Randomized Trial of Early Hemodynamic Management of Patients following Acute Spinal Cord Injury: TEMPLE
Miriam Treggiari, MD
Experiencing lower blood pressure is a common event following high spinal cord injury (SCI). Prevention of low blood pressure and early management in an Intensive Care Unit has saved lives and improved the functional results among survivors of SCI. When there is swelling of the spinal cord due to contusion, there is a window of opportunity to preserve some sections of the spinal cord near the level of injury, before they suffer irreversible damage. Today, it is unknown what blood pressure is optimal to help preserve these sections of the spinal cord at risk of ongoing damage. While it is known that managing blood pressure improves outcomes for patients, the best blood pressure range is not yet known. This study will provide guidance to care providers on how to manage blood pressure in the first week after the injury to achieve the best short- and long-term results to improve the life of victims of SCI. The objective of this study is to determine if targeted blood pressure manipulation will improve patient outcomes, including neurological function, functional independence, pain levels, and quality of life after SCI. The trial is currently enrolling participants in a multi-center, randomized, controlled study designed to assess the efficacy and safety of early targeted blood pressure management (TPM) in an intensive care unit (ICU) setting in adult patients with acute spinal cord injury involving the cervical and thoracic spine. Participating sites include Oregon Health and Science University (Clinical Site and Coordinating Center), University of Maryland, University of Pennsylvania, University of Cincinnati, and University of Washington.
Clinical Trials Identifier NCT02878850
Funding: Congressionally Directed Medical Research Program - US army –Department of Defense