Complement Inhibition: Attacking the Overshooting Inflammation @Fter Subarachnoid Hemorrhage (CIAO@SAH)

Launched by HAAGLANDEN MEDICAL CENTRE · Apr 5, 2024

Keywords

ClinConnect Summary

The CIAO@SAH clinical trial is studying a new treatment for patients who have experienced a type of brain bleed called aneurysmal subarachnoid hemorrhage (SAH). This condition can lead to serious problems like cognitive decline due to early brain injury and delayed lack of blood flow to the brain. Researchers believe that a part of the immune system called the complement system plays a significant role in causing inflammation during this condition. The trial is testing an approved medication called Cinryze, which blocks the complement system, to see if it can help reduce inflammation and improve outcomes for patients with SAH.

To participate in the trial, individuals must be at least 18 years old and have a confirmed diagnosis of aneurysmal SAH as shown on a CT scan. They should also be classified as having a specific level of severity (WFNS grade 1-5). However, people who have certain other types of brain bleeds, are pregnant, or have specific health conditions may not be eligible. Participants will receive either the Cinryze treatment or a placebo (a dummy treatment) and will be closely monitored to assess safety and effectiveness. This trial could provide valuable insights into a promising new approach to treating this serious condition.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Confirmed diagnosis of aneurysmal subarachnoid hemorrhage on CT-scan;
• • Age ≥ 18 years on admission;
• • WFNS grade 1-5.
• Exclusion Criteria:
• • Subarachnoid hemorrhage deemed most likely of 'peri mesencephalic' origin after consideration of history, clinical examination and radiological findings (including angiographic imaging); (not originated from an aneurysm and patients have by definition a favourable clinical outcome)
• • Subarachnoid hemorrhage deemed most likely of post-traumatic origin after consideration of history, clinical examination and radiological findings (including angiographic imaging); (does not occur spontaneous)
• • Participation in another clinical therapeutic study;
• • Patients with definite infaust prognosis on arrival and/or expected death within 24 hours of admission
• • 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 (when known at time of inclusion);
• • Pregnant woman