Brain Injury Traumatic SevereMAWERICNCT05038930
Mobilising Patients With Severe Brain Injury in Intensive Care
A study testing Mobilisation using the Sara Combilizer in people with Brain Injury Traumatic Severe and Subarachnoid Hemorrhage, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
Introduction Patients with severe brain injury are often restricted to bed rest during the early period of brain injury which may lead to unwanted secondary complications. There is lack of evidence of when to initiate the first mobilisation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Injury Traumatic Severe, Subarachnoid Hemorrhage, Intracranial Hematoma
- What is being tested?
- Mobilisation using the Sara Combilizer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Oct 2021to 16 Mar 2023
- Phase
- Interventional
- 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
- Traumatic brain injury, subarachnoid haemorrhage, intracranial haematoma
- Sedated for at least 48 hours after admission
- Equipment measuring partial brain tissue oxygenation and intracranial pressure
- Understands spoken and written Danish
Who cannot join
- Unstable spinal cord injury
- Unstable injury in the lower extremities prohibiting mobilisation
- No consent from nearest relative
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Neuroanaesthesiology, Rigshospitalet
Copenhagen, Copenhagen, 2100
About this study
Introduction Patients with severe brain injury are often restricted to bed rest during the early period of brain injury which may lead to unwanted secondary complications. There is lack of evidence of when to initiate the first mobilisation. The Sara Combilizer® is an easy and efficient tool for mobilising patients with severe injuries, including brain injury.
Through a randomised cross-over trial the investigators will investigate the impact of early mobilisation on patients with severe acquired brain injury caused by traumatic brain injury, subarachnoid brain injury or intracranial haematoma.
The investigators hypothesise that mobilisation using the Sara Combilizer® does not affect partial oxygenation of brain tissue.
Read the detailed description
The primary purpose of this study is to quantify cerebral oxygenation, when mobilising patients with severe brain injury using a Sara Combilizer® to the seated position and during passive standing.
This study is conducted at the Department of Neurointensive care and Neuroanaesthesiology, Rigshospitalet, Copenhagen.
Based on the International Conference on harmonisation-Good Clinical Practice guidelines and the Danish "Good Clinical Practice" administrative order, a table regarding the responsibilities of sponsor/investigators before, during and after the clinical trial, will be filled and signed in order to avoid misunderstandings. This table can be found in the Trial Master File (TMF) located at the primary investigator's office and the sponsor's office.
This study is designed as a cross-over study with patients randomly assigned to (1) an initial intervention protocol on the first day and with a passive sedentary protocol on the second, or (2) an initial passive sedentary protocol on the first day followed by an intervention protocol on the second day.
Randomisation Included patients will, after stabilisation of ICP, be randomised to start with either the intervention or sedentary protocol, with the opposite protocol on the second day. A computer-generated randomisation algorithm will be created in REDCap, with age and Glasgow Coma Score (GCS) as dichotomised stratification variables. Age will be divided into young (18 to 60 years) and old (61+ years), and the GCS into severe brain injury (GCS 3-8) and moderate to mild injury (GCS 9-15). The following four composite groups of age and GCS will ensure an equal distribution of the patients within each stratum.
- Being tested
- Mobilisation using the Sara Combilizer
- Keywords
- Acquired brain injury, Early mobilisation, Cerebral oxygenation
- Medical subject headings
- Subarachnoid Hemorrhage, Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobilisation using the Sara CombilizerDevice
Also called Arjo, Malmø, Sweden
The mobilisation with the Sara Combilizer, will be done one time either 24 or 48 hours after stable intracranial pressure
| Study group | Role | What they receive |
|---|---|---|
| Intervention protocol | Experimental | Phase 1. The patient will be positioned in a supine position for 20 minutes on the Sara Combilizer®. When necessary, the head of the patient can be elevated to a maximum of 30 degrees during the 20 minutes baseline measurements.
Phase 2. The patient will be positioned in a seated position for 10 minutes with the trunk and head elevated to at least 70 degrees.
Phase 3. The patient will be moved to the standing position for 20 minutes with an elevation angle of the Sara Combilizer of at least 70 degrees. If patients become haemodynamically unstable during the seated or standing position, they will be returned to the supine position, and the intervention will be terminated.
Phase 4. The patient is returned to the phase 1 position (supine). Further measurements are made for at least 20 minutes. Receives: Device: Mobilisation using the Sara Combilizer |
| Sedentary protocol | No intervention | The sedentary protocol will follow the same four phases as the intervention protocol only the patient will remain in the supine position on the Sara Combilizer®. Ideally, no interventions will occur during the 70-minute protocol. If medications are given or other interventions are necessary, this will be registered. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in partial oxygenation of brain tissue (PbtO2)
PbtO2 measures the partial pressure of oxygen in the extra-cellular fluid of the brain continuously. Therefore, this value represents the balance between oxygen delivered and consumed and reflects the perfusion of the capillaries in the area of interest.
