RecruitingRare disease

Study on Tranexamic Acid to Prevent Surgery in Patients with Chronic Subdural Hematoma

Fast replyRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a condition known as Chronic Subdural Hematoma (cSDH). This condition involves the collection of blood on the brain's surface, often due to minor head injuries, and can lead to symptoms like headaches, confusion, and weakness. The study is investigating the use of a medication called Tranexamic Acid, which is taken in capsule form. Tranexamic Acid is an antifibrinolytic, meaning it helps prevent the breakdown of blood clots, which might help reduce the need for surgery in patients with cSDH.

The purpose of this study is to determine if patients with cSDH who receive Tranexamic Acid as a primary conservative treatment are less likely to require surgery within 12 weeks compared to those who receive a placebo. Participants in the study will be monitored over a period of time to see if the medication helps in managing their condition without the need for surgical intervention.

Throughout the study, participants will take Tranexamic Acid orally, and their progress will be observed to assess the effectiveness of the treatment. The study aims to provide valuable insights into whether this medication can be a viable option for reducing the need for surgery in patients with chronic subdural hematoma.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, eligibility is confirmed. Participants must be 50 years or older and have a confirmed diagnosis of chronic subdural hematoma (cSDH) via a CT scan performed within the last 14 days.
Participants should have a stable neurological condition, with a Glasgow Coma Scale score of 14 or higher and a modified National Institutes of Health Stroke Scale (mNIHSS) score of 4 or lower.
Step 2
Treatment initiation
The treatment involves taking tranexamic acid orally. The specific dosage and frequency are determined by the study protocol and communicated to the participant at this stage.
The goal of the treatment is to reduce the need for surgical intervention for cSDH within 12 weeks of starting the medication.
Step 3
Monitoring period
Participants are monitored regularly to assess their response to the treatment. This includes evaluating any changes in symptoms and overall health status.
The monitoring period lasts for up to 12 weeks, during which the need for surgery is assessed.
Step 4
End of treatment evaluation
At the end of the 12-week period, a final evaluation is conducted to determine the effectiveness of the treatment in preventing the need for surgery.
The results are compared to those of participants who received a placebo to assess the primary objective of the study.

Who can join the trial?

6 criteria

The patient must be **50 years old or older**.
The patient must have a **chronic subdural hematoma (cSDH)** confirmed by a **CT scan**. This scan should have been done no more than **14 days** before joining the study. A CT scan is a special type of X-ray that gives detailed pictures of the inside of the body.
The patient should be receiving **primary conservative treatment**. This means they are being treated based on their symptoms without surgery.
The patient must have a **Glasgow Coma Scale score of 14 or higher**. This scale is used to check how well a person can open their eyes, speak, and move. A score of 14 means the person is almost fully alert.
The patient must have a **modified National Institutes of Health Stroke Scale (mNIHSS) score of 4 or lower**. This scale measures the severity of symptoms related to a stroke. A lower score means fewer symptoms.
The patient must have a **stable neurological deficit**. This means there should be no new symptoms or worsening of existing symptoms between the time they are checked by a neurologist (a doctor who specializes in the brain and nerves) and a neurosurgeon (a doctor who performs surgery on the brain and nerves).

Who cannot join the trial?

5 criteria

Patients who have a different medical condition other than Chronic Subdural Hematoma (a condition where blood collects on the brain's surface under its outer covering).
Patients who are not within the specified age range for the study.
Patients who are not part of the specified clinical trial group.
Patients who are not male or female, as both genders are included in the study.
Patients who are considered part of a vulnerable population, meaning they might need special protection or care.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Amsterdam UMC
Amsterdam, The Netherlands
Responsive
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Rotterdam, The Netherlands
Responsive
Universitair Medisch Centrum Utrecht
Utrecht, The Netherlands

Trial locations

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Investigated drugs

Tranexamic Acid (TXA) is a medication used in this trial to see if it can help patients with chronic subdural hematoma (cSDH) avoid the need for surgery. It works by helping to prevent bleeding, which might reduce the size of the hematoma and the need for surgical intervention.

Tranexamic Acid

What is already known about the treatment

Tranexamic Acid – Tranexamic Acid is administered orally or intravenously and is currently being studied for its effectiveness in treating chronic subdural hematoma. It is widely recognized in medical literature for its role in reducing bleeding by inhibiting the breakdown of blood clots. The main therapeutic indication for Tranexamic Acid in this context is to prevent the need for surgical intervention in patients with chronic subdural hematoma. At the molecular level, it works by blocking the activation of plasminogen to plasmin, an enzyme involved in the breakdown of fibrin clots. Tranexamic Acid is classified as an antifibrinolytic agent.

Investigated diseases

Chronic Subdural Hematoma – This condition involves the accumulation of blood between the brain and its outermost covering, the dura mater. It typically occurs due to minor head injuries, especially in older adults, and can develop over weeks or months. As the blood slowly collects, it can put pressure on the brain, leading to symptoms such as headaches, confusion, and weakness. The progression of the condition can vary, with some individuals experiencing gradual worsening of symptoms. In some cases, the hematoma may resolve on its own, while in others, it may require medical intervention to relieve the pressure. The condition is considered a rare disease, and its management often depends on the severity and progression of symptoms.