NCT06510842

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
354

participants targeted

Target at P75+ for not_applicable

Timeline
38mo left

Started Jan 2025

Longer than P75 for not_applicable

Geographic Reach
1 country

12 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress29%
Jan 2025Jul 2029

First Submitted

Initial submission to the registry

July 8, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 19, 2024

Completed
6 months until next milestone

Study Start

First participant enrolled

January 16, 2025

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2029

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2029

Last Updated

January 28, 2026

Status Verified

January 1, 2026

Enrollment Period

4 years

First QC Date

July 8, 2024

Last Update Submit

January 26, 2026

Conditions

Intraventricular HemorrhageLumbar DrainageExternal Ventricular Drainage

Outcome Measures

Primary Outcomes (1)

  • Rate of mRS

    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.

    180 days (+/- 14 days)

Secondary Outcomes (8)

  • Amount of CSF drained by external ventricular drain

    up to 14 days (duration of hospital stay)

  • Amount of CSF drained by lumbar drain

    up to 14 days (duration of hospital stay)

  • Need for VP shunt

    up to 14 days (duration of hospital stay)

  • Need for VP shunt

    at 180 days

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

    up to 14 days (duration of hospital stay)

  • +3 more secondary outcomes

Study Arms (2)

Intervention arm

EXPERIMENTAL

Additional insertion of a lumbar drainage.

Other: External drainage of intraventricular hemorrhage

Control arm

ACTIVE COMPARATOR

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

Other: External drainage of intraventricular hemorrhage

Interventions

External drainage of intraventricular hemorrhageOTHER

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.

Control armIntervention arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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 the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Department of Neurology, University Hospital Heidelberg

Heidelberg, Baden-Wurttemberg, 69120, Germany

RECRUITING

LMU München

München, Bavaria, Germany

RECRUITING

Augsburg University Hospital

Augsburg, Germany

RECRUITING

Charite Universitätsmedizin Berlin

Berlin, Germany

NOT YET RECRUITING

Düsseldorf Universitiy Hospital

Düsseldorf, Germany

RECRUITING

Frankfurt University Hospital

Frankfurt, Germany

NOT YET RECRUITING

Goettingen University Hospital

Göttingen, Germany

NOT YET RECRUITING

Augsburg University Hospital Department of Neurosurgery

Heidelberg, Germany

RECRUITING

Heidelberg University Hospital Department of Neurosurgery

Heidelberg, Germany

RECRUITING

Mainz University Hospital

Mainz, Germany

NOT YET RECRUITING

Mannheim University Hospital

Mannheim, Germany

RECRUITING

Osnabrück Clinic

Osnabrück, Germany

RECRUITING

Related Publications (3)

  • Staykov D, Kuramatsu JB, Bardutzky J, Volbers B, Gerner ST, Kloska SP, Doerfler A, Schwab S, Huttner HB. Efficacy and safety of combined intraventricular fibrinolysis with lumbar drainage for prevention of permanent shunt dependency after intracerebral hemorrhage with severe ventricular involvement: A randomized trial and individual patient data meta-analysis. Ann Neurol. 2017 Jan;81(1):93-103. doi: 10.1002/ana.24834.

    PMID: 27888608BACKGROUND

  • Staykov D, Huttner HB, Struffert T, Ganslandt O, Doerfler A, Schwab S, Bardutzky J. Intraventricular fibrinolysis and lumbar drainage for ventricular hemorrhage. Stroke. 2009 Oct;40(10):3275-80. doi: 10.1161/STROKEAHA.109.551945. Epub 2009 Aug 13.

    PMID: 19679848BACKGROUND

  • Kuramatsu JB, Gerner ST, Ziai W, Bardutzky J, Sembill JA, Sprugel MI, Mrochen A, Kolbl K, Ram M, Avadhani R, Falcone GJ, Selim MH, Lioutas VA, Endres M, Zweynert S, Vajkoczy P, Ringleb PA, Purrucker JC, Volkmann J, Neugebauer H, Erbguth F, Schellinger PD, Knappe UJ, Fink GR, Dohmen C, Minnerup J, Reichmann H, Schneider H, Rother J, Reimann G, Schwarz M, Bazner H, Classen J, Michalski D, Witte OW, Gunther A, Hamann GF, Lucking H, Dorfler A, Ishfaq MF, Chang JJ, Testai FD, Woo D, Alexandrov AV, Staykov D, Goyal N, Tsivgoulis G, Sheth KN, Awad IA, Schwab S, Hanley DF, Huttner HB; Collaborators. Association of Intraventricular Fibrinolysis With Clinical Outcomes in Intracerebral Hemorrhage: An Individual Participant Data Meta-Analysis. Stroke. 2022 Sep;53(9):2876-2886. doi: 10.1161/STROKEAHA.121.038455. Epub 2022 May 6.

    PMID: 35521958BACKGROUND

Study Officials

  • Silvia Schönenberger, MD

    Heidelberg University Hospital, Department of Neurology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Silvia Schönenberger, MD

CONTACT

0049/6221/567504silvia.schoenenberger@med.uni-heidelberg.de

Min Chen, MD

CONTACT

0049/6221/567504min.chen@med.uni-heidelberg.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. Silvia Schönenberger

Study Record Dates

First Submitted

July 8, 2024

First Posted

July 19, 2024

Study Start

January 16, 2025

Primary Completion (Estimated)

January 1, 2029

Study Completion (Estimated)

July 1, 2029

Last Updated

January 28, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share

Locations

DE(12)