Measured: Head-up tilt PbtO2 (delta between supine and standing values) compared to sedentary PbtO2 (delta by subtracting two values measured with the same duration and distance) measured continuously after 24 and 48 hours from stable intracranial pressure
Secondary outcomes (10)
Change in mean arterial pressure (MAP)
Arterial line
Measured: Head-up tilt MAP (delta between supine and standing values) compared to sedentary MAP (delta by subtracting two values measured with the same duration and distance) measured continuously after 24 and 48 hours from stable intracranial pressure
Change in heart rate (HR)
Three-lead electrocardiography
Measured: Head-up tilt HR (delta between supine and standing values) compared to sedentary HR (delta by subtracting two values measured with the same duration and distance) measured continuously after 24 and 48 hours from stable intracranial pressure
Change in intracranial pressure (ICP)
Electrode placed in the intraparenchymal area
Measured: Head-up tilt ICP (delta between supine and standing values) compared to sedentary ICP (delta by subtracting two values measured with the same duration and distance) measured continuously after 24 and 48 hours from stable intracranial pressure
Change in middle cerebral artery flow velocity (MCAv)
Transcranial Doppler sonography using a 2 Megahertz probe.
Measured: Head-up tilt MCAv (delta between supine and standing values) compared to sedentary MCAv (delta by subtracting two values measured with the same duration and distance) measured continuously after 24 and 48 hours from stable intracranial pressure
Change in microdialysis of cerebrospinal fluid: Glucose level (MDg)
Extracellular brain fluids through a small catheter with a semipermeable membrane.
Measured: Intervention protocol MDg (delta between supine and standing values) compared to sedentary MDg (calculated by subtracting baseline from after protocol values) measured continuously after 24 and 48 hours from stable intracranial pressure
Change in microdialysis of cerebrospinal fluid: Lactate/pyruvate level (MDl/p)
Extracellular brain fluids through a small catheter with a semipermeable membrane.
Measured: Intervention protocol MDl/p (delta between supine and standing values) compared to sedentary MDl/p (calculated by subtracting baseline from after protocol values) measured continuously after 24 and 48 hours from stable intracranial pressure
Change in cerebral perfusion pressure (CPP)
Cerebral perfusion pressure calculated from mean arterial pressure and intracranial pressure
Measured: Head-up tilt CPP (delta between supine and standing values) compared to sedentary CPP (delta by subtracting two values measured with the same duration and distance) measured continuously after 24 and 48 hours from stable intracranial pressure
Change in mean flow index (Mx)
Pearson's correlation coefficient from mean flow velocity af the middle cerebral artery measured by transcranial Doppler and the cerebral perfusion pressure
Measured: Head-up tilt Mx (delta between supine and standing values) compared to sedentary Mx (delta by subtracting two values measured with the same duration and distance) measured continuously after 24 and 48 hours from stable intracranial pressure
Change in pressure reactivity index (PRx)
Correlation between intracranial pressure and arterial blood pressure
Measured: Head-up tilt PRx (delta between supine and standing values) compared to sedentary PRx (delta by subtracting two values measured with the same duration and distance) measured continuously after 24 and 48 hours from stable intracranial pressure
Change in artial arterial carbon dioxide (PaCO2) levels
Blood samples drawn from arterial line
Measured: Head-up tilt PaCO2 (delta between supine and standing values) compared to sedentary PaCO2 (delta by subtracting two values measured with the same duration and distance) measured continuously after 24 and 48 hours from stable intracranial pressure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2021
- Study start1 Oct 2021
- Primary completion16 Mar 2023
- Study completion16 Mar 2023
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 Brain Injury Traumatic SevereStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This study is designed as a cross-over study with patients randomly assigned to (1) an initial intervention protocol on the first day and with a passive sedentary protocol on the second, or (2) an initial passive sedentary protocol on the first day followed by an intervention protocol on the second day.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christian Riberholt, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Kirsten Møller, Professor, Study chair, Department of Neuroanaesthesiology, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05038930
- Sponsor's protocol ID
- H-21002728
- Acronym
- MAWERIC
- Status last verified
- Sep 2025
- First submitted
- 23 Aug 2021
- Last updated
- 10 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be shared by reasonable request from other researcher. Due to the small number of included patients this will be done in an anonymised way, so that recognising individual patients are not possible.
