AuthorisedTherapeutic exploratory (Phase II)Interventional

Complement Inhibition: Attacking the Overshooting Inflammation @fter Subarachnoid Hemorrhage - A phase II trial on the safety and efficacy of C1 esterase inhibitor for the acute management of subarachnoid hemorrhage

This study is investigating a new medicine called C1 esterase inhibitor (Cinryze) for people who have had a specific type of stroke called an aneurysmal subarachnoid haemorrhage. This kind of stroke involves bleeding around the brain. The researchers want to find out if this medicine is safe and if it can help prevent a serious problem called 'delayed cerebral ischaemia' (DCI). DCI happens when parts of the brain don't get enough blood after the initial bleeding, which can lead to further brain damage. The study will also look at other important things like how long people stay in hospital, their recovery, and any side effects of the medicine. Participants will receive either the study medicine or a salt water solution.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Haaglanden Medisch Centrum Stichting

Enrolment target

128

Start

27 Jan 2025

aneurysmal subarachnoid hemorrhage

What is this study about?

This clinical trial is designed to investigate a new treatment for people who have experienced a particular kind of stroke called an "aneurysmal subarachnoid haemorrhage." This happens when a weak spot in a blood vessel in the brain (an aneurysm) bursts and bleeds into the space around the brain. This can be a very serious condition. After the initial bleeding, some people can develop another problem called "delayed cerebral ischaemia," or DCI. This is when the brain doesn't get enough blood, which can lead to further damage and affect a person's recovery.

The study medicine, called C1 esterase inhibitor (Cinryze), is thought to help calm down the body's overactive inflammatory response that can happen after this type of stroke. Researchers believe this inflammation might contribute to DCI. By giving this medicine, they hope to protect the brain and improve recovery for patients. This is a "Phase II" trial, which means they are carefully looking at how safe the medicine is and how well it works in a smaller group of people.

During the study, some participants will receive the C1 esterase inhibitor, while others will receive a simple salt water solution (placebo). This helps the researchers accurately compare the effects of the new medicine. They will closely monitor participants for signs of DCI, changes in their brain scans, how long they stay in intensive care, and their overall recovery in hospital. The goal is to see if this new treatment can make a meaningful difference for patients after this severe type of stroke.

Key takeaways

Exploring a new treatment for a serious type of stroke.
Aims to reduce further brain damage after a subarachnoid haemorrhage.
Participants will receive either the study drug or a salt solution.
Focus is on safety and effectiveness in preventing complications.
Involves close medical monitoring during hospital stay.

Who may be eligible?

To join this study, participants must be at least 18 years old, and there is no upper age limit. The study is open to both men and women.

The specific medical condition for this study is having had an aneurysmal subarachnoid haemorrhage. This means you would have recently experienced a bleeding stroke caused by an aneurysm in your brain.

While the exact details about who cannot join are not provided here, generally, studies like this might exclude people with certain other serious health conditions or those taking specific medications that could interfere with the study treatment. Your doctor will be able to tell you if you meet all the criteria.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you at least 18 years old?
Have you recently had an aneurysmal subarachnoid haemorrhage?
Are you able to stay in hospital for close monitoring?
Do you want to potentially try a new investigational treatment?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will either receive the study medicine, C1 esterase inhibitor (Cinryze), or a salt water solution through a drip into your vein. This will happen during your hospital stay for the subarachnoid haemorrhage. The study involves close monitoring of your health, including regular checks of your brain function, possibly daily. Doctors will use brain scans (like CT or MRI) to look for any changes in your brain, especially around 14 days after the stroke.

Blood and spinal fluid samples may also be taken to measure how the medicine is affecting your body and the inflammation response. The healthcare team will keep a close eye on any complications you might experience during your hospital stay, how long you stay in the intensive care unit, and how many days you need help breathing from a machine (ventilator). The main focus will be on monitoring for delayed cerebral ischaemia and overall recovery during your time in the hospital.

Potential risks and benefits

Participating in this study might offer potential benefits, such as receiving a new treatment that could help reduce brain damage after a subarachnoid haemorrhage. However, like all medicines, the C1 esterase inhibitor might have side effects, and the salt water solution has no active medical effect. Researchers will closely monitor you for any potential complications. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Netherlands

Common questions

What is aneurysmal subarachnoid haemorrhage?

It's a serious type of stroke caused by bleeding into the space around the brain, usually from a burst blood vessel called an aneurysm.

What is delayed cerebral ischaemia (DCI)?

DCI is a complication after this type of stroke where parts of the brain don't get enough blood, potentially causing more brain damage.

What is C1 esterase inhibitor?

It's a medicine being tested to see if it can reduce inflammation and help prevent DCI after a subarachnoid haemorrhage.

Will I definitely get the new medicine?

You will either receive the new medicine or a salt water solution (placebo). This helps researchers fairly compare its effects.

What is a Phase II trial?

It's an early stage of a clinical trial where researchers check the safety of a new treatment and how well it seems to work in a smaller group of people.