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ACTIVE Study - Use of ACTIVE Fluid Exchange to Treat Intraventricular Hemorrhage

NCT05204849 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2022-02-10

No results posted yet for this study

Summary

Randomised controlled trial evaluating active irrigation using IRRAflow device in patients with intraventricular hemorrhages (IVH). Patients will be randomized in a 1:1 fashion to IRRAflow active irrigation and aspiration compared to standard passive external ventricular drainage.

The investigators hypothesize that active irrigation using the IRRAflow system will reduce the occlusion rates of the ventricular drain. Further, reduce the rate of catheter related infection and reduce time needed for clearance of blood from the intraventricular space compared with passive drainage alone. Further more, reduce treatment time, patient length of stay, and overall treatment cost when compared with passive drainage.

Conditions

  • Intraventricular Hemorrhage

Interventions

DEVICE

IRRAflow

Ventriculostomy using IRRAflow with active irrigation and aspiration

PROCEDURE

Standard ventriculostomy

Standard passive external ventricular drainage

Sponsors & Collaborators

  • Aarhus University Hospital

    collaborator OTHER

  • IRRAS

    collaborator INDUSTRY

  • University of Aarhus

    lead OTHER

Principal Investigators

  • Anders Korshøj, MD, PhD · Dept. of Neurosurgery, Aarhus University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-13
Primary Completion
2025-02-01
Completion
2025-02-01

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05204849 on ClinicalTrials.gov