OHSU leads three NIH-funded ‘exception from informed consent’ studies in Oregon, Southwest Washington
07/23/12 Portland, Ore.
Oregon Health & Science University is leading three multi-center studies in Oregon and Southwest Washington as part of the National Institutes of Health-funded Resuscitation Outcomes Consortium (ROC). ROC is a group of regional health centers across the United States and Canada conducting clinical trials inside and outside the hospital to improve outcomes in patients with severe traumatic injury and cardiac arrest.
Participating fire rescue and emergency medical services agencies include Life Flight Network, Clark County American Medical Response, Camas Fire, and three trauma centers, Legacy Emanuel Medical Center, Peace Health Southwest Medical Center and OHSU.
The ROC clinical trial HypoResus, scheduled to begin on July 27, will determine whether people with hemorrhagic shock do better when given either small or large amounts of saline during resuscitation. Giving large amounts of saline is currently the standard treatment.
“There are two schools of thought on how to treat these patients. The current standard is to give lots of fluid through an intravenous line to keep blood flowing to vital organs. Now we suspect that too much fluid may actually increase bleeding by popping established clots off holes in blood vessels,” said Mohamud Daya, M.D., associate professor of emergency medicine at OHSU, and Oregon’s site principal investigator for ROC.
HypoResus, short for “Field Trial of Hypotensive Resuscitation Versus Standard Resuscitation for Hemorrhagic Shock After Trauma,” will be conducted at seven locations in the United States and Canada. A total of 200 patients will be enrolled — approximately 20 in the Portland-Vancouver metro area.
A second ROC trial, called PROPPR, short for “Pragmatic, Randomized Optimal Platelet and Plasma Ratios,” will determine the best combination or ratio of blood products for significantly bleeding trauma patients. Red blood cells, plasma, and platelets are routinely given to patients with significant loss of blood, but the best way to combine blood products is unknown. This study, slated to launch in fall 2012, will only take place at OHSU and compares how patients respond to two different ratios of blood products in common use.
“Severe hemorrhage due to traumatic injury is the leading cause of preventable death for people younger than 45, and many victims require specialized care such as massive blood transfusions and extensive surgery due to their injuries,” said Martin Schreiber, M.D., professor of surgery, director of the OHSU Trauma Program and Oregon’s principal investigator for ROC-PROPPR. "Patients who emergently require more than 10 units of red blood cells have a high mortality rate — historically about 45 percent. This study is an effort to improve outcomes for that group of patients.”
PROPPR will be conducted at 12 trauma centers in the United States and Canada. A total of 580 patients will be enrolled, including approximately 30 in the Portland-Vancouver metro area.
A third ROC trial called ALPS, which began June 6, will determine whether standard heart rhythm drugs, amiodarone or lidocaine, improve survival for participants with shock-resistant ventricular fibrillation, a condition in which the heart beats chaotically, resulting in the complete loss of its ability to pump blood.
Dr. Daya is also the principal investigator for ALPS, or “Amiodarone, Lidocaine or Neither (saline) for Out-Of-Hospital Cardiac Arrest Due to Ventricular Fibrillation or Tachycardia.” ALPS is being conducted at 10 locations in the United States and Canada, and will enroll 3,000 participants – 300 in the Portland/Vancouver metro area.
Because patients eligible for these studies will be unconscious and therefore unable to provide consent in advance of treatment, the study will be conducted under FDA regulations that allow research in certain life-threatening situations without giving consent. The federal regulations that allow this exception from informed consent require community consultation and notification to ensure the public is aware of the studies.