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Study on the Safety and Effectiveness of C1 Esterase Inhibitor and Sodium Chloride for 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 a treatment for patients who have experienced a subarachnoid hemorrhage, which is a type of bleeding in the space around the brain. The treatment being tested is called Cinryze, which contains a substance known as C1 esterase inhibitor (human). This substance is already approved for use in other conditions and works by blocking part of the body's immune system called the complement system. The trial will compare the effects of Cinryze to a placebo to see if it can help reduce inflammation and improve outcomes for patients with subarachnoid hemorrhage.

The purpose of the study is to evaluate the safety and effectiveness of Cinryze in managing the acute phase of subarachnoid hemorrhage. Participants in the study will receive either Cinryze or a placebo through an IV infusion, which means the treatment is given directly into a vein. The study will monitor participants for any complications during their hospital stay and assess their neurological condition over a period of 14 days. Researchers will also look at the activity of the complement system in the blood and spinal fluid, as well as other factors like the length of stay in the intensive care unit and the number of days on a ventilator.

By temporarily blocking the complement system, the study aims to limit the risk of delayed cerebral ischemia, a condition where the brain does not get enough blood flow, which can occur after a subarachnoid hemorrhage. The hope is that this approach will lead to better recovery and outcomes for patients by reducing the body's inflammatory response. The trial is expected to start recruiting participants in November 2024 and aims to complete by August 2025.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Upon joining the study, a confirmed diagnosis of aneurysmal subarachnoid hemorrhage is required. This is verified through a CT scan.

    Eligibility criteria include being 18 years or older and having a WFNS grade between 1 and 5.

  2. Step 2

    Treatment administration

    The treatment involves the administration of C1 esterase inhibitor (Cinryze) and sodium chloride.

    Cinryze is provided as a 500 IU powder and solvent for solution for injection. It is administered through an intravenous infusion.

    Sodium chloride is used as a 0.9% solution for infusion, also administered intravenously.

  3. Step 3

    Monitoring and evaluation

    The primary focus is on monitoring the number of participants experiencing delayed cerebral ischemia (DCI). This is identified by new neurological impairments or a decrease of at least 2 points on the Glasgow Coma Scale, lasting for at least 1 hour.

    Complications during hospitalization are also recorded.

  4. Step 4

    Secondary assessments

    Secondary assessments include checking for cerebral infarction on a brain CT at 14 days and monitoring mortality rates.

    Daily neurological condition is measured using the Glasgow Coma Scale during the first 14 days.

    Other evaluations include measuring complement activity in serum and cerebrospinal fluid (CSF), coagulation cascade activation, ICU length of stay, and ventilator days.

  5. Step 5

    Trial duration

    The estimated end date for the trial is August 1, 2025.

    Recruitment for the trial is expected to start on November 7, 2024.

Who can join the trial?

4 criteria

  • Must have a confirmed diagnosis of aneurysmal subarachnoid hemorrhage on a CT scan. This means that a special type of brain bleed has been identified using a detailed imaging test.
  • Must be 18 years of age or older.
  • Must have a WFNS grade between 1 and 5. This is a scale used by doctors to assess the severity of the brain bleed based on symptoms and consciousness level.
  • Both males and females can participate.

Who cannot join the trial?

5 criteria

  • Patients who have a different type of brain bleeding than the one being studied, called **aneurysmal subarachnoid hemorrhage**.
  • Patients who are not within the specified age range for the study.
  • Patients who are not part of the specific group being studied.
  • Patients who are not male or female, as both genders are included in the study.
  • Patients who are considered part of a vulnerable population, which means they might need special protection or care.
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Investigated drugs

Cinryze is a medication used in this clinical trial to study its safety and effectiveness in patients who have experienced a subarachnoid hemorrhage, which is a type of bleeding in the brain. This medication works by temporarily blocking a part of the immune system called the complement system. The goal is to reduce inflammation and prevent further brain damage, potentially leading to better recovery outcomes for patients.

What is already known about the treatment

Cinryze – This medication is administered intravenously and is currently being studied in clinical trials for its safety and effectiveness in treating aneurysmal subarachnoid hemorrhage. It is already approved for use as a complement system inhibitor. The main therapeutic indication is to reduce inflammation and prevent delayed cerebral ischemia in patients with subarachnoid hemorrhage. At the molecular level, Cinryze works by inhibiting the C1 component of the complement system, which plays a role in the body's inflammatory response. It is classified pharmacologically as a complement inhibitor.

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, decreased consciousness, or even coma. The bleeding can also lead to complications like delayed cerebral ischemia, where reduced blood flow causes further brain injury. This condition requires immediate medical attention to manage the bleeding and prevent further complications.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-520540-15-00Estimated enrolment128 patientsSponsorHaaglanden Medisch Centrum Stichting

sourced from the EU Clinical Trials Register and site verification

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