Early Predictors for Neurological Outcome After Traumatic Spinal Cord Injury (NCT07210879) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Early Predictors for Neurological Outcome After Traumatic Spinal Cord Injury
Germany800 participantsStarted 2022-07-20
Plain-language 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. 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
General Inclusion Criteria:
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
Exclusion Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.