Intraventricular HemorrhageDRAIN IVHNCT06510842
Lumbar Drainage of Intraventricular Hemorrhage
A study testing External drainage of intraventricular hemorrhage in people with Intraventricular Hemorrhage and Lumbar Drainage, run by University Hospital Heidelberg at 12 sites in Germany.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intraventricular Hemorrhage, Lumbar Drainage, External Ventricular Drainage
- What is being tested?
- External drainage of intraventricular hemorrhage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 354 participants
- Where
- 12 sitesGermany
- Study dates
- 16 Jan 2025to Jul 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
12 sites in 1 country. Contact the study team or a site near you to ask about taking part.
12 sites in 1 country
Germany12 sites, 12 recruiting
- Recruiting
Augsburg University Hospital
Augsburg
Hauke Schneider, PD Dr., 0049/821/400-01, hauke.schneider@uk-augsburg.de
- Not yet recruiting
Charite Universitätsmedizin Berlin
Berlin
Stefan Wolf, Dr.
- Recruiting
Düsseldorf Universitiy Hospital
Düsseldorf
Kerim Beseoglu, Prof. Dr., +49 (0) 2 11-81 00, Kerim.Beseoglu@med.uni-duesseldorf.de
- Not yet recruiting
Frankfurt University Hospital
Frankfurt
Marcus Czabanka, Prof. Dr., 049/69 63010, Czabanka@med.uni-frankfurt.de
- Not yet recruiting
Goettingen University Hospital
Göttingen
Tammam Abboud, PD Dr., 049/551/390, Tammam.abboud@med.uni-goettingen.de
- Recruiting
Department of Neurology, University Hospital Heidelberg
Heidelberg, Baden-Wurttemberg, 69120
Silvia Schönenberger, Dr., 0049-6221-5637549, silvia.schoenenberger@med.uni-heidelberg.de
Silvia Schönenberger, Dr.
- Recruiting
Augsburg University Hospital Department of Neurosurgery
Heidelberg
Nadine Lilla, PD Dr., 0049/821 400-01, Nadine.Lilla@uk-augsburg.de
- Recruiting
Heidelberg University Hospital Department of Neurosurgery
Heidelberg
Martin Jakobs, Prof. Dr., 0049/6221/560, martin.jakobs@med.uni-heidelberg.de
- Not yet recruiting
Mainz University Hospital
Mainz
Thomas Kerz, Dr., +49 6131 39-0, kerz@uni-mainz.de
- Recruiting
Mannheim University Hospital
Mannheim
Christopher Beynon, Prof. Dr., 0049/621/383-0, christopher.beynon@umm.de
- Recruiting
LMU München
München, Bavaria
Konstantinos Dimitriadis, Prof. Dr., 004989440073690, Konstantin.Dimitriadis@med.uni-muenchen.de
- Recruiting
Osnabrück Clinic
Osnabrück
Volker Schulte, Dr., 049/541/4050, Volker.Schulte@klinikum-os.de
About this study
Official title: Lumbar Drainage of Intraventricular Hemorrhage The DRAIN IVH Randomized Controlled Trial
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.
- Being tested
- External drainage of intraventricular hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Experimental | Additional insertion of a lumbar drainage. Receives: 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. Receives: Other: External drainage of intraventricular hemorrhage |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 180 days (+/- 14 days)
Secondary outcomes (8)
Amount of CSF drained by external ventricular drain
in ml
Measured: up to 14 days (duration of hospital stay)
Amount of CSF drained by lumbar drain
in ml
Measured: up to 14 days (duration of hospital stay)
Need for VP shunt
operative implantation of VP shunt
Measured: up to 14 days (duration of hospital stay)
Need for VP shunt
operative implantation of VP shunt
Measured: at 180 days
Clearance of intraventricular blood (via neuroimaging with CT or MRI)
Opening of third ventricle (y/n)
Measured: up to 14 days (duration of hospital stay)
Clearance of intraventricular blood (via neuroimaging with CT or MRI)
Opening of fourth ventricle (y/n)
Measured: up to 14 days (duration of hospital stay)
Bacterial Ventriculitis/Meningitis leading to antibiotic treatment
(y/n)
Measured: up to 14 days (duration of hospital stay)
Mortality
cerebral cause of death (y/n)
Measured: up to 14 days (duration of hospital stay) and 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2024
- Study start16 Jan 2025
- Primary completionJan 2029 (estimated)
- Study completionJul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Intraventricular HemorrhageStudies of the same condition, open and under way.
