Intracerebral HemorrhagePhase 2WEANINGNCT01176214
WEANING-Study: "Weaning by Early Versus lAte Tracheostomy iN supratentorIal iNtracerebral Bleedings
A Phase 2 study testing Early tracheostomy and Late tracheostomy in people with Intracerebral Hemorrhage, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
Trial summary
Background: One third of all ICH patients require intubation and mechanical ventilation and 1/3 of all ventilated patients require tracheostomy (i.e.≈10% of all ICH patients require tracheostomy). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Intracerebral Hemorrhage
- What is being tested?
- Early tracheostomy and Late tracheostomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2010to Apr 2014
- Phase
- Phase 2
- 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
- Patients requiring intubation / mechanical ventilation
- Supratentorial intracerebral hemorrhage (including:)
- primary spontaneous ICH (lobar / deep)
- ICH related to anticoagulant therapy
- with or without intraventricular hemorrhage
- with or without occlusive and / or communicating hydrocephalus
Show all 9Show fewer
- Hematoma volume >0 ml and <60 ml
- Age 18 - 85 years
- Informed consent (legal representative)
Who cannot join
- Patients with elective intubation/ventilation for EVD placement
- Patients with "do not treat" / "do not resuscitate" orders, severe co- morbidity and life expectancy of less than 3 months
- Absent consent of relatives for invasive (neuro-)critical care
- Contraindication for tracheostomy
- Other than primary supratentorial ICH or supratentorial ICH related to oral anticoagulants
- Pre-existing COPD (known/treated)
- Pre-existing congestive heart failure (≥3 NYHA)
- Pre-existing modified Rankin Scale (≥4)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Weaning by Early Versus lAte Tracheostomy iN supratentorIal iNtracerebral Bleedings
Background:
One third of all ICH patients require intubation and mechanical ventilation and 1/3 of all ventilated patients require tracheostomy (i.e.≈10% of all ICH patients require tracheostomy). As shown previously, predisposing factors for tracheostomy are hematoma volume, hemorrhage location, presence of intraventricular hemorrhage (IVH), and occlusive hydrocephalus as well as presence of COPD (Huttner HB et al 2006 CVD).
Read more
Sustained restricted vigilance and impaired consciousness after ICH is likely to result in failure of extubation, raise in incidence of ventilator-associated pneumonia, increased amount of sedative drugs and prolonged duration of neurocritical care.
Hence an early tracheostomy may be beneficial in terms of reduced duration of mechanical ventilation.
Basic hypothesis:
Compared to patients with conventional ("late") tracheostomy between day 12 - 14, patients with "early" tracheostomy within 72h after admission will have:
- shorter cumulative time of mechanical ventilation
- less incidence of ventilator-associated pneumonia
- less consumption of sedative drugs
- shorter duration of stay in neurocritical care unit
Randomization:
Consecutive eligible patients are randomly assigned to Either "early" tracheostomy within 72h after hospital admission Or "late" tracheostomy (= control group; undergoing conventional tracheostomy between day 12 - 14 if extubation fails) Both groups receive plastic tracheostomy
- Conditions
- Intracerebral Hemorrhage
- Being tested
- Early tracheostomy, Late tracheostomy
- Keywords
- supratentorial intracerebral hemorrhage, tracheostomy, sedation, weaning
- Medical subject headings
- Cerebral Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early tracheostomyProcedure or surgery
Patients with supratentorial ICH who require mechanical ventilation, fulfill the inclusion criteria, and have been randomized to the "treatment arm" will receive an early tracheostomy within 72h after symptom onset.
Late tracheostomyProcedure or surgery
Compared to the "early tracheostomy"-group, those patients who have been randomized to "late tracheostomy" will undergo conventional tracheostomy between day 12 - 14 if extubation fails
| Study group | Role | What they receive |
|---|---|---|
| early tracheostomy | Experimental | see study description Receives: Procedure: Early tracheostomy |
| late tracheostomy | Active comparator | Compared to the "early tracheostomy"-group, those patients who have been randomized to "late tracheostomy" will undergo conventional tracheostomy between day 12 - 14 if extubation fails Receives: Procedure: Late tracheostomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative time requiring mechanical ventilation and Overall duration of neurocritical care
Primary End-points:
- Cumulative time requiring mechanical ventilation
- Overall duration of neurocritical care
Measured: 30 days
Secondary outcomes (5)
Incidence of respirator-associated pneumonia
Measured: 30 days
Cumulative consumption of sedative drugs
Measured: 30 days
Incidence of episodes with increased intracranial pressure
Measured: 30 days
In-hospital mortality
Measured: 30 days
3-months functional outcome (mRS)
functional outcome after 3 months using the modified Rankin Scale
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2010 (estimated)
- Study startJul 2010
- Primary completionApr 2014
- Study completionApr 2014
Why it stopped: slow recruitment of patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Erlangen-Nürnberg Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hagen B Huttner, MD, Principal investigator, Department of Neurology, University of Erlangen-Nuremberg, GermanyMartin Köhrmann, MD, Study director, Department of Neurology, University of Erlangen, GermanyDimitre Staykov, MD, Study director, Department of Neurology, University of Erlangen, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01176214
- Sponsor's protocol ID
- WEANING-Study2010
- Acronym
- WEANING
- Status last verified
- Apr 2014
- First submitted
- 26 Jul 2010
- Last updated
- 28 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Weaning by Early Versus lAte Tracheostomy iN supratentorIal iNtracerebral Bleedings
- ClinicalTrials.gov ID
- NCT01176214
- Acronym / sponsor ID
- WEANING / WEANING-Study2010
- Conditions
- Intracerebral Hemorrhage
- Keywords
- supratentorial intracerebral hemorrhage, tracheostomy, sedation, weaning
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: slow recruitment of patients
- Enrolment
- 7 participants (actual)
- Lead sponsor
- University of Erlangen-Nürnberg Medical SchoolUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 5 Aug 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.
