Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:50 PM
Ignite Modification Date:
2025-12-24 @ 11:50 PM
NCT ID:
NCT07280351
Eligibility Criteria:
Inclusion Criteria:
* In initial hospitalization for recent (less than 24 hours) acute, traumatic spinal cord injury at a participating site
* Diagnosis of acute, traumatic spinal cord injury
* AIS grade A - C
* C3 - C7 neurological level of injury on ISNCSCI exam
* Imaging showing cord compression
* Surgical decompression initiated within 24 hours after injury
* At sites where lumbar drain placement is standard of care: placement of lumbar drain
* Able to cooperate in the completion of standardized neurological examinations
Exclusion Criteria:
* Injury arising from penetrating mechanism
* Pregnancy
* In custody
* Under psychiatric hold
* Presence of traumatic durotomy severe enough to preclude study treatment or procedures, in the opinion of the treating surgeon
* Extensive polytrauma as determined by ISS score of \>25
* History of prior spinal cord injury
* Concomitant non-traumatic spinal cord injury (e.g. infection or tumor)
* Significant concomitant head injury as defined by a Glasgow Coma Scale (GCS) \<14 or a clinically significant abnormality on a head CT (head CT required only for patients suspected to have a brain injury at the discretion of the investigator)
* GCS Motor score \< 6
* Pre-existing neurologic or mental disorder which would preclude accurate evaluation and follow-up (i.e. Alzheimer's disease, Parkinson's disease, unstable psychiatric disorder with hallucinations and/or delusions or schizophrenia)
* The treating surgeon deems that an anterior-only approach to decompression and/or stabilization (e.g. anterior cervical discectomy and fusion) is the best treatment plan based on the patient's injury pattern
* Recent history (less than 1 year) of chemical substance dependency or significant psychosocial disturbance that may impact the outcome or study participation, in the opinion of the investigator
* Active malignancy or history of invasive malignancy within the last five years, with the exception of superficial basal cell carcinoma or squamous cell carcinoma of the skin that has been definitely treated. Patients with carcinoma in situ of the uterine cervix treated definitely more than 1 year prior to enrollment may enter the study.
* Thrombocytopenia, defined as less than 100,000 platelets per microliter of blood, that is not correctible by transfusion
* Coagulopathy, defined as INR \> 1.4, that is not correctible by transfusion
* Allergy to the study material, which may include fetal bovine tissue and collagen.
* Contraindications for study treatment or procedures
* Unable to give informed consent prior to their standard of care surgery
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT07280351
Study Brief:
Protocol Section:
NCT07280351