Publications
Riberholt CG, Olsen MH, Berg RMG, Moller K. Mobilising patients with severe acquired brain injury in intensive care (MAWERIC) - Protocol for a randomised cross-over trial. Contemp Clin Trials. 2022 May;116:106738. doi: 10.1016/j.cct.2022.106738. Epub 2022 Mar 21.
PubMed 35331944
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mobilising Patients With Severe Brain Injury in Intensive Care
- ClinicalTrials.gov ID
- NCT05038930
- Acronym / sponsor ID
- MAWERIC / H-21002728
- Keywords
- Acquired brain injury, Early mobilisation, Cerebral oxygenation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 16 Mar 2023 (actual)
- Study completion
- 16 Mar 2023 (actual)
- First posted
- 9 Sep 2021 (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.
Introduction Patients with severe brain injury are often restricted to bed rest during the early period of brain injury which may lead to unwanted secondary complications. There is lack of evidence of when to initiate the first mobilisation. The Sara Combilizer® is an easy and efficient tool for mobilising patients with severe injuries, including brain injury.
Through a randomised cross-over trial the investigators will investigate the impact of early mobilisation on patients with severe acquired brain injury caused by traumatic brain injury, subarachnoid brain injury or intracranial haematoma.
The investigators hypothesise that mobilisation using the Sara Combilizer® does not affect partial oxygenation of brain tissue.
Detailed description
The primary purpose of this study is to quantify cerebral oxygenation, when mobilising patients with severe brain injury using a Sara Combilizer® to the seated position and during passive standing.
This study is conducted at the Department of Neurointensive care and Neuroanaesthesiology, Rigshospitalet, Copenhagen.
Based on the International Conference on harmonisation-Good Clinical Practice guidelines and the Danish "Good Clinical Practice" administrative order, a table regarding the responsibilities of sponsor/investigators before, during and after the clinical trial, will be filled and signed in order to avoid misunderstandings. This table can be found in the Trial Master File (TMF) located at the primary investigator's office and the sponsor's office.
This study is designed as a cross-over study with patients randomly assigned to (1) an initial intervention protocol on the first day and with a passive sedentary protocol on the second, or (2) an initial passive sedentary protocol on the first day followed by an intervention protocol on the second day.
Randomisation Included patients will, after stabilisation of ICP, be randomised to start with either the intervention or sedentary protocol, with the opposite protocol on the second day. A computer-generated randomisation algorithm will be created in REDCap, with age and Glasgow Coma Score (GCS) as dichotomised stratification variables. Age will be divided into young (18 to 60 years) and old (61+ years), and the GCS into severe brain injury (GCS 3-8) and moderate to mild injury (GCS 9-15). The following four composite groups of age and GCS will ensure an equal distribution of the patients within each stratum.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- This study is designed as a cross-over study with patients randomly assigned to (1) an initial intervention protocol on the first day and with a passive sedentary protocol on the second, or (2) an initial passive sedentary protocol on the first day followed by an intervention protocol on the second day.
| Arm | Type | Receives |
|---|---|---|
| Intervention protocol | Experimental | Device: Mobilisation using the Sara CombilizerPhase 1. The patient will be positioned in a supine position for 20 minutes on the Sara Combilizer®. When necessary, the head of the patient can be elevated to a maximum of 30 degrees during the 20 minutes baseline measurements. Phase 2. The patient will be positioned in a seated position for 10 minutes with the trunk and head elevated to at least 70 degrees. Phase 3. The patient will be moved to the standing position for 20 minutes with an elevation angle of the Sara Combilizer of at least 70 degrees. If patients become haemodynamically unstable during the seated or standing position, they will be returned to the supine position, and the intervention will be terminated. Phase 4. The patient is returned to the phase 1 position (supine). Further measurements are made for at least 20 minutes. |
| Sedentary protocol | No intervention | –The sedentary protocol will follow the same four phases as the intervention protocol only the patient will remain in the supine position on the Sara Combilizer®. Ideally, no interventions will occur during the 70-minute protocol. If medications are given or other interventions are necessary, this will be registered. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Traumatic brain injury, subarachnoid haemorrhage, intracranial haematoma
- Sedated for at least 48 hours after admission
- Equipment measuring partial brain tissue oxygenation and intracranial pressure
- Understands spoken and written Danish
Key exclusion criteria (3 listed)
- Unstable spinal cord injury
- Unstable injury in the lower extremities prohibiting mobilisation
- No consent from nearest relative
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 |
|---|---|---|
| Mobilisation using the Sara CombilizerAlso: Arjo, Malmø, SwedenThe mobilisation with the Sara Combilizer, will be done one time either 24 or 48 hours after stable intracranial pressure | Device | Intervention protocol |
Primary outcome
Change in partial oxygenation of brain tissue (PbtO2)
Time frame: Head-up tilt PbtO2 (delta between supine and standing values) compared to sedentary PbtO2 (delta by subtracting two values measured with the same duration and distance) measured continuously after 24 and 48 hours from stable intracranial pressure
PbtO2 measures the partial pressure of oxygen in the extra-cellular fluid of the brain continuously. Therefore, this value represents the balance between oxygen delivered and consumed and reflects the perfusion of the capillaries in the area of interest.
