Clinical trial NCT05118997: Active Removal of IntraCerebral Hematoma Via Active Irrigation
Official title: Active Removal of IntraCerebral Hematoma Via Active Irrigation of the Ventricular System
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cerebral Hemorrhage
Intraventricular Hemorrhage
Keywords: Hemorrhage
Cerebral Hemorrhage
Intraventricular Hemorrhage
Lead sponsor: IRRAS
Sponsor class: INDUSTRY
Collaborators: name: University of Helsinki
name: Northwestern University
name: West Virginia University
name: Klinikum Bergmannstrost
name: Stony Brook University Hospital
name: Icahn School of Medicine at Mount Sinai
name: Buffalo General Medical Center
First posted: 2021-11-12
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
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.
timeFrame: Intra-procedure
measure: Radiographic evaluation of ventricular blood removal as measured by head CT scan
timeFrame: Intra-procedure
measure: Comparison of patient outcome between groups at as measured by the Glasgow Coma Scale, extended Glasgow Outcome Scale, modified Rankin Scale.
timeFrame: 0-30 days post discharge from hospital
Secondary outcomes:
measure: Procedural Success
timeFrame: Intra-Procedural
measure: Technical Success
timeFrame: Intra-Procedural
measure: Technical Success
timeFrame: Intra-Procedural
measure: Safety - Catheter misplacement
timeFrame: Intra-Procedural
measure: Safety - Infection
timeFrame: Intra-Procedural
measure: Safety - Bleeding events
timeFrame: Intra-Procedural
Other outcomes:
measure: Length of ICU stay (days)
timeFrame: Intra-Procedural
measure: Length of overall length (days) of hospital stay
timeFrame: Intra-Procedural
measure: Rate of mortality during treatment
timeFrame: Intra-Procedural
measure: Rate of shunt dependency
timeFrame: 30 days
measure: Radiological evaluation of ventricles as measured by CT scan of head
timeFrame: Intra-Procedural
measure: Duration of EVD and IRRAflow catheter in place
timeFrame: Intra-Procedural
measure: Rate of clot removal as assessed by CT
timeFrame: Intra-Procedural
measure: Duration of catheter drainage
timeFrame: Intra-Procedural
measure: Catheter occlusion rate
timeFrame: Intra-Procedural
measure: Revision rate of the EVD and IRRAflow catheter
timeFrame: Intra-Procedural
measure: Repeat hemorrhagic events
timeFrame: Intra-Procedural
measure: Catheter occlusion
timeFrame: Intra-Procedural
measure: Functional Status
timeFrame: Intra-Procedural
measure: Functional Status
timeFrame: 30 day
measure: Total cost of procedure
timeFrame: Intra-Procedural
Locations:
city: Helsinki
country: Finland
facility: Helsinki University
Study officials:
affiliation: University of Helsinki
name: Behnam Rezai Jahromi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Northwestern University
name: Babak Jahromi, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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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.
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.
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.