Litigation

Enrollment Halted in Study of Concentrated Saline for Patients with Traumatic Brain Injury

By Michael Kaplen

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.

The TBI study is the largest randomized clinical trial ever conducted in this severely injured patient population. It is one of two clinical trials on the use of hypertonic saline for trauma being conducted by a network of clinical research sites in the United States and Canada called the Resuscitation Outcomes Consortium (ROC). In March, the NHLBI stopped a parallel study of hypertonic saline in trauma patients who went into shock due to severe bleeding because the highly concentrated saline solutions did not improve survival compared to standard saline solution.

Typically, in the crucial early minutes before blood transfusions can be safely administered in the hospital, trauma patients receive normal saline solution intravenously in the field to compensate for blood loss and to buy time. Compared to normal saline, concentrated saline solution was believed to compensate for blood loss more effectively, lessen excessive inflammatory responses, and prevent brain swelling.

You can read the full government press release by clicking here.

Full post as published by Brain Injury News and Information on June 03, 2009 (boomark / email).