Active Removal of IntraCerebral Hematoma Via Active Irrigation

Not Applicable

Recruiting

• Conditions: Cerebral Hemorrhage; Intraventricular Hemorrhage
• Interventions: Device: IRRAflow; Device: EVD

• Registration Number: NCT05118997
• Lead Sponsor: IRRAS

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.

Study Timeline

• Study First Submitted: 2021-10-15
• Study Start: 2021-10-25
• Study First Submitted QC: 2021-11-03
• Study First Posted: 2021-11-12
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-30
• Last Update Posted: 2024-08-01
• Primary Completion: 2025-07
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Treatment Arm #1	IRRAflow	IRRAflow with manual tPA administration followed by Active Fluid Exchange
Treatment Arm #2	IRRAflow	IRRAflow with continuous infusion of tPA combined with Active Fluid Exchange
Treatment Arm #3	EVD	Standard EVD with manual tPA administration

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Procedural Success	Intra-Procedural	Less than or equal to 30% residual clot burden in the ventricular system
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

Trial Locations

Locations (1)

Helsinki University; 🇫🇮 Helsinki, Finland