Background: The CRASH-3 trial hypothesised that timely tranexamic acid (TXA) treatment might reduce deaths from intracranial bleeding after traumatic brain injury (TBI). To explore the mechanism of action of TXA in TBI, we examined the timing of its effect on death.Methods: The CRASH-3 trial randomised 9202 patients within 3 h of injury with a GCS score ≤ 12 or intracranial bleeding on CT scan and no significant extracranial bleeding to receive TXA or placebo. We conducted an exploratory analysis of the effects of TXA on all-cause mortality within 24 h of injury and within 28 days, excluding patients with a GCS score of 3 or bilateral unreactive pupils, stratified by severity and country income. We pool data from the CRASH-2 and CRASH-3 trials in a one-step fixed effects individual patient data meta-analysis.Results: There were 7637 patients for analysis after excluding patients with a GCS score of 3 or bilateral unreactive pupils. Of 1112 deaths, 23.3% were within 24 h of injury (early deaths). The risk of early death was reduced with TXA (112 (2.9%) TXA group vs 147 (3.9%) placebo group; risk ratio [RR] RR 0.74, 95% CI 0.58-0.94). There was no evidence of heterogeneity by severity (p = 0.64) or country income (p = 0.68). The risk of death beyond 24 h of injury was similar in the TXA and placebo groups (432 (11.5%) TXA group vs 421 (11.7%) placebo group; RR 0.98, 95% CI 0.69-1.12). The risk of death at 28 days was 14.0% in the TXA group versus 15.1% in the placebo group (544 vs 568 events; RR 0.93, 95% CI 0.83-1.03). When the CRASH-2 and CRASH-3 trial data were pooled, TXA reduced early death (RR 0.78, 95% CI 0.70-0.87) and death within 28 days (RR 0.88, 95% CI 0.82-0.94).Conclusions: Tranexamic acid reduces early deaths in non-moribund TBI patients regardless of TBI severity or country income. The effect of tranexamic acid in patients with isolated TBI is similar to that in polytrauma. Treatment is safe and even severely injured patients appear to benefit when treated soon after injury.Trial Registration: ISRCTN15088122 , registered on 19 July 2011; NCT01402882 , registered on 26 July 2011. [ABSTRACT FROM AUTHOR]

Published
2020
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45. Public

Author

Ritchie, Christina, Sheridan, Sarah Robayo, Wren, Jacob, Agamben, Giorgio, Aqpik, James, Benzaquén, Adriana S., Brenner, Amy, Carver, Lisa, Dionne, Caroline, Duke, Emily Vey, Eyland, Cliff, Fannin, Nops, Graham, Dan, Hadzihasanovic, Sadko, Kibbins, Gary, Morrison, Alex, Olson, Daniel, Peretti, Jonah H., Thomas, Chantal, Von Zwehl, Bettina, Zwehl, Bettina von, Ritchie, Christina, Sheridan, Sarah Robayo, Wren, Jacob, Agamben, Giorgio, Aqpik, James, Benzaquén, Adriana S., Brenner, Amy, Carver, Lisa, Dionne, Caroline, Duke, Emily Vey, Eyland, Cliff, Fannin, Nops, Graham, Dan, Hadzihasanovic, Sadko, Kibbins, Gary, Morrison, Alex, Olson, Daniel, Peretti, Jonah H., Thomas, Chantal, Von Zwehl, Bettina, and Zwehl, Bettina von

Abstract

Childhood is evoked and examined from a variety of perspectives and with a variety of means in this issue of Public. Children’s drawings, artist’s projects, poetry, memoirs, interviews, and academic essays all contribute to a complex survey of the issues facing everyone who has, is, or was a child. Biographical notes on contributors. List of illustrations. 15 bibl. ref.

46. Public

Author

Ritchie, Christina, Sheridan, Sarah Robayo, Wren, Jacob, Agamben, Giorgio, Aqpik, James, Benzaquén, Adriana S., Brenner, Amy, Carver, Lisa, Dionne, Caroline, Duke, Emily Vey, Eyland, Cliff, Fannin, Nops, Graham, Dan, Hadzihasanovic, Sadko, Kibbins, Gary, Morrison, Alex, Olson, Daniel, Peretti, Jonah H., Thomas, Chantal, Von Zwehl, Bettina, Zwehl, Bettina von, Ritchie, Christina, Sheridan, Sarah Robayo, Wren, Jacob, Agamben, Giorgio, Aqpik, James, Benzaquén, Adriana S., Brenner, Amy, Carver, Lisa, Dionne, Caroline, Duke, Emily Vey, Eyland, Cliff, Fannin, Nops, Graham, Dan, Hadzihasanovic, Sadko, Kibbins, Gary, Morrison, Alex, Olson, Daniel, Peretti, Jonah H., Thomas, Chantal, Von Zwehl, Bettina, and Zwehl, Bettina von

Abstract

Childhood is evoked and examined from a variety of perspectives and with a variety of means in this issue of Public. Children’s drawings, artist’s projects, poetry, memoirs, interviews, and academic essays all contribute to a complex survey of the issues facing everyone who has, is, or was a child. Biographical notes on contributors. List of illustrations. 15 bibl. ref.

