Objective of the NACTN SCI registry

The mission of the North American Clinical Trials Network (NACTN) is to bring promising therapies out of the laboratory and into clinical trials with rigorous evidence of effectiveness and safety.

In addition to accelerating the development of promising treatments, NACTN maintains a SCI Registry to capture information on individuals who are admitted to a NACTN hospital with an acute traumatic spinal cord injury. The patient is then tracked over the course of a year to collect additional data on their follow-up care and progress.

The purpose of the NACTN SCI Registry is threefold:

  1. Establish the natural course of recovery following a spinal cord injury using standardized and validated acute-care and follow-up data.
  2. Facilitate scholarly research and publications.
  3. Serve as a comparison group in spinal cord clinical trials and help establish protocols.

By collecting and analyzing data from individuals with acute injuries, researchers are able to shape future studies based on real-world insights and recovery patterns.

Overview of the data collected

All data are collected starting at the time of admission to a NACTN clinical center. The Registry data include extensive demographic information, past medical history, pre-injury medication use, circumstances of injury, time of injury, and the time of arrival to the treating NACTN hospital.

Further detail is recorded about the condition of the patient on arrival and includes a clinical evaluation, measurement of state of consciousness with the Glasgow Coma Scale (GCS) and of associated injuries with the Abbreviated Injury Scale (AIS). Data is also collected on radiographic findings, non-operative and operative treatments, timing of treatments, and pre/post surgical complications.

Additionally, the ISNCSCI (International Standards for Neurological Classification of Spinal Cord Injury) is scored on admission and at key times throughout the patient's hospital and post-hospital course. The discharge ISNCSCI score and the type of facility to which the patient is transferred are also documented in the discharge form.

Long-term follow-up is scheduled at six and 12 months after discharge to capture additional insights such as the course of treatment and evolving neurological status.

Information for the Registry is collected under a protocol approved by the Institutional Review Board at each NACTN clinical center. Individuals who agree to participate sign an Informed Consent, which clearly states the purpose of the Registry. All data are “de-identified,” meaning no patient names are used.

Why is this data important?

Data drives the discovery process and the translation of scientific findings to the clinic. The information from the Registry is used in the design of clinical trials and in assessing the safety and efficacy of the treatment being tested.

NACTN’s ability to standardize patient data collection and ensure its validation means that the scientists and clinicians who use it can be assured of its integrity. For example, in the Phase I safety study of the neuroprotective riluzole, NACTN used the SCI Registry to form a comparison group of subjects who did not receive the drug.

There is a rigorous process by which scientists and clinical investigators can request access to information found in the Registry. Data collected by NACTN are currently being shared with two academic networks, STASCIS (the Surgical Treatment of Acute Spinal Cord Injury database, University of Toronto) and EM-SCI (the European Multicenter Study about Spinal Cord Injury). NACTN is also engaged in a new initiative, the International Spine Data Network (ISDN), which is exploring the possibility of collaborative research using the combined datasets of multiple organizations.