Evaluation of Tranexamic Acid in Reducing Surgical Intervention in Patients with Chronic Subdural Hematoma: A Randomized Controlled Trial

The primary objective of the study is to evaluate whether patients with **chronic subdural hematoma** (cSDH) who receive primary conservative treatment with **tranexamic acid** (TXA) require surgical intervention for cSDH within 12 weeks after treatment initiation less frequently compared to those receiving a placebo. This objective is clinically relevant as it aims to determine the efficacy of TXA in reducing the need for surgical procedures, which can be invasive and carry significant risks for patients with cSDH. The study does not list any secondary objectives.

The clinical trial focuses on patients diagnosed with **Chronic Subdural Hematoma** (cSDH), aiming to evaluate the necessity of surgical intervention following primary conservative treatment with TXA. The study population includes both male and female participants aged 50 years and above. Participants are required to have a CT-confirmed diagnosis of cSDH within 14 days prior to inclusion, and must exhibit stable neurological symptoms, as indicated by a Glasgow Coma Scale score of 14 or higher and an mNIHSS score of 4 or lower. The trial includes a vulnerable population, although specific lifestyle considerations such as diet or physical activity are not detailed. The sponsor has not provided information regarding the total number of participants involved in the study.

The clinical trial is designed to evaluate the efficacy of **tranexamic acid** in reducing the need for surgical intervention in patients with **chronic subdural hematoma**. This study is a randomized, double-blind, placebo-controlled trial, ensuring that neither the participants nor the researchers know who is receiving the active treatment or the placebo, thus minimizing bias. The trial is expected to run until December 31, 2029, with recruitment having commenced on June 27, 2018. Participants will be involved in the study for a maximum of 28 days, during which they will receive either tranexamic acid or a placebo orally. The primary endpoint is to determine if the need for surgery within 12 weeks after treatment initiation is less frequent in the tranexamic acid group compared to the placebo group.

The sequence of study visits begins with an inclusion (screening) visit, where eligibility is confirmed based on criteria such as age (50 years and above) and a CT-confirmed diagnosis of chronic subdural hematoma. Participants must also exhibit stable neurological symptoms. Follow-up visits will be scheduled to monitor the participants' health status and any potential side effects of the treatment. The end-of-study visit will conclude the participant's involvement, assessing the final outcomes and any long-term effects of the treatment. Participants may be withdrawn from the study early if they experience significant adverse effects or if they no longer meet the inclusion criteria. The trial's methodology and design are structured to provide robust data on the effectiveness of tranexamic acid in this patient population.

The clinical trial involves the administration of **Tranexamic Acid**, an antifibrinolytic agent, as the experimental medication. Tranexamic Acid is provided in capsule form and is administered orally. The dosing regimen consists of a maximum daily dose of 2 capsules, with a total maximum dose of 56 capsules over a treatment period of 28 days. The primary objective of the trial is to evaluate the efficacy of Tranexamic Acid in reducing the need for surgical intervention in patients with chronic subdural hematoma (cSDH) when used as a primary conservative treatment.

The study also includes a **placebo** group for comparison. The placebo capsules are not over-encapsulated and contain a mixture of cellulose and magnesium. These capsules are administered orally, following the same dosing schedule as the experimental medication, to maintain blinding and ensure the integrity of the trial. The placebo serves as a control to assess the true efficacy of Tranexamic Acid in the management of cSDH.

Participant compliance with the dosing schedule is monitored throughout the trial to ensure adherence to the treatment protocol. This monitoring is crucial for maintaining the validity of the trial results and for accurately assessing the impact of Tranexamic Acid on the need for surgical intervention in cSDH patients.

Efficacy in the clinical trial titled "TORCH: Tranexamic Acid to Prevent Operation in Chronic Subdural Hematoma" will be assessed by evaluating the primary endpoint, which is the need for surgery for chronic subdural hematoma (cSDH) within 12 weeks after the initiation of treatment with **tranexamic acid** (TXA) compared to a placebo. The primary objective is to determine if patients receiving TXA require surgical intervention less frequently than those receiving a placebo. The assessment will focus on the incidence of surgical procedures within the specified 12-week period following treatment initiation. The trial will involve patients with cSDH who are receiving primary conservative treatment, and the efficacy will be measured by comparing the surgical intervention rates between the TXA and placebo groups. The trial is designed to provide insights into the potential benefits of TXA in reducing the need for surgery in patients with cSDH.