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NCT Number: NCT05118997

Active Removal of IntraCerebral Hematoma Via Active Irrigation

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.

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Key information

Conditions

Cerebral Hemorrhage Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Hemorrhage Intracranial Hemorrhages Intraventricular Hemorrhage Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

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 EVD
  • Active treatment
  • Signed informed consent obtained

a. Based on institutional and country laws

  • Spontaneous ICH with maximum 30 square cm's
  • If needed, normal coagulation profile (PT, PTT, platelet count)
  • Treatment within 72 hours of ictus
  • Ability to administer 2.0 mg of tPA per day for 3 days

Exclusion criteria

  • Age < 18 years
  • No need of EVD
  • Patient has fixed and dilated pupils
  • Coagulopathy uncorrectable
  • Vascular pathology (e.g. Aneurysm involvement, AVM involvement)
  • Pregnant women

Treatment and study plan

IRRAflow

Device

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.

EVD

Device

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.

Primary outcomes

  1. Efficacy and safety of evacuation of intraventricular hematoma by Active External Ventricular Drainage (IRRAflow) with tPA administration compared to Passive External Ventricular Drainage (EVD) with tPA administration.

    Time frame: Intra-procedure

    Efficacy is defined as the efficiency of each arm to remove the hematoma (70% cm3). Safety is measured as the frequency of bacterial central nervous system (measures as positive bacterial growth in cerebrospinal fluid), symptomatic brain bleeds (clinical symptoms drop in modified Rankin scale), and mortality (death).

  2. Radiographic evaluation of ventricular blood removal as measured by head CT scan

    Time frame: Intra-procedure

    Change in blood volume (cm3) measured between stability scan and end of treatment scan.

  3. Comparison of patient outcome between groups at as measured by the Glasgow Coma Scale, extended Glasgow Outcome Scale, modified Rankin Scale.

    Time frame: 0-30 days post discharge from hospital

    Defined as the comparison of patients outcomes between the three groups as measured by Glasgow Coma Scale, extended Glasgow Outcome Scale, and modified Rankin Scale.

Secondary outcomes

  1. Procedural Success

    Time frame: Intra-Procedural

    Less than or equal to 30% residual clot burden in the ventricular system

  2. Technical Success

    Time frame: Intra-Procedural

    Percentage of patients in which correct placement of IRRAflow and EVD catheter occurred

  3. Technical Success

    Time frame: Intra-Procedural

    Percent obstruction of the IRRAflow catheter and EVD catheter

  4. Safety - Catheter misplacement

    Time frame: Intra-Procedural

    Measurement of if the catheter needs to be re-inserted or re-positioned.

  5. Safety - Infection

    Time frame: Intra-Procedural

    Comparison of rate of infection as measured by routine cerebrospinal fluid (CSF) analysis

  6. Safety - Bleeding events

    Time frame: Intra-Procedural

    Comparison of new bleeding events on routine neuroimaging

Other outcomes

  1. Length of ICU stay (days)

    Time frame: Intra-Procedural

    Time (days) the patient is admitted to the ICU till the patient is discharged from the ICU

  2. Length of overall length (days) of hospital stay

    Time frame: Intra-Procedural

    Time (days) the patient is admitted to the hospital till the patient is discharged from the hospital

  3. Rate of mortality during treatment

    Time frame: Intra-Procedural

    Percentage of patients having a mortality event during active treatment

  4. Rate of shunt dependency

    Time frame: 30 days

    Percentage of patients that require a shunt after treatment

  5. Radiological evaluation of ventricles as measured by CT scan of head

    Time frame: Intra-Procedural

    Radiologic evaluation of the ventricles by the neurosurgeon or radiologist

  6. Duration of EVD and IRRAflow catheter in place

    Time frame: Intra-Procedural

    Number of days between catheter insertion and with drawl of the catheter

  7. Rate of clot removal as assessed by CT

    Time frame: Intra-Procedural

    Change in blood volume measured between stability scan and end of treatment scan

  8. Duration of catheter drainage

    Time frame: Intra-Procedural

    Number of days catheter was utilized for drainage

  9. Catheter occlusion rate

    Time frame: Intra-Procedural

    Percentage of time in which the catheter is unable to drain

  10. Revision rate of the EVD and IRRAflow catheter

    Time frame: Intra-Procedural

    Percentage of time that the physician must replace or manipulate the EVD or IRRAflow catheter

  11. Repeat hemorrhagic events

    Time frame: Intra-Procedural

    Number of repeated symptomatic hemorrhagic events

  12. Catheter occlusion

    Time frame: Intra-Procedural

    Number of flushes required to clear a catheter occlusion

  13. Functional Status

    Time frame: Intra-Procedural

    modified Rankin Score (mRS)

  14. Functional Status

    Time frame: 30 day

    Difference in modified Rankin Score (mRS) as proportioned to IVH size

  15. Total cost of procedure

    Time frame: Intra-Procedural

    Measured as total cost involved in treating patient during treatment with IRRAflow and EVD

Study contacts

Contact information is provided by the study sponsor or research team.

John Unser, MBA

CONTACT

[email protected]

19712195984

Sponsors and collaborators

Lead sponsor

IRRAS

Industry

Collaborators

  • Buffalo General Medical Center
  • Icahn School of Medicine at Mount Sinai
  • Klinikum Bergmannstrost
  • Northwestern University
  • Stony Brook University Hospital
  • University of Helsinki
  • West Virginia University

Registry information

Official study title

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

Acronym: ARCH

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Nov 12, 2021
Registry last updated
Aug 1, 2024

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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