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Stereotactic Cisternal Lavage Therapy in Patients with Aneurysmal Subarachnoid Hemorrhage with Urokinase and Nimodipine for the Prevention of Secondary Brain Injury. A Randomized Controlled Trial - SPLASH
EU CTIS ID: 2024-517798-25-00
What this study is testing
To assess whether cisternal lavage therapy with Urokinase, Ringer's solution and Nimodipine administered via a stereotactically implanted catheter into the prepontine cistern (IT, Investigational Treatment) improves neurological outcome and is safe in patients with aSAH.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. Male or female patients aged ≥18 years and <80 years 2. Modified Fisher grade 3 or 42 3. Cisternal/Ventricular blood amount according to Hijdra Score ≥ 203 4. Admission WFNS grade ≥ 3 (if grade 5 only with fixed dilated pupil due to raised ICP for less than 45 minutes) XML File Identifier: 1QQAfUUsgOy4U/EmSL6g0y1IS/g= Page 18/31 5. External ventricular drain (EVD) in situ or indication for placement of EVD 6. Disease duration ≤96 hours before randomization 7. Written informed consent, either by patient or by patient's legally authorized representative 8. Cerebral aneurysm as definitive source of subarachnoid hemorrhage 9. Patients in whom the cerebral aneurysm has been safely treated via open surgical or endovascular technique.
- 2. Modified Fisher grade 3 or 42
- 3. Cisternal/Ventricular blood amount according to Hijdra Score ≥ 20
- 4. Admission WFNS grade 1-5 (if grade 5 only with fixed dilated pupil due to raised ICP for less than 45 minutes)
- 5. External ventricular drain (EVD) in situ or indication for placement of EVD
- 6. Disease duration ≤96 hours before randomization
You likely can't join if
- 1. Pregnancy
- 10. Clinical signs of brain stem / midbrain compression (dilated pupil not reacting to light) persisting for more than 45 minutes 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
- 2. Surgical contraindications according to the opinion of the investigator
- 3. Inability to administer study medication (known allergy to urokinase or nimodipine)
See the full eligibility criteria
- 1. Male or female patients aged ≥18 years and <80 years 2. Modified Fisher grade 3 or 42 3. Cisternal/Ventricular blood amount according to Hijdra Score ≥ 203 4. Admission WFNS grade ≥ 3 (if grade 5 only with fixed dilated pupil due to raised ICP for less than 45 minutes) XML File Identifier: 1QQAfUUsgOy4U/EmSL6g0y1IS/g= Page 18/31 5. External ventricular drain (EVD) in situ or indication for placement of EVD 6. Disease duration ≤96 hours before randomization 7. Written informed consent, either by patient or by patient's legally authorized representative 8. Cerebral aneurysm as definitive source of subarachnoid hemorrhage 9. Patients in whom the cerebral aneurysm has been safely treated via open surgical or endovascular technique.
- 2. Modified Fisher grade 3 or 42
- 3. Cisternal/Ventricular blood amount according to Hijdra Score ≥ 20
- 4. Admission WFNS grade 1-5 (if grade 5 only with fixed dilated pupil due to raised ICP for less than 45 minutes)
- 5. External ventricular drain (EVD) in situ or indication for placement of EVD
- 6. Disease duration ≤96 hours before randomization
- 7. Written informed consent, either by patient or by patient's legally authorized representative
- 8. Cerebral aneurysm as definitive source of subarachnoid hemorrhage
- 9. Patients in whom the cerebral aneurysm has been safely treated via open surgical or endovascular technique.
- 1. Pregnancy
- 10. Clinical signs of brain stem / midbrain compression (dilated pupil not reacting to light) persisting for more than 45 minutes 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
- 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 ≥ 30ml (assessed using the AxBxC/2 method)5 or in eloquent location prior to randomization
- 8. Presence of a condition or abnormality that in the opinion of the Investigator would compromise safety of the patient
- 9. Known severe complications during aneurysm securing (e.g. dissections of blood vessels, vessel occlusions, re-hemorrhage)
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.