Study on the Safety and Effects of Ixodes ricinus Contact Phase Inhibitor in Adults with Spontaneous Brain Bleeding

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What is this study about?

This clinical trial is focused on studying a condition known as spontaneous intracerebral hemorrhage, which is a type of bleeding that occurs inside the brain without any obvious cause. The study is testing a new treatment called Ixodes ricinus Contact Phase Inhibitor, also known by its code name Ir-CPI. This treatment is given as a solution through an infusion into the veins. The main goal of the study is to evaluate how safe and tolerable this new treatment is for patients who have experienced this type of brain bleed.

Participants in the study will receive either the new treatment or a placebo. The study will monitor various health indicators to ensure the safety of the participants, such as checking for any adverse events, conducting physical and neurological examinations, and performing blood tests to assess biochemistry and coagulation. The study will also use CT scans to measure changes in the volume of the hemorrhage and other related factors.

The study is designed to provide important information about the potential benefits and risks of using Ir-CPI in treating spontaneous intracerebral hemorrhage. By participating in this study, researchers hope to gather data that could lead to new treatment options for this serious condition. The study is expected to continue for several years to ensure comprehensive results are obtained.

1 enrollment

Upon joining the study, you will be required to provide written informed consent. This means you agree to participate after understanding the study’s purpose and procedures.

Eligibility will be confirmed based on criteria such as age (18 years or older), having a first-ever spontaneous intracerebral hemorrhage (ICH) with a specific volume, and certain scores on medical scales.

2 initial assessment

You will undergo a series of initial assessments. These include physical examinations, neurological evaluations, and tests like ECGs (which check your heart’s electrical activity).

Blood tests will be conducted to check biochemistry, hematology, and coagulation levels.

3 treatment administration

You will receive the study medication, Ixodes ricinus contact phase inhibitor, as a solution for infusion. This means it will be administered directly into your bloodstream through a vein.

The dosage, frequency, and duration of administration will be determined by the study protocol and communicated to you by the medical team.

4 monitoring and follow-up

Throughout the study, you will be closely monitored for any adverse events or side effects. This includes regular checks of your vital signs and additional physical and neurological evaluations.

Further blood tests will be conducted to measure changes in the medication’s concentration in your plasma and its effects on blood coagulation.

5 imaging assessments

You will undergo CT scans to measure changes in the volume of the hemorrhage and other related parameters.

These imaging assessments help evaluate the effects of the treatment on your condition.

6 completion

At the end of the study, a final assessment will be conducted to evaluate your overall health and the outcomes of the treatment.

You will be informed about the results and any further steps if necessary.

Who Can Join the Study?

Patients must be male or female and at least 18 years old.
Patients must provide written informed consent, which means they agree to participate after understanding the study details.
Patients must have a first-ever, spontaneous, supratentorial intracerebral hemorrhage (ICH) with a blood volume between 5 mL and 60 mL. This means a type of stroke caused by bleeding in a specific part of the brain.
Patients must have a Glasgow Coma Scale (GCS) best motor score of at least 5. The GCS is a scale used to measure a person’s level of consciousness after a brain injury, and a score of 5 indicates some level of motor response.
Patients must have a Modified Rankin Scale (mRS) score between 0 and 2. The mRS measures the degree of disability or dependence in daily activities, with lower scores indicating less disability.

Who Cannot Join the Study?

Patients who have a medical condition other than spontaneous intracerebral haemorrhage cannot participate. This means if you have a different health issue, you may not be eligible.
Patients who are not within the specified age range cannot participate. The study is open to certain age groups only.
Patients who are not part of the specified clinical trial groups cannot participate. This means the study is looking for specific types of participants.
Patients who are not male or female cannot participate. The study is open to both men and women.
Patients who are not considered part of a vulnerable population cannot participate. This refers to groups of people who 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
Katholieke Universiteit te Leuven	Leuven	Belgium
Université Libre de Bruxelles – Hôpital Erasme	Brussels	Belgium

Other Sites

Site Name	City	Country
Az St-Jan Brugge-Oostende A.V.	Brugge	Belgium
CHC MontLegia	Liege	Belgium
Universitair Ziekenhuis Gent	Gent	Belgium
Vrije Universiteit Brussel	Jette	Belgium
Algemeen Ziekenhuis Groeninge	Kortrijk	Belgium
Algemeen Ziekenhuis Damiaan Oostende	Ostend	Belgium
Cma Hkkvwe	Mons	Belgium
Ccwahgfph Uetehlgqbvfjot Semrphvpc	Woluwe-Saint-Lambert	Belgium

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	08.04.2023

Trial locations

Investigated drugs:

Ixodes Ricinus Contact Phase Inhibitor

Ir-CPI is a medication being studied to see if it is safe and well-tolerated in patients who have had a spontaneous bleeding in the brain, known as intracerebral hemorrhage. This study is trying to find out if Ir-CPI can help these patients by evaluating how their bodies handle the medication and if it causes any side effects. The goal is to understand if Ir-CPI can be a potential treatment option for people who experience this type of brain bleeding.

Spontaneous intracerebral hemorrhage – This condition involves bleeding within the brain tissue itself, which occurs without any external trauma. It is often caused by the rupture of small blood vessels due to high blood pressure or other vascular abnormalities. The bleeding leads to a sudden increase in pressure within the skull, which can damage brain cells and disrupt normal brain function. As the hemorrhage progresses, it can cause symptoms such as sudden headache, weakness, confusion, and loss of consciousness. The size and location of the bleed determine the severity of the symptoms and the potential for recovery. Over time, the body may reabsorb the blood, but the initial damage to brain tissue can have lasting effects.

Trial ID:

2022-500491-53-00

Protocol code:

Clin_IrCPI_201

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Safety and Effects of Ixodes ricinus Contact Phase Inhibitor in Adults with Spontaneous Brain Bleeding

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?