Traumatic Brain InjuryPhase 4THIC CuNCT02404779
Treatment of Intracranial Hypertension of Severe Tramatic Brain Injured Patients. Physiopathologic Effects of Neuromuscular Blocking Agents
A Phase 4 study testing cisatracurium besilate in people with Traumatic Brain Injury and Intracranial Hypertension, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
Severely brain injured patients are at high risk of intracranial hypertension. Among medical treatments (sedatives), neuromuscular blocking agents (NMBA) are recommended by french but not english speaking societies. Effects of NMBA are unknown. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Traumatic Brain Injury, Intracranial Hypertension
- What is being tested?
- cisatracurium besilate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteFrance
- Study dates
- 19 Mar 2015to 18 Jun 2022
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- - Age over 18
- Mechanical ventilation and deep sedation
- Severe traumatic brain injury
- Intracranial hypertension (ICP > 20 mmHg during > 15 minutes)
- Intracranial pressure monitoring
- Hemodynamically stable
Who cannot join
- - History of anaphylaxia with neuromuscular agents
- Hemodynamic instability
- Pregnant and/or breast feeding women
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU de Clermont-Ferrand
Clermont-Ferrand, 63003
Patrick LACARIN, 04 73 75 11 95, placarin@chu-clermontferrand.fr
Sophie KAUFFMANN
About this study
Official title: Treatment of Intracranial Hypertension of Severe Tramatic Brain Injured Patients. Physiopathologic Effects of Neuromuscular Blocking Agents. A Controlled Randomized Study Versus Placebo
Severely brain injured patients are at high risk of intracranial hypertension. Among medical treatments (sedatives), neuromuscular blocking agents (NMBA) are recommended by french but not english speaking societies.
Effects of NMBA are unknown. The present study is designed to compare the effects of NMBA versus placebo in the treatment of intracranial hypertension, and the underlying physiopathologic effects.
Read the detailed description
In case of intracranial hypertension, french neurocritical care society argue for the use of neuromuscular blocking agents before osmotherapy, barbituric coma, hypothermia and craniectomy.
English speaking societies don't sustain this approach. Since then, the use of NMBA remains controversial in case of intracranial hypertension and no study is available.
We propose to study severely brain injured patients presenting with intracranial hypertension and treat them with cisatracurium besilate or placebo.
Our hypothesis is that neuromuscular blockade might act on several parameters:
- Hemodynamics
- respiratory parameters, mechanical ventilation and blood gaz analysis
- cerebral velocities
- diminished O2 peripheral consumption
- cerebrospinal diffusion and concentration of cisatracurium and a metabolite laudanosine We wish to assess changes in ICP according to the above parameters in a controlled randomized non blinded fashion against placebo (NaCl 0,9%).
- Conditions
- Traumatic Brain Injury, Intracranial Hypertension
- Being tested
- cisatracurium besilate, Placebo
- Keywords
- ICU, Deep sedation, Mechanical ventilation, Traumatic brain injury, Intracranial hypertension, Cisatracurium, Neuromuscular Blocking Agent, Randomization versus placebo
- Medical subject headings
- Brain Injuries, Traumatic, Intracranial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cisatracurium besilateDrug
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| CISATRACURIUM | Experimental | To compare the evolution of intracranial pressure (ICP) of severely brain injured patients with intracranial hypertension after administration of cisatracurium versus placebo. Receives: Drug: cisatracurium besilate |
| PLACEBO | Placebo comparator | To compare the evolution of intracranial pressure (ICP) of severely brain injured patients with intracranial hypertension after administration of cisatracurium versus placebo. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
area under the curve of the temporal evolution of intracranial pressure
The primary outcome is the area under the curve of the temporal evolution of intracranial pressure, over a period of 30 minutes after the administration of neuromuscular blocking agent or placebo.
Measured: at day 1
Secondary outcomes (15)
Course of intracranial and cerebral perfusion pressures and various cerebral monitoring data if available (SvjO2, PtiO2)
Measured: at day 1
Monitoring of the time spent by intracranial pressure above 20 mmHg using continuous recording
Measured: at day 1
Course of intracranial pressure based on the type of brain injury
diffuse axonal injury, subarachnoid hemorrhage, intracerebral hematoma)
Measured: at day 1
Monitoring of the curare effect
train of four and PTC
Measured: at day 1
Course of ventilation parameters
tidal volume, FiO2, PEEP
Measured: at day 1
Course of transcranial Doppler data
velocities
Measured: at day 1
Course of arterial blood gas data
pH, paO2, paCO2, Excess Base, HCO3-
Measured: at day 1
Course of plasma and cerebrospinal fluid concentrations of cistracurium and laudanosine
Measured: at day 1
Cerebrospinal fluid concentrations of cisatracurium and laudanosin in case of cerebrospinal fluid derivation
Measured: at day 1
Occurrence of cardiovascular complications
hypotension, myocardial ischemia
Measured: at day 1
Occurrence of pulmonary complications
acute respiratory distress syndrome, pneumonia acquired under mechanical ventilation
Measured: at day 1
Occurrence of renal complications
use of renal replacement therapy
Measured: at day 1
Occurrence of infectious complications
Measured: at day 1
Doses of vasopressors or catecholamines
Measured: at day 1
Need to increase therapeutics
barbiturate coma, hypothermia, osmotherapy, decompressive craniectomy
Measured: at day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2015 (estimated)
- Study start19 Mar 2015
- Primary completion19 Mar 2022 (estimated)
- Study completion18 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02404779
- Sponsor's protocol ID
- CHU-0225
- Other IDs
- 2014-004951-30, 2014
- Acronym
- THIC Cu
- Status last verified
- Jun 2020
- First submitted
- 16 Mar 2015
- Last updated
- 7 Jul 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Intracranial Hypertension of Severe Tramatic Brain Injured Patients. Physiopathologic Effects of Neuromuscular Blocking Agents. A Controlled Randomized Study Versus Placebo
- ClinicalTrials.gov ID
- NCT02404779
- Acronym / sponsor ID
- THIC Cu / CHU-0225
- Conditions
- Traumatic Brain Injury, Intracranial Hypertension
- Keywords
- ICU, Deep sedation, Mechanical ventilation, Traumatic brain injury, Intracranial hypertension, Cisatracurium, Neuromuscular Blocking Agent, Randomization versus placebo
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 19 Mar 2015 (actual)
- Primary completion
- 19 Mar 2022 (estimated)
- Study completion
- 18 Jun 2022 (estimated)
- First posted
- 1 Apr 2015 (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.
