Active Removal of IntraCerebral Hematoma Via Active Irrigation (ARCH)

July 30, 2024 updated by: IRRAS

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age >18 years of age
  2. Need of EVD
  3. Active treatment

  4. Signed informed consent obtained

    a. Based on institutional and country laws

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Treatment Arm #1
IRRAflow with manual tPA administration followed by Active Fluid Exchange
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.
Experimental: Treatment Arm #2
IRRAflow with continuous infusion of tPA combined with Active Fluid Exchange
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.
Active Comparator: Treatment Arm #3
Standard EVD with manual tPA administration
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
Intra-procedure
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.
Intra-procedure
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.
0-30 days post discharge from hospital

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Procedural Success
Time Frame: Intra-Procedural
Less than or equal to 30% residual clot burden in the ventricular system
Intra-Procedural
Technical Success
Time Frame: Intra-Procedural
Percentage of patients in which correct placement of IRRAflow and EVD catheter occurred
Intra-Procedural
Technical Success
Time Frame: Intra-Procedural
Percent obstruction of the IRRAflow catheter and EVD catheter
Intra-Procedural
Safety - Catheter misplacement
Time Frame: Intra-Procedural
Measurement of if the catheter needs to be re-inserted or re-positioned.
Intra-Procedural
Safety - Infection
Time Frame: Intra-Procedural
Comparison of rate of infection as measured by routine cerebrospinal fluid (CSF) analysis
Intra-Procedural
Safety - Bleeding events
Time Frame: Intra-Procedural
Comparison of new bleeding events on routine neuroimaging
Intra-Procedural

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Intra-Procedural
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
Intra-Procedural
Rate of mortality during treatment
Time Frame: Intra-Procedural
Percentage of patients having a mortality event during active treatment
Intra-Procedural
Rate of shunt dependency
Time Frame: 30 days
Percentage of patients that require a shunt after treatment
30 days
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
Intra-Procedural
Duration of EVD and IRRAflow catheter in place
Time Frame: Intra-Procedural
Number of days between catheter insertion and with drawl of the catheter
Intra-Procedural
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
Intra-Procedural
Duration of catheter drainage
Time Frame: Intra-Procedural
Number of days catheter was utilized for drainage
Intra-Procedural
Catheter occlusion rate
Time Frame: Intra-Procedural
Percentage of time in which the catheter is unable to drain
Intra-Procedural
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
Intra-Procedural
Repeat hemorrhagic events
Time Frame: Intra-Procedural
Number of repeated symptomatic hemorrhagic events
Intra-Procedural
Catheter occlusion
Time Frame: Intra-Procedural
Number of flushes required to clear a catheter occlusion
Intra-Procedural
Functional Status
Time Frame: Intra-Procedural
modified Rankin Score (mRS)
Intra-Procedural
Functional Status
Time Frame: 30 day
Difference in modified Rankin Score (mRS) as proportioned to IVH size
30 day
Total cost of procedure
Time Frame: Intra-Procedural
Measured as total cost involved in treating patient during treatment with IRRAflow and EVD
Intra-Procedural

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
IRRAS

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Northwestern University
Icahn School of Medicine at Mount Sinai
University of Helsinki
West Virginia University
Buffalo General Medical Center
Klinikum Bergmannstrost
Stony Brook University Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Behnam Rezai Jahromi, MD, University of Helsinki
  • Principal Investigator: Babak Jahromi, MD, Northwestern University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 25, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 15, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 3, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 12, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 1, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 30, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 001 (Marta Eliza Miller Foundation)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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