Intravenous tranexamic acid for hyperacute primary intracerebral hemorrhage: protocol for a randomized, placebo-controlled trial
Rationale: Outcome after intracerebral hemorrhage remains poor. Tranexamic acid is easy to administer, readily available, inexpensive, and effective in other hemorrhagic conditions. Aim: This randomized trial aims to test the hypothesis that intravenous tranexamic acid given within 8 h of spontan...
| Main Authors: | , , , , , , , , , , , , , , , , , , , , , , , |
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| Format: | Article |
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SAGE
2016
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| Online Access: | https://eprints.nottingham.ac.uk/35724/ |
| _version_ | 1848795147403264000 |
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| author | Sprigg, Nikola Robson, Katie Bath, Philip M.W. Dineen, Robert A. Roberts, Ian Robinson, Tom Roffe, Christine Werring, David Al-Shahi Salman, Rustam Pocock, Stuart J. Duley, Lelia England, Timothy J. Whynes, David Ciccone, Alfonso Laska, Ann Charlotte Christensen, Hanne Ozturk, Serefnur Collins, Ronan Bereczki, Daniel Egea-Guerrero, Juan Jose Law, Zhe Kang Czlonkowska, Anna Seiffge, David Beredzie, Maia |
| author_facet | Sprigg, Nikola Robson, Katie Bath, Philip M.W. Dineen, Robert A. Roberts, Ian Robinson, Tom Roffe, Christine Werring, David Al-Shahi Salman, Rustam Pocock, Stuart J. Duley, Lelia England, Timothy J. Whynes, David Ciccone, Alfonso Laska, Ann Charlotte Christensen, Hanne Ozturk, Serefnur Collins, Ronan Bereczki, Daniel Egea-Guerrero, Juan Jose Law, Zhe Kang Czlonkowska, Anna Seiffge, David Beredzie, Maia |
| author_sort | Sprigg, Nikola |
| building | Nottingham Research Data Repository |
| collection | Online Access |
| description | Rationale: Outcome after intracerebral hemorrhage remains poor. Tranexamic acid is easy to administer, readily available, inexpensive, and effective in other hemorrhagic conditions.
Aim: This randomized trial aims to test the hypothesis that intravenous tranexamic acid given within 8 h of spontaneous intracerebral hemorrhage reduces death or dependency.
Design: Phase III prospective double-blind randomized placebo-controlled trial. Participants within 8 h of spontaneous intracerebral hemorrhage are randomized to receive either intravenous tranexamic acid 1 g 10 min bolus followed by 1 g 8 h infusion, or placebo.
Sample size estimates: A trial of 2000 participants (300 from start-up phase and 1700 from main phase) will have 90% power to detect an ordinal shift of the modified Rankin Scale with odds ratio 0.79.
Study outcomes: The primary outcome is death or dependency measured by ordinal shift analysis of the 7 level mRS at day 90. Secondary outcomes are neurological impairment at day 7 and disability, quality of life, cognition, and mood at day 90. Safety outcomes are death, serious adverse events, thromboembolic events, and seizures. Cost outcomes are length of stay in hospital, readmission, and institutionalization.
Discussion: This pragmatic trial is assessing efficacy of tranexamic acid after spontaneous intracerebral hemorrhage. Recruitment started in 2013; as of 15th January 2016 1355 participants have been enrolled, from 95 centers in seven countries. Recruitment is due to end in 2017. TICH-2 Trial is registered as ISRCTN93732214. |
| first_indexed | 2025-11-14T19:27:28Z |
| format | Article |
| id | nottingham-35724 |
| institution | University of Nottingham Malaysia Campus |
| institution_category | Local University |
| last_indexed | 2025-11-14T19:27:28Z |
| publishDate | 2016 |
| publisher | SAGE |
| recordtype | eprints |
| repository_type | Digital Repository |
