Clearance of Intracranial Blood Products by Continuous Irrigation With the IRRAflow System

Launched by CHRISTOPHER P KELLNER · Oct 17, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new device called the IRRAflow® Active Fluid Exchange System, which is designed to help manage conditions like bleeding in the brain (intracranial hemorrhage), infections (ventriculitis), and collections of pus (intracranial abscess). The trial aims to see how effective this system is compared to the standard treatment, which usually involves using external drains to remove excess fluid from the brain.

To participate in this trial, individuals must be at least 18 years old and have confirmed intracranial hemorrhage shown on a CT or MRI scan. They should also need active fluid exchange as determined by their doctor and be enrolled within 72 hours of their last known well condition. Participants will receive treatment and careful monitoring, and their progress will be compared to those receiving the standard care. It's important to note that people with very low consciousness, pregnancy, serious eye conditions, or life-threatening health issues cannot participate.

Gender

ALL

Eligibility criteria

• Inclusion criteria:
• • Age \>=18 years of age
• • Intracranial hemorrhage documented on head CT or MRI scan.
• • Indication for active fluid exchange evaluated by treating physician.
• • Signed informed consent obtained by patient or Legal Authorized Representative
• • Scheduled enrollment and treatment within 72 hours of last known well (LKW)
• Exclusion criteria:
• • GCS ≤ 5
• • Pregnancy
• • Fixed and dilated pupil
• • Life-threatening medical condition