Enrollment for a clinical trial on the effects of highly concentrated (hypertonic) saline solutions on patients with severe traumatic brain injury was stopped early after it was determined that the hypertonic solutions were no better than the normal saline solutions for improving survival or reducing brain injury. Patients were given the saline solutions before arriving in the emergency room.
According to the lead federal sponsor, the NIH National Heart, Lung, and Blood Institute (NHLBI), further enrollment would most likely not change the study's outcome. No safety concerns figured into the closing.
An independent Data and Safety Monitoring Board recommended stopping enrollment after findings from the 1,073 participants already tested (about half of the total planned enrollment) did not support any significant benefit of hypertonic saline over standard saline in patients with either traumatic brain injury or shock from excessive bleeding. There was also no difference in risks with the two treatments.
Experts from the Resuscitation Outcomes Consortium (ROC) — a network of 10 clinical research sites in the US and Canada that conduct real-world trials on patients with life-threatening traumatic injury or cardiac arrest — decided to test whether highly concentrated saline would more effectively compensate for blood loss, reduce excessive inflammation, and improve brain function in severely injured patients compared to normal saline. Animal and smaller clinical trials suggested that hypertonic saline might improve survival when given after injury, and it is currently approved and used in over a dozen European medical centers.
Hypertonic saline solutions “should be further tested for head injury in the ICU. It is unlikely to be tested further for pre-hospital use,” said David Hoyt, MD, a co-principal investigator of the ROC hypertonic saline studies and ROC vice chair for trauma. Dr. Hoyt is professor and chairman of the department of surgery and executive vice dean of the School of Medicine at the University of California- Irvine. “There have been no concerns for regular saline and there were no concerns for safety in this head injury trial.”
Participants enrolled before the closing in May who have not completed their six-month follow-up will continue to be followed according to the study design. Findings from both ROC studies have not yet been published.