Active Removal of IntraCerebral Hematoma Via Active Irrigation

Intraventricular Hemorrhage Clinical Trial

— ARCH  

Official title:

Active Removal of IntraCerebral Hematoma Via Active Irrigation of the Ventricular System

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05118997
• Other study ID #: 001
• Status: Recruiting
• Phase: N/A
• Start date: October 25, 2021
• Est. completion date: July 2024

Study information

• Verified date: March 2023
• Source: IRRAS
• Contact: John Unser, MBA
• Phone: 19712195984
• Email: john.unser[@]irras.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: July 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Hemorrhage
• Hematoma
• Hemorrhage
• Intraventricular Hemorrhage

Intervention

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.
• 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.

Locations

Country	Name	City	State
Finland	Helsinki University	Helsinki

Sponsors (6)

Lead Sponsor	Collaborator
IRRAS	Brigham and Women's Hospital, Klinikum Bergmannstrost, Northwestern University, University of Helsinki, West Virginia University

Country where clinical trial is conducted

Finland, 

References & Publications (8)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Length of ICU stay (days)	Time (days) the patient is admitted to the ICU till the patient is discharged from the ICU	Intra-Procedural
Other	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
Other	Rate of mortality during treatment	Percentage of patients having a mortality event during active treatment	Intra-Procedural
Other	Rate of shunt dependency	Percentage of patients that require a shunt after treatment	30 days
Other	Radiological evaluation of ventricles as measured by CT scan of head	Radiologic evaluation of the ventricles by the neurosurgeon or radiologist	Intra-Procedural
Other	Duration of EVD and IRRAflow catheter in place	Number of days between catheter insertion and with drawl of the catheter	Intra-Procedural
Other	Rate of clot removal as assessed by CT	Change in blood volume measured between stability scan and end of treatment scan	Intra-Procedural
Other	Duration of catheter drainage	Number of days catheter was utilized for drainage	Intra-Procedural
Other	Catheter occlusion rate	Percentage of time in which the catheter is unable to drain	Intra-Procedural
Other	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
Other	Repeat hemorrhagic events	Number of repeated symptomatic hemorrhagic events	Intra-Procedural
Other	Catheter occlusion	Number of flushes required to clear a catheter occlusion	Intra-Procedural
Other	Functional Status	modified Rankin Score (mRS)	Intra-Procedural
Other	Functional Status	Difference in modified Rankin Score (mRS) as proportioned to IVH size	30 day
Other	Total cost of procedure	Measured as total cost involved in treating patient during treatment with IRRAflow and EVD	Intra-Procedural
Primary	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
Primary	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
Primary	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	Procedural Success	Less than or equal to 30% residual clot burden in the ventricular system	Intra-Procedural
Secondary	Technical Success	Percentage of patients in which correct placement of IRRAflow and EVD catheter occurred	Intra-Procedural
Secondary	Technical Success	Percent obstruction of the IRRAflow catheter and EVD catheter	Intra-Procedural
Secondary	Safety - Catheter misplacement	Measurement of if the catheter needs to be re-inserted or re-positioned.	Intra-Procedural
Secondary	Safety - Infection	Comparison of rate of infection as measured by routine cerebrospinal fluid (CSF) analysis	Intra-Procedural
Secondary	Safety - Bleeding events	Comparison of new bleeding events on routine neuroimaging	Intra-Procedural