Lumbar Drainage of Intraventricular Hemorrhage

Not Applicable

Recruiting

• Conditions: Intraventricular Hemorrhage; Lumbar Drainage; External Ventricular Drainage
• Interventions: Other: External drainage of intraventricular hemorrhage

• Registration Number: NCT06510842
• Lead Sponsor: University Hospital Heidelberg

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-07-08
• Study First Submitted QC: 2024-07-18
• Study First Posted: 2024-07-19
• Status Verified: 2025-01
• Study Start: 2025-01-16
• Last Update Submitted: 2025-01-16
• Last Update Posted: 2025-01-20
• Primary Completion: 2029-01
• Study Completion: 2029-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 354

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control arm	External drainage of intraventricular hemorrhage	Standard of care consists of drainage of CSF via EVD with or without intraventricular thrombolysis.
Intervention arm	External drainage of intraventricular hemorrhage	Additional insertion of a lumbar drainage.

Primary Outcome Measures

Name	Time	Method
Rate of mRS	180 days (+/- 14 days)	The mRS is frequently employed to assess functional outcome of stroke therapy - its ease of use, simplicity of interpretation for clinicians and families, and agreement with other stroke scales are appealing features. The use of fixed dichotomous analysis of ordered categorical outcomes after stroke (mRS 0-3 favorable vs. 4-6 non-favorable outcome) has proved to be valid and reliable for defining outcome in stroke patients in many previous studies.

Secondary Outcome Measures

Name	Time	Method
Amount of CSF drained by external ventricular drain	up to 14 days (duration of hospital stay)	in ml
Need for VP shunt	at 180 days	operative implantation of VP shunt
Clearance of intraventricular blood (via neuroimaging with CT or MRI)	up to 14 days (duration of hospital stay)	Opening of fourth ventricle (y/n)
Bacterial Ventriculitis/Meningitis leading to antibiotic treatment	up to 14 days (duration of hospital stay)	(y/n)
Amount of CSF drained by lumbar drain	up to 14 days (duration of hospital stay)	in ml
Mortality	up to 14 days (duration of hospital stay) and 6 month	cerebral cause of death (y/n)

Trial Locations

Locations (3)

LMU München; 🇩🇪 München, Bayern, Germany

Department of Neurology, University Hospital Heidelberg; 🇩🇪 Heidelberg, Baden-Württemberg, Germany

Charite Universitätsmedizin Berlin; 🇩🇪 Berlin, Germany