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Acute Adverse Events After Spinal Cord Injury and Their Relationship to Long-term Neurologic and Functional Outcomes: Analysis From the North American Clinical Trials Network for Spinal Cord Injury

Jiang, Fan MD, FRCSC1,2; Jaja, Blessing N. R. MD, PhD1,3; Kurpad, Shekar N. MD, PhD4; Badhiwala, Jetan H. MD1; Aarabi, Bizhan MD5; Grossman, Robert G. MD6; Harrop, James S. MD7; Guest, Jim D. MD, PhD8; Schär, Ralph T. MD3; Shaffrey, Chris I. MD9; Boakye, Max MD, MPH, MBA10; Toups, Elizabeth G. MSc, MSN6; Wilson, Jefferson R. MD, PhD, FRCSC3; Fehlings, Michael G. MD, PhD, FRCSC, FACS1; on behalf of the North American Clinical Trials Network Collaborators

doi: 10.1097/CCM.0000000000003937
Online Clinical Investigations

Objectives: There are few contemporary, prospective multicenter series on the spectrum of acute adverse events and their relationship to long-term outcomes after traumatic spinal cord injury. The goal of this study is to assess the prevalence of adverse events after traumatic spinal cord injury and to evaluate the effects on long-term clinical outcome.

Design: Multicenter prospective registry.

Setting: Consortium of 11 university-affiliated medical centers in the North American Clinical Trials Network.

Patients: Eight-hundred one spinal cord injury patients enrolled by participating centers.

Interventions: Appropriate spinal cord injury treatment at individual centers.

Measurements and Main Results: A total of 2,303 adverse events were recorded for 502 patients (63%). Penalized maximum logistic regression models were fitted to estimate the likelihood of neurologic recovery (ASIA Impairment Scale improvement ≥ 1 grade point) and functional outcomes in subjects who developed adverse events at 6 months postinjury. After accounting for potential confounders, the group that developed adverse events showed less neurologic recovery (odds ratio, 0.55; 95% CI, 0.32–0.96) and was more likely to require assisted breathing (odds ratio, 6.55; 95% CI, 1.17–36.67); dependent ambulation (odds ratio, 7.38; 95% CI, 4.35–13.06) and have impaired bladder (odds ratio, 9.63; 95% CI, 5.19–17.87) or bowel function (odds ratio, 7.86; 95% CI, 4.31–14.32) measured using the Spinal Cord Independence Measure subscores.

Conclusions: Results from this contemporary series demonstrate that acute adverse events are common and are associated with worsened long-term outcomes after traumatic spinal cord injury.

1Division of Neurosurgery, Toronto Western Hospital, University of Toronto, Toronto, ON, Canada.

2Division of Orthopaedic Surgery, Toronto Western Hospital, University of Toronto, Toronto, ON, Canada.

3Division of Neurosurgery, St. Michael’s Hospital, University of Toronto, Toronto, ON, Canada.

4Division of Neurosurgery, Medical College of Wisconsin, Milwaukee, WI.

5Division of Neurosurgery, Shock Trauma, University of Maryland, Baltimore, MD.

6Division of Neurosurgery, Methodist Hospital, Houston, TX.

7Division of Neurosurgery, Thomas Jefferson University Hospital, Philadelphia, PA.

8Division of Neurosurgery, University of Miami, Miami, FL.

9Division of Neurosurgery, University of Virginia, Chalottesville, VA.

10Division of Neurosurgery, University of Louisville, Louisville, KY.

Drs. Jiang and Jaja contributed equally to this work and are co-first authors.

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Christopher Reeve Foundation supports the North American Clinical Trials Network for the Treatment of Spinal Cord Injury and the AOSpine Spinal Cord Injury Knowledge Forum.

Dr. Grossman received funding from InSightec. Dr. Guest’s institution received funding from North American Clinical Trials Network (NACTN); he received funding from the California Institute of Regenerative Medicine and Abbvie; and he received support for article research from NACTN. Dr. Shaffrey’s institution received funding from NACTN and Zimmer-Biomet, and he received funding from Medtronic, NuVasive, EOS, and Siemens. Dr. Toups’s institution received funding from the Department of Defense Joint Warfare Medical Research Program grant. Dr. Fehlings received funding from Fortuna Fix; he disclosed that the Christopher Reeve Foundation supports the NACTN for the Treatment of Spinal Cord Injury; and he would like to acknowledge support from the Gerry and Tootsie Halbert Chair in Neural Repair and Regeneration and the DeZwirek Family Foundation. The remaining authors have disclosed that they do not have any potential conflicts of interest.

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