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Triple-drug therapy with Goreisan, tranexamic acid and carbazochrome sodium sulfonate hydrate to prevent recurrence after chronic subdural haematoma surgery: a multicentre, randomised, controlled trial protocol

Por: Negishi · H. · Hirata · K. · Aiyama · H. · Fujita · K. · Komatsu · Y. · Kato · N. · Shibata · Y. · Tsuda · K. · Yamazaki · T. · Sato · M. · Watanabe · S. · Sugii · N. · Konishi · T. · Mathis · B. J. · Ohigashi · T. · Endo · M. · Ishikawa · E. · Matsumaru · Y. · The Triple Study Investigato
Introduction

Chronic subdural haematoma (CSDH) is a common neurosurgical condition in older adults, with a recurrence rate of approximately 7.1–13% after burr-hole drainage. Although surgical adjuncts such as subdural drains and middle meningeal artery embolisation may reduce recurrence, these are not suitable for all patients. Pharmacological strategies, including tranexamic acid, Goreisan and carbazochrome sodium sulfonate hydrate, have shown potential, but high-level evidence remains lacking. A prior retrospective study suggested that a triple oral regimen combining these agents may reduce recurrence. This randomised controlled trial aims to evaluate its efficacy and safety.

Methods and analysis

This is a prospective, multicentre, open-label, randomised controlled trial conducted across six hospitals in Ibaraki, Japan. A total of 180 patients undergoing first-time burr-hole surgery for CSDH will be randomised 1:1 to receive either triple therapy (Goreisan 7.5 g/day, carbazochrome sodium sulfonate hydrate 90 mg/day and tranexamic acid 750 mg/day for up to 90 days) or standard postoperative care. The primary outcome is recurrence requiring reoperation within 90 days. Secondary outcomes include time to recurrence and haematoma volume reduction on serial CT imaging. All analyses will follow the intention-to-treat principle, using logistic regression, Cox proportional hazards models and mixed-effects models.

Ethics and dissemination

Written, informed consent will be obtained from all participants at each participating hospital by trained staff from that hospital. The trial protocol has been approved by the ethics committee of the University of Tsukuba Hospital (approval no. TCRB23-025) and the Institutional Review Boards of all participating centres. Study findings will be disseminated through presentations at scientific conferences and publications in peer-reviewed journals. A summary of the results will also be provided to participating institutions and made publicly available in accordance with the BMJ Open data sharing policy.

Trial registration number

jRCTs031240007.

Development and validation of a postoperative risk calculator (POP-score) for patients undergoing cardiac surgery: a retrospective cohort study

Por: Pölzl · L. · Sutter · C. · Lohmann · R. · Eder · J. · Ioannou-Nikolaidou · M. · Engler · C. · Graber · M. · Naegele · F. · Hirsch · J. · Maier · S. · Ulmer · H. · Mathis · S. · Reinstadler · S. J. · Grimm · M. · Bonaros · N. · Holfeld · J. · Gollmann-Tepeköylü · C.
Objectives

This study aimed to identify intraoperative and perioperative factors influencing 30-day mortality after cardiac surgery and to develop a risk score (POP-score) for its prediction.

Design

Retrospective cohort study with multivariable regression analysis.

Setting

A tertiary care cardiac surgery centre in Austria; data from consecutive patients undergoing cardiac surgery between 2010 and 2020 were analysed.

Participants

A total of 8072 patients were included. The cohort was randomly divided into a derivation cohort (75%) and a validation cohort (25%).

Outcome measures

The primary outcome measure was 30-day mortality. We analysed associations between intraoperative and perioperative variables and 30-day mortality, assessed via multivariable regression analysis.

Results

Several factors were significantly associated with 30-day mortality, including intraoperative RBC transfusion (OR 3.407 (95% CI 2.124–5.464)), postoperative high-sensitive cardiac troponin T cut-off levels (OR 2.856 (95% CI 1.958 to 4.165)), need for dialysis/haemofiltration (OR 2.958 (95% CI 2.013 to 4.348)) and temporary extracorporeal membrane oxygenation support (OR 5.218 (95% CI 3.329 to 8.179)) (p

Conclusions

The validated POP-score provides an improved tool for predicting 30-day mortality after cardiac surgery by incorporating intraoperative and perioperative factors alongside the EuroSCORE II. Although model performance was evaluated using 7-day peak troponin data, the score can be calculated within the first 72 hours postoperatively in most patients, supporting its clinical applicability for early decision-making, resource allocation and patient counselling. Further research is warranted to assess its clinical utility in diverse populations.

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