NCT06510842 Lumbar Drainage of Intraventricular Hemorrhage
| NCT ID | NCT06510842 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital Heidelberg |
| Condition | Intraventricular Hemorrhage |
| Study Type | INTERVENTIONAL |
| Enrollment | 354 participants |
| Start Date | 2025-01-16 |
| Primary Completion | 2029-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 354 participants in total. It began in 2025-01-16 with a primary completion date of 2029-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Intracerebral hemorrhage (ICH) is a debilitating and fatal disease, especially when the hemorrhage is also entering the cerebral ventricles leading to acute hydrocephalus. In these cases, patients need a drainage through external ventricular drains (EVD). In the longer term, patients often need a permanent ventriculoperitoneal (VP) shunt to avoid hydrocephalus. Here we hypothesize that the early insertion of a lumbar drainage in addition to the EVD could lead to better functional outcome and avoidance of VP shunting by drainage of the blood which promotes inflammatory and adverse effects in the subarachnoid space. For that we propose a multi-center randomized clinical trial to investigate the hypothesis.
Eligibility Criteria
Inclusion Criteria: * ICH with IVH (with hemorrhage in the 3rd and/or 4rth ventricle) with the need for EVD placement due to acute hydrocephalus * Age ≥ 18 y * Lumbar drain can be inserted within 72 h after symptom onset or patient last seen well Exclusion Criteria: * Premorbid mRS score \> 2 * Pregnancy * Life expectancy \<6 months * Patient/family/caregiver unwilling or unlikely to opt for at least two weeks of aggressive therapy prior to consideration of transition to comfort measures/discontinuation of life support measures. * Treating physicians deeming the prognosis as so grave that an aggressive therapy is not warranted. * Other clear contraindication for treatment with a lumbar drain
Contact & Investigator
Silvia Schönenberger, MD
PRINCIPAL INVESTIGATOR
Heidelberg University Hospital, Department of Neurology
Frequently Asked Questions
Who can join the NCT06510842 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Intraventricular Hemorrhage. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06510842 currently recruiting?
Yes, NCT06510842 is actively recruiting participants. Contact the research team at silvia.schoenenberger@med.uni-heidelberg.de for enrollment information.
Where is the NCT06510842 trial being conducted?
This trial is being conducted at Heidelberg, Germany, München, Germany, Augsburg, Germany, Berlin, Germany and 8 additional locations.
Who is sponsoring the NCT06510842 clinical trial?
NCT06510842 is sponsored by University Hospital Heidelberg. The principal investigator is Silvia Schönenberger, MD at Heidelberg University Hospital, Department of Neurology. The trial plans to enroll 354 participants.