6/30/23, 12:06 AM ULTRA Pathway Feedback Search Clinical Topics Home Studies ULTRA ULTRA Disease Subarachnoid hemorrhage Trial question What is the role of ultra-early, short-term treatment with tranexamic acid in patients with subarachnoid hemorrhage? Study design Multi-center Open label RCT Population Characteristics of study participants 67.0% female N = 955 33.0% male 955 patients (644 female, 311 male) Inclusion criteria: adult patients with spontaneous CT-proven subarachnoid hemorrhage Key exclusion criteria: no loss of consciousness after the hemorrhage, traumatic subarachnoid hemorrhage pattern on CT, treatment for deep vein thrombosis or PE, history of hypercoagulability disorder, history of severe renal failure, imminent death within 24 hours Interventions N=480 tranexamic acid (1 g bolus, followed by continuous infusion of 1 g every 8 h, terminated immediately before aneurysm treatment, or 24 h after start of the medication, whichever came first plus standard care) N=475 control (standard care alone) Primary outcome Good clinical outcome at 6 months, modified Rankin Scale score of 0-3 https://web.pathway.md/studies/recR2vLPhQHipEQ6R 1/2 6/30/23, 12:06 AM ULTRA Pathway 64.0 % 64 60 48.0 % 32.0 % 16.0 % No significant difference 0.0 % Tranexamic acid Control No significant difference in good clinical outcome at 6 months, mRS score of 0-3 (60% vs. 64%; aOR 0.86, 95% CI 0.66 to 1.12) Secondary outcomes Borderline significant decrease in excellent clinical outcome, mRS score of 0-2 (48% vs. 56%; OR 0.74, 95% CI 0.57 to 0.96) No significant difference in death from all causes at 30 days (22% vs. 22%; OR 0.98, 95% CI 0.72 to 1.33) No significant difference in death from all causes at 6 months (27% vs. 24%; OR 1.15, 95% CI 0.86 to 1.54) Safety outcomes No significant difference in any serious adverse events. Significant difference in all rebleeding before aneurysm treatment (10% vs. 14%). Conclusion In adult patients with spontaneous CT-proven subarachnoid hemorrhage, tranexamic acid was not superior to control with respect to good clinical outcome at 6 months, mRS score of 0-3. Reference Ren Post, Menno R Germans, Maud A Tjerkstra et al. Ultra-early tranexamic acid after subarachnoid haemorrhage (ULTRA): a randomised controlled trial. Lancet. 2021 Jan 9;397(10269):112-118. Open reference URL https://web.pathway.md/studies/recR2vLPhQHipEQ6R 2/2