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Active Removal of IntraCerebral Hematoma Via Active Irrigation (ARCH)

Primary Purpose

Cerebral Hemorrhage, Intraventricular Hemorrhage

Status
Recruiting
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
IRRAflow
EVD
Sponsored by
IRRAS
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Hemorrhage focused on measuring Hemorrhage, Cerebral Hemorrhage, Intraventricular Hemorrhage

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Helsinki UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Treatment Arm #1

Treatment Arm #2

Treatment Arm #3

Arm Description

IRRAflow with manual tPA administration followed by Active Fluid Exchange

IRRAflow with continuous infusion of tPA combined with Active Fluid Exchange

Standard EVD with manual tPA administration

Outcomes

Primary Outcome Measures

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).
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.
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.

Secondary Outcome Measures

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

Full Information

First Posted
October 15, 2021
Last Updated
March 10, 2023
Sponsor
IRRAS
Collaborators
University of Helsinki, Northwestern University, West Virginia University, Klinikum Bergmannstrost, Brigham and Women's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05118997
Brief Title
Active Removal of IntraCerebral Hematoma Via Active Irrigation
Acronym
ARCH
Official Title
Active Removal of IntraCerebral Hematoma Via Active Irrigation of the Ventricular System
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 25, 2021 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
July 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
IRRAS
Collaborators
University of Helsinki, Northwestern University, West Virginia University, Klinikum Bergmannstrost, Brigham and Women's Hospital

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Hemorrhage, Intraventricular Hemorrhage
Keywords
Hemorrhage, Cerebral Hemorrhage, Intraventricular Hemorrhage

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment Arm #1
Arm Type
Experimental
Arm Description
IRRAflow with manual tPA administration followed by Active Fluid Exchange
Arm Title
Treatment Arm #2
Arm Type
Experimental
Arm Description
IRRAflow with continuous infusion of tPA combined with Active Fluid Exchange
Arm Title
Treatment Arm #3
Arm Type
Active Comparator
Arm Description
Standard EVD with manual tPA administration
Intervention Type
Device
Intervention Name(s)
IRRAflow
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
EVD
Intervention Description
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 Outcome Measure Information:
Title
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.
Description
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).
Time Frame
Intra-procedure
Title
Radiographic evaluation of ventricular blood removal as measured by head CT scan
Description
Change in blood volume (cm3) measured between stability scan and end of treatment scan.
Time Frame
Intra-procedure
Title
Comparison of patient outcome between groups at as measured by the Glasgow Coma Scale, extended Glasgow Outcome Scale, modified Rankin Scale.
Description
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.
Time Frame
0-30 days post discharge from hospital
Secondary Outcome Measure Information:
Title
Procedural Success
Description
Less than or equal to 30% residual clot burden in the ventricular system
Time Frame
Intra-Procedural
Title
Technical Success
Description
Percentage of patients in which correct placement of IRRAflow and EVD catheter occurred
Time Frame
Intra-Procedural
Title
Technical Success
Description
Percent obstruction of the IRRAflow catheter and EVD catheter
Time Frame
Intra-Procedural
Title
Safety - Catheter misplacement
Description
Measurement of if the catheter needs to be re-inserted or re-positioned.
Time Frame
Intra-Procedural
Title
Safety - Infection
Description
Comparison of rate of infection as measured by routine cerebrospinal fluid (CSF) analysis
Time Frame
Intra-Procedural
Title
Safety - Bleeding events
Description
Comparison of new bleeding events on routine neuroimaging
Time Frame
Intra-Procedural
Other Pre-specified Outcome Measures:
Title
Length of ICU stay (days)
Description
Time (days) the patient is admitted to the ICU till the patient is discharged from the ICU
Time Frame
Intra-Procedural
Title
Length of overall length (days) of hospital stay
Description
Time (days) the patient is admitted to the hospital till the patient is discharged from the hospital
Time Frame
Intra-Procedural
Title
Rate of mortality during treatment
Description
Percentage of patients having a mortality event during active treatment
Time Frame
Intra-Procedural
Title
Rate of shunt dependency
Description
Percentage of patients that require a shunt after treatment
Time Frame
30 days
Title
Radiological evaluation of ventricles as measured by CT scan of head
Description
Radiologic evaluation of the ventricles by the neurosurgeon or radiologist
Time Frame
Intra-Procedural
Title
Duration of EVD and IRRAflow catheter in place
Description
Number of days between catheter insertion and with drawl of the catheter
Time Frame
Intra-Procedural
Title
Rate of clot removal as assessed by CT
Description
Change in blood volume measured between stability scan and end of treatment scan
Time Frame
Intra-Procedural
Title
Duration of catheter drainage
Description
Number of days catheter was utilized for drainage
Time Frame
Intra-Procedural
Title
Catheter occlusion rate
Description
Percentage of time in which the catheter is unable to drain
Time Frame
Intra-Procedural
Title
Revision rate of the EVD and IRRAflow catheter
Description
Percentage of time that the physician must replace or manipulate the EVD or IRRAflow catheter
Time Frame
Intra-Procedural
Title
Repeat hemorrhagic events
Description
Number of repeated symptomatic hemorrhagic events
Time Frame
Intra-Procedural
Title
Catheter occlusion
Description
Number of flushes required to clear a catheter occlusion
Time Frame
Intra-Procedural
Title
Functional Status
Description
modified Rankin Score (mRS)
Time Frame
Intra-Procedural
Title
Functional Status
Description
Difference in modified Rankin Score (mRS) as proportioned to IVH size
Time Frame
30 day
Title
Total cost of procedure
Description
Measured as total cost involved in treating patient during treatment with IRRAflow and EVD
Time Frame
Intra-Procedural

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
John Unser, MBA
Phone
19712195984
Email
john.unser@irras.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Behnam Rezai Jahromi, MD
Organizational Affiliation
University of Helsinki
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Babak Jahromi, MD
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Helsinki University
City
Helsinki
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Behnam Rezai Jahromi, MD
Phone
+358 45 123 0273
Email
behnam.rezai-jahromi@hus.fi

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34168930
Citation
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.
Results Reference
background
PubMed Identifier
19427958
Citation
Qureshi AI, Mendelow AD, Hanley DF. Intracerebral haemorrhage. Lancet. 2009 May 9;373(9675):1632-44. doi: 10.1016/S0140-6736(09)60371-8.
Results Reference
background
PubMed Identifier
11346811
Citation
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.
Results Reference
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PubMed Identifier
19038914
Citation
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.
Results Reference
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PubMed Identifier
2496328
Citation
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.
Results Reference
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PubMed Identifier
3491339
Citation
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.
Results Reference
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PubMed Identifier
16636233
Citation
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.
Results Reference
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PubMed Identifier
17038942
Citation
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.
Results Reference
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Active Removal of IntraCerebral Hematoma Via Active Irrigation

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