Evidence map›Paper›PMID 42616160›Full record

Trial reportJournal of neurology2026

Tranexamic acid after aneurysmal subarachnoid hemorrhage is associated with worse outcome in males: post hoc analysis of the ULTRA trial.

Raoul J Koopmans, Maud A Tjerkstra, Menno R Germans, Mervyn D I Vergouwen, Korné Jellema, Radboud W Koot, Nyika D Kruyt, Jasper F C Wolfs, Hans Kieft, Dharmin Nanda and 20 more

Registry-linked trialAbstract readClinical Trial, Phase IIClinical Trial, Phase IIIMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of neurology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02684812 (Ultra-early Tranexamic Acid After Subarachnoid Hemorrhage. A Prospective, Randomized, Multicenter Study.), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02684812 phase2 / phase3completednot on this map

Ultra-early Tranexamic Acid After Subarachnoid Hemorrhage. A Prospective, Randomized, Multicenter Study.

TypeinterventionalSponsorAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)Ran2012 to 2020Enrolled955ConditionsSubarachnoid HemorrhageArmsTranexamic Acid
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

30 authors.

Raoul J KoopmansDepartment of Neurosurgery, Amsterdam UMC Location University of Amsterdam, Meibergdreef 9, PO Box 22660, 1100 DD, Amsterdam, the Netherlands. r.j.koopmans@amsterdamumc.nl.ORCID http://orcid.org/0000-0002-7024-6255
Maud A TjerkstraDepartment of Neurosurgery, Amsterdam UMC Location University of Amsterdam, Meibergdreef 9, PO Box 22660, 1100 DD, Amsterdam, the Netherlands.
Menno R GermansDepartment of Neurosurgery, Clinical Neuroscience Center, University Hospital Zurich, Zurich, Switzerland.
Mervyn D I VergouwenDepartment of Neurology and Neurosurgery, UMC Utrecht Brain Centre, University Medical Centre Utrecht, Utrecht University, Utrecht, the Netherlands.
Korné JellemaDepartment of Neurology, Haaglanden Medical Centre, The Hague, the Netherlands.
Radboud W KootDepartment of Neurosurgery, Leids University Medical Centre, Leiden, the Netherlands.
Nyika D KruytDepartment of Neurology, Leids University Medical Centre, Leiden, the Netherlands.
Jasper F C WolfsDepartment of Neurosurgery, Haaglanden Medical Centre, The Hague, the Netherlands.
Hans KieftDepartment of Intensive Care, Isala Hospital, Zwolle, the Netherlands.
Dharmin NandaDepartment of Neurosurgery, Isala Hospital, Zwolle, the Netherlands.
Bram van der PolDepartment of Neurosurgery, Elisabeth Tweesteden Ziekenhuis, Tilburg, the Netherlands.
Gerwin RoksDepartment of Neurology, Elisabeth Tweesteden Ziekenhuis, Tilburg, the Netherlands.
Frank de BeerDepartment of Neurology, Spaarne Gasthuis, Haarlem, the Netherlands.
Loes J A ReichmanDepartment of Neurology, Ziekenhuisgroep Twente, Almelo, the Netherlands.
Paul J A M BrouwersDepartment of Neurology, Medisch Spectrum Twente, Enschede, the Netherlands.
Vincent I H KwaDepartment of Neurology, OLVG, Amsterdam, the Netherlands.
Taco C van der ReeDepartment of Neurology, Dijklander Hospital, Hoorn, the Netherlands.
Henri P BienfaitDepartment of Neurology, Gelre Hospital, Apeldoorn, The Netherlands.
Hieronymus D BoogaartsDepartment of Neurosurgery, Radboud University Medical Centre, Nijmegen, the Netherlands.
Catharina J M KlijnDepartment of Neurology, Donders Institute for Brain, Cognition and Behaviour, Radboud University Medical Centre, Nijmegen, the Netherlands.
René van den BergAmsterdam Neuroscience, Neurovascular Disorders, Amsterdam, the Netherlands.
Bert A CoertDepartment of Neurosurgery, Amsterdam UMC Location University of Amsterdam, Meibergdreef 9, PO Box 22660, 1100 DD, Amsterdam, the Netherlands.
Janneke HornDepartment of Intensive Care, Amsterdam UMC, University of Amsterdam, Neuroscience Amsterdam, Meibergdreef 9, Amsterdam, Netherlands.
Charles B L M MajoieAmsterdam Neuroscience, Neurovascular Disorders, Amsterdam, the Netherlands.
Gabriël J E RinkelDepartment of Neurology and Neurosurgery, UMC Utrecht Brain Centre, University Medical Centre Utrecht, Utrecht University, Utrecht, the Netherlands.
Yvo B W E M RoosAmsterdam Neuroscience, Neurovascular Disorders, Amsterdam, the Netherlands.
W Peter VandertopDepartment of Neurosurgery, Amsterdam UMC Location University of Amsterdam, Meibergdreef 9, PO Box 22660, 1100 DD, Amsterdam, the Netherlands.
René PostDepartment of Neurosurgery, Amsterdam UMC Location University of Amsterdam, Meibergdreef 9, PO Box 22660, 1100 DD, Amsterdam, the Netherlands.
Dagmar VerbaanDepartment of Neurosurgery, Amsterdam UMC Location University of Amsterdam, Meibergdreef 9, PO Box 22660, 1100 DD, Amsterdam, the Netherlands.
ULTRA Investigators

