Early Predictors for Neurological Outcome After Traumatic Spinal Cord Injury

NCT07210879 | Active Not Recruiting

• 1 other identifier: 22057
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 1

Brief Summary

This project investigates early predictors of neurological recovery after traumatic spinal cord injury through three main aims:

1. 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. 2.Pharmacological interventions - evaluate the impact of other medications, particularly opioids in the acute stage, on recovery.
3. 3.Biomarkers - identify diagnostic and prognostic biomarkers (blood-borne or digital) from routine clinical measurements within the first year after injury.

Conditions

Acute Traumatic Spinal Cord Injury

Keywords

Spinal cord injuries; Blood pressure; Hemodynamics; Critical care; Biomarkers; Neurological recovery

Outcome Measures

Primary Outcomes (1)

• ISNCSCI

  International Standards for Neurological Classification about Spinal Cord Injury

  Days after Injury (DAI) 1-546

Study Arms (3)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with traumatic spinal cord injury

You may qualify if:

• Data from patients who sustained traumatic SCI, and who
• completed at least one neurological examination in the acute / sub-acute stage of injury (between the day of injury and 40 days post-SCI) and in the chronic stage of injury (the latest neurological assessment between day 70 and day 546 after SCI)
• agreed to provide their medical data for research purposes in the European Multicenter Study about Spinal Cord Injury (EMSCI) database
• specific for Cohort 1: MAP Cohort patients who
• were initially admitted to the BG Trauma Center Murnau, or transferred for acute SCI care within two days after trauma
• were treated in the intensive care unit (ICU) and underwent hemodynamic monitoring for at least 24 hours
• specific for Cohort 2: Biomarker Cohort - 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
• specific for Cohort 3: Opioid Cohort
• \- patients who were treated in the ICU and received opioid therapy, including detailed information on timing, dosage, and duration of administration

You may not qualify if:

• 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

Sponsors & Collaborators

• BG Unfallklinik Murnau: lead
• Foundation Wings For Life: collaborator
• University of California, San Francisco: collaborator

Study Sites (1)

BG Trauma Center Murnau

Murnau am Staffelsee, Bavaria, 82418, Germany

Location

Related Links

• Related Info

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Research SCI

Study Record Dates

• First Submitted: September 30, 2025
• First Posted: October 7, 2025
• Study Start: July 20, 2022
• Primary Completion: June 30, 2025
• Study Completion (Estimated): August 30, 2026
• Last Updated: October 7, 2025

Record last verified: 2025-09

Locations

DE (1)