The National Heart, Lung, and Blood Institute of the National Institutes of Health has stopped enrollment into a clinical trial testing the effects of highly concentrated saline solutions on patients with severe traumatic brain injury 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 The National Heart, Lung, and Blood Institute (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 traumatic brain injury study is reportedly 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 US and Canada called the Resuscitation Outcomes Consortium.
In March 2009, 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.
Elizabeth Nabel, director of the NHLBI, said: Improving treatment and survival of traumatic injury are critical public health problems. While these study results did not show the expected benefit of one type of treatment, other findings by the resuscitation consortium researchers – and the hundreds of emergency and fire services teams they are working with – may lead to new life-saving intervention strategies.