Browsing by Subject "North American Clinical Trials Network Collaborators"

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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.
    (Critical care medicine, 2019-11) Jiang, Fan; Jaja, Blessing NR; Kurpad, Shekar N; Badhiwala, Jetan H; Aarabi, Bizhan; Grossman, Robert G; Harrop, James S; Guest, Jim D; Schär, Ralph T; Shaffrey, Chris I; Boakye, Max; Toups, Elizabeth G; Wilson, Jefferson R; Fehlings, Michael G; North American Clinical Trials Network Collaborators

    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.