- More trials run by University Hospital HeidelbergThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 354 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Heidelberg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Silvia Schönenberger, MD, University Hospital Heidelberg
- Investigators
- Silvia Schönenberger, MD, Principal investigator, Heidelberg University Hospital, Department of Neurology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06510842
- Sponsor's protocol ID
- DRAIN IVH
- Other IDs
- S-304/2024
- Acronym
- DRAIN IVH
- Status last verified
- Jan 2026
- First submitted
- 8 Jul 2024
- Last updated
- 28 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 27888608Staykov 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.
PubMed 19679848Kuramatsu 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.
PubMed 35521958Chen M, Sauer LD, Herweh C, Sander A, Klose C, Wick W, Wolf S, Schonenberger S. Lumbar drainage in intracerebral haemorrhage with intraventricular haemorrhage (DRAIN IVH): protocol for a multi-centre, randomised-controlled, two-arm, assessor-blinded trial. Eur Stroke J. 2026 May 4;11(5):aakag046. doi: 10.1093/esj/aakag046.
PubMed 42132469
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lumbar Drainage of Intraventricular Hemorrhage The DRAIN IVH Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06510842
- Acronym / sponsor ID
- DRAIN IVH / DRAIN IVH
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 354 participants (estimated)
- Lead sponsor
- University Hospital HeidelbergUniversity, hospital or other
- Study start
- 16 Jan 2025 (actual)
- Primary completion
- Jan 2029 (estimated)
- Study completion
- Jul 2029 (estimated)
- First posted
- 19 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Experimental | Other: External drainage of intraventricular hemorrhageAdditional insertion of a lumbar drainage. |
| Control arm | Active comparator | Other: External drainage of intraventricular hemorrhageStandard of care consists of drainage of CSF via EVD with or without intraventricular thrombolysis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| External drainage of intraventricular hemorrhageAn 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. | Other | Control arm, Intervention arm |
Primary outcome
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.
8 secondary outcomes
Amount of CSF drained by external ventricular drain
Time frame: up to 14 days (duration of hospital stay)
Amount of CSF drained by lumbar drain
Time frame: up to 14 days (duration of hospital stay)
Need for VP shunt
Time frame: up to 14 days (duration of hospital stay)
Need for VP shunt
Time frame: at 180 days
Clearance of intraventricular blood (via neuroimaging with CT or MRI)
Time frame: up to 14 days (duration of hospital stay)
Clearance of intraventricular blood (via neuroimaging with CT or MRI)
Time frame: up to 14 days (duration of hospital stay)
Bacterial Ventriculitis/Meningitis leading to antibiotic treatment
Time frame: up to 14 days (duration of hospital stay)
Mortality
Time frame: up to 14 days (duration of hospital stay) and 6 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2026.
- Background: PubMed 27888608Staykov 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.
- Background: PubMed 19679848Staykov 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.
- Background: PubMed 35521958Kuramatsu 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.
- Derived from this study: PubMed 42132469Chen M, Sauer LD, Herweh C, Sander A, Klose C, Wick W, Wolf S, Schonenberger S. Lumbar drainage in intracerebral haemorrhage with intraventricular haemorrhage (DRAIN IVH): protocol for a multi-centre, randomised-controlled, two-arm, assessor-blinded trial. Eur Stroke J. 2026 May 4;11(5):aakag046. doi: 10.1093/esj/aakag046.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Silvia Schönenberger, MD principal investigator
Heidelberg University Hospital, Department of Neurology
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing External drainage of intraventricular hemorrhage in people with Intraventricular Hemorrhage and Lumbar Drainage, run by University Hospital Heidelberg at 12 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Silvia Schönenberger, MD (0049/6221/567504, silvia.schoenenberger@med.uni-heidelberg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of mRS (time frame: 180 days (+/- 14 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06510842, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2026.