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NCT Number: NCT06510842

Lumbar Drainage of Intraventricular Hemorrhage

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.

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Key information

Conditions

Intraventricular Hemorrhage External Ventricular Drainage Lumbar Drainage

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Neurology, University Hospital Heidelberg, Heidelberg, Baden-Wurttemberg, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

External drainage of intraventricular hemorrhage

Other

An EVD is required to be eligible for the DRAIN IVH study. Weaning from the EVD is at the discretion of the local investigators. Imaging is at discretion of local investigators. Use, timing and frequency of fibrinolysis via EVD is at local discretion, too.

Primary outcomes

  1. Rate of mRS

    Time frame: 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 outcomes

  1. Amount of CSF drained by external ventricular drain

    Time frame: up to 14 days (duration of hospital stay)

    in ml

  2. Amount of CSF drained by lumbar drain

    Time frame: up to 14 days (duration of hospital stay)

    in ml

  3. Need for VP shunt

    Time frame: up to 14 days (duration of hospital stay)

    operative implantation of VP shunt

  4. Need for VP shunt

    Time frame: at 180 days

    operative implantation of VP shunt

  5. Clearance of intraventricular blood (via neuroimaging with CT or MRI)

    Time frame: up to 14 days (duration of hospital stay)

    Opening of third ventricle (y/n)

  6. Clearance of intraventricular blood (via neuroimaging with CT or MRI)

    Time frame: up to 14 days (duration of hospital stay)

    Opening of fourth ventricle (y/n)

  7. Bacterial Ventriculitis/Meningitis leading to antibiotic treatment

    Time frame: up to 14 days (duration of hospital stay)

    (y/n)

  8. Mortality

    Time frame: up to 14 days (duration of hospital stay) and 6 month

    cerebral cause of death (y/n)

Study contacts

Contact information is provided by the study sponsor or research team.

Min Chen, MD

CONTACT

[email protected]

0049/6221/567504

Silvia Schönenberger, MD

CONTACT

[email protected]

0049/6221/567504

Sponsors and collaborators

Lead sponsor

University Hospital Heidelberg

Other

Registry information

Official study title

Lumbar Drainage of Intraventricular Hemorrhage The DRAIN IVH Randomized Controlled Trial

Acronym: DRAIN IVH

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Jul 19, 2024
Registry last updated
Jan 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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