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Cerebral HemorrhageARCHNCT05118997

Active Removal of IntraCerebral Hematoma Via Active Irrigation

A study testing IRRAflow and EVD in people with Cerebral Hemorrhage and Intraventricular Hemorrhage, run by IRRAS at 1 site in Finland.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
IRRAflow and EVD
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteFinland
Study dates
25 Oct 2021to Sep 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age >18 years of age
  • Need of EVD
  • Active treatment
  • Signed informed consent obtained
  • Based on institutional and country laws
  • Spontaneous ICH with maximum 30 square cm's
Show all 9Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

John Unser, MBA contact

19712195984

john.unser@irras.com

Finland1 site, 1 recruiting

  • Helsinki University

    Helsinki

    Behnam Rezai Jahromi, MD, +358 45 123 0273, behnam.rezai-jahromi@hus.fi

    Recruiting

Other trials in Finland

About this study

Official title: 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.

Read the 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.

Being tested
IRRAflow, EVD
Keywords
Hemorrhage, Cerebral Hemorrhage, Intraventricular Hemorrhage
Medical subject headings
Cerebral Hemorrhage, Hemorrhage

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IRRAflowDevice

    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.

  • EVDDevice

    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.

Study groups in NCT05118997
Study groupRoleWhat they receive
Treatment Arm #1ExperimentalIRRAflow with manual tPA administration followed by Active Fluid Exchange
Receives: Device: IRRAflow
Treatment Arm #2ExperimentalIRRAflow with continuous infusion of tPA combined with Active Fluid Exchange
Receives: Device: IRRAflow
Treatment Arm #3Active comparatorStandard EVD with manual tPA administration
Receives: Device: EVD

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    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).

    Measured: Intra-procedure

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

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

    Measured: Intra-procedure

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

    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.

    Measured: 0-30 days post discharge from hospital

Secondary outcomes (6)

  1. Procedural Success

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

    Measured: Intra-Procedural

  2. Technical Success

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

    Measured: Intra-Procedural

  3. Technical Success

    Percent obstruction of the IRRAflow catheter and EVD catheter

    Measured: Intra-Procedural

  4. Safety - Catheter misplacement

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

    Measured: Intra-Procedural

  5. Safety - Infection

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

    Measured: Intra-Procedural

  6. Safety - Bleeding events

    Comparison of new bleeding events on routine neuroimaging

    Measured: Intra-Procedural

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Nov 2021
  2. Study start25 Oct 2021
  3. Primary completionJul 2025 (estimated)
  4. Study completionSep 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Factorial
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05118997
Sponsor's protocol ID
001
Acronym
ARCH
Status last verified
Jul 2024
First submitted
15 Oct 2021
Last updated
1 Aug 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Rajjoub K, Hess RM, O'Connor TE, Khan A, Siddiqui AH, Levy EI. Drainage, Irrigation, and Fibrinolytic Therapy (DRIFT) for Adult Intraventricular Hemorrhage Using IRRAflow(R) Self-Irrigating Catheter. Cureus. 2021 May 22;13(5):e15167. doi: 10.7759/cureus.15167.

    PubMed 34168930

  • Qureshi AI, Mendelow AD, Hanley DF. Intracerebral haemorrhage. Lancet. 2009 May 9;373(9675):1632-44. doi: 10.1016/S0140-6736(09)60371-8.

    PubMed 19427958

  • Qureshi AI, Tuhrim S, Broderick JP, Batjer HH, Hondo H, Hanley DF. Spontaneous intracerebral hemorrhage. N Engl J Med. 2001 May 10;344(19):1450-60. doi: 10.1056/NEJM200105103441907. No abstract available.

    PubMed 11346811

  • Sacco S, Marini C, Toni D, Olivieri L, Carolei A. Incidence and 10-year survival of intracerebral hemorrhage in a population-based registry. Stroke. 2009 Feb;40(2):394-9. doi: 10.1161/STROKEAHA.108.523209. Epub 2008 Nov 26.

    PubMed 19038914

  • Findlay JM, Weir BK, Gordon P, Grace M, Baughman R. Safety and efficacy of intrathecal thrombolytic therapy in a primate model of cerebral vasospasm. Neurosurgery. 1989 Apr;24(4):491-8. doi: 10.1227/00006123-198904000-00002.

    PubMed 2496328

  • Pang D, Sclabassi RJ, Horton JA. Lysis of intraventricular blood clot with urokinase in a canine model: Part 2. In vivo safety study of intraventricular urokinase. Neurosurgery. 1986 Oct;19(4):547-52. doi: 10.1227/00006123-198610000-00009.

    PubMed 3491339

  • Davis SM, Broderick J, Hennerici M, Brun NC, Diringer MN, Mayer SA, Begtrup K, Steiner T; Recombinant Activated Factor VII Intracerebral Hemorrhage Trial Investigators. Hematoma growth is a determinant of mortality and poor outcome after intracerebral hemorrhage. Neurology. 2006 Apr 25;66(8):1175-81. doi: 10.1212/01.wnl.0000208408.98482.99.

    PubMed 16636233

  • Steiner T, Diringer MN, Schneider D, Mayer SA, Begtrup K, Broderick J, Skolnick BE, Davis SM. Dynamics of intraventricular hemorrhage in patients with spontaneous intracerebral hemorrhage: risk factors, clinical impact, and effect of hemostatic therapy with recombinant activated factor VII. Neurosurgery. 2006 Oct;59(4):767-73; discussion 773-4. doi: 10.1227/01.NEU.0000232837.34992.32.

    PubMed 17038942

Questions about this trial

What is this clinical trial studying?

A study testing IRRAflow and EVD in people with Cerebral Hemorrhage and Intraventricular Hemorrhage, run by IRRAS at 1 site in Finland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 1 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact John Unser, MBA (19712195984, john.unser@irras.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05118997, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2024.

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