Active Removal of IntraCerebral Hematoma Via Active Irrigation

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.

Conditions

• Cerebral Hemorrhage
• Intraventricular Hemorrhage

Interventions

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.

Sponsors & Collaborators

• University of Helsinki

  collaborator OTHER

• Northwestern University

  collaborator OTHER

• West Virginia University

  collaborator OTHER

• Klinikum Bergmannstrost

  collaborator UNKNOWN

• Stony Brook University Hospital

  collaborator UNKNOWN

• Icahn School of Medicine at Mount Sinai

  collaborator OTHER

• Buffalo General Medical Center

  collaborator UNKNOWN

• IRRAS

  lead INDUSTRY

Principal Investigators

• Behnam Rezai Jahromi, MD · University of Helsinki

• Babak Jahromi, MD · Northwestern University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

FACTORIAL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-10-25

Primary Completion

2025-07-31

Completion

2025-09-30

Countries

• Finland

Study Locations