Study on Deferoxamine for Patients with Aneurysmal Subarachnoid Hemorrhage

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What is this study about?

This clinical trial is focused on studying the effects of a medication called Deferoxamine in patients who have experienced an aneurysmal subarachnoid hemorrhage. An aneurysmal subarachnoid hemorrhage is a type of bleeding that occurs in the space around the brain, often due to a burst blood vessel. The purpose of the study is to investigate how Deferoxamine, which is administered as a solution for injection or infusion, can impact the recovery process in these patients.

Participants in the study will receive either Deferoxamine or a placebo. The study will monitor the presence of new ischemia, which is a condition where blood flow (and thus oxygen) is restricted or reduced in a part of the body, at two weeks and six months after treatment. Additionally, the study will assess various outcomes related to neurological and functional health, such as serum ferritin levels and scores on scales like the modified Rankin Scale (mRS), the Glasgow Outcome Scale-Extended (GOS-E), and the EQ-5D, which is a standardized measure of health status.

The trial will follow participants over a period of time to gather data on these outcomes, aiming to provide insights into the potential benefits of Deferoxamine for individuals who have suffered from an aneurysmal subarachnoid hemorrhage. This research could help improve understanding and treatment of this serious condition.

1 enrollment

Eligibility is confirmed based on criteria such as age (18-85 years), diagnosis of subarachnoid hemorrhage by CT, and successful surgical or endovascular treatment.

Written informed consent is obtained from the patient.

2 initial assessment

Initial health assessments are conducted to establish baseline measurements.

These assessments include neurological and functional evaluations using scales like mRS, GOS-E, and EQ-5D.

3 treatment administration

The medication deferoxamine mesilate is administered intravenously.

The dosage and frequency are determined by the study protocol and medical team.

4 monitoring and follow-up

Regular monitoring is conducted to observe the effects of the treatment.

Control imaging is performed at 2 weeks and 6 months to check for new ischemia.

Serum ferritin levels and other health indicators are measured.

5 final assessment

A comprehensive evaluation is conducted at the end of the study period.

This includes a review of neurological and functional outcomes using the same scales as the initial assessment.

Who Can Join the Study?

Age between 18 and 85 years old.
Diagnosed with a subarachnoid hemorrhage by a CT scan when admitted to the hospital. A subarachnoid hemorrhage is bleeding in the space around the brain.
No history of the subarachnoid hemorrhage being caused by an injury.
Can be included in the study within 72 hours of the subarachnoid hemorrhage occurring.
Has a saccular intracranial aneurysm confirmed by cerebral angiography or CTA. This means there is a bulge in a blood vessel in the brain.
Has had successful surgical or endovascular treatment to fix the aneurysm. Endovascular treatment is a procedure done inside the blood vessels.
Able to provide written informed consent, meaning the patient understands the study and agrees to participate.
In good clinical condition, with a WFNS score of 1-3 and a GCS score of 13-15 at the time of randomization. WFNS and GCS are scales used to assess the severity of brain injury and the patient’s level of consciousness.

Who Cannot Join the Study?

Patients who have a medical condition other than a subarachnoid hemorrhage, which is bleeding in the space around the brain.
Patients who are not within the specified age range for the study.
Patients who belong to a vulnerable population, meaning they might need special protection or care.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Ujjhmpsgfgmy Mbpaylj Cwhpmtt Gcdvemaaa	Groningen	The Netherlands
Sdzjcemhn Ryrfrem Ukrryspfvz Mwiqmre Cpocei	Nijmegen	The Netherlands

Trial status

Country	Status	Recruitment Start
The Netherlands	Recruiting	01.12.2022

Trial locations

Investigated drugs:

Deferoxamine Mesilate

Deferoxamine is a medication being studied for its potential benefits in patients who have experienced an aneurysmal subarachnoid hemorrhage, which is a type of bleeding in the brain. The study aims to see if using deferoxamine can help reduce the risk of new ischemic events, which are areas of reduced blood flow in the brain, as observed in follow-up imaging. Additionally, the study will assess the impact of deferoxamine on various health and recovery scales over a six-month period.

Subarachnoid Hemorrhage – This condition occurs when there is bleeding in the space between the brain and the surrounding membrane, known as the subarachnoid space. It often results from a ruptured aneurysm, which is a weakened area in a blood vessel. The bleeding can lead to increased pressure on the brain, causing severe headaches, neck stiffness, and sensitivity to light. As the condition progresses, it may result in confusion, decreased consciousness, or even coma. The bleeding can also cause complications such as vasospasm, where blood vessels constrict, potentially leading to reduced blood flow and ischemia. Recovery and symptoms can vary widely depending on the severity and location of the hemorrhage.

Trial ID:

2024-514615-10-01

NCT ID:

NCT02875262

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study on Deferoxamine for Patients with Aneurysmal Subarachnoid Hemorrhage

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?