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Randomized Controlled Trial
. 2025 Aug;32(8):e70208.
doi: 10.1111/ene.70208.

Cost-Effectiveness of Ultra-Early Tranexamic Acid as Add-On to Standard Care After Subarachnoid Hemorrhage (ULTRA Trial)

Affiliations
Randomized Controlled Trial

Cost-Effectiveness of Ultra-Early Tranexamic Acid as Add-On to Standard Care After Subarachnoid Hemorrhage (ULTRA Trial)

Nadine Denneman et al. Eur J Neurol. 2025 Aug.

Abstract

Objective: To evaluate the cost-effectiveness and cost-utility of adding ultra-early and short-term administration of tranexamic acid (TXA) to standard care in patients with subarachnoid hemorrhage (SAH).

Materials and methods: An economic evaluation was performed alongside the ultra-early tranexamic acid after subarachnoid hemorrhage (ULTRA) trial. The main outcomes were the incremental cost-effectiveness ratio (ICER), expressed as costs per one-point increase in modified Rankin scale (mRS) score, and the incremental cost-utility ratio (ICUR), expressed as costs per quality-adjusted life-year (QALY). Cost-effectiveness acceptability curves (CEACs) were visualized with varying ICER cut-offs. Bootstrapping techniques and sensitivity analyses were performed to account for uncertainty.

Results: The ULTRA trial included 955 patients, with 480 assigned to the TXA group and 475 to the control group. The mean mRS score was 3.4 (95% CI: 3.2-3.5) in the TXA group and 3.2 (95% CI: 3.0-3.4) in the control group. The mean QALY was 0.26 (95% CI: 0.24-0.28) in the TXA group and 0.28 (95% CI: 0.26-0.30) in the control group. Mean costs were €62,180 (95% CI: 57,589-66,913) in the TXA group and €58,624 (95% CI: 53,693-63,955) in the control group. The probability of treatment with TXA being cost-effective ranged from 4% to 16% for mRS and from 8% to 16% for QALYs.

Conclusions: Ultra-early and short-term administration of TXA to patients with SAH is not cost-effective. Therefore, we recommend against using TXA for this patient group.

Trial registration: Netherlands Trial Register: NTR3272.

Clinicaltrials: gov identifier: NCT02684812.

Keywords: cost‐effectiveness; intracranial aneurysm; quality of life; subarachnoid hemorrhage; tranexamic acid.

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Conflict of interest statement

The authors declare no conflicts of interest.

Figures

FIGURE 1
FIGURE 1
Flowchart of study patients. mRS, modified rankin scale; TXA, tranexamic acid.
FIGURE 2
FIGURE 2
Cost‐effectiveness plane showing differences between the TXA and control group in costs and mRS score in all 5000 bootstrap samples. Note: Since a higher mRS score indicates worse clinical outcome, northeast = TXA is less effective than control and also more expensive, “inferior”; southeast = TXA is less effective and less expensive; northwest = TXA is more effective and more expensive; and southwest = TXA is more effective and less expensive, “dominant.”
FIGURE 3
FIGURE 3
Cost‐effectiveness acceptability curve for mRS. Cost‐effectiveness acceptability curve showing the proportion of bootstrap samples that were found in TXA to be cost‐effective for mRS (y‐axis) when compared to a range of threshold monetary values (x‐axis).
FIGURE 4
FIGURE 4
Cost‐effectiveness plane showing differences between the TXA and control group in costs and EQ‐5D‐3L based difference in QALYs in all 5000 bootstrap samples. Note: Northeast = TXA is more effective than control and also more expensive; southeast = TXA is more effective and less expensive, “dominant”; northwest = TXA is less effective and more expensive, “inferior”; and southwest = TXA is less effective and less expensive.
FIGURE 5
FIGURE 5
Cost‐effectiveness acceptability curve for QALY. Cost‐effectiveness acceptability curve showing the proportion of bootstrap samples that were found in TXA to be cost‐effective for QALYs (y‐axis) when compared to a range of threshold monetary values (x‐axis).

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