Acute Traumatic Spinal Cord InjuryMurnauMAPNCT07210879
Early Predictors for Neurological Outcome After Traumatic Spinal Cord Injury
An observational study of Acute Traumatic Spinal Cord Injury, run by BG Unfallklinik Murnau at 1 site in Germany.
Trial summary
This project investigates early predictors of neurological recovery after traumatic spinal cord injury through three main aims: 1. MAP and vasopressors - determine whether continuous monitoring of mean arterial pressure (MAP) and the use of vasopressors in the ICU influence neurological outcome. 2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Traumatic Spinal Cord Injury
- How many people
- 800 participants
- Where
- 1 siteGermany
- Study dates
- 20 Jul 2022to 30 Aug 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 with traumatic spinal cord injury
Who may be able to join
None listed.
Who cannot join
- Patients with non-traumatic spinal cord injury or non-spinal cord injury
- Patients who were initially admitted and/or surgically treated in another hospital and transferred to the BG Trauma Center Murnau later than two days post-SCI
Trial locations and contacts
1 site in 1 country.
About this study
This project investigates early predictors of neurological recovery after traumatic spinal cord injury through three main aims:
- MAP and vasopressors - determine whether continuous monitoring of mean arterial pressure (MAP) and the use of vasopressors in the ICU influence neurological outcome.
- Pharmacological interventions - evaluate the impact of other medications, particularly opioids in the acute stage, on recovery.
- Biomarkers - identify diagnostic and prognostic biomarkers (blood-borne or digital) from routine clinical measurements within the first year after injury.
Using high-frequency ICU data and advanced data science methods, the study seeks to provide insights that support individualized treatment strategies and improve outcomes after SCI.
Read the detailed description
Study rationale In order to address the question whether MAP targets and pharmacological interventions affect the neurological outcome after traumatic SCI, a large sample size of longitudinal data is required. The BG Trauma Center Murnau is a level Ia trauma center in Bavaria (Germany) and approximately 120 patients are treated with acute traumatic SCI every year. Therefore the spinal cord injury center at the Trauma Center Murnau represents one of the largest centers in Europe specializing in the treatment of SCI.
A retrospective analysis of routinely collected data during the ICU stay would create an opportunity to investigate the relation of hemodynamic parameters, pharmacological interventions, and neurological recovery in a large cohort of individuals who sustained acute traumatic SCI.
A better understanding of the effect of interventions in the very acute stages of SCI on neurological recovery, as well as the identification of new biomarkers would be of utmost interest for physicians. The knowledge gain from this study could inform clinical decision-making in the future and would therefore ultimately improve the treatment of acute SCI.
Specific aims and hypothesis of the project:
AIM 1 Investigate if continuous monitoring of arterial pressure and augmentation via administration of vasopressors during the ICU stay affect the neurological outcome in individuals who sustained traumatic SCI.
Hypothesis 1.1 The administration of high doses of vasopressor medication within the acute stage of SCI negatively affects long-term neurological outcome.
Hypothesis 1.2 MAP goals need to be defined depending on several contributing factors, such as the patient's age, the presence of co-morbidities, and medication intake prior to the SCI instead of universal MAP targets for the whole SCI population.
AIM 2 Evaluate if other pharmacological interventions (opioids, sedatives, neuroleptics, pain medication especially neuropathic pain medication) during ICU stay are related to neurological recovery and adverse events after SCI.
Hypothesis Administration of high doses of opioids and sedatives negatively affect the neurological outcome after SCI.
AIM 3 Evaluate if diagnostic (for the presence and severity of SCI), and/or prognostic (for neurological recovery and disease progression) biomarkers (blood-borne, or digital) can be identified derived from routine clinical measurements during the first year after injury in clinical routine in the very acute post-injury phase.
Hypothesis 3 Biomarkers with either a diagnostic value (for injury severity) as well as prognostic markers (for neurological recovery and disease progression) could assist clinical decision-making and would therefore be of utmost interest for treating physicians, and for clinical research.