Funding

Fonds NutsOhra project 1202-31
6 · The paper itself

Abstract

backgroundThe ULTRA trial demonstrated no improvement in clinical outcome at 6 months in patients with subarachnoid hemorrhage (SAH) when treated with ultra-early and short-term tranexamic acid (TXA). In this post hoc analysis, we evaluated the effect of TXA in females and males on clinical outcome after aneurysmal SAH (aSAH).

methodsThe ULTRA trial was a prospective, randomized, controlled, open-label trial, conducted between 2013 and 2020. Patients with spontaneous SAH were assigned to ultra-early, short-term TXA in addition to usual care, or usual care only. In this study, we only included ULTRA participants with radiologically proven aSAH. We analyzed the potential effect of sex on the association between treatment group and clinical outcome by assessing effect modification, and evaluated the effect of TXA separately in females and males. The primary endpoint was clinical outcome at 6 months, assessed by the distribution of the modified Rankin Scale (mRS). Odds ratios (OR) and adjusted OR (aOR) with 95% confidence intervals (CI) were calculated using ordinal regression analyses. Secondary outcomes included good (mRS score 0-3) and excellent (mRS score 0-2) clinical outcome at 6 months, all-cause mortality at 30 days, all-cause mortality at 6 months, and in-hospital complications.

resultsOf the 812 patients, 577 (71%) were female, of whom 286 (50%) received TXA. Of the 235 males, 109 (46%) received TXA. Significant effect modification of sex on the relation between treatment group and clinical outcome was observed (p = 0.044) in all aSAH patients. No significant differences in outcomes were observed among females. In males, ordinal regression analysis showed a difference in mRS distribution at 6 months to the detriment of males treated with TXA (aOR 1.94; 95% CI 1.20-3.14). No significant differences were observed between male treatment groups in secondary outcome measures. DISCUSSION: In this post hoc analysis of the ULTRA trial, we observed a potential association between ultra-early, short-term TXA treatment and worse clinical outcomes in males at 6 months. Conversely, we did not observe a significant association between TXA treatment and clinical outcome in females. Consequently, these findings reinforce that routine use of TXA cannot be recommended in either females or males.

trial registrationThe trial was registered on ClinicalTrials.gov (NCT02684812).

Indexed as

Antifibrinolytic AgentsOutcome Assessment, Health CareSubarachnoid HemorrhageTranexamic AcidAgedFemaleHumansMaleMiddle AgedProspective StudiesSex FactorsTreatment Effect HeterogeneityTreatment OutcomeAntifibrinolytic AgentsTranexamic AcidAntifibrinolytic therapyHemocoagulationSex differencesSubarachnoid hemorrhageTranexamic acidTreatment outcome

Identifiers

PMID42616160
PMCPMC13490208

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.