EUCTR2020-005731-67-NLActive, not recruitingPhase 1
Complement Inhibition: Attacking the Overshooting Inflammation @fter Subarachnoid Hemorrhage - A phase II trial on the safety and efficacy of C1esterase inhibitor for the acute management of subarachnoid hemorrhage - CIAO@SAH
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Haaglanden Medisch Centrum
- Enrollment
- 128
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- •-Confirmed diagnosis of aneurysmal subarachnoid hemorrhage on CT-scan or lumbar puncture (in the presence of a negative CT-scan);
- •-Age = 18 years on admission;
- •-WFNS grade 1-5
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 60
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 68
Exclusion Criteria
- •A potential subject who meets any of the following criteria will be excluded from participation in this study:
- •-Subarachnoid hemorrhage deemed most likely to ‘peri mesencephalic’ origin after consideration of history, clinical examination and radiological findings (including angiographic imaging);
- •-Subarachnoid hemorrhage deemed most likely of post-traumatic origin after consideration of history, clinical examination and radiological findings (including angiographic imaging);
- •-Participation in another clinical therapeutic study;
- •-Patients with a known hereditary complement deficiency (including hereditary angioedema);
- •-Patients with a history of sensibility to blood products or C1-inhibitor;
- •-Patients with a history of thrombosis;
- •-Pregnant woman
Investigators
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