NIH -- The National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health has stopped enrollment into a clinical trial testing the effects of highly concentrated (hypertonic) saline solutions on patients with severe traumatic brain injury (TBI) when given as soon as possible after the injury — that is, before the patient arrives at the hospital or emergency room. After reviewing data on more than 1,000 participants, the study’s monitoring board and the NHLBI determined that the hypertonic saline solutions were no better than the standard treatment of normal saline and that it is unlikely that continuing to enroll new patients would change the outcome of the study. There were no concerns about safety. Previously enrolled participants who have not yet completed their six month follow-up visits will continue to be monitored according to the study design.
