Tranexamic acid to prevent operation in chronic subdural haematoma (TORCH): study protocol for a randomised placebo-controlled clinical trial

Immenga, Steven; Lodewijkx, Roger; Roos, Yvo B.W.E.M.; Majoie, Charles B; Willems, Hanna C.; Verbaan, Dagmar

doi:10.1186/s13063-021-05907-0

Cited by 7 publications

(5 citation statements)

References 28 publications

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“…Further studies, including RCTs, would be useful for clarifying the safety of TXA as a treatment for CSDH. 47 Forth, adjusting time-dependent confounders was difficult in this study. However, the bias might be small for estimating the effect of TXA as general clinical studies do not restrict the usage of drugs that were included in this study.…”

Section: Limitationsmentioning

confidence: 85%

Administration of Tranexamic Acid After Burr Hole Craniotomy Reduced Postoperative Recurrence of Chronic Subdural Hematoma in a Japanese Regional Population

Miyakoshi

Nakatani²,

Kaneda

et al. 2023

Neurosurgery

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BACKGROUND: Although tranexamic acid (TXA) has occasionally been used to prevent postoperative recurrence of chronic subdural hematoma (CSDH) after burr hole craniotomy (BC), robust evidence of its efficacy has been lacking. OBJECTIVE: To assess the efficacy and safety of postoperative oral administration of TXA after BC for CSDH among the elderly. METHODS: This retrospective, propensity score–matched cohort study was carried out with a large Japanese local population–based longitudinal cohort in the Shizuoka Kokuho Database between April 2012 and September 2020. Patients included were age 60 years or older and had undergone BC for CSDH but were not undergoing dialysis. Covariates were collected from records of the preceding 12 months from the month of first BC, and patients were followed up for 6 months after surgery. The primary outcome was repeat surgery, and the secondary outcome was death or the onset of thrombosis. Data on postoperative TXA administration were collected and compared with controls using propensity score matching. RESULTS: Of the 8544 patients who underwent BC for CSDH, 6647 were included, with 473 placed in the TXA group and 6174 placed in the control group. After 1:1 matching, repeated BC was found to have been performed in 30 of 465 patients (6.5%) in the TXA group and in 78 of 465 patients (16.8%) in the control group (relative risk, 0.38; 95% CI, 0.26-0.56). No significant difference was observed for death or the onset of thrombosis. CONCLUSION: Oral administration of TXA reduced the occurrence of repeat surgery after BC for CSDH.

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Section: Limitationsmentioning

confidence: 85%

Administration of Tranexamic Acid After Burr Hole Craniotomy Reduced Postoperative Recurrence of Chronic Subdural Hematoma in a Japanese Regional Population

Miyakoshi

Nakatani²,

Kaneda

et al. 2023

Neurosurgery

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“…The patient described in this study was prescribed a dosage regimen that was finalized at 650 mg, twice daily by mouth for eight weeks. This dosing regimen was established through the use of the Tranexamic Acid in Chronic Subdural Hematomas (TRACS) and Tranexamic Acid to Prevent OpeRation in Chronic Subdural Hematoma (TORCH) clinical trials that measured the efficacy of TXA in the treatment of chronic subdural hematomas [ 9 , 10 ]. In these trials, the dosages of TXA varied from 750 mg daily (TRACS) to 500 mg, twice daily (TORCH) [ 9 , 10 ].…”

Section: Discussionmentioning

confidence: 99%

“…This dosing regimen was established through the use of the Tranexamic Acid in Chronic Subdural Hematomas (TRACS) and Tranexamic Acid to Prevent OpeRation in Chronic Subdural Hematoma (TORCH) clinical trials that measured the efficacy of TXA in the treatment of chronic subdural hematomas [ 9 , 10 ]. In these trials, the dosages of TXA varied from 750 mg daily (TRACS) to 500 mg, twice daily (TORCH) [ 9 , 10 ]. In regards to the duration of treatment, the TRACS trial suggests the usage of TXA until hematoma resolution with concomitant CT imaging throughout the duration of treatment or an upper limit of 20 weeks of treatment is reached [ 9 ].…”