| spelling | nottingham-357242020-05-04T20:01:49Z https://eprints.nottingham.ac.uk/35724/ Intravenous tranexamic acid for hyperacute primary intracerebral hemorrhage: protocol for a randomized, placebo-controlled trial Sprigg, Nikola Robson, Katie Bath, Philip M.W. Dineen, Robert A. Roberts, Ian Robinson, Tom Roffe, Christine Werring, David Al-Shahi Salman, Rustam Pocock, Stuart J. Duley, Lelia England, Timothy J. Whynes, David Ciccone, Alfonso Laska, Ann Charlotte Christensen, Hanne Ozturk, Serefnur Collins, Ronan Bereczki, Daniel Egea-Guerrero, Juan Jose Law, Zhe Kang Czlonkowska, Anna Seiffge, David Beredzie, Maia Rationale: Outcome after intracerebral hemorrhage remains poor. Tranexamic acid is easy to administer, readily available, inexpensive, and effective in other hemorrhagic conditions. Aim: This randomized trial aims to test the hypothesis that intravenous tranexamic acid given within 8 h of spontaneous intracerebral hemorrhage reduces death or dependency. Design: Phase III prospective double-blind randomized placebo-controlled trial. Participants within 8 h of spontaneous intracerebral hemorrhage are randomized to receive either intravenous tranexamic acid 1 g 10 min bolus followed by 1 g 8 h infusion, or placebo. Sample size estimates: A trial of 2000 participants (300 from start-up phase and 1700 from main phase) will have 90% power to detect an ordinal shift of the modified Rankin Scale with odds ratio 0.79. Study outcomes: The primary outcome is death or dependency measured by ordinal shift analysis of the 7 level mRS at day 90. Secondary outcomes are neurological impairment at day 7 and disability, quality of life, cognition, and mood at day 90. Safety outcomes are death, serious adverse events, thromboembolic events, and seizures. Cost outcomes are length of stay in hospital, readmission, and institutionalization. Discussion: This pragmatic trial is assessing efficacy of tranexamic acid after spontaneous intracerebral hemorrhage. Recruitment started in 2013; as of 15th January 2016 1355 participants have been enrolled, from 95 centers in seven countries. Recruitment is due to end in 2017. TICH-2 Trial is registered as ISRCTN93732214. SAGE 2016-08 Article PeerReviewed Sprigg, Nikola, Robson, Katie, Bath, Philip M.W., Dineen, Robert A., Roberts, Ian, Robinson, Tom, Roffe, Christine, Werring, David, Al-Shahi Salman, Rustam, Pocock, Stuart J., Duley, Lelia, England, Timothy J., Whynes, David, Ciccone, Alfonso, Laska, Ann Charlotte, Christensen, Hanne, Ozturk, Serefnur, Collins, Ronan, Bereczki, Daniel, Egea-Guerrero, Juan Jose, Law, Zhe Kang, Czlonkowska, Anna, Seiffge, David and Beredzie, Maia (2016) Intravenous tranexamic acid for hyperacute primary intracerebral hemorrhage: protocol for a randomized, placebo-controlled trial. International Journal of Stroke, 11 (6). pp. 683-694. ISSN 1747-4949 Hyperacute intracerebral hemorrhage tranexamic acid randomized trial placebo controlled http://wso.sagepub.com/content/11/6/683.1 doi:10.1177/1747493016641960 doi:10.1177/1747493016641960 |
| spellingShingle | Hyperacute intracerebral hemorrhage tranexamic acid randomized trial placebo controlled Sprigg, Nikola Robson, Katie Bath, Philip M.W. Dineen, Robert A. Roberts, Ian Robinson, Tom Roffe, Christine Werring, David Al-Shahi Salman, Rustam Pocock, Stuart J. Duley, Lelia England, Timothy J. Whynes, David Ciccone, Alfonso Laska, Ann Charlotte Christensen, Hanne Ozturk, Serefnur Collins, Ronan Bereczki, Daniel Egea-Guerrero, Juan Jose Law, Zhe Kang Czlonkowska, Anna Seiffge, David Beredzie, Maia Intravenous tranexamic acid for hyperacute primary intracerebral hemorrhage: protocol for a randomized, placebo-controlled trial |
| title | Intravenous tranexamic acid for hyperacute primary intracerebral hemorrhage: protocol for a randomized, placebo-controlled trial |
| title_full | Intravenous tranexamic acid for hyperacute primary intracerebral hemorrhage: protocol for a randomized, placebo-controlled trial |
| title_fullStr | Intravenous tranexamic acid for hyperacute primary intracerebral hemorrhage: protocol for a randomized, placebo-controlled trial |
| title_full_unstemmed | Intravenous tranexamic acid for hyperacute primary intracerebral hemorrhage: protocol for a randomized, placebo-controlled trial |
| title_short | Intravenous tranexamic acid for hyperacute primary intracerebral hemorrhage: protocol for a randomized, placebo-controlled trial |
| title_sort | intravenous tranexamic acid for hyperacute primary intracerebral hemorrhage: protocol for a randomized, placebo-controlled trial |
| topic | Hyperacute intracerebral hemorrhage tranexamic acid randomized trial placebo controlled |
| url | https://eprints.nottingham.ac.uk/35724/ https://eprints.nottingham.ac.uk/35724/ https://eprints.nottingham.ac.uk/35724/ |