Denver Health recently announced it is beginning patient enrollment in a national clinical trial to evaluate the safety and efficacy of PolyHeme, an oxygen-carrying blood substitute.
In this study, patients who are severely injured and losing a lot of blood will be randomly assigned to receive infusions of either PolyHeme or the current standard treatment, which is a saline solution. The study is projected to include up to 20 major trauma centers across the country.
What makes this study a little different is that it will be performed outside of the hospital. The treatment will begin either at the scene of the injury or in the ambulance, and then continue during a 12-hour post injury period in the hospital.
Getting patients to consent to such treatment at the scene of an accident would be difficult, as in many cases the patient would be unable to provide consent due to his or her injuries. Because of this, the study is being conducted under a federal regulation that provides an exception from informed consent requirements.
Denver Health, under the direction of the Colorado Multiple Institution Review Board, recently completed a process of community notification and consultation in connection with this study, as is mandated by federal regulation. Based upon its review of the protocol and the response of the community to participation in the study, COMIRB has given approval for the study to be conducted at the hospital, and emergency medical personnel and hospital staff have been properly trained.
For those who do not wish to decline participation in the study for any reason, may contact the study coordinator, Jeffrey Long, at 303-436-7906, to obtain a wristband indicating this decision.
"We’ve been going through the very careful process of community education," said Ernest E. Moore, M.D., chief of surgery and trauma services at Denver Health, principal investigator. "Fundamentally, what it all amounts to is that patients who are served by the Denver Paramedics group and have sustained severe trauma with sufficient blood loss will be randomized to either receive standard care or this product."
After the definitive medical care has been established, patients will then be assessed for eligibility to participate in this trial.
The patients who can receive the PolyHeme treatment in the field have to meet a number of criteria before it is administered. The patient must have sustained either blunt or penetrating trauma; patient must be at least 18 years of age; must demonstrate evidence of apparent blood loss due to injury; and the patient must have a systolic blood pressure of less than or equal to 90mmHg.
Patients will not be treated if their death is thought to be imminent, suggesting a futile resuscitation effort; demonstrates evidence of a severe head injury; patient is asystolic or requires CPR prior to randomization; patient is pregnant; or has already received 1,000 ml of crystalloid prior to randomization.
"This has been a very complex process to go through, because patients will be in a situation where they cannot give consent to participate in the study," Moore said. "Now, as soon as the patients arrive at the hospital, their family and they – as soon as they are resuscitated to a point where they are cognitively aware of the situation – will be advised of the study and certainly have the option to continue with the study."
When asked about the safety of the PolyHeme, Moore said it has been used for quite a while in the hospital, just not at the scene of an injury.
"Our institution, specifically, has worked with this product – both in the patient lab and in the clinical arena – for the last 11 years," Moore said. "There are huge benefits to this product," Moore said. "We believe there are patients who die in the United States currently because of the lack of availability of a product that carries oxygen. That is probably more logical in more rural areas of the country where blood isn’t available, but I can assure you that all of us who have worked in downtown Denver have seen people die because they have not had blood available in time."
Although there is no time limit set on the study, it may take up to a year or longer, according to Moore. "It may be over sooner – if there is an overwhelming positive effect, the FDA may believe there is sufficient evidence to dismiss further randomization and allow it to be used for patients," Moore said. "We think not only is it safe, but we believe that from the data we have right now that it can save lives."