Section: Discussionmentioning

confidence: 99%

Usage of Tranexamic Acid for Treatment of Subdural Hematomas

Wu¹,

Wajeeh²,

McPhail³

et al. 2023

Cureus

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The collection of blood in the subdural layer within the cranium is classified as a subdural hematoma. Prevalence of subdural hematomas is most common among older populations with the current standard of treatment being invasive surgical evacuation for patients presenting with acute subdural hematomas with a midline shift greater than 5 mm on computed tomography (CT). Tranexamic acid (TXA) has been identified as an alternative, non-invasive option to treat patients presenting with subdural hematoma who are not suitable for surgical intervention.The presenting case involves a 90-year-old female who arrived with a code stroke with the chief complaint of right lower extremity weakness. A stroke series CT panel revealed a left frontal multiloculated subdural hematoma, measuring 130 mL with mass effect and a midline shift of 7 mm. The patient was recommended a craniotomy for hematoma evacuation or access to hospice for comfort care. A second opinion resulted in the administration of TXA. After the full completion of a TXA course, the patient achieved baseline mobility.The final measurements revealed a final hematoma volume of 10 mL and a midline shift of less than 2 mm. Current literature, as well as the case described, has begun demonstrating the efficacy of the usage of TXA in the reabsorption of subdural hematomas and should encourage further exploration into society guidelines for the usage of TXA as a non-invasive alternative to treat subdural hematomas.

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“…[205][206][207][208] Prevention of recurrences is therefore important, and various nonsurgical treatments are now being explored in randomized clinical trials, including medication (tranexamic acid). 9,209 In a recent RCT, the use of dexamethasone vs placebo demonstrated that fewer recurrences occurred but that less favorable outcomes and more adverse events were noted in the dexamethasone group. 10 This systematic review also provided information on recurrence rates depending on the method of irrigation used.…”

Section: Discussionmentioning

confidence: 99%

Recurrent Chronic Subdural Hematoma After Burr-Hole Surgery and Postoperative Drainage: A Systematic Review and Meta-Analysis

Lodewijkx

Foppen

Slot

et al. 2023

Operative Neurosurgery

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BACKGROUND AND OBJECTIVE: Reported recurrence rates of chronic subdural hematoma treated by burr-hole surgery with postoperative drainage vary considerably in the literature. We performed a systematic review and meta-analysis to define the recurrence rate of burr-hole surgery with postoperative drainage. METHODS: PubMed and EMBASE were searched, and Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines were followed. We used the Newcastle-Ottawa scale and Cochrane risk-of-bias tool for quality assessment of included studies and the random-effects model to calculate pooled incidence rates in R with the metaprop function if appropriate. RESULTS: The search yielded 2969 references; 709 were screened full text, and 189 met the inclusion criteria. In 174 studies (34 393 patients), the number of recurrences was reported as per patient and 15 studies (3078 hematomas) reported the number of recurrences per hematoma, for a pooled incidence of 11.2% (95% CI: 10.3-12.1; I2 = 87.7%) and 11.0% (95% CI: 8.6-13.4; I2 = 78.0%), respectively. The pooled incidence of 48 studies (15 298 patients) with the highest quality was 12.8% (95% CI 11.4-14.2; I2 = 86.1%). Treatment-related mortality (56 patients) has a pooled incidence of 0.7% (95% CI 0.0-1.4; I2 = 0.0%). CONCLUSION: The recurrence rate of chronic subdural hematoma treated by burr-hole surgery and postoperative drainage is 12.8%.

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Tranexamic acid to prevent operation in chronic subdural haematoma (TORCH): study protocol for a randomised placebo-controlled clinical trial

Cited by 7 publications

References 28 publications

Administration of Tranexamic Acid After Burr Hole Craniotomy Reduced Postoperative Recurrence of Chronic Subdural Hematoma in a Japanese Regional Population

Administration of Tranexamic Acid After Burr Hole Craniotomy Reduced Postoperative Recurrence of Chronic Subdural Hematoma in a Japanese Regional Population

Usage of Tranexamic Acid for Treatment of Subdural Hematomas

Recurrent Chronic Subdural Hematoma After Burr-Hole Surgery and Postoperative Drainage: A Systematic Review and Meta-Analysis

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