Skip to main content

Table 2 In-/exclusion criteria

From: Stereotactic cisternal lavage in patients with aneurysmal subarachnoid hemorrhage with urokinase and nimodipine for the prevention of secondary brain injury (SPLASH): study protocol for a randomized controlled trial

Inclusion criteria

1. Male or female patients aged ≥18 years and < 80 years

2. Modified Fisher grade 3 or 4

3. Cisternal/ventricular blood amount according to Hijdra score ≥ 20

4. Admission WFNS grade ≥ 3 (if grade 5 only with fixed dilated pupil due to raised ICP for less than 45 min)

5. External ventricular drain (EVD) in situ or indication for placement of EVD

6. Disease duration ≤96 h before randomization

7. Written informed consent, either by the patient or by the patient’s legally authorized representative

8. Cerebral aneurysm as a definitive source of subarachnoid hemorrhage

9. Patients in whom the cerebral aneurysm has been safely treated via open surgical or endovascular technique

Exclusion criteria

1. Pregnancy

2. Surgical contraindications according to the opinion of the investigator

3. Inability to administer study medication (known allergy to urokinase or nimodipine)

4. Presence of a severe illness prior to aSAH (e.g., progressive cancer, terminal organ failure, severe neurological disorder, life expectancy < 1 year)

5. Known and persistent abuse of medication or drugs

6. Presence of severe cerebral infarction related to the aSAH or medical procedures prior to randomization

7. Presence of intracerebral hematoma that is ≥30 ml (assessed using the AxBxC/2 method) or in eloquent location prior to randomization

8. Presence of a condition or abnormality that in the opinion of the investigator would compromise the safety of the patient

9. Known severe complications during aneurysm securing (e.g., dissections of blood vessels, vessel occlusions, re-hemorrhage)

10. Clinical signs of brain stem/midbrain compression (dilated pupil not reacting to light) persisting for more than 45 min at any time between aSAH onset and randomization

11. Persons who are in a relationship of dependence/employment with the sponsor or the investigator

12. For MRI follow-up: cardiac pacemaker and/or cardiac defibrillator. Stent implantation within the last 6 weeks prior to MRI, claustrophobia