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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.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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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.

Germany1 site
  • BG Trauma Center Murnau

    Murnau am Staffelsee, Bavaria, 82418

Other trials in Germany

About this study

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. Pharmacological interventions - evaluate the impact of other medications, particularly opioids in the acute stage, on recovery.
  3. 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.

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 groups in NCT07210879
Study groupRoleWhat they receive
MAP cohortAIM 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 CohortAIM 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 CohortAIM 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.

  1. 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.

  1. First posted7 Oct 2025
  2. Study start20 Jul 2022
  3. Primary completion30 Jun 2025
  4. Study completion30 Aug 2026 (estimated)

Resources

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)
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

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.

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