Acute Brain InjuriesNCT01069250
Dynamic and Static Autoregulation After Brain Injury
An observational study of Acute Brain Injuries and TBI (Traumatic Brain Injury), run by Johannes Gutenberg University Mainz at 1 site in Germany.
Trial summary
The aim of the study assesses static and dynamic cerebrovascular autoregulation daily over one week in patients with traumatic brain injury or intracranial hemorrhage to quantify the temporal profile of the autoregulatory status. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Brain Injuries, TBI (Traumatic Brain Injury), Intracranial Hemorrhages
- How many people
- 16 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2001to Feb 2010
- Phase
- Observational
- 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
Study population: Patients after traumatic brain injury or intracranial bleeding wich had a Glasgow-Coma-Scale (GCS) of less than 8 and were initially sedated, intubated and mechanically ventilated.
Who may be able to join
- Traumatic brain injury
- Intracranial hemorrhage
Who cannot join
- Measurement of TCD were impossible
- Injury of the legs (if the both tigh cuffs for dynamic autoregulation could not be fixed)
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Medical Center of the Johannes Gutenberg-University Mainz
Mainz, 55131
About this study
Official title: Serial Measurement of Static and Dynamic Cerebrovascular Autoregulation After Brain Injury
The aim of the study assesses static and dynamic cerebrovascular autoregulation daily over one week in patients with traumatic brain injury or intracranial hemorrhage to quantify the temporal profile of the autoregulatory status.
- Being tested
- There are no interventions in this study
- Keywords
- dynamic cerebrovascular autoregulation, static cerebrovascular autoregulation, acute brain injury, transcranial Doppler ultrasound, critical care
- Medical subject headings
- Brain Injuries, Brain Injuries, Traumatic, Intracranial Hemorrhages
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
There are no interventions in this studyOther
| Study group | Role | What they receive |
|---|---|---|
| Brain injury | Patients after traumatic brain injury or spontaneous intracranial bleeding Receives: Other: There are no interventions in this study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disturbed cerebrovascular autoregulation after brain injury
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2010 (estimated)
- Study startAug 2001
- Primary completionDec 2009
- Study completionFeb 2010
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 Acute Brain InjuriesStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johannes Gutenberg University Mainz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Patrick Schramm, Johannes Gutenberg University Mainz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01069250
- Sponsor's protocol ID
- 2001 448/01
- Status last verified
- Aug 2013
- First submitted
- 16 Feb 2010
- Last updated
- 22 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Schramm P, Klein KU, Pape M, Berres M, Werner C, Kochs E, Engelhard K. Serial measurement of static and dynamic cerebrovascular autoregulation after brain injury. J Neurosurg Anesthesiol. 2011 Jan;23(1):41-4. doi: 10.1097/ANA.0b013e3181f35854.
PubMed 21252706
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serial Measurement of Static and Dynamic Cerebrovascular Autoregulation After Brain Injury
- ClinicalTrials.gov ID
- NCT01069250
- Acronym / sponsor ID
- 2001 448/01
- Keywords
- dynamic cerebrovascular autoregulation, static cerebrovascular autoregulation, acute brain injury, transcranial Doppler ultrasound, critical care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Johannes Gutenberg University MainzUniversity, hospital or other
- Study start
- Aug 2001
- Primary completion
- Dec 2009 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 17 Feb 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 aim of the study assesses static and dynamic cerebrovascular autoregulation daily over one week in patients with traumatic brain injury or intracranial hemorrhage to quantify the temporal profile of the autoregulatory status.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Brain injury | – | Other: There are no interventions in this studyPatients after traumatic brain injury or spontaneous intracranial bleeding |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients after traumatic brain injury or intracranial bleeding wich had a Glasgow-Coma-Scale (GCS) of less than 8 and were initially sedated, intubated and mechanically ventilated.
Key inclusion criteria (2 listed)
- Traumatic brain injury
- Intracranial hemorrhage
Key exclusion criteria (2 listed)
- Measurement of TCD were impossible
- Injury of the legs (if the both tigh cuffs for dynamic autoregulation could not be fixed)
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 |
|---|---|---|
| There are no interventions in this study | Other | Brain injury |
Primary outcome
Disturbed cerebrovascular autoregulation after brain injury
Time frame: 7 days
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 22 Aug 2013.
- Results publication: PubMed 21252706Schramm P, Klein KU, Pape M, Berres M, Werner C, Kochs E, Engelhard K. Serial measurement of static and dynamic cerebrovascular autoregulation after brain injury. J Neurosurg Anesthesiol. 2011 Jan;23(1):41-4. doi: 10.1097/ANA.0b013e3181f35854.
Related trials for Acute Brain Injuries
Not yet recruiting
Supplementary Neuromuscular Rehabilitation During Acute Concussion Recovery
Concussion (Diagnosis), Gait Abnormality
Recruiting
Percutaneous Electrical Nerve Field Stimulation (PENFS) in Patients With Post Concussion Syndrome (PCS)
Post-Concussion Syndrome, COVID Long-Haul
Active, not recruitingObservational study
Psychoactive Drug Use and Acute Care Use After Trauma and Out-of-Hospital Cardiac Arrest
Wounds and Injuries, Out-of-Hospital Cardiac Arrest
Recruiting
Assessment of the Rehabilitative Effects of Curved-walking Training in Stroke, Parkinson and Orthopaedic Populations
Stroke, Acute, Parkinson Disease
Not yet recruitingPhase 3
Sovateltide for the Treatment of Acute Traumatic Brain Injury
Traumatic Brain Injury
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Brain Injuries and TBI (Traumatic Brain Injury), run by Johannes Gutenberg University Mainz 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 2 inclusion and 2 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 22 Aug 2013. 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.
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?
Disturbed cerebrovascular autoregulation after brain injury (time frame: 7 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 NCT01069250, 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 22 Aug 2013.