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Effect of Low‑Dose Dexamethasone on Surgical Re‑operation Rate in Adults with Chronic Subdural Hematoma after Burr‑hole Drainage

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What is this trial about?

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

Chronic subdural hematoma is a buildup of blood under the outer covering of the brain that can cause pressure, headache, confusion, or weakness. Standard care often involves a small surgical opening called a burr‑hole to drain the blood. In this study, participants receive either a low‑dose oral tablet of dexamehthasone (a steroid that reduces inflammation) or a matching placebo after the operation.

The purpose of the study is to determine whether the postoperative steroid regimen lowers the chance of needing another surgery for the same condition within six months, without increasing disability or death.

After surgery, participants take the assigned tablets for ten days, reaching a total dose of 41 mg. Follow‑up visits occur over the next six months to monitor for repeat surgery, overall health, and ability to perform daily activities. Functional ability is assessed with the modified Rankin Scale, a simple rating from 0 (no symptoms) to 6 (severe disability), as well as other standard questionnaires that capture quality of life and daily living skills.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Randomization and Receiving Study Medication

    After you have undergone the required burr‑hole surgery, you will be randomly assigned to receive either dexamethasone tablets or identical placebo tablets. The assignment is done by the study team and you will not know which one you receive.

    You will be given a supply of tablets and written instructions on how to take them.

  2. Step 2

    Medication Period – First 10 Days

    You will take the tablets by mouth as instructed, usually one tablet each day. The total amount of dexamethasone you will receive over the 10‑day period is 41 mg, which is achieved by the specific dosing schedule provided to you.

    If you have been assigned to the placebo group, you will take the same number of tablets on the same schedule, but the tablets contain no active medicine.

    During this time you should note any new symptoms or side effects and report them to the study clinician at the next scheduled contact.

  3. Step 3

    Early Post‑Medication Check

    Within a few days after the 10‑day medication period, you will have a brief telephone or in‑person check to confirm that the medication course was completed and to discuss any concerns.

  4. Step 4

    First Follow‑Up Visit (Approximately 1 Month After Surgery)

    You will attend a clinic visit about one month after your surgery. During this visit the study team will assess your recovery, including a simple questionnaire about daily activities and any new neurological symptoms.

    The assessment may include a brief version of a memory test called the Mini‑MoCA.

  5. Step 5

    Second Follow‑Up Visit (Approximately 3 Months After Surgery)

    A second clinic visit will be scheduled around three months after surgery. The same types of assessments as at the one‑month visit will be repeated to monitor your progress.

  6. Step 6

    Primary Outcome Visit (6 Months After Surgery)

    At six months you will have a comprehensive follow‑up appointment. The study will evaluate whether another surgery was needed for the same side of the brain, using the information from your medical records.

    Your functional ability will be measured with the Modified Rankin Scale (a score from 0 = no symptoms to 6 = death). Scores of 4–6 indicate an unfavorable outcome.

    Your ability to perform daily activities will be measured with the Barthel Index.

    Quality of life will be assessed with a questionnaire called EQ‑5D‑5L.

    Cognitive function will be checked again with the Mini‑MoCA test.

    All‑cause mortality (whether you are alive or not) will also be recorded.

  7. Step 7

    Long‑Term Follow‑Up (2 Years After Surgery)

    Approximately two years after the surgery, you may be asked to provide information about your functional status using the Modified Rankin Scale and to confirm your vital status.

Who can join the trial?

5 criteria

  • Age: You must be 18 years old or older at the time of the surgery.
  • Symptomatic chronic subdural hematoma confirmed by a brain scan (cranial CT or MRI) that requires a small‑hole surgical drainage (burr‑hole drainage).
  • You must be randomly assigned to a treatment group and receive the first dose of the study medication within 2 days after the surgery.
  • You must provide written informed consent. If you cannot give consent because of your condition, a legally authorized representative (such as a family member or legal guardian) can sign for you, and you will confirm your agreement later when you are able.
  • Patients with mild cognitive problems or dementia are allowed to join if a legal representative gives consent on their behalf.

Who cannot join the trial?

13 criteria

  • Had another surgery for chronic subdural hematoma (CSDH) within the past 12 months.
  • Known allergy (hypersensitivity) to dexamethasone or any ingredient in the study medication.
  • Regular use of strong steroids (corticosteroids) at a dose higher than prednisolone 10 mg per day (equivalent to dexamethasone 1.5 mg per day) for more than one month before admission.
  • Planned to have a special procedure called MMA embolization as part of the first treatment for the current CSDH.
  • Any health condition where dexamethasone should not be used, such as an active infection needing IV antibiotics, a fungal infection, active tuberculosis, blood cancer (hematological malignancy) or very low bone‑marrow function, a stomach ulcer, Cushing’s syndrome, severe mental illness (psychosis), or uncontrolled diabetes.
  • Serious illness with expected survival less than 6 months.
  • Women who could become pregnant (not confirmed post‑menopausal or permanently surgically sterile).
  • Already took part in this trial for a different CSDH episode.
  • Unable to attend follow‑up visits (no fixed address, moving abroad, not living in Finland).
  • Cannot understand or speak Finnish or Swedish.
  • Already enrolled in another CSDH clinical trial.
  • Has a cerebrospinal fluid (CSF) shunt placed.
  • The CSDH is located in an arachnoid cyst.
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Investigated drugs

Dexamethasone is a steroid medication taken by mouth in tablet form. In this study, patients receive it after surgery for a chronic subdural hematoma to try to lower the chance that the blood collection returns and needs another operation. The drug works by reducing inflammation and swelling in the brain area that was operated on. Researchers are watching to see if it can prevent repeat surgery without causing more disability or increasing the risk of death within six months.

What is already known about the treatment

  • Dexametason Abcur 1 mg tabletter

    This medication is taken by mouth as a swallowed tablet. Dexamethasone is an approved corticosteroid that is widely used in medical practice and well described in the scientific literature. It is mainly used to treat inflammation, allergic reactions, and certain immune conditions by attaching to glucocorticoid receptors and lowering the activity of inflammatory chemicals in the body. It belongs to the drug class called glucocorticoids, a type of steroid medication.

  • Placebo 9 mm tablet

    This is an inert tablet taken orally in the same way as the active drug, but it contains no medication and therefore has no therapeutic effect. Placebos are commonly used in clinical trials to compare the effects of the real drug against a neutral control. They look the same as the active tablets so that participants and doctors cannot tell the difference. This helps researchers see whether any benefit comes from the drug itself.

Investigated diseases

Chronic subdural hematoma - It is a slow‑growing collection of blood that accumulates beneath the outer membrane covering the brain, usually after a minor head injury. Over weeks, the blood expands and puts gentle pressure on the brain tissue. This pressure can cause symptoms such as headache, confusion, weakness, or balance problems that may gradually worsen. If the collection re‑accumulates after an initial drainage, it may require another surgical procedure. The condition most often occurs in older adults.
Trial detailsLast updated 2 Nov 2026
Age18+ yearsPhasePhase IIITrial ID2026-527048-41-00Protocol codeFINDEXEstimated enrolment670 patientsSponsorHUS-yhtymae

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