Active Removal of IntraCerebral Hematoma Via Active Irrigation

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

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.

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.

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