10 secondary outcomes
Change in mean arterial pressure (MAP)
Time frame: Head-up tilt MAP (delta between supine and standing values) compared to sedentary MAP (delta by subtracting two values measured with the same duration and distance) measured continuously after 24 and 48 hours from stable intracranial pressure
Change in heart rate (HR)
Time frame: Head-up tilt HR (delta between supine and standing values) compared to sedentary HR (delta by subtracting two values measured with the same duration and distance) measured continuously after 24 and 48 hours from stable intracranial pressure
Change in intracranial pressure (ICP)
Time frame: Head-up tilt ICP (delta between supine and standing values) compared to sedentary ICP (delta by subtracting two values measured with the same duration and distance) measured continuously after 24 and 48 hours from stable intracranial pressure
Change in middle cerebral artery flow velocity (MCAv)
Time frame: Head-up tilt MCAv (delta between supine and standing values) compared to sedentary MCAv (delta by subtracting two values measured with the same duration and distance) measured continuously after 24 and 48 hours from stable intracranial pressure
Change in microdialysis of cerebrospinal fluid: Glucose level (MDg)
Time frame: Intervention protocol MDg (delta between supine and standing values) compared to sedentary MDg (calculated by subtracting baseline from after protocol values) measured continuously after 24 and 48 hours from stable intracranial pressure
Change in microdialysis of cerebrospinal fluid: Lactate/pyruvate level (MDl/p)
Time frame: Intervention protocol MDl/p (delta between supine and standing values) compared to sedentary MDl/p (calculated by subtracting baseline from after protocol values) measured continuously after 24 and 48 hours from stable intracranial pressure
Change in cerebral perfusion pressure (CPP)
Time frame: Head-up tilt CPP (delta between supine and standing values) compared to sedentary CPP (delta by subtracting two values measured with the same duration and distance) measured continuously after 24 and 48 hours from stable intracranial pressure
Change in mean flow index (Mx)
Time frame: Head-up tilt Mx (delta between supine and standing values) compared to sedentary Mx (delta by subtracting two values measured with the same duration and distance) measured continuously after 24 and 48 hours from stable intracranial pressure
Change in pressure reactivity index (PRx)
Time frame: Head-up tilt PRx (delta between supine and standing values) compared to sedentary PRx (delta by subtracting two values measured with the same duration and distance) measured continuously after 24 and 48 hours from stable intracranial pressure
Change in artial arterial carbon dioxide (PaCO2) levels
Time frame: Head-up tilt PaCO2 (delta between supine and standing values) compared to sedentary PaCO2 (delta by subtracting two values measured with the same duration and distance) measured continuously after 24 and 48 hours from stable intracranial pressure
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 10 Sep 2025.
- Derived from this study: PubMed 35331944Riberholt CG, Olsen MH, Berg RMG, Moller K. Mobilising patients with severe acquired brain injury in intensive care (MAWERIC) - Protocol for a randomised cross-over trial. Contemp Clin Trials. 2022 May;116:106738. doi: 10.1016/j.cct.2022.106738. Epub 2022 Mar 21.
- Individual participant dataSharing planned: Yes. Data will be shared by reasonable request from other researcher. Due to the small number of included patients this will be done in an anonymised way, so that recognising individual patients are not possible.
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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.
Kirsten Møller, Professor study chair
Department of Neuroanaesthesiology, Rigshospitalet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobilisation using the Sara Combilizer in people with Brain Injury Traumatic Severe and Subarachnoid Hemorrhage, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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 4 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: finished, as of the sponsor's last update on 10 Sep 2025. 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 Denmark. 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?
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?
Change in partial oxygenation of brain tissue (PbtO2) (time frame: Head-up tilt PbtO2 (delta between supine and standing values) compared to sedentary PbtO2 (delta by subtracting two values measured with the same duration and distance) measured continuously after 24 and 48 hours from stable intracranial pressure). 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 NCT05038930, 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 10 Sep 2025.