ArticleStroke and vascular neurology2022
Tranexamic acid for intracerebral haemorrhage within 2 hours of onset: protocol of a phase II randomised placebo-controlled double-blind multicentre trial.
Article in Stroke and vascular neurology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers, 2 of them syntheses that pooled it.
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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.
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Who cites it
13 citing papers in PubMed, 2 syntheses or guidelines pooled it, 22 citations in OpenAlex.
- Haemostatic therapies for stroke due to acute, spontaneous intracerebral haemorrhage.The Cochrane database of systematic reviews · 2023Pooled it
- Pooled it
- Quantification of hounsfield unit difference in heterogeneous hematoma predicts poor functional outcomes in acute intracerebral hemorrhage.Scientific reports · 2025Observational
- An Experimental 10-Port Microwave System for Brain Stroke Diagnosis-Potentials and Limitations.Sensors (Basel, Switzerland) · 2025Article
- Adaptive Trials in Stroke: Current Use and Future Directions.Neurology · 2024Review
- Mechanism and application of immune interventions in intracerebral haemorrhage.Expert reviews in molecular medicine · 2024Review
- Prehospital identification of intracerebral haemorrhage: a scoping review of early clinical features and portable devices.BMJ open · 2024Article
- Patients with acute intracerebral hemorrhage and severe symptoms are highly sensitive to prehospital delay. A subgroup analysis from the RESIST and TRIAGE-STROKE trials.Frontiers in stroke · 2024Article
- Association Between Hematoma Expansion Severity and Outcome and Its Interaction With Baseline Intracerebral Hemorrhage Volume.Neurology · 2023Article
- Tranexamic acid in a mouse model of cerebral amyloid angiopathy: setting the stage for a novel stroke treatment approach.Research and practice in thrombosis and haemostasis · 2023Article
- Clinical features and novel technologies for prehospital detection of intracerebral haemorrhage: a scoping review protocol.BMJ open · 2023Article
- Does tranexamic acid affect intraventricular hemorrhage growth in acute ICH? An analysis of the STOP-AUST trial.European stroke journal · 2022Article
- European Stroke Organisation (ESO) guidelines on mobile stroke units for prehospital stroke management.European stroke journal · 2022Article
Corrections and comments
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Authors and funding
36 authors at 20 institutions in 5 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
rationaleHaematoma growth is common early after intracerebral haemorrhage (ICH), and is a key determinant of outcome. Tranexamic acid, a widely available antifibrinolytic agent with an excellent safety profile, may reduce haematoma growth. METHODS AND
designStopping intracerebral haemorrhage with tranexamic acid for hyperacute onset presentation including mobile stroke units (STOP-MSU) is a phase II double-blind, randomised, placebo-controlled, multicentre, international investigator-led clinical trial, conducted within the estimand statistical framework. HYPOTHESIS: In patients with spontaneous ICH, treatment with tranexamic acid within 2 hours of onset will reduce haematoma expansion compared with placebo. SAMPLE SIZE ESTIMATES: A sample size of 180 patients (90 in each arm) would be required to detect an absolute difference in the primary outcome of 20% (placebo 39% vs treatment 19%) under a two-tailed significance level of 0.05. An adaptive sample size re-estimation based on the outcomes of 144 patients will allow a possible increase to a prespecified maximum of 326 patients.
interventionParticipants will receive 1 g intravenous tranexamic acid over 10 min, followed by 1 g intravenous tranexamic acid over 8 hours; or matching placebo. PRIMARY EFFICACY MEASURE: The primary efficacy measure is the proportion of patients with haematoma growth by 24±6 hours, defined as either ≥33% relative increase or ≥6 mL absolute increase in haematoma volume between baseline and follow-up CT scan. DISCUSSION: We describe the rationale and protocol of STOP-MSU, a phase II trial of tranexamic acid in patients with ICH within 2 hours from onset, based in participating mobile stroke units and emergency departments.
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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.