Lumbar Drainage of Intraventricular Hemorrhage (DRAIN IVH)

University Hospital Heidelberg

Status: Enrolling

Conditions: Intraventricular Hemorrhage; External Ventricular Drainage; Lumbar Drainage

Treatments: Other: External drainage of intraventricular hemorrhage

Study type: Interventional

Funder types: Other

Identifiers

NCT06510842

S-304/2024

Details and patient eligibility

About

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.

Enrollment: 354 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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354 participants in 2 patient groups

Intervention arm

Experimental group

Description:

Additional insertion of a lumbar drainage.

Treatment:

Other: External drainage of intraventricular hemorrhage

Control arm

Active Comparator group

Description:

Standard of care consists of drainage of CSF via EVD with or without intraventricular thrombolysis.

Treatment:

Other: External drainage of intraventricular hemorrhage