Ultra-early Tranexamic Acid After Subarachnoid Hemorrhage.

Summary

This is a multicenter, prospective, randomized, open-label trial with blinded endpoint (PROBE) assessment. Adult patients with the diagnosis of non-traumatic SAH, as proven by computed tomography (CT) within 24 hours after the onset of headache, will be randomly assigned to the treatment group or the control group. Patients in the treatment group will receive standard treatment with the addition of a bolus of TXA (1 g intravenously) immediately after randomization, followed by continuous infusion of 1 g per 8 hours until the start of aneurysm treatment, or a maximum of 24 hours after the start of medication. Patients in the control group will receive standard treatment without TXA. The primary outcome measure is favorable functional outcome, defined as a score of 0 to 3 on the modified Rankin Scale (mRS), at 6 months after SAH. Primary outcome will be determined by a trial nurse blinded for treatment allocation.

Timeline

Start

2012-07-16

Primary completion

2019-07-29

Completion

2020-11-01

Publications

• Results Germans MR, Post R, Coert BA, Rinkel GJ, Vandertop WP, Verbaan D. Ultra-early tranexamic acid after subarachnoid hemorrhage (ULTRA): study protocol for a randomized controlled trial. Trials. 2013 May 16;14:143. doi: 10.1186/1745-6215-14-143.
• Denneman N, Kamra T, Post R, Tjerkstra MA, Germans MR, Vergouwen MDI, Jellema K, Koot RW, Kruyt ND, Wolfs JFC, Nanda D, Van Der Pol B, Roks G, Reichman LJA, Brouwers PJAM, Kwa VIH, Bienfait HP, Boogaarts HD, Klijn CJ, van den Berg R, Coert BA, Horn J, Majoie CBLM, Rinkel GJE, Roos YBWEM, Vandertop WP, Verbaan D; ULTRA trial study group. Quality of life after tranexamic acid in subarachnoid hemorrhage: post-hoc analysis of the ULTRA trial. Qual Life Res. 2026 May 3;35(6):148. doi: 10.1007/s11136-026-04263-3.
• Denneman N, Post R, van Eekelen R, Tjerkstra MA, Kempeneers MA, Labib H, Germans MR, Vergouwen MDI, Jellema K, Koot RW, Kruyt ND, Wolfs JFC, Nanda D, Van Der Pol B, Roks G, De Beer F, Reichman LJA, Brouwers PJAM, Vincent HK 1st, Bienfait HP, Boogaarts HD, Klijn CJM, van den Berg R, Coert BA, Horn J, Majoie CBLM, Rinkel GJE, Roos YBWEM, Vandertop WP, Verbaan D; ULTRA trial study group. Cost-Effectiveness of Ultra-Early Tranexamic Acid as Add-On to Standard Care After Subarachnoid Hemorrhage (ULTRA Trial). Eur J Neurol. 2025 Aug;32(8):e70208. doi: 10.1111/ene.70208.
• Tjerkstra MA, Post R, Germans MR, Vergouwen MDI, Jellema K, Koot RW, Kruyt ND, Wolfs JFC, De Beer FC, Kieft HH, Nanda D, Van Der Pol B, Roks G, De Beer F, Reichman LJA, Brouwers PJAM, Kwa VIH, Van Der Ree TC, Bienfait HP, Boogaarts HD, Klijn CJ, Visser V, van den Berg R, Coert BA, Horn J, Majoie CBLM, Rinkel GJE, Roos YBWEM, Vandertop WP, Verbaan D; ULTRA trial study group. Ultra-Early and Short-Term Tranexamic Acid Treatment in Patients With Good- and Poor-Grade Aneurysmal Subarachnoid Hemorrhage. Neurology. 2024 Jun 25;102(12):e209169. doi: 10.1212/WNL.0000000000209169. Epub 2024 May 24.
• Vergouwen MD, Germans MR, Post R, Tjerkstra MA, Coert BA, Rinkel GJ, Peter Vandertop W, Verbaan D. Aneurysm treatment within 6 h versus 6-24 h after rupture in patients with subarachnoid hemorrhage. Eur Stroke J. 2023 Sep;8(3):802-807. doi: 10.1177/23969873231173273. Epub 2023 May 1.
• Tjerkstra MA, Post R, Germans MR, Vergouwen MDI, Jellema K, Koot RW, Kruyt ND, Willems PWA, Wolfs JFC, de Beer FC, Kieft H, Nanda D, van der Pol B, Roks G, de Beer F, Halkes PHA, Reichman LJA, Brouwers PJAM, Van den Berg-Vos RM, Kwa VIH, van der Ree TC, Bronner I, Bienfait HP, Boogaarts H, Klijn CJM, van den Berg R, Coert BA, Horn J, Majoie CBLM, Rinkel GJE, Roos YBWM, Vandertop WP, Verbaan D; ULTRA investigators. Tranexamic Acid After Aneurysmal Subarachnoid Hemorrhage: Post Hoc Analysis of the ULTRA Trial. Neurology. 2022 Dec 5;99(23):e2605-e2614. doi: 10.1212/WNL.0000000000201160.
• Post R, Germans MR, Tjerkstra MA, Vergouwen MDI, Jellema K, Koot RW, Kruyt ND, Willems PWA, Wolfs JFC, de Beer FC, Kieft H, Nanda D, van der Pol B, Roks G, de Beer F, Halkes PHA, Reichman LJA, Brouwers PJAM, van den Berg-Vos RM, Kwa VIH, van der Ree TC, Bronner I, van de Vlekkert J, Bienfait HP, Boogaarts HD, Klijn CJM, van den Berg R, Coert BA, Horn J, Majoie CBLM, Rinkel GJE, Roos YBWEM, Vandertop WP, Verbaan D; ULTRA Investigators. Ultra-early tranexamic acid after subarachnoid haemorrhage (ULTRA): a randomised controlled trial. Lancet. 2021 Jan 9;397(10269):112-118. doi: 10.1016/S0140-6736(20)32518-6. Epub 2020 Dec 23.
• Post R, Germans MR, Coert BA, Rinkel GJE, Vandertop WP, Verbaan D. Update of the ULtra-early TRranexamic Acid after Subarachnoid Hemorrhage (ULTRA) trial: statistical analysis plan. Trials. 2020 Feb 18;21(1):199. doi: 10.1186/s13063-020-4118-5.

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Indications