Researchers and the federal agency overseeing the research have decided to stop enrollment in a multi-center clinical trial testing how much intravenous fluid should be given to people with blood loss after a traumatic injury.
The pilot study has been stopped after being conducted for about nine months at seven locations throughout the United States, including in the Portland/Vancouver region. The study was stopped after 191 patients had been enrolled — nine short of the study's goal of 200 participants.
Study leaders determined that little additional information could be gained from continuing the study to enroll nine more participants.
"We hope to use the information we’ve gathered during this preliminary study to help guide a larger study that will help determine the best fluid treatment strategy — standard or hypotensive resuscitation — for people who are in hemorrhagic shock after severe traumatic injury,” said Mohamud Daya, M.D., associate professor of emergency medicine at Oregon Health & Science University and the principal investigator for the Oregon site for the Resuscitation Outcomes Consortium, which is overseeing the study.
“We are grateful for all of the work our rescue and emergency medical service partners as well as participant hospitals put into the study. This important study wouldn’t have been possible without their help,” said Martin Schreiber, M.D., division chief of trauma and critical care at OHSU and principal investigator for the fluid study.
A number of fire rescue and emergency medical services participated in the study in the Portland region, including Life Flight Network, Clark County American Medical Response, the Camas Fire Department and three regional trauma centers — Peace Health Southwest Medical Center in Vancouver, Wa., and Legacy Emanuel Medical Center and Oregon Health & Science University hospital in Portland.
Because patients eligible for the study were unconscious after their injuries and were therefore unable to provide consent in advance of treatment, the study was conducted under Food and Drug Administration regulations that allow research in certain life-threatening situations without consent. The regulations that allow this exception require community consultation and notification to ensure that the public is aware of the studies. The regulations also require an opportunity for people to opt out of the studies by wearing a "NO STUDY" bracelet.
The study was one of a group of studies being conducted by the Research Outcomes Consortium, or ROC, a network of 10 regional clinical centers studying better ways to help people who suffer severe traumatic injury or cardiac arrest outside of a hospital. The fluid study was called HypoResus, short for hypotensive resuscitation versus standard resuscitation.
The ROC-HypoResus study tested two ways of giving fluid to study participants during resuscitation — either in large amounts, as is the current standard, or in much smaller amounts.
"There have been two schools of thought on how much fluid to give to these patients intravenously," Schreiber said. "Our standard has been to give significant amounts of fluid to keep blood flowing to vital organs. But there also has been concern that too much fluid may actually increase bleeding by popping off blood clots in holes in blood vessels."
The National Heart, Lung and Blood Institute, part of the National Institutes of Health, is the lead sponsor of the ROC studies. It stopped the pilot HypoResus study after a recommendation by a committee of medical experts overseeing the ROC studies. The committee noted that enrollment in the study had slowed and that it was essentially completed after enrolling the 191 participants.
Schreiber said study results have yet to be analyzed and are expected to be available within the next few months.
People in the Portland area continue to be enrolled in other ROC studies. One study, called PROPPR, short for “Pragmatic, Randomized Optimal Platelet and Plasma Ratios,” is exploring the best ratio of blood products for significantly bleeding trauma patients. This in-hospital study is currently being conducted at OHSU. Another ROC study, called ALPS, short for “Amiodarone, Lidocaine or Neither (Placebo) for Out-Of-Hospital Cardiac Arrest Due to Ventricular Fibrillation or Tachycardia,” is exploring whether standard heart rhythm drugs improve survival for cardiac arrest patients.
If an individual does not want to be enrolled in a ROC study, he or she can decline participation by wearing a “NO STUDY” bracelet. To request a bracelet, call 503-494-8083 or send an email.
The National Institutes of Health has more details on each of the ROC studies: HypoResus (NCT01411852), PROPPR (NCT01545232) and ALPS (NCT01401647).