Active Removal of IntraCerebral Hematoma Via Active Irrigation (ARCH)

IRRAS

Status: Enrolling

Conditions: Cerebral Hemorrhage; Intraventricular Hemorrhage

Treatments: Device: IRRAflow; Device: EVD

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05118997

001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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60 participants in 3 patient groups

Treatment Arm #1

Experimental group

Description:

IRRAflow with manual tPA administration followed by Active Fluid Exchange

Treatment:

Device: IRRAflow

Treatment Arm #2

Experimental group

Description:

IRRAflow with continuous infusion of tPA combined with Active Fluid Exchange

Treatment:

Device: IRRAflow

Treatment Arm #3

Active Comparator group

Description:

Standard EVD with manual tPA administration

Treatment:

Device: EVD