eprintid: 10172554 rev_number: 7 eprint_status: archive userid: 699 dir: disk0/10/17/25/54 datestamp: 2023-06-30 15:03:05 lastmod: 2023-06-30 15:03:05 status_changed: 2023-06-30 15:03:05 type: article metadata_visibility: show sword_depositor: 699 creators_name: Appleton, Jason Philip creators_name: Law, Zhe Kang creators_name: Woodhouse, Lisa Jane creators_name: Al-Shahi Salman, Rustam creators_name: Beridze, Maia creators_name: Christensen, Hanne creators_name: Dineen, Robert A creators_name: Guerrero, Juan José Egea creators_name: England, Timothy J creators_name: Karlinski, Michal creators_name: Krishnan, Kailash creators_name: Laska, Ann Charlotte creators_name: Lyrer, Philippe creators_name: Ozturk, Serefnur creators_name: Roffe, Christine creators_name: Roberts, Ian creators_name: Robinson, Thompson G creators_name: Scutt, Polly creators_name: Werring, David J creators_name: Bath, Philip M creators_name: Sprigg, Nikola title: Effects of blood pressure and tranexamic acid in spontaneous intracerebral haemorrhage: a secondary analysis of a large randomised controlled trial ispublished: pub divisions: UCL divisions: B02 divisions: C07 divisions: D07 divisions: F82 note: This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/. abstract: BACKGROUND: Tranexamic acid reduced haematoma expansion and early death, but did not improve functional outcome in the tranexamic acid for hyperacute spontaneous intracerebral haemorrhage-2 (TICH-2) trial. In a predefined subgroup, there was a statistically significant interaction between prerandomisation baseline systolic blood pressure (SBP) and the effect of tranexamic acid on functional outcome (p=0.019). METHODS: TICH-2 was an international prospective double-blind placebo-controlled randomised trial evaluating intravenous tranexamic acid in patients with acute spontaneous intracerebral haemorrhage (ICH). Prerandomisation baseline SBP was split into predefined ≤170 and >170 mm Hg groups. The primary outcome at day 90 was the modified Rankin Scale (mRS), a measure of dependency, analysed using ordinal logistic regression. Haematoma expansion was defined as an increase in haematoma volume of >33% or >6 mL from baseline to 24 hours. Data are OR or common OR (cOR) with 95% CIs, with significance at p<0.05. RESULTS: Of 2325 participants in TICH-2, 1152 had baseline SBP≤170 mm Hg and were older, had larger lobar haematomas and were randomised later than 1173 with baseline SBP>170 mm Hg. Tranexamic acid was associated with a favourable shift in mRS at day 90 in those with baseline SBP≤170 mm Hg (cOR 0.73, 95% CI 0.59 to 0.91, p=0.005), but not in those with baseline SBP>170 mm Hg (cOR 1.05, 95% CI 0.85 to 1.30, p=0.63). In those with baseline SBP≤170 mm Hg, tranexamic acid reduced haematoma expansion (OR 0.62, 95% CI 0.47 to 0.82, p=0.001), but not in those with baseline SBP>170 mm Hg (OR 1.02, 95% CI 0.77 to 1.35, p=0.90). CONCLUSIONS: Tranexamic acid was associated with improved clinical and radiological outcomes in ICH patients with baseline SBP≤170 mm Hg. Further research is needed to establish whether certain subgroups may benefit from tranexamic acid in acute ICH. TRIAL REGISTRATION NUMBER: ISRCTN93732214. date: 2023-04 date_type: published publisher: BMJ official_url: http://dx.doi.org/10.1136/bmjno-2023-000423 oa_status: green full_text_type: pub language: eng primo: open primo_central: open_green verified: verified_manual elements_id: 2030812 doi: 10.1136/bmjno-2023-000423 medium: Electronic-eCollection pii: bmjno-2023-000423 lyricists_name: Werring, David lyricists_id: DJWER24 actors_name: Flynn, Bernadette actors_id: BFFLY94 actors_role: owner full_text_status: public publication: BMJ Open Neurology volume: 5 number: 1 article_number: e000423 event_location: England issn: 2632-6140 citation: Appleton, Jason Philip; Law, Zhe Kang; Woodhouse, Lisa Jane; Al-Shahi Salman, Rustam; Beridze, Maia; Christensen, Hanne; Dineen, Robert A; ... Sprigg, Nikola; + view all <#> Appleton, Jason Philip; Law, Zhe Kang; Woodhouse, Lisa Jane; Al-Shahi Salman, Rustam; Beridze, Maia; Christensen, Hanne; Dineen, Robert A; Guerrero, Juan José Egea; England, Timothy J; Karlinski, Michal; Krishnan, Kailash; Laska, Ann Charlotte; Lyrer, Philippe; Ozturk, Serefnur; Roffe, Christine; Roberts, Ian; Robinson, Thompson G; Scutt, Polly; Werring, David J; Bath, Philip M; Sprigg, Nikola; - view fewer <#> (2023) Effects of blood pressure and tranexamic acid in spontaneous intracerebral haemorrhage: a secondary analysis of a large randomised controlled trial. BMJ Open Neurology , 5 (1) , Article e000423. 10.1136/bmjno-2023-000423 <https://doi.org/10.1136/bmjno-2023-000423>. Green open access document_url: https://discovery-pp.ucl.ac.uk/id/eprint/10172554/1/e000423.full.pdf