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Study on the Effects of Dexamethasone in Patients with Aneurysmal Subarachnoid Hemorrhage

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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 an anti-inflammatory treatment for patients who have experienced an aneurysmal subarachnoid hemorrhage (SAH). This condition occurs when there is bleeding in the space surrounding the brain, often due to a burst blood vessel. The treatment being tested is called dexamethasone sodium phosphate, which is a medication used to reduce inflammation. In this study, some patients will receive dexamethasone, while others will receive a placebo, which looks like the medication but does not contain the active substance.

The purpose of the study is to understand how dexamethasone affects recovery in patients with SAH, whether or not they initially show signs of inflammation in their blood. Participants in the study will receive either the dexamethasone treatment or a placebo. The study will monitor patients over a period of time to assess their recovery and any changes in their condition. This includes looking at survival rates, the length of time spent in the hospital, and any complications that may arise, such as delayed ischemic neurological deficits, which are problems with brain function that occur after the initial bleeding.

Throughout the study, various health indicators will be measured, such as levels of inflammation in the blood and overall quality of life. The study aims to provide valuable insights into whether dexamethasone can improve outcomes for patients who have suffered from an aneurysmal subarachnoid hemorrhage. The results will help determine if this treatment can be beneficial in managing the condition and improving patient recovery.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Participation begins after providing written consent. This can be given by the patient or a legal representative. In emergencies, consent may be provided by a next of kin or a consultant physician.

    Eligibility requires being 18 years or older and having a confirmed diagnosis of aneurysmal subarachnoid hemorrhage (SAH) within 48 hours before joining the study.

  2. Step 2

    Treatment administration

    The study involves receiving an anti-inflammatory treatment with dexamethasone or a placebo. The medication is administered as a solution for injection.

    The route of administration is intravenous, meaning the medication is given directly into a vein.

  3. Step 3

    Monitoring and assessments

    The impact of the treatment is analyzed by comparing outcomes between the treatment and placebo groups.

    Primary assessment occurs 6 months after the hemorrhage, using the modified Rankin Scale (mRS) to evaluate mortality and severe disability.

  4. Step 4

    Secondary evaluations

    Additional evaluations include mortality analysis at 7, 90, and 365 days after the hemorrhage.

    Other assessments involve the length of stay in the intensive care unit and overall hospitalization, as well as the occurrence of delayed ischemic neurological deficits and symptomatic vasospasm.

  5. Step 5

    Inflammation and quality of life assessments

    Inflammation levels are measured through various parameters such as CRP, PCT, WBC, and IL-6 in the blood.

    Quality of life is assessed using SF36 and EQ-ED scores at discharge and at 90, 180, and 365 days after the hemorrhage.

  6. Step 6

    Adverse events analysis

    Any adverse events are analyzed based on their number, severity, and relationship to the treatment.

Who can join the trial?

4 criteria

  • Participants can be either male or female.
  • Participants must be **18 years old** or older.
  • Participants or their legal representative must provide **written consent** to join the study. In emergencies, consent can be given by a close family member or a doctor, under the main researcher's responsibility.
  • Participants must have a **confirmed diagnosis** of aneurysmal subarachnoid hemorrhage (SAH), which is a type of bleeding in the brain, and this must have started within **48 hours** before joining the study.

Who cannot join the trial?

4 criteria

  • Patients who have a different medical condition than the one being studied, which is **Aneurysmal Subarachnoid Hemorrhage (SAH)**. This is a type of bleeding in the brain.
  • Patients who are not within the specified age range for the study.
  • Patients who belong to a clinical trial group that is not included in this study.
  • Patients who are part of a vulnerable population, which means they might need special protection or care.
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Investigated drugs

Dexamethasone is a medication used in this trial to reduce inflammation. It is being tested to see if it can improve outcomes for patients who have experienced an acute aneurysmal subarachnoid hemorrhage, which is a type of bleeding in the brain. The study aims to determine if this anti-inflammatory treatment can help patients recover better by reducing inflammation in the body.

What is already known about the treatment

Dexamethasone – Dexamethasone is administered orally or via injection, depending on the specific medical needs. It is currently well-established in medical literature as a potent anti-inflammatory and immunosuppressant medication. The main therapeutic indication for dexamethasone in this context is to reduce inflammation in patients with aneurysmal subarachnoid hemorrhage. At the molecular level, dexamethasone works by binding to glucocorticoid receptors, which then modulate the expression of anti-inflammatory proteins and suppress pro-inflammatory cytokines. It is classified pharmacologically as a corticosteroid.

Investigated diseases

Aneurysmal Subarachnoid Hemorrhage – This condition occurs when a blood vessel on the surface of the brain bursts, leading to bleeding in the space between the brain and the surrounding membrane. It often results from a weakened area in a blood vessel wall, known as an aneurysm. The bleeding can increase pressure on the brain, leading to symptoms such as a sudden severe headache, neck stiffness, and sensitivity to light. As the condition progresses, it may cause confusion, seizures, or loss of consciousness. The initial bleeding can also lead to complications like rebleeding or delayed ischemic neurological deficits. Recovery and outcomes can vary, depending on the severity and location of the hemorrhage.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-512314-17-00Protocol codeNCH-201803Estimated enrolment334 patientsSponsorRheinische Friedrich-Wilhelms-Universitaet Bonn

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