Active Removal of IntraCerebral Hematoma Via Active Irrigation

NCT05118997 | Recruiting DMC

• 1 other identifier: 001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Hemorrhage; Intraventricular Hemorrhage

Keywords

Hemorrhage; Cerebral Hemorrhage; Intraventricular Hemorrhage

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (6)

• Procedural Success

  Intra-Procedural

• Technical Success

  Intra-Procedural

• Technical Success

  Intra-Procedural

• Safety - Catheter misplacement

  Intra-Procedural

• Safety - Infection

  Intra-Procedural

Other Outcomes (15)

• Length of ICU stay (days)

  Intra-Procedural

• Length of overall length (days) of hospital stay

  Intra-Procedural

• Rate of mortality during treatment

  Intra-Procedural

Study Arms (3)

Treatment Arm #1

EXPERIMENTAL

IRRAflow with manual tPA administration followed by Active Fluid Exchange

Device: IRRAflow

Treatment Arm #2

EXPERIMENTAL

IRRAflow with continuous infusion of tPA combined with Active Fluid Exchange

Device: IRRAflow

Treatment Arm #3

ACTIVE COMPARATOR

Standard EVD with manual tPA administration

Device: EVD

Interventions

IRRAflow DEVICE

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.

Treatment Arm #1; Treatment Arm #2

EVD DEVICE

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.

Treatment Arm #3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• IRRAS: lead
• University of Helsinki: collaborator
• Northwestern University: collaborator
• West Virginia University: collaborator
• Klinikum Bergmannstrost: collaborator
• Stony Brook University Hospital: collaborator
• Icahn School of Medicine at Mount Sinai: collaborator
• Buffalo General Medical Center: collaborator

Study Sites (1)

Helsinki University

Helsinki, Finland

RECRUITING

Related Publications (8)

• 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.

  PMID: 34168930 BACKGROUND

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

  PMID: 19427958 BACKGROUND

• 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.

  PMID: 11346811 BACKGROUND

• 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.

  PMID: 19038914 BACKGROUND

• 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.

  PMID: 2496328 BACKGROUND

• 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.

  PMID: 3491339 BACKGROUND

• 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.

  PMID: 16636233 BACKGROUND

• 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.

  PMID: 17038942 BACKGROUND

MeSH Terms

Conditions

Cerebral Hemorrhage; Hemorrhage

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Behnam Rezai Jahromi, MD

  University of Helsinki

  PRINCIPAL INVESTIGATOR

• Babak Jahromi, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

John Unser, MBA

CONTACT

19712195984; john.unser@irras.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2021
• First Posted: November 12, 2021
• Study Start: October 25, 2021
• Primary Completion: July 1, 2025
• Study Completion: September 1, 2025
• Last Updated: August 1, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)