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NCT Number: NCT05649904

AFFECT Study for Patients With Intraventricular Hemorrhage, Subarachnoid Hemorrhage, Subdural Hematoma, and Ventriculitis

The goal of this clinical trial is to evaluate efficacy and safety of evacuation of cerebrospinal fluid, blood, and harmful bacteria from the intraventricular, subdural and subarachnoid spaces by Active Controlled Irrigation and Drainage (IRRAflow) compared to Passive External Ventricular Drainage (EVD).

Subjects with intraventricular hemorrhage, subarachnoid hemorrhage, subdural bleeding, and ventriculitis will be randomized to receive the IRRAflow device or EVD device and followed for one month post-procedure to compare outcomes between the subject groups.

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Key information

Conditions

Intraventricular Hemorrhage Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Craniocerebral Trauma Hematoma Hematoma, Subdural Hemorrhage Intracranial Hemorrhage, Traumatic Intracranial Hemorrhages Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Subarachnoid Hemorrhage Subdural Hematoma Trauma, Nervous System Vascular Diseases Ventriculitis Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥18 years of age
  • Need of drainage for one of the following underlying conditions: Intraventricular hemorrhage, intracranial hemorrhage, subarachnoid hemorrhage, chronic subdural hematoma and ventriculitis
  • Indication for active treatment evaluated by treating physician for underlying conditions; Intraventricular hemorrhage, subarachnoid hemorrhage, chronic subdural hematoma and ventriculitis
  • Signed informed consent obtained by subject or Legally Authorized Representative

Exclusion criteria

  • Subject has fixed and dilated pupils
  • Pregnant women
  • Presence of Moyamoya
  • History or presence of clotting disorder.
  • Platelet count less than 100,000, INR greater than 1.4

Treatment and study plan

IRRAflow with Active Fluid Exchange System

Device

IRRAflow® Active Fluid Exchange System is an intracranial drainage system intended for use by professional medical hospital personnel, trained and experienced in neurosurgical medical care.

The intracranial pressure is kept at a safe level by draining excessive intracranial fluid. The system incorporates an irrigation support mechanism, used to irrigate the system in a controlled, programmed manner to minimize catheter occlusion. Additionally, a manual bolus can be given to facilitate keeping the catheter clear of occlusion or to clear the catheter of occlusion if one is present. This mechanism works by producing a bolus pulse using short periods of high flow (i.e. flow pulses).

Other names: IRRAflow

External Ventricular Drain

Device

The External Ventricular Drain (EVD) is used standard of care at the study site for ventricular drainage.

Other names: EVD

Primary outcomes

  1. Rate of revision procedures for the IRRAflow and EVD/Drainage catheters

    Time frame: Immediately post-procedure

Secondary outcomes

  1. Time to clearance of blood or bacterial mass as measured by head CT scan

    Time frame: Immediately post-procedure

  2. Rate of catheter-related infection

    Time frame: Immediately post-procedure

  3. Length of ICU stay

    Time frame: Baseline

  4. Rate of shunt dependency

    Time frame: Immediately post-procedure

  5. Indwell time of EVD/Drainage and IRRAflow Catheter

    Time frame: Immediately post-procedure

  6. Functional Status - at inclusion and 30 days

    Time frame: 30 days post subject discharge

    The Modified Rankin Scale will be used to assess functional status. The Modified Rankin Scale ranges from 0 (no disability) to 6 (death).

  7. Mortality rates - intraprocedural and at 30 days

    Time frame: 30 days post subject discharge

  8. Functional Status - at inclusion and 30 days

    Time frame: 30 days post subject discharge

    The Extended Glasgow Coma Scale will be used to assess functional status. Results range from 1 (death) to 8 (upper good recovery).

  9. Functional Status - at inclusion and 30 days

    Time frame: 30 days post subject discharge

    The Barthel Index will be used to assess functional status. Scores for this assessment tool range from 0 - 100, with a higher number indicating a better functional status.

  10. Functional Status - at inclusion and 30 days

    Time frame: 30 days post subject discharge

    The Stroke Impact Scale will be used to assess functional status. Scores for this scale range from 0 - 100, with a higher number indicating a better functional status.

  11. Functional Status - at inclusion and 30 days

    Time frame: 30 days post subject discharge

    The EQ-VAS will be used to assess functional status. Participants rate their health from 0 (worst imaginable health) to 100 (best imaginable health).

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Ohio State University

Other

Collaborators

  • IRRAS

Registry information

Official study title

Use of Active Fluid Exchange to Therapeutically Treat Intracranial Bleeding and Infection

Acronym: AFFECT

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Dec 14, 2022
Registry last updated
Apr 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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