Detailed research plan:
We will retrospectively analyze routinely collected data from patients who sustained traumatic SCI, and were treated in the ICU at the Trauma Center Murnau (Germany). Data to be extracted from the patient data management system include medication (timing, dosage and cumulative dose), routine blood chemistry data, high frequency hemodynamic parameters, ventilation (duration and technique), and complications (infections, etc.) during the ICU stay. In the first step, we aim to investigate the effect of MAP monitoring, vasopressor administration, and other pharmacological interventions on neurological recovery. In a second step of analysis, we will evaluate if new biomarkers can be derived from routinely collected data. We anticipate that a better understanding of the relation between early interventions during intensive care and neurological recovery, as well as the identification of new biomarkers will inform clinical decision-making in the future and would therefore ultimately improve the treatment of acute SCI.
- Conditions
- Acute Traumatic Spinal Cord Injury
- Keywords
- Spinal cord injuries, Blood pressure, Hemodynamics, Critical care, Biomarkers, Neurological recovery
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| MAP cohort | AIM 1 is to investigate if continuous monitoring of arterial pressure and augmentation via administration of vasopressors during the ICU stay affect the neurological outcome after traumatic SCI. For this, data of 161 patients who underwent hemodynamic monitoring in the acute stage after traumatic SCI have been included in the analysis. | |
| Biomarker Cohort | AIM 3 is to evaluate if diagnostic and/or prognostic biomarkers can be derived from measurements in clinical routine. For this analysis, we will include data from 747 patients who had at least five blood samples collected within the first year after injury, with the first sample obtained within two weeks post-injury, and who completed both acute and chronic neurological assessments. | |
| Opioid Cohort | AIM 2 is to evaluate if other pharmacological interventions - specifically opioids - during the ICU stay are related to neurological recovery after SCI. For this, we will analyze data from approximately 240 individuals treated in our ICU who received opioid therapy, including detailed information on timing, dosage, and duration of administration, in relation to their acute and long-term neurological outcomes. |
What is being measured
The primary outcome is the main question the study is designed to answer.
ISNCSCI
International Standards for Neurological Classification about Spinal Cord Injury
Measured: Days after Injury (DAI) 1-546
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2025
- Study start20 Jul 2022
- Primary completion30 Jun 2025
- Study completion30 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Traumatic Spinal Cord InjuryStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 800 participants (actual)
Sponsor and investigators
- Lead sponsor
- BG Unfallklinik Murnau
- Sponsor type
- University, hospital or other
- Collaborators
- Foundation Wings For Life, University of California, San Francisco
- Responsible party
- Principal investigator, Iris Leister, BG Unfallklinik Murnau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07210879
- Sponsor's protocol ID
- 22057
- Acronym
- MurnauMAP
- Status last verified
- Sep 2025
- First submitted
- 30 Sep 2025
- Last updated
- 7 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Predictors for Neurological Outcome After Traumatic Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT07210879
- Acronym / sponsor ID
- MurnauMAP / 22057
- Conditions
- Acute Traumatic Spinal Cord Injury
- Keywords
- Spinal cord injuries, Blood pressure, Hemodynamics, Critical care, Biomarkers, Neurological recovery
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 800 participants (actual)
- Lead sponsor
- BG Unfallklinik MurnauUniversity, hospital or other
- Collaborators
- Foundation Wings For Life, University of California, San Francisco
- Study start
- 20 Jul 2022 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Aug 2026 (estimated)
- First posted
- 7 Oct 2025 (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.
This project investigates early predictors of neurological recovery after traumatic spinal cord injury through three main aims:
- MAP and vasopressors - determine whether continuous monitoring of mean arterial pressure (MAP) and the use of vasopressors in the ICU influence neurological outcome.
- Pharmacological interventions - evaluate the impact of other medications, particularly opioids in the acute stage, on recovery.
- Biomarkers - identify diagnostic and prognostic biomarkers (blood-borne or digital) from routine clinical measurements within the first year after injury.
Using high-frequency ICU data and advanced data science methods, the study seeks to provide insights that support individualized treatment strategies and improve outcomes after SCI.
Detailed description
Study rationale In order to address the question whether MAP targets and pharmacological interventions affect the neurological outcome after traumatic SCI, a large sample size of longitudinal data is required. The BG Trauma Center Murnau is a level Ia trauma center in Bavaria (Germany) and approximately 120 patients are treated with acute traumatic SCI every year. Therefore the spinal cord injury center at the Trauma Center Murnau represents one of the largest centers in Europe specializing in the treatment of SCI.
A retrospective analysis of routinely collected data during the ICU stay would create an opportunity to investigate the relation of hemodynamic parameters, pharmacological interventions, and neurological recovery in a large cohort of individuals who sustained acute traumatic SCI.
