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Study on the Safety and Effectiveness of C1 Esterase Inhibitor and Sodium Chloride for Patients with Traumatic Brain Injury

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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 individuals who have experienced a Traumatic Brain Injury (TBI). The treatment being tested is called C1 Esterase Inhibitor (Human), also known by the brand name Cinryze. This medication is administered as a solution for injection. The study also involves the use of a Saline Solution, which is a common fluid used in medical settings, often for hydration or as a vehicle for other medications.

The purpose of the study is to evaluate the safety and effectiveness of the C1 Esterase Inhibitor in patients with traumatic brain injury. Participants in the study will receive either the C1 Esterase Inhibitor or a placebo, and their progress will be monitored over a period of time. The study aims to understand how well the treatment works in reducing inflammation and improving outcomes after a traumatic brain injury.

Throughout the study, participants will be closely observed to track any changes in their condition and to identify any potential side effects. The study will use various scales and assessments to measure the intensity of therapy required and the overall recovery of the participants. The goal is to gather valuable information that could lead to better treatment options for those affected by traumatic brain injuries in the future.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, the patient will be informed about the trial's purpose, which is to study the safety and effectiveness of a treatment for traumatic brain injury.
The patient will be required to meet certain criteria, such as being over 18 years old and having a specific level of consciousness as measured by the Glasgow Coma Scale.
Step 2
Treatment administration
The patient will receive a medication called Cinryze 500 IU, which is a powder mixed with a liquid to create a solution for injection.
This medication will be administered through a vein, a process known as intravenous use.
Additionally, a saline solution will be used, which is a simple saltwater solution given through a vein to help with hydration and medication delivery.
Step 3
Monitoring and follow-up
Throughout the trial, the patient's response to the treatment will be closely monitored.
The primary focus will be on the therapy intensity level scale, which measures the level of treatment required.
Secondary observations will include any serious adverse events and the patient's recovery progress as measured by the Glasgow Outcome Scale Extended.
Step 4
Completion of the trial
The trial is expected to continue until July 1, 2025.
Upon completion, the patient's overall health and recovery will be assessed to determine the effectiveness and safety of the treatment.

Who can join the trial?

4 criteria

The patient must have a Traumatic Brain Injury.
The patient must be older than 18 years.
The patient must have a GCS score of less than 13. GCS stands for Glasgow Coma Scale, which is a way to measure how conscious a person is after a brain injury.
The patient must have an ICP monitor. ICP stands for Intracranial Pressure, and the monitor is a device used to measure the pressure inside the skull.

Who cannot join the trial?

8 criteria

Patients who have a history of **severe allergic reactions** to the study medication cannot participate. A severe allergic reaction is a serious response by the body to a substance, which can cause symptoms like swelling, difficulty breathing, or a rash.
Patients who are currently participating in another clinical trial are not eligible. This means if you are already part of another study, you cannot join this one.
Patients with **uncontrolled medical conditions** that could interfere with the study results cannot participate. Uncontrolled medical conditions are health issues that are not being managed well with treatment.
Patients who are pregnant or breastfeeding are not allowed to join the study. This is to ensure the safety of both the mother and the baby.
Patients with a history of **substance abuse** within the past year are excluded. Substance abuse refers to the harmful use of substances like drugs or alcohol.
Patients who have had a **major surgery** within the last 30 days cannot participate. Major surgery is a significant medical procedure that requires a longer recovery time.
Patients with **severe liver or kidney disease** are not eligible. These are serious conditions affecting the liver or kidneys, which are important organs for filtering and cleaning the blood.
Patients who have a **mental health condition** that could interfere with their ability to participate in the study are excluded. This means if a mental health issue makes it difficult to follow study instructions, you cannot join.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Responsive
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Rotterdam, The Netherlands
Responsive
Leids Universitair Medisch Centrum (LUMC)
Leiden, The Netherlands
Verified
Medical Center Haaglanden
Leidschendam, The Netherlands

Trial locations

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Investigated drugs

C1-INH is a medication being studied for its potential to help people who have suffered a traumatic brain injury. This medication works by blocking certain proteins in the body that can cause inflammation. After a brain injury, inflammation can become excessive and harmful, so C1-INH aims to reduce this overshooting inflammation, potentially leading to better recovery outcomes for patients. The trial is focused on understanding how safe and effective C1-INH is for these patients.

What is already known about the treatment

C1-INH – C1-INH is administered through an injection, typically given intravenously, meaning it is delivered directly into the bloodstream. Currently, this medication is being studied in clinical trials to assess its safety and effectiveness for treating traumatic brain injury. The main therapeutic use of C1-INH is to reduce excessive inflammation that occurs after a traumatic brain injury. At the molecular level, C1-INH works by inhibiting certain proteins in the immune system that can cause inflammation, helping to prevent further damage to the brain. It is classified pharmacologically as a complement inhibitor, which means it helps control parts of the immune system that can become overactive.

Investigated diseases

Traumatic Brain Injury – Traumatic Brain Injury (TBI) occurs when an external force injures the brain. It can result from falls, vehicle accidents, or violence. The injury can cause a range of physical and psychological effects, which may appear immediately or develop over time. Symptoms can include headaches, confusion, dizziness, blurred vision, and difficulty concentrating. As the condition progresses, individuals may experience mood changes, memory problems, and sleep disturbances. In severe cases, TBI can lead to long-term complications affecting cognitive and motor functions.