Dr. Raymond DuBois Jr.
Vanderbilt University Medical Center recently participated in a research study to evaluate Hu23F2G, an investigational drug that may help severely injured patients. The drug acts on the white blood cells and may prevent them from causing damage to the body’s major organs following trauma.
In order to determine the safety and effectiveness of this new drug, researchers studied 150 trauma victims at 11 trauma centers throughout the United States. In the clinical trial, some patients received Hu23F2G along with standard care and some patients received only the standard care for the severe injury.
Patients were enrolled into the study in one of three ways:
• patients gave their own informed consent if they were able;
• if a patient was unable to give consent, on arrival in the Emergency Department, hospital staff attempted to reach a family member, and, if successful, the family was asked to provide informed consent;
• if a family member was not located within three hours, the patient was enrolled under the FDA regulations waiving the requirement to obtain informed consent.
Efforts to locate and inform family continued after the patient had been enrolled into the study under the FDA regulations waiving the requirement to obtain an informed consent. Use of the FDA regulations waiving the requirement to obtain an informed consent in this study was approved by the FDA and VUMC's Institutional Review Board, which is charged with ethical oversight of patient research at the medical center.
Enrollment into the study was completed in late January. At VUMC eight patients were enrolled into the study. None of the patients signed their own consent, all eight had a family member provide informed assent, and no patients were enrolled with a waiver of consent.
Nationally, 14 percent of patients signed their own consent, 53 percent had a family member provide informed consent and 33 percent were enrolled with waiver of informed consent.
Preliminary analysis of the study has been performed and Hu23F2G appeared to be safe in this patient population. A total of 11 patients nationwide, or 7 percent, died. The death rate was 10 percent in patients who received standard of care alone and 6 percent in patients who received Hu23F2G.
Although the endpoints that the study was designed to measure were no different between the patients who received standard of care and those who received the investigational drug along with standard of care, there was a suggestion that those patients who received the higher dose of Hu23F2G had decreased heart and lung failure compared with those patients who received standard care only. Further analyses of the data are under way.
Any questions about this study should be directed to Dr. John Morris at 936-0175.