Severely brain injured patients are at high risk of intracranial hypertension. Among medical treatments (sedatives), neuromuscular blocking agents (NMBA) are recommended by french but not english speaking societies.
Effects of NMBA are unknown. The present study is designed to compare the effects of NMBA versus placebo in the treatment of intracranial hypertension, and the underlying physiopathologic effects.
Detailed description
In case of intracranial hypertension, french neurocritical care society argue for the use of neuromuscular blocking agents before osmotherapy, barbituric coma, hypothermia and craniectomy.
English speaking societies don't sustain this approach. Since then, the use of NMBA remains controversial in case of intracranial hypertension and no study is available.
We propose to study severely brain injured patients presenting with intracranial hypertension and treat them with cisatracurium besilate or placebo.
Our hypothesis is that neuromuscular blockade might act on several parameters:
- Hemodynamics
- respiratory parameters, mechanical ventilation and blood gaz analysis
- cerebral velocities
- diminished O2 peripheral consumption
- cerebrospinal diffusion and concentration of cisatracurium and a metabolite laudanosine We wish to assess changes in ICP according to the above parameters in a controlled randomized non blinded fashion against placebo (NaCl 0,9%).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CISATRACURIUM | Experimental | Drug: cisatracurium besilateTo compare the evolution of intracranial pressure (ICP) of severely brain injured patients with intracranial hypertension after administration of cisatracurium versus placebo. |
| PLACEBO | Placebo comparator | Other: PlaceboTo compare the evolution of intracranial pressure (ICP) of severely brain injured patients with intracranial hypertension after administration of cisatracurium versus placebo. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- - Age over 18
- Mechanical ventilation and deep sedation
- Severe traumatic brain injury
- Intracranial hypertension (ICP > 20 mmHg during > 15 minutes)
- Intracranial pressure monitoring
Key exclusion criteria (3 listed)
- - History of anaphylaxia with neuromuscular agents
- Hemodynamic instability
- Pregnant and/or breast feeding women
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 |
|---|---|---|
| cisatracurium besilate | Drug | CISATRACURIUM |
| Placebo | Other | PLACEBO |
Primary outcome
area under the curve of the temporal evolution of intracranial pressure
Time frame: at day 1
The primary outcome is the area under the curve of the temporal evolution of intracranial pressure, over a period of 30 minutes after the administration of neuromuscular blocking agent or placebo.
15 secondary outcomes
Course of intracranial and cerebral perfusion pressures and various cerebral monitoring data if available (SvjO2, PtiO2)
Time frame: at day 1
Monitoring of the time spent by intracranial pressure above 20 mmHg using continuous recording
Time frame: at day 1
Course of intracranial pressure based on the type of brain injury
Time frame: at day 1
Monitoring of the curare effect
Time frame: at day 1
Course of ventilation parameters
Time frame: at day 1
Course of transcranial Doppler data
Time frame: at day 1
Course of arterial blood gas data
Time frame: at day 1
Course of plasma and cerebrospinal fluid concentrations of cistracurium and laudanosine
Time frame: at day 1
Cerebrospinal fluid concentrations of cisatracurium and laudanosin in case of cerebrospinal fluid derivation
Time frame: at day 1
Occurrence of cardiovascular complications
Time frame: at day 1
Occurrence of pulmonary complications
Time frame: at day 1
Occurrence of renal complications
Time frame: at day 1
Occurrence of infectious complications
Time frame: at day 1
Doses of vasopressors or catecholamines
Time frame: at day 1
Need to increase therapeutics
Time frame: at day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2020.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing cisatracurium besilate in people with Traumatic Brain Injury and Intracranial Hypertension, run by University Hospital, Clermont-Ferrand at 1 site in France.
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 6 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 7 Jul 2020. 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 France. 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Patrick LACARIN (04 73 75 11 95, placarin@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
area under the curve of the temporal evolution of intracranial pressure (time frame: at day 1). 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 7 Jul 2020.