FRIDAY, March 27 (HealthDay News) -- A U.S.-Canadian trial to assess in-ambulance administration of a hypertonic saline solution to trauma patients in shock from severe bleeding has been halted due to lack of a survival benefit, the National Heart, Lung, and Blood Institute (NHLBI) announced on March 26.
The Resuscitation Outcomes Consortium Data and Safety Monitoring Board, an independent group monitoring the study, analyzed in-hospital data on 545 hypertonic saline patients in the largest enrolling hospital from each site.
The researchers' report confirmed 2008 findings that early mortality was more common among hypertonic saline patients than in normal saline patients and that there was no significant group difference in cumulative 28-day mortality. Although the report did not fully explain the mortality findings, the investigators are planning to publish a more comprehensive analysis in a peer-reviewed scientific journal.
"Survival from traumatic injury is a critical public health issue and the large clinical trials under way in this effort are needed to improve the treatment of patients," Elizabeth G. Nabel, M.D., director of the NHLBI, said in a statement. "Of course, it is always disappointing when new therapies, such as concentrated saline for shock, fail to offer added benefit to patients. However, we look forward to results from the other ongoing studies that are part of this important research consortium."
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