ARCH: Active Removal of IntraCerebral Hematoma Via Active Irrigation
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
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 Design
Arms and Interventions
| 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.
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| 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.
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Outcome Measures
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. [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).
- Radiographic evaluation of ventricular blood removal as measured by head CT scan [Intra-procedure]
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. [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 Outcome Measures
- Procedural Success [Intra-Procedural]
Less than or equal to 30% residual clot burden in the ventricular system
- Technical Success [Intra-Procedural]
Percentage of patients in which correct placement of IRRAflow and EVD catheter occurred
- Technical Success [Intra-Procedural]
Percent obstruction of the IRRAflow catheter and EVD catheter
- Safety - Catheter misplacement [Intra-Procedural]
Measurement of if the catheter needs to be re-inserted or re-positioned.
- Safety - Infection [Intra-Procedural]
Comparison of rate of infection as measured by routine cerebrospinal fluid (CSF) analysis
- Safety - Bleeding events [Intra-Procedural]
Comparison of new bleeding events on routine neuroimaging
Other Outcome Measures
- Length of ICU stay (days) [Intra-Procedural]
Time (days) the patient is admitted to the ICU till the patient is discharged from the ICU
- Length of overall length (days) of hospital stay [Intra-Procedural]
Time (days) the patient is admitted to the hospital till the patient is discharged from the hospital
- Rate of mortality during treatment [Intra-Procedural]
Percentage of patients having a mortality event during active treatment
- Rate of shunt dependency [30 days]
Percentage of patients that require a shunt after treatment
- Radiological evaluation of ventricles as measured by CT scan of head [Intra-Procedural]
Radiologic evaluation of the ventricles by the neurosurgeon or radiologist
- Duration of EVD and IRRAflow catheter in place [Intra-Procedural]
Number of days between catheter insertion and with drawl of the catheter
- Rate of clot removal as assessed by CT [Intra-Procedural]
Change in blood volume measured between stability scan and end of treatment scan
- Duration of catheter drainage [Intra-Procedural]
Number of days catheter was utilized for drainage
- Catheter occlusion rate [Intra-Procedural]
Percentage of time in which the catheter is unable to drain
- Revision rate of the EVD and IRRAflow catheter [Intra-Procedural]
Percentage of time that the physician must replace or manipulate the EVD or IRRAflow catheter
- Repeat hemorrhagic events [Intra-Procedural]
Number of repeated symptomatic hemorrhagic events
- Catheter occlusion [Intra-Procedural]
Number of flushes required to clear a catheter occlusion
- Functional Status [Intra-Procedural]
modified Rankin Score (mRS)
- Functional Status [30 day]
Difference in modified Rankin Score (mRS) as proportioned to IVH size
- Total cost of procedure [Intra-Procedural]
Measured as total cost involved in treating patient during treatment with IRRAflow and EVD
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age >18 years of age
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Need of EVD
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Active treatment
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Signed informed consent obtained
- Based on institutional and country laws
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Spontaneous ICH with maximum 30 square cm's
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If needed, normal coagulation profile (PT, PTT, platelet count)
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Treatment within 72 hours of ictus
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Ability to administer 2.0 mg of tPA per day for 3 days
Exclusion Criteria:
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Age < 18 years
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No need of EVD
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Patient has fixed and dilated pupils
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Coagulopathy uncorrectable
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Vascular pathology (e.g. Aneurysm involvement, AVM involvement)
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Pregnant women
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Helsinki University | Helsinki | Finland |
Sponsors and Collaborators
- IRRAS
- University of Helsinki
- Northwestern University
- West Virginia University
- Klinikum Bergmannstrost
- Brigham and Women's Hospital
Investigators
- Principal Investigator: Behnam Rezai Jahromi, MD, University of Helsinki
- Principal Investigator: Babak Jahromi, MD, Northwestern University
Study Documents (Full-Text)
None provided.More Information
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.
- 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.
- 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.
- Qureshi AI, Mendelow AD, Hanley DF. Intracerebral haemorrhage. Lancet. 2009 May 9;373(9675):1632-44. doi: 10.1016/S0140-6736(09)60371-8. Review.
- 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. Review.
- 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® Self-Irrigating Catheter. Cureus. 2021 May 22;13(5):e15167. doi: 10.7759/cureus.15167.
- 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.
- 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.
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