NCT05118997

Active Removal of IntraCerebral Hematoma Via Active Irrigation

Active Removal of IntraCerebral Hematoma Via Active Irrigation of the Ventricular System

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: IRRAS · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Study evaluating if active irrigation by IRRAflow® with infusion of tPA will reduce the time needed for clearance of intracerebral and intraventricular hemorrhage compared with passive drainage.

Detailed description

The ARCH study is an international prospective, controlled, randomized, multicenter study to evaluate the hypothesis that active irrigation with IRRAflow® will reduce the time needed for clearance of intraventricular and intracerebral blood from intraventricular and intracerebral space compared with passive drainage and administration of tPA. This might affect the patient neurological outcome assessed by GCS and mRankin scale.

Conditions

• Cerebral Hemorrhage
• Intraventricular Hemorrhage

Interventions

Type	Name	Description
DEVICE	IRRAflow	IRRAflow consists of a control unit and disposables (dual-lumen catheter and tube set) to offer an integrated and synchronized active fluid exchange system. Active fluid exchange is the combination of traditional gravity-driven drainage with periodic, controlled irrigation of the catheter probe to exchange any pathological fluid collection with neutral physiological fluids.
DEVICE	EVD	An external ventricular drain (EVD), also known as a ventriculostomy or extraventricular drain, is a device used in neurosurgery to treat hydrocephalus and relieve elevated intracranial pressure when the normal flow of cerebrospinal fluid inside the brain is obstructed.

Timeline

• Start date: 2021-10-25
• Primary completion: 2025-07-01
• Completion: 2025-09-01
• First posted: 2021-11-12
• Last updated: 2024-08-01

Locations

1 site across 1 country: Finland