Tranexamic acid for intracerebral haemorrhage within 2 hours of onset: protocol of a phase II randomised placebo-controlled double-blind multicentre trial

Yassi, Nawaf; Zhao, Henry; Чурилов, Леонид; Campbell, Bruce C.V.; Wu, Teddy Y; Ma, Henry; Cheung, Andrew; Kleinig, Timothy; Brown, Helen; Choi, Philip; Jeng, Jiann‐Shing; Ranta, Annemarei; Wang, Hao‐Kuang; Cloud, Geoffrey; Grimley, Rohan; Shah, Darshan; Spratt, Neil; Cho, Der Yang; Mahawish, Karim; Sanders, Lauren; Worthington, John; Clissold, B.; Meretoja, Atte; Yogendrakumar, Vignan; Ton, Mai Duy; Dang, Duc Phuc; Phuong, Nguyen Thai My; Nguyen, Huy-Thang; Hsu, Chung Y.; Sharma, Gagan; Mitchell, Peter; Yan, Bernard; Levi, Christopher; Donnan, Geoffrey A; Davis, Stephen M.

doi:10.1136/svn-2021-001070

Cited by 15 publications

(17 citation statements)

References 29 publications

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“…However, these results do not allow any overall conclusion as the information only comes from a very limited number of patients. Further research is needed to prove the potential clinical benefits of MSU treatment for ICH patients, and ongoing ICH treatment trials 80,81 , of which some are performed with MSU management 82 , will potentially open the field for additional therapeutic possibilities in the near future.…”

Section: Discussionmentioning

confidence: 99%

European Stroke Organisation (ESO) guidelines on mobile stroke units for prehospital stroke management

Walter

Audebert

Katsanos

et al. 2022

European Stroke Journal

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The safety and efficacy of mobile stroke units (MSUs) in prehospital stroke management has recently been investigated in different clinical studies. MSUs are ambulances equipped with a CT scanner, point-of-care lab, telemedicine and are staffed with a stroke specialised medical team. This European Stroke Organisation (ESO) guideline provides an up-to-date evidence-based recommendation to assist decision-makers in their choice on using MSUs for prehospital management of suspected stroke, which includes patients with acute ischaemic stroke (AIS), intracranial haemorrhage (ICH) and stroke mimics. The guidelines were developed according to the ESO standard operating procedure and Grading of Recommendations, Assessment, Development and Evaluation (GRADE) methodology. The working group identified relevant clinical questions, performed systematic reviews and aggregated data meta-analyses of the literature, assessed the quality of the available evidence and made specific recommendations. Expert consensus statements are provided where sufficient evidence was not available to provide recommendations based on the GRADE approach. We found moderate evidence for suggesting MSU management for patients with suspected stroke. The patient group diagnosed with AIS shows an improvement of functional outcomes at 90 days, reduced onset to treatment times and increased proportion receiving IVT within 60 min from onset. MSU management might be beneficial for patients with ICH as MSU management was associated with a higher proportion of ICH patients being primarily transported to tertiary care stroke centres. No safety concerns (all-cause mortality, proportion of stroke mimics treated with IVT, symptomatic intracranial bleeding and major extracranial bleeding) could be identified for all patients managed with a MSU compared to conventional care. We suggest MSU management to improve prehospital management of suspected stroke patients.

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Section: Discussionmentioning

confidence: 99%

European Stroke Organisation (ESO) guidelines on mobile stroke units for prehospital stroke management

Walter

Audebert

Katsanos

et al. 2022

European Stroke Journal

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“…Tranexamic acid competitively inhibits the adsorption of plasminogen on fibrin by binding to the lysine binding site on fibrin, thereby inhibiting the activation of plasminogen and preventing the degradation of fibrinolytic proteins by fibrinolytic enzymes, thus achieving antifibrinolytic and hemostatic effects [42,43]. It can also increase collagen synthesis in fibrin clots, thereby increasing the strength and stability of clots and reducing bleeding [5,44]. Normally, fibrinogen binds to lysine binding sites on fibrin molecules and is converted to fibrinogenase in the presence of tissue plasminogen activator [45].…”

Section: Discussionmentioning

confidence: 99%

“…Tranexamic acid is a widely used anti-fiber solvent [5]. It is a synthetic lysine analog that competes with lysine residues on fibrin for the binding of plasminogen that effectively inhibits the interaction between fibrinolytic enzymes and fibrin and prevents the dissolution of fibrin clots [6].…”

