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

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What is this study about?

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.

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 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 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 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 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 adverse events analysis

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

Who Can Join the Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Medizinische Hochschule Hannover Hanover Germany
Universitaetsmedizin Goettingen Goettingen Germany
Universitaet Leipzig Leipzig Germany

Other Sites

Site Name City Country Status
Universitaetsklinikum Regensburg AöR Regensburg Germany
Universitaetsklinikum Tuebingen AöR Tuebingen Germany
Universitaetsklinikum Magdeburg AöR Magdeburg Germany
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Rheinische Friedrich-Wilhelms-Universitaet Bonn Bonn Germany
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum) Munich Germany
Ulttshbyks Moxxyjf Cyohae Hhdaqmhwqkljqridq Hamburg Germany
Urjkuofculedcyxmesauv Evrtn Aco Essen Germany
Brlfnvvvnwkimbgcdu Gsaxzgtcqs Guenzburg Germany
Ubxkdvycnw Hodpnzgu Caufgqk Cologne Germany
Gmmulk Ukyhjqbljw Fznlanlvp Frankfurt Germany

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Germany Germany
Not recruiting
18.12.2021

Trial locations

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.

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 ID:
2024-512314-17-00
Protocol code:
NCH-201803
Trial Phase:
Therapeutic confirmatory (Phase III)

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