C1-inhibitor for the acute management of subarachnoid hemorrhage

Phase 1

• Conditions: Subarachnoid hemorrhage; MedDRA version: 20.1Level: LLTClassification code 10042320Term: Subarachnoid hemorrhageSystem Organ Class: 100000004852; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2020-005731-67-NL
• Lead Sponsor: Haaglanden Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-03-10
• Last Update Posted: 5 July 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 128

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified