In short
Currently, there is 1 ongoing clinical trial investigating new treatment approaches for subdural haematoma. This trial is exploring whether a medication called Tranexamic Acid can help patients with chronic subdural haematoma avoid the need for surgery. The study is being conducted in the Netherlands and focuses on using this oral medication as a primary conservative treatment option.
Clinical trial locations
Study on Tranexamic Acid to Prevent Surgery in Patients with Chronic Subdural Hematoma
This clinical trial is investigating a medication called Tranexamic Acid as a potential treatment for chronic subdural haematoma. A chronic subdural haematoma occurs when blood slowly collects between the brain and its outer covering, often following minor head injuries. This condition is particularly common in older adults and can cause symptoms such as headaches, confusion, and weakness.
Who can participate:
- Patients must be 50 years of age or older
- They must have a confirmed chronic subdural haematoma shown on a CT scan performed within the past 14 days
- Patients should be receiving treatment based on their symptoms without immediate surgery
- They must have a Glasgow Coma Scale score of 14 or higher, which indicates they are almost fully alert and able to open their eyes, speak, and move appropriately
- Their modified National Institutes of Health Stroke Scale score must be 4 or lower, meaning they have relatively mild symptoms
- Participants must have a stable neurological condition, with no new symptoms or worsening between assessments by neurologists and neurosurgeons
Who cannot participate:
- Patients with medical conditions other than chronic subdural haematoma
- Those who fall outside the specified age range
- Patients who are part of vulnerable populations requiring special protection or care
What the trial involves:
The main goal of this study is to determine whether patients who take Tranexamic Acid are less likely to need surgery within 12 weeks compared to those who receive a placebo. Tranexamic Acid is an antifibrinolytic medication, which means it helps prevent blood clots from breaking down. By stabilizing blood clots, it may help reduce the size of the haematoma and prevent further bleeding, potentially eliminating the need for surgical drainage.
Participants will take Tranexamic Acid in capsule form according to the study protocol. Throughout the 12-week monitoring period, their progress will be carefully observed to assess whether the medication effectively manages their condition without requiring surgery. Regular evaluations will track any changes in symptoms and overall health status. At the end of the 12 weeks, researchers will compare the outcomes between those who received the medication and those who received the placebo to determine the treatment's effectiveness.
Investigational medication:
Tranexamic Acid works at the molecular level by blocking the activation of plasminogen to plasmin, an enzyme involved in breaking down fibrin clots. By preventing this breakdown, the medication helps maintain clot stability and may reduce the bleeding that contributes to haematoma growth. This medication is already widely used in other medical situations to control bleeding, and this trial aims to explore its potential benefit specifically for chronic subdural haematoma.
Summary
At present, only one clinical trial is actively recruiting patients with subdural haematoma. This trial, conducted in the Netherlands, represents an important step in exploring non-surgical treatment options for chronic subdural haematoma. The focus on Tranexamic Acid reflects a growing interest in finding conservative treatment approaches that could help patients avoid surgery and its associated risks, particularly in older populations who may be more vulnerable to surgical complications. If successful, this research could offer a valuable alternative treatment pathway for managing this condition.