A better understanding of the effect of interventions in the very acute stages of SCI on neurological recovery, as well as the identification of new biomarkers would be of utmost interest for physicians. The knowledge gain from this study could inform clinical decision-making in the future and would therefore ultimately improve the treatment of acute SCI.
Specific aims and hypothesis of the project:
AIM 1 Investigate if continuous monitoring of arterial pressure and augmentation via administration of vasopressors during the ICU stay affect the neurological outcome in individuals who sustained traumatic SCI.
Hypothesis 1.1 The administration of high doses of vasopressor medication within the acute stage of SCI negatively affects long-term neurological outcome.
Hypothesis 1.2 MAP goals need to be defined depending on several contributing factors, such as the patient's age, the presence of co-morbidities, and medication intake prior to the SCI instead of universal MAP targets for the whole SCI population.
AIM 2 Evaluate if other pharmacological interventions (opioids, sedatives, neuroleptics, pain medication especially neuropathic pain medication) during ICU stay are related to neurological recovery and adverse events after SCI.
Hypothesis Administration of high doses of opioids and sedatives negatively affect the neurological outcome after SCI.
AIM 3 Evaluate if diagnostic (for the presence and severity of SCI), and/or prognostic (for neurological recovery and disease progression) biomarkers (blood-borne, or digital) can be identified derived from routine clinical measurements during the first year after injury in clinical routine in the very acute post-injury phase.
Hypothesis 3 Biomarkers with either a diagnostic value (for injury severity) as well as prognostic markers (for neurological recovery and disease progression) could assist clinical decision-making and would therefore be of utmost interest for treating physicians, and for clinical research.
Detailed research plan:
We will retrospectively analyze routinely collected data from patients who sustained traumatic SCI, and were treated in the ICU at the Trauma Center Murnau (Germany). Data to be extracted from the patient data management system include medication (timing, dosage and cumulative dose), routine blood chemistry data, high frequency hemodynamic parameters, ventilation (duration and technique), and complications (infections, etc.) during the ICU stay. In the first step, we aim to investigate the effect of MAP monitoring, vasopressor administration, and other pharmacological interventions on neurological recovery. In a second step of analysis, we will evaluate if new biomarkers can be derived from routinely collected data. We anticipate that a better understanding of the relation between early interventions during intensive care and neurological recovery, as well as the identification of new biomarkers will inform clinical decision-making in the future and would therefore ultimately improve the treatment of acute SCI.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MAP cohort | – | –AIM 1 is to investigate if continuous monitoring of arterial pressure and augmentation via administration of vasopressors during the ICU stay affect the neurological outcome after traumatic SCI. For this, data of 161 patients who underwent hemodynamic monitoring in the acute stage after traumatic SCI have been included in the analysis. |
| Biomarker Cohort | – | –AIM 3 is to evaluate if diagnostic and/or prognostic biomarkers can be derived from measurements in clinical routine. For this analysis, we will include data from 747 patients who had at least five blood samples collected within the first year after injury, with the first sample obtained within two weeks post-injury, and who completed both acute and chronic neurological assessments. |
| Opioid Cohort | – | –AIM 2 is to evaluate if other pharmacological interventions - specifically opioids - during the ICU stay are related to neurological recovery after SCI. For this, we will analyze data from approximately 240 individuals treated in our ICU who received opioid therapy, including detailed information on timing, dosage, and duration of administration, in relation to their acute and long-term neurological outcomes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with traumatic spinal cord injury
Key inclusion criteria (0 listed)
Key exclusion criteria (2 listed)
- Patients with non-traumatic spinal cord injury or non-spinal cord injury
- Patients who were initially admitted and/or surgically treated in another hospital and transferred to the BG Trauma Center Murnau later than two days post-SCI
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
ISNCSCI
Time frame: Days after Injury (DAI) 1-546
International Standards for Neurological Classification about Spinal Cord Injury
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2025.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
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 Traumatic Spinal Cord Injury, run by BG Unfallklinik Murnau 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 0 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: under way, not looking for participants, as of the sponsor's last update on 7 Oct 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 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?
This study is still under way. Results are not available in the source record yet.
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?
ISNCSCI (time frame: Days after Injury (DAI) 1-546). 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 Oct 2025.