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A study to evaluate the safety, tolerability and the effects of Ixodes ricinus-Contact Phase Inhibitor (Ir-CPI) in adult patients with spontaneous intracerebral haemorrhage - the BIRCH study
EU CTIS ID: 2022-500491-53-00
What this study is testing
To assess the safety and tolerability profile of Ir-CPI in ICH patients
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Male or female patients aged ≥ 18 years
- written informed consent obtained
- First-ever, spontaneous, supratentorial ICH with a volume ≥ 5 mL but ≤ 60 mL
- Glasgow Coma Scale (GCS) best motor score no less than 5
- Modified Rankin Scale (mRS) score 0-2
You likely can't join if
- History of bleeding disorders
- Planned anticoagulation reversal treatment
- Patient with IVH having a Graeb score >3 on initial presentation
- use of immunosuppressive or immune modulating therapy at admission
- Patients with active systemic infections
- Women of childbearing potential
See the full eligibility criteria
- Male or female patients aged ≥ 18 years
- written informed consent obtained
- First-ever, spontaneous, supratentorial ICH with a volume ≥ 5 mL but ≤ 60 mL
- Glasgow Coma Scale (GCS) best motor score no less than 5
- Modified Rankin Scale (mRS) score 0-2
- History of bleeding disorders
- Planned anticoagulation reversal treatment
- Patient with IVH having a Graeb score >3 on initial presentation
- use of immunosuppressive or immune modulating therapy at admission
- Patients with active systemic infections
- Women of childbearing potential
- body weight > 120 kg
- severe renal impairement
- Known deficiency in FXII or haemophilia
- Infratentorial ICH
- Secondary ICH
- Planned neurosurgical hematoma evacuation or other urgent surgical intervention on intial presentation
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.