Background:
One third of all ICH patients require intubation and mechanical ventilation and 1/3 of all ventilated patients require tracheostomy (i.e.≈10% of all ICH patients require tracheostomy). As shown previously, predisposing factors for tracheostomy are hematoma volume, hemorrhage location, presence of intraventricular hemorrhage (IVH), and occlusive hydrocephalus as well as presence of COPD (Huttner HB et al 2006 CVD).
Sustained restricted vigilance and impaired consciousness after ICH is likely to result in failure of extubation, raise in incidence of ventilator-associated pneumonia, increased amount of sedative drugs and prolonged duration of neurocritical care.
Hence an early tracheostomy may be beneficial in terms of reduced duration of mechanical ventilation.
Basic hypothesis:
Compared to patients with conventional ("late") tracheostomy between day 12 - 14, patients with "early" tracheostomy within 72h after admission will have:
- shorter cumulative time of mechanical ventilation
- less incidence of ventilator-associated pneumonia
- less consumption of sedative drugs
- shorter duration of stay in neurocritical care unit
Randomization:
Consecutive eligible patients are randomly assigned to Either "early" tracheostomy within 72h after hospital admission Or "late" tracheostomy (= control group; undergoing conventional tracheostomy between day 12 - 14 if extubation fails) Both groups receive plastic tracheostomy
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| early tracheostomy | Experimental | Procedure: Early tracheostomysee study description |
| late tracheostomy | Active comparator | Procedure: Late tracheostomyCompared to the "early tracheostomy"-group, those patients who have been randomized to "late tracheostomy" will undergo conventional tracheostomy between day 12 - 14 if extubation fails |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients requiring intubation / mechanical ventilation
- Supratentorial intracerebral hemorrhage (including:)
- primary spontaneous ICH (lobar / deep)
- ICH related to anticoagulant therapy
- with or without intraventricular hemorrhage
Key exclusion criteria (8 listed)
- Patients with elective intubation/ventilation for EVD placement
- Patients with "do not treat" / "do not resuscitate" orders, severe co- morbidity and life expectancy of less than 3 months
- Absent consent of relatives for invasive (neuro-)critical care
- Contraindication for tracheostomy
- Other than primary supratentorial ICH or supratentorial ICH related to oral anticoagulants
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 |
|---|---|---|
| Early tracheostomyPatients with supratentorial ICH who require mechanical ventilation, fulfill the inclusion criteria, and have been randomized to the "treatment arm" will receive an early tracheostomy within 72h after symptom onset. | Procedure or surgery | early tracheostomy |
| Late tracheostomyCompared to the "early tracheostomy"-group, those patients who have been randomized to "late tracheostomy" will undergo conventional tracheostomy between day 12 - 14 if extubation fails | Procedure or surgery | late tracheostomy |
Primary outcome
Cumulative time requiring mechanical ventilation and Overall duration of neurocritical care
Time frame: 30 days
Primary End-points: * Cumulative time requiring mechanical ventilation * Overall duration of neurocritical care
5 secondary outcomes
Incidence of respirator-associated pneumonia
Time frame: 30 days
Cumulative consumption of sedative drugs
Time frame: 30 days
Incidence of episodes with increased intracranial pressure
Time frame: 30 days
In-hospital mortality
Time frame: 30 days
3-months functional outcome (mRS)
Time frame: 90 days
Results and safety
The study was stopped early (reason given: slow recruitment of patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2014.
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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 B Huttner, MD principal investigator
Department of Neurology, University of Erlangen-Nuremberg, Germany
Martin Köhrmann, MD study director
Department of Neurology, University of Erlangen, Germany
Dimitre Staykov, MD study director
Department of Neurology, University of Erlangen, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Early tracheostomy and Late tracheostomy in people with Intracerebral Hemorrhage, 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 9 inclusion and 8 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: stopped early, as of the sponsor's last update on 28 Apr 2014. 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 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.
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 was stopped early (reason given: slow recruitment of patients). Results are not available in the source record.
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?
Cumulative time requiring mechanical ventilation and Overall duration of neurocritical care (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Apr 2014.