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Study on Early vs. Late Restart of Anticoagulation with Edoxaban, Apixaban, and Warfarin for Patients with Chronic Subdural Hematoma and Atrial Fibrillation

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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 the effects of restarting blood-thinning medications, known as anticoagulants, in patients who have undergone surgery for a condition called chronic subdural hematoma and also have atrial fibrillation. Chronic subdural hematoma is a condition where blood collects on the surface of the brain, often requiring surgical intervention. Atrial fibrillation is a common heart rhythm disorder that can increase the risk of stroke. The trial will compare the outcomes of starting these medications early versus later after surgery.

The medications being studied include Edoxaban, Apixaban, Warfarin, Dabigatran Etexilate, and Rivaroxaban. These are all oral anticoagulants, which means they are taken by mouth to help prevent blood clots. The purpose of the study is to understand the overall effects of these medications when resumed at different times after surgery, focusing on events like stroke, bleeding, and death related to blood vessels.

Participants in the study will be randomly assigned to either restart their anticoagulation medication early or later after their surgery. The study will monitor various health outcomes over a period of time to determine the best approach for managing anticoagulation in these patients. The trial aims to provide valuable information that could help improve treatment strategies for individuals with both chronic subdural hematoma and atrial fibrillation.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the trial
Upon joining the study, you will be randomly assigned to one of two groups. This process is called randomization and ensures that each participant has an equal chance of being placed in either group.
Step 2
Surgery and initial recovery
You will undergo a procedure called burr-hole evacuation to treat your chronic subdural hematoma. This is a surgical process to remove the buildup of blood on the brain's surface.
After surgery, you will begin your recovery in the hospital. During this time, your health will be closely monitored by medical professionals.
Step 3
Resumption of medication
Depending on the group you are assigned to, you will restart your oral anticoagulation medication either early or later after surgery. This medication helps prevent blood clots and is important for managing atrial fibrillation.
The medications used in this trial include edoxaban, apixaban, warfarin, dabigatran etexilate, and rivaroxaban. These are taken orally, meaning you will swallow them as pills.
Step 4
Follow-up visits
You will have regular follow-up visits with the study team. These visits are important to monitor your health and the effects of the medication.
During these visits, you may undergo various tests and assessments to check for any thromboembolic events (such as stroke), hemorrhagic events (such as bleeding), and other health outcomes.
Step 5
Completion of the trial
The trial is expected to continue until December 31, 2026. Your participation will last until the study is completed or until your doctor advises otherwise.
At the end of the trial, the results will be analyzed to understand the effects of early versus later resumption of anticoagulation medication.

Who can join the trial?

6 criteria

Must be at least 18 years old.
Have a chronic subdural hematoma (CSDH) that needs surgery. This is a condition where blood collects on the brain's surface under its outer covering.
Currently taking oral anticoagulation medication because of atrial fibrillation (AF). Atrial fibrillation is a heart condition that causes an irregular and often rapid heartbeat.
Randomization, which is the process of assigning participants to different groups in a study, must be done within 4 days after surgery.
People with cognitive impairment, such as mild memory problems or dementia, can participate if someone legally authorized can give consent for them.
Taking either standard or reduced doses of oral anticoagulants for preventing strokes due to atrial fibrillation is acceptable. Reduced doses should follow approved guidelines based on factors like kidney function, age, and body weight.

Who cannot join the trial?

5 criteria

Patients who do not have a diagnosis of chronic subdural hematoma or atrial fibrillation cannot participate.
Patients who are not within the specified age range for the study cannot participate.
Patients who are not part of the specified clinical trial group cannot participate.
Patients who are not able to provide informed consent cannot participate.
Patients who are part of a vulnerable population that the study does not include cannot participate.

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Verified sites

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Helsinki University Central Hospital
Helsinki, Finland
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Karolinska University Hospital
Solna, Sweden
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Kuopio University Hospital
Kuopio, Finland

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Investigated drugs

Oral Anticoagulation Medication is a type of medicine that helps prevent blood clots from forming in your body. This is important for people with atrial fibrillation, a condition where the heart beats irregularly, which can lead to blood clots. In this trial, the focus is on when to restart this medication after surgery for a condition called chronic subdural hematoma, which is a type of bleeding in the brain. The goal is to find out if starting the medication early or later is better for preventing problems like strokes or further bleeding.

What is already known about the treatment

Oral Anticoagulation Medication – This medication is taken by mouth and is used to prevent blood clots. It is currently being studied in the RELACS clinical trial to determine the best time to restart it after surgery for patients with atrial fibrillation who have had a chronic subdural hematoma. The main use of this medication is to reduce the risk of stroke and other clot-related problems in people with irregular heartbeats. It works by interfering with the blood's ability to clot, which helps prevent dangerous clots from forming. This medication is classified as an anticoagulant, which means it helps keep the blood flowing smoothly.

Investigated diseases

Chronic subdural hematoma
This condition involves the accumulation of blood between the brain's surface and its outer covering, known as 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 is gradual, and symptoms may worsen over time if the hematoma enlarges. It can cause changes in mental status, balance issues, and in severe cases, seizures. The condition may require medical intervention to relieve the pressure on the brain.
Atrial fibrillation
This is a common heart rhythm disorder characterized by an irregular and often rapid heartbeat. It occurs when the heart's upper chambers, the atria, beat out of coordination with the lower chambers, the ventricles. This can lead to symptoms such as palpitations, shortness of breath, and fatigue. The condition can be persistent or intermittent, with episodes that may last from minutes to hours. Over time, atrial fibrillation can lead to complications such as blood clots, which can increase the risk of stroke. The irregular heart rhythm can also affect the heart's efficiency in pumping blood, potentially leading to heart failure.