Denver Health has been conducting a COMBAT (Control Of Major Bleeding After Trauma) Research Study since March 2013. The most interesting part of the study is that the participants are enrolled in the study before they can actually consent to it. A subject is included in the study when he/she is incapacitated, and the only way to make sure you will not be involved is to wear a special bracelet or dog tag that specifies that desire.
Traditionally, paramedics give their patients a saline IV after they have lost a large quantity of blood to increase their blood volume. However, since the study began Denver Health paramedics can now give their patients blood plasma so long as the patient has a heart rate and blood pressure which makes them a candidate for the experimental treatment. Once the treatment has been administered, the researchers follow the patients recovery for up to 28 days in the hospital to monitor the short and longer term effects.The idea is that the extra clotting factors present in the administered blood plasma will not only increase blood volume but also help control bleeding to prevent the patient from going into shock.
The study is set to finish up in March 2016, after which they can share their results and possibly change the protocol for the prehospital treatment of major trauma. If this study is a success, paramedics will be able to fight the main cause of death after trauma (shock post uncontrollable hemorrhage).
More information can be found at the Denver Health website:
http://www.denverhealth.org/for-professionals/clinical-specialties/trauma-center/research-and-publications/combattrial
Super interesting study! I am particularly interested in the aspect where the patient has to specifically opt out. Denver Health COMBAT trial site says that community outreach had to be done before the trial could be initiated. However, I wonder how many people in the general Denver area are actually aware of this trial and the option to opt-out- I am guessing not many. Although the premise of the trial is promising and there is a need for research to advance emergency medicine, this opt-out consent process seems a bit flawed. For example, what if there is a Jehovah's Witness patient who was most likely not aware of this study? What would the patient think after finding out they received blood product?
ReplyDeleteI found this blog post particularly interesting not only because of the new methods being proposed but also how you are automatically enrolled unless you wear a certain ID that informs them not to include you. I think in order to do research on this type of scenario, this may be the only way to do it. In an alternate universe those signing up for the research study would be be acknowledging that they would need to experience some type of major trauma to be applicable, which in reality who would sign up for that?
ReplyDeleteI think that giving the blood plasma in the ambulance versus later in the hospital could really help with the problem of death due to shock because of blood loss. Also not everyone who goes through this experiment gets the plasma, they are randomly selected to do the plasma vs saline to see if there is a response, and the selection would have to be random to make sure that they plasma is even eliciting a response. Saline is given to a patient in order to increase blood pressure, while the plasma does that as well as introduces proteins so the blood can clot which would kill two birds with one stone in a sense. I know that some people are probably uncomfortable being entered into a study without prior consent, yet in order to come up with new treatment methods for that scenario it is perhaps the only way that makes sense. As a result bleeding out due to trauma can be avoided and the process can be studied and perhaps a better solution can be found. I do agree with Heagie that the selection process seems a bit flawed and she brings up a good point about if a Jehovah's Witness were to receive a blood product. Also the website does state that even people who opt out by wearing say dog tags can be misconstrued because it is possible that during a trauma event that these articles could be lost so a better selection and outreach program is necessary. Maybe an online form that you can fill out and the hospital will have on file for those who do not want to be included, but again during a trauma event and life saving measures who has time to check those databases? So I think the system is flawed yet I am not sure what else could be done better.