47. Public

Author

Ritchie, Christina, Sheridan, Sarah Robayo, Wren, Jacob, Agamben, Giorgio, Aqpik, James, Benzaquén, Adriana S., Brenner, Amy, Carver, Lisa, Dionne, Caroline, Duke, Emily Vey, Eyland, Cliff, Fannin, Nops, Graham, Dan, Hadzihasanovic, Sadko, Kibbins, Gary, Morrison, Alex, Olson, Daniel, Peretti, Jonah H., Thomas, Chantal, Von Zwehl, Bettina, Zwehl, Bettina von, Ritchie, Christina, Sheridan, Sarah Robayo, Wren, Jacob, Agamben, Giorgio, Aqpik, James, Benzaquén, Adriana S., Brenner, Amy, Carver, Lisa, Dionne, Caroline, Duke, Emily Vey, Eyland, Cliff, Fannin, Nops, Graham, Dan, Hadzihasanovic, Sadko, Kibbins, Gary, Morrison, Alex, Olson, Daniel, Peretti, Jonah H., Thomas, Chantal, Von Zwehl, Bettina, and Zwehl, Bettina von

Abstract

Childhood is evoked and examined from a variety of perspectives and with a variety of means in this issue of Public. Children’s drawings, artist’s projects, poetry, memoirs, interviews, and academic essays all contribute to a complex survey of the issues facing everyone who has, is, or was a child. Biographical notes on contributors. List of illustrations. 15 bibl. ref.

49. Effect of early tranexamic acid treatment on fatigue in patients with mild traumatic brain injury: data from the CRASH-3 clinical trial.

Author

Mansukhani R, Belli A, Brenner A, Chaudhri R, Frimley L, Faizah Jamaluddin S, Jooma R, Shakur-Still H, Shokunbi T, and Roberts I

Abstract

Background: Each year world-wide about 65 million people sustain a mild traumatic brain injury (mTBI). Fatigue is a common and distressing symptom after mTBI. We examine the effect of tranexamic acid (TXA) on fatigue in patients with mTBI using data from the CRASH-3 trial., Methods: The CRASH-3 trial randomised 9,202 patients with traumatic brain injury and no significant extracranial bleeding to receive TXA or placebo within 3 hours of injury. The primary outcome was death from head injury within 28 days of injury. The methods and results are presented elsewhere. Fatigue was recorded as "None", "Moderate" or "Extreme." This study examines the effect of TXA on extreme fatigue in the 2,632 patients with mTBI (Glasgow Coma Scale [GCS] score≥13). Our analyses were not prespecified., Results: Our study primary outcome, extreme fatigue, was reported for 10 (0.8%) of 1,328 patients receiving TXA and 19 (1.5%) of 1,288 patients receiving placebo (risk ratio [RR]=0.51, 95% confidence interval [CI] 0.24-1.09). Death within 28 days of injury was reported for 34 (2.6%) of 1,328 patients receiving TXA versus 47 (3.6%) of 1,288 patients receiving placebo (RR=0.70, 95% CI 0.45-1.08). Among patients allocated to TXA, 44 (3.3%) patients either died or reported extreme fatigue versus 66 (5.1%) patients among those allocated to placebo (RR=0.65, 95% CI 0.44-0.94). This composite outcome is disproportionately influenced by deaths which account for 74% (81 from 110) of events., Conclusions: We found no evidence that tranexamic acid reduces fatigue in patients with mTBI. Given, 1) our analyses were not prespecified, 2) our outcome measure is not based on a validated fatigue severity scale, and 3) TBI patients can suffer from hospital-induced delirium, which hinders clinician assessment, these results need to be replicated in another study., Registration: ISRCTN (ISRCTN15088122, 19/07/2011), ClinicalTrials.gov (NCT01402882, 26/07/2011), EudraCT (2011-003669-14, 25/07/2011), Pan African Clinical Trial Registry (PACTR20121000441277, 30/10/2012)., Competing Interests: No competing interests were disclosed., (Copyright: © 2024 Mansukhani R et al.)

Published
2024
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50. Tranexamic acid for the prevention of postpartum bleeding: Protocol for a systematic review and individual patient data meta-analysis.

Author

Ker K, Shakur-Still H, Sentilhes L, Pacheco LD, Saade G, Deneux-Tharaux C, Brenner A, Mansukhani R, Ageron FX, Prowse D, Chaudhri R, Olayemi O, and Roberts I

Abstract

Background: Tranexamic acid (TXA) reduces the risk of death and is recommended as a treatment for women with severe postpartum bleeding. There is hope that giving TXA shortly before or immediately after birth could prevent postpartum bleeding. Extending the use of TXA to prevent harmful postpartum bleeding could improve outcomes for millions of women; however we must carefully consider the balance of benefits and potential harms. This article describes the protocol for a systematic review and individual patient data (IPD) meta-analysis to assess the effectiveness and safety of TXA for preventing postpartum bleeding in all women giving birth, and to explore how the effects vary by underlying risk and other patient characteristics.   Methods: We will search for prospectively registered, randomised controlled trials involving 500 patients or more assessing the effects of TXA in women giving birth. Two authors will extract data and assess risk of bias. IPD data will be sought from eligible trials. Primary outcomes will be life-threatening bleeding and thromboembolic events. We will use a one-stage model to analyse the data. Subgroup analyses will be conducted to explore whether the effectiveness and safety of TXA varies by underlying risk, type birth, maternal haemoglobin (Hb), and timing of TXA. This protocol is registered on PROSPERO (CRD42022345775).  Conclusions: This systematic review and IPD meta-analysis will address important clinical questions about the effectiveness and safety of the use of TXA for the prevention of postpartum bleeding that cannot be answered reliably using aggregate data and will inform the decision of who to treat.   PROSPERO registration: CRD42022345775  Keywords   Anti-fibrinolytics; Tranexamic acid; childbirth; postpartum haemorrhage; meta-analysis., Competing Interests: Competing interests: LS reports receiving lecture and consulting fees from Ferring. No competing interests were disclosed for any other author., (Copyright: © 2023 The Anti-fibrinolytics Trialists Collaborators – Obstetric Trialists Group et al.)

Published
2023
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