Intracerebral HemorrhagePhase 2/3LUCAS-IVHNCT01041950
A Randomised Controlled Trial of Lumbar Drainage to Treat Communicating Hydrocephalus After Severe Intraventricular Hemorrhage
A Phase 2/3 study testing Lumbar drainage in people with Intracerebral Hemorrhage and Obstructive Hydrocephalus, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
Trial summary
The purpose of this study is to determine if usage of early lumbar drainage leads to less shunt surgery and less catheter associated complications in patients with communicating hydrocephalus after intracerebral hemorrhage with severe ventricular involvement. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Intracerebral Hemorrhage, Obstructive Hydrocephalus
- What is being tested?
- Lumbar drainage
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- May 2012to Jul 2015
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- supratentorial intracerebral hemorrhage <60ml
- intraventricular hemorrhage with casting of the third and fourth ventricles
- obstructive hydrocephalus with need of external ventricular drainage
- GCS <9 on admission or within 48h of symptom onset
- admission within 48h of symptom onset
- preceding modified Rankin scale ≤3
- age 18-85 years
Who cannot join
- ICH related to oral anticoagulation, trauma, tumor, arteriovenous malformation, aneurysm, systemic thrombolysis or sinus thrombosis
- infratentorial hemorrhage
- pregnancy
- admission 48h after symptom onset
- preceding modified Rankin scale >3
Trial locations and contacts
1 site in 1 country.
Germany1 site
Neurology Department, University of Erlangen-Nuremberg
Erlangen, 91054
About this study
Official title: Lumbar Drainage for Communicating Hydrocephalus After Intraventricular Hemorrhage: a Randomised, Controlled Trial(LUCAS-IVH: LUmbar CAtheter for Severe IntraVentricular Hemorrhage)
The purpose of this study is to determine if usage of early lumbar drainage leads to less shunt surgery and less catheter associated complications in patients with communicating hydrocephalus after intracerebral hemorrhage with severe ventricular involvement.
Read the detailed description
All patients requiring external ventricular drain (EVD) for treatment of acute obstructive hydrocephalus receive intraventricular fibrinolysis with rt-PA via the ventricular catheter. Lumbar drainage (LD) is inserted at a timepoint, when communication between the internal and the external CSF-spaces is recognizable on CT ("opening" of third and fourth ventricle and aqueduct).
- Being tested
- Lumbar drainage
- Keywords
- intracerebral hemorrhage, intraventricular hemorrhage, hydrocephalus, Intracerebral hemorrhage with severe ventricular involvement and obstructive hydrocephalus
- Medical subject headings
- Cerebral Hemorrhage, Hydrocephalus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lumbar drainageProcedure or surgery
Lumbar CSF drainage is started after communication between the internal and external CSF-spaces is seen on CT.
| Study group | Role | What they receive |
|---|---|---|
| Lumbar drainage | Experimental | Not described Receives: Procedure: Lumbar drainage |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Requirement of permanent VP-shunt
if three attempts to clamp the EVD (control group) or LD (treatment group) fail, or overall extra-corporal drainage time exceeds 14 days, a VP-shunt is placed.
Measured: 14 days
Secondary outcomes (2)
Safety aspects
(i) catheter-associated infections (ii) fibrinolysis- and catheter-associated bleedings (iii)overdrainage and herniation
Measured: during hospital stay
mortality and outcome
modified Rankin Scale 3 and 6 months after treatment, as well as in-hospital mortality.
Measured: 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2010 (estimated)
- Study startMay 2012
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intracerebral HemorrhageStudies of the same condition, open and under way.
- More trials run by University of Erlangen-Nürnberg Medical SchoolThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Erlangen-Nürnberg Medical School
- Sponsor type
- University, hospital or other
- Collaborators
- University of Freiburg
- Responsible party
- Principal investigator, Dimitre Staykov, University of Erlangen-Nürnberg Medical School
- Investigators
- Hagen Huttner, MD, Principal investigator, University of Erlangen-NürnbergDimitre Staykov, MD, Principal investigator, University of Erlangen-NürnbergJürgen Bardutzky, MD, Study chair, University of Freiburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01041950
- Sponsor's protocol ID
- LUCAS-IVH
- Acronym
- LUCAS-IVH
- Status last verified
- Oct 2016
- First submitted
- 4 Jan 2010
- Last updated
- 27 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
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 27888608
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lumbar Drainage for Communicating Hydrocephalus After Intraventricular Hemorrhage: a Randomised, Controlled Trial(LUCAS-IVH: LUmbar CAtheter for Severe IntraVentricular Hemorrhage)
- ClinicalTrials.gov ID
- NCT01041950
- Acronym / sponsor ID
- LUCAS-IVH / LUCAS-IVH
- Keywords
- intracerebral hemorrhage, intraventricular hemorrhage, hydrocephalus, Intracerebral hemorrhage with severe ventricular involvement and obstructive hydrocephalus
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of Erlangen-Nürnberg Medical SchoolUniversity, hospital or other
- Collaborators
- University of Freiburg
- Study start
- May 2012
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 5 Jan 2010 (estimated)
- 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.
The purpose of this study is to determine if usage of early lumbar drainage leads to less shunt surgery and less catheter associated complications in patients with communicating hydrocephalus after intracerebral hemorrhage with severe ventricular involvement.
Detailed description
All patients requiring external ventricular drain (EVD) for treatment of acute obstructive hydrocephalus receive intraventricular fibrinolysis with rt-PA via the ventricular catheter. Lumbar drainage (LD) is inserted at a timepoint, when communication between the internal and the external CSF-spaces is recognizable on CT ("opening" of third and fourth ventricle and aqueduct).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lumbar drainage | Experimental | Procedure: Lumbar drainage |
| Control | No intervention | – |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- supratentorial intracerebral hemorrhage <60ml
- intraventricular hemorrhage with casting of the third and fourth ventricles
- obstructive hydrocephalus with need of external ventricular drainage
- GCS <9 on admission or within 48h of symptom onset
- admission within 48h of symptom onset
Key exclusion criteria (5 listed)
- ICH related to oral anticoagulation, trauma, tumor, arteriovenous malformation, aneurysm, systemic thrombolysis or sinus thrombosis
- infratentorial hemorrhage
- pregnancy
- admission 48h after symptom onset
- preceding modified Rankin scale >3
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 |
|---|---|---|
| Lumbar drainageLumbar CSF drainage is started after communication between the internal and external CSF-spaces is seen on CT. | Procedure or surgery | Lumbar drainage |
Primary outcome
Requirement of permanent VP-shunt
Time frame: 14 days
if three attempts to clamp the EVD (control group) or LD (treatment group) fail, or overall extra-corporal drainage time exceeds 14 days, a VP-shunt is placed.
2 secondary outcomes
Safety aspects
Time frame: during hospital stay
mortality and outcome
Time frame: 3 and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2016.
- Derived from this study: 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.
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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. This study is not recruiting at the moment.
Hagen Huttner, MD principal investigator
University of Erlangen-Nürnberg
Dimitre Staykov, MD principal investigator
University of Erlangen-Nürnberg
Jürgen Bardutzky, MD study chair
University of Freiburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Lumbar drainage in people with Intracerebral Hemorrhage and Obstructive Hydrocephalus, run by University of Erlangen-Nürnberg Medical School at 1 site 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 7 inclusion and 5 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: finished, as of the sponsor's last update on 27 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Requirement of permanent VP-shunt (time frame: 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 NCT01041950, which also lists 1 linked publication.
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 27 Oct 2016.