Active Removal of IntraCerebral Hematoma Via Active Irrigation (ARCH)

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: Recruiting
• Conditions: Intraventricular Hemorrhage; Cerebral Hemorrhage
• Intervention / Treatment: Device: IRRAflow; Device: EVD

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: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: John Unser, MBA; Phone Number: 19712195984; Email: john.unser@irras.com

Study Locations

• Finland
  • Helsinki, Finland
    • Recruiting
    • Helsinki University
    • Contact: Behnam Rezai Jahromi, MD; Phone Number: +358 45 123 0273; Email: behnam.rezai-jahromi@hus.fi

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

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.	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	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.	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

Outcome Measure	Measure Description	Time Frame
Procedural Success	Less than or equal to 30% residual clot burden in the ventricular system	Intra-Procedural
Technical Success	Percentage of patients in which correct placement of IRRAflow and EVD catheter occurred	Intra-Procedural
Technical Success	Percent obstruction of the IRRAflow catheter and EVD catheter	Intra-Procedural
Safety - Catheter misplacement	Measurement of if the catheter needs to be re-inserted or re-positioned.	Intra-Procedural
Safety - Infection	Comparison of rate of infection as measured by routine cerebrospinal fluid (CSF) analysis	Intra-Procedural
Safety - Bleeding events	Comparison of new bleeding events on routine neuroimaging	Intra-Procedural

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of ICU stay (days)	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 (days) the patient is admitted to the hospital till the patient is discharged from the hospital	Intra-Procedural
Rate of mortality during treatment	Percentage of patients having a mortality event during active treatment	Intra-Procedural
Rate of shunt dependency	Percentage of patients that require a shunt after treatment	30 days
Radiological evaluation of ventricles as measured by CT scan of head	Radiologic evaluation of the ventricles by the neurosurgeon or radiologist	Intra-Procedural
Duration of EVD and IRRAflow catheter in place	Number of days between catheter insertion and with drawl of the catheter	Intra-Procedural
Rate of clot removal as assessed by CT	Change in blood volume measured between stability scan and end of treatment scan	Intra-Procedural
Duration of catheter drainage	Number of days catheter was utilized for drainage	Intra-Procedural
Catheter occlusion rate	Percentage of time in which the catheter is unable to drain	Intra-Procedural
Revision rate of the EVD and IRRAflow catheter	Percentage of time that the physician must replace or manipulate the EVD or IRRAflow catheter	Intra-Procedural
Repeat hemorrhagic events	Number of repeated symptomatic hemorrhagic events	Intra-Procedural
Catheter occlusion	Number of flushes required to clear a catheter occlusion	Intra-Procedural
Functional Status	modified Rankin Score (mRS)	Intra-Procedural
Functional Status	Difference in modified Rankin Score (mRS) as proportioned to IVH size	30 day
Total cost of procedure	Measured as total cost involved in treating patient during treatment with IRRAflow and EVD	Intra-Procedural

Collaborators and Investigators

• Sponsor: IRRAS
• Collaborators: 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: Principal Investigator: Behnam Rezai Jahromi, MD, University of Helsinki; Principal Investigator: Babak Jahromi, MD, Northwestern University

Publications and helpful links

General Publications

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

Study record dates

Study Major Dates

• Study Start (Actual): October 25, 2021
• Primary Completion (Estimated): July 1, 2025
• Study Completion (Estimated): September 1, 2025

Study Registration Dates

• First Submitted: October 15, 2021
• First Submitted That Met QC Criteria: November 3, 2021
• First Posted (Actual): November 12, 2021

Study Record Updates

• Last Update Posted (Actual): August 1, 2024
• Last Update Submitted That Met QC Criteria: July 30, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Cerebral Hemorrhage; Hemorrhage; Intraventricular Hemorrhage
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Hemorrhages; Hemorrhage; Cerebral Hemorrhage; Hematoma
• Other Study ID Numbers: 001 (Buy Pharma Ecza Deposu San. Tic. Ltd.)

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