Study Summary
Duraplasty for Acute Traumatic Spinal Cord Injury (DATSCI) is a Phase 2 prospective, multi-center, randomized, single-blinded controlled trial aimed at evaluating safety and effectiveness of expansile duraplasty in adult patients with acute spinal cord injury (SCI).
Traumatic spinal cord injury (SCI) remains a challenging clinical problem for which treatment options remain limited, despite significant ongoing efforts by industry, non-profit organizations and academia to unveil the mechanisms behind it. There is currently no clearly beneficial pharmaceutical therapy for SCI, so in the absence of suitable pharmacotherapy, early surgical decompression and optimization of spinal cord perfusion have been emerged as targets for intervention. Common surgical techniques do not address intrathecal compression due to spinal cord swelling. The lack of dural decompression after SCI is in contrast to traumatic brain injury, where dural opening is a routine part of decompressive craniectomy. There remains a paucity of data on whether durotomy or expansile duraplasty may provide additional benefit in decompressing the injured spinal cord, though preclinical animal data has for decades been in favor of early decompression, and there is evidence from non-randomized human studies that suggest duraplasty may lead to improved outcomes for SCI patients. These data, along with other published SCI research, served as motivation to explore expansile duraplasty in humans.
Objectives of this randomized clinical trial are to evaluate (i) effectiveness of the expansile duraplasty in improving neurologic motor outcomes in patients with acute SCI; (ii) safety of expansile duraplasty in acute SCI patients; (iii) exploratory effectiveness of reducing ITP by expansile duraplasty in patients with acute SCI.
Subjects will be recruited among the patients treated at one of 4 clinical sites: University of California San Francisco/San Francisco General Hospital, University of Washington/Harborview Medical Center, Thomas Jefferson University/Jefferson University Hospital, and University of Miami/Jackson Memorial Hospital. Enrolled subjects will be randomized 1:1 to standard of care only (early surgical decompression and stabilization) (Control Arm) or standard of care plus surgical expansile duraplasty (Experimental Arm).
Study Site Locations
- University of California, San Francisco/Zuckerberg San Francisco General Hospital (San Francisco, California) (central site)
- University of Washington/Harborview Medical Center (Seattle, Washington) (onboarding)
- University of Miami/Jackson Memorial Hospital (Coral Gables, Florida) (onboarding)
- Thomas Jefferson University/Jefferson University Hospital (Philadelphia, Pennsylvania) (onboarding)
What is involved?
- Access to the patient's hospitalization records for the SCI visit.
- One blood draw of about 5 mL (1 tsp), during surgery.
- Three cerebrospinal fluid draws of about 5 mL (1 tsp) each, at 0, 1, and 2 days post-injury.
- Insertion of lumbar drain during standard of care surgery (already done as standard of care at some sites).
- Magnetic Resonance Imaging (MRI) on admission and at 3 days post-injury (already done as standard of care at some sites).
- International Standard for Neurological Classification of Spinal Cord Injury (ISNCSCI) motor and sensory assessments conducted at days 0 and 7, and at 6 and 12 months post-injury.
- Questionnaires on health and well-being conducted during hospital stay and at 6 and 12 months post-injury.
- Pain questionnaires on day 7 and at 6 and 12 months post-injury.
- Vitals measurements at 6 and 12 months post-injury.
Who can participate?
Patients who meet the following inclusion criteria are eligible for admission into the study, providing they do not meet exclusion criteria.
- Age 18-80, inclusive
- Diagnosis of acute, traumatic spinal cord injury
AIS grade A - C - C3 - T10 neurological level of injury on ISNCSCI exam
- Imaging showing cord compression
- Surgical decompression initiated within 24 hrs 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
- Patients unable to give informed consent prior to their standard of care surgery