Section: Introductionmentioning

confidence: 99%

Efficacy and safety of tranexamic acid in intracranial haemorrhage: A meta-analysis

et al. 2023

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Background Although some studies have shown that tranexamic acid is beneficial to patients with intracranial haemorrhage, the efficacy and safety of tranexamic acid for intracranial haemorrhage remain controversial. Method The PubMed, EMBASE, and Cochrane Library databases were systematically searched. The review followed PRISMA guidelines. Data were analyzed using the random-effects model. Results Twenty-five randomized controlled trials were included. Tranexamic acid significantly inhibited hematoma growth in intracranial hemorrhage (ICH) and traumatic brain injury (TBI) patients. (ICH: mean difference -1.76, 95%CI -2.78 to -0.79, I2 = 0%, P < .001; TBI: MD -4.82, 95%CI -8.06 to -1.58, I2 = 0%, P = .004). For subarachnoid hemorrhage (SAH) patients, it significantly decreased the risk of hydrocephalus (OR 1.23, 95%CI 1.01 to 1.50, I2 = 0%, P = .04) and rebleeding (OR, 0.52, 95%CI 0.35 to 0.79, I2 = 56% P = .002). There was no significance in modified Rankin Scale, Glasgow Outcome Scale 3–5, mortality, deep vein thrombosis, pulmonary embolism, or ischemic stroke/transient ischemic. Conclusion Tranexamic acid can significantly reduce the risk of intracranial haemorrhage growth in patients with ICH and TBI. Tranexamic acid can reduce the incidence of complications (hydrocephalus, rebleeding) in patients with SAH, which can indirectly improve the quality of life of patients with intracranial haemorrhage.

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“…In this trial, we plan to further examine IVH growth both as an individual variable and in combination with ICH growth. 13 The FASTEST trial will evaluate rFVIIa within the 2 h of symptom onset and will also aim to assess IVH growth (NCT03496883).…”

Section: Discussionmentioning

confidence: 99%

Does tranexamic acid affect intraventricular hemorrhage growth in acute ICH? An analysis of the STOP-AUST trial

Yogendrakumar

Чурилов

et al. 2022

European Stroke Journal

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Background Trials of tranexamic acid (TXA) in acute intracerebral hemorrhage (ICH) have focused on the imaging outcomes of intraparenchymal hematoma growth. However, intraventricular hemorrhage (IVH) growth is also strongly associated with outcome after ICH. Revised definitions of hematoma expansion incorporating IVH growth have been proposed. Aims We sought to evaluate the effect of TXA on IVH growth. Methods We analyzed data from the STOP-AUST trial, a prospective randomized trial comparing TXA to placebo in ICH patients presenting ≤ 4.5 h from symptom onset with a CT-angiography spot sign. New IVH development at follow-up, any interval IVH growth, and IVH growth ≥ 1 mL were compared between the treatment groups using logistic regression. The treatment effect of TXA against placebo using conventional (> 6 mL or 33%), and revised definitions of hematoma expansion (> 6 mL or 33% or IVH expansion ≥ 1 mL, > 6 mL or 33%, or any IVH expansion, and > 6 mL or 33% or new IVH development) were also assessed. Treatment effects were adjusted for baseline ICH volume. Results The analysis population consisted of 99 patients (50 placebo, 49 TXA). New IVH development at follow-up was observed in 6/49 (12%) who received TXA and 13/50 (26%) who received placebo (aOR: 0.38 [95% CI: 0.13–1.13]). Any interval IVH growth was observed in 12/49 (25%) who received TXA versus 26/50 (32%) receiving placebo (aOR: 0.69 [95% CI: 0.28–1.66]). IVH growth ≥ 1 mL did not differ between the two groups. Using revised definitions of hematoma expansion, no significant difference in treatment effect was observed between TXA and placebo. Conclusions IVH may be attenuated by TXA following ICH; however, studies with larger cohorts are required to investigate this further. Registration http://www.clinicaltrials.gov ; Unique identifier: NCT01702636.

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Tranexamic acid for intracerebral haemorrhage within 2 hours of onset: protocol of a phase II randomised placebo-controlled double-blind multicentre trial

Cited by 15 publications

References 29 publications

European Stroke Organisation (ESO) guidelines on mobile stroke units for prehospital stroke management

European Stroke Organisation (ESO) guidelines on mobile stroke units for prehospital stroke management

Efficacy and safety of tranexamic acid in intracranial haemorrhage: A meta-analysis

Does tranexamic acid affect intraventricular hemorrhage growth in acute ICH? An analysis of the STOP-AUST trial

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