ArticleTrials2022
Tranexamic acid to prevent operation in chronic subdural haematoma (TORCH): study protocol for a randomised placebo-controlled clinical trial.
Article in Trials, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 13 papers, 1 of them a synthesis that pooled it.
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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.
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.
Tranexamic Acid to Prevent OpeRation in Chronic Subdural Hematoma. A Double-blind, Placebo-controlled, Multicentre, Randomized Controlled Clinical Trial
TRACE STUDY: A Randomized Controlled Trial Using Tranexamic Acid in the Treatment of Subdural Hematoma
Who cites it
13 citing papers in PubMed, 1 synthesis or guideline pooled it, 17 citations in OpenAlex.
- Unilateral or bilateral drainage for patients with bilateral chronic subdural hematoma: a systematic review and retrospective cohort study.Neurosurgical review · 2025Pooled it
- Middle meningeal artery embolization in chronic subdural hematoma: bridging surgical innovations and molecular mechanisms.Frontiers in surgery · 2026Review
- Embolization of the middle meningeal artery for chronic subdural hematoma: The OTEMACS multicenter, randomized, clinical trial protocol.Interventional neuroradiology : journal of peritherapeutic neuroradiology, surgical procedures and related neurosciences · 2025Article
- Article
- Timing of surgery for chronic subdural hematoma in patients with mild to moderate symptoms: a retrospective cohort study.Acta neurochirurgica · 2025Article
- Update on Neuroprotection after Traumatic Brain Injury.CNS drugs · 2025Review
- Article
- Chronic Subdural Hematoma Treatment with Embolization Versus Surgery Study (CHESS): Trial Rationale and Protocol.International journal of cerebrovascular disease and stroke · 2025Article
- Chronic subdural hematoma with mild to moderate symptoms: The effect of initial treatment approach on clinical outcome.Brain & spine · 2025Article
- Middle meningeal artery embolization and tranexamic acid therapy for subdural hematoma in a patient with hereditary hemorrhagic telangiectasia: illustrative case.Journal of neurosurgery. Case lessons · 2024Article
- A Case Report of Tranexamic Acid for the Treatment of Chronic Subdural Hematoma in an 86-Year-Old Patient.Cureus · 2024Article
- Factors associated with success of conservative therapy in chronic subdural hematoma: a single-center retrospective analysis.Journal of neurology · 2024Article
- Article
Corrections and comments
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Authors and funding
8 authors at 3 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundChronic subdural haematoma (cSDH) occurs mainly in the elderly. Surgical evacuation is effective, but in these old, often frail, patients with multi-comorbidity, surgery carries significant risks for future cognitive functioning and loss of independency. Therefore, a growing interest is noted for a non-surgical treatment with medication such as tranexamic acid (TXA). In five small retrospective series, this antifibrinolytic drug showed a beneficial effect on the spontaneous resolution of the haematoma, and with that, the necessity for surgery.
methodsFor this randomised, placebo-controlled clinical multicentre trial, all cSDH patients, over 50 years old with mild symptoms (Glasgow Coma Score (GCS) ≥ 14, modified National Institutes of Health Stroke Scale (mNIHSS) ≤ 4), a midline shift of ≤ 10 mm and in whom a primary conservative treatment is chosen, are eligible for study participation. After informed consent, 140 patients will be randomised to receive either TXA 500 mg or placebo two times daily for 28 days. The primary outcome is the necessity for surgery within 12 weeks; secondary outcomes are cSDH volume, neurological impairment (mNIHSS), falling incidents, cognitive functioning (Montreal Cognitive Assessment (MOCA)), performance in activities of daily living (Barthel and Lawton score), functional outcome (modified Rankin Scale (mRS)), quality of life (Short Form Health Survey (SF-36) and EuroQol 5-Dimension Health Survey (EQ-5D)), mortality and the use of care and health-related costs (Medical Consumption Questionnaire (iMCQ) and Productivity Cost Questionnaire (iPCQ)) at 12 weeks and 6 months. DISCUSSION: This phase III trial investigating the efficacy of TXA to prevent surgery for cSDH is the first in including patients using anticoagulants and mentally incompetent patients, since these comprise a significant part of the target population. Also, this study is one of the first to prospectively measure functional outcome and quality of life in cSDH patients. Final results of this study are expected in 2024.
trial registrationDutch Trial Registry (Nederlands Trial Register) NL6584 . Registered on 11 November 2017 ClinicalTrials.gov NCT03582293 . Registered on 11 July 2018 EU Clinical Trials Register 2017-004311-40 . Registered on 29 March 2018.
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Registered trials
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