The Division of Trauma, Burn & Critical Care Surgery at Harborview Medical Center is doing a study to test whether people who have life threatening injuries do better after receiving a drug called Kcentra, or Prothrombin Complex Concentrate.
Kcentra is already approved by the FDA. Doctors use it to stop bleeding. For example, it is used to help people who are on blood thinners and can’t stop bleeding, or people who need surgery right away.
After a trauma, like a gunshot or car accident, bleeding can cause the person to die. Doctors try to stop that bleeding, and they try to replace the blood that has already been lost. One way to do with that is to have the EMT’s use human plasma. Unfortunately, it is hard to handle and store, and often the EMT’s do not have it right there at the scene of the accident.
Kcentra is a drug that is made of parts of the blood that help stop bleeding. What is good about KCentra is that it comes in a small vial, it is easy to carry, and EMT’s or doctors can give it to patients in very fast.
In this study, patients who have suffered a trauma will be randomized (like flipping a coin) to get either Kcentra or a placebo. A ‘placebo’ is a fluid that looks like Kcentra but does not have any effect on the patient. All patients will have the potential to benefit because they may be randomized to receive Kcentra. Subjects who receive Kcentra may benefit by having bleeding controlled sooner. Some scientists also think that Kcentra may help stabilize the cells inside the patient’s veins. We think it will slow down the bleeding, help these people stay alive and reduce bad things that happen due to bleeding after trauma.
A possible side effect of Kcentra is a higher risk of clots in lower legs and lungs. We will keep an eye on these risks throughout the study.
This study will be done in 3 US cities: Seattle, Portland, and Houston, and will include up to 60 patients over a year.
Subjects in this study will be enrolled when the EMT’s arrive to treat them and before arriving at the hospital. When medics decide that a person can be included due to their injuries, the patient will be randomized to get either Kcentra or placebo. All other treatments will be the same. People who choose not to be in the study will receive only regular treatments determined by the medics and physicians. Participation in the study will end when the subject leaves the hospital.
Normally, before someone joins a research study, we discuss the study with them in detail. Usually, we use a consent form that lists the details of the study, benefits and risks from being in the study. We only enroll the person if they agree to be in the study and sign the form. This is called "informed consent" and makes sure that the person volunteered for the research study only after being given the information necessary to make a decision.
For this study, we will not be able to get written consent from each study participant because they will be enrolled while being treated for a life-threatening injury. If the person can talk, or if there is a family member there, the medics will ask very quickly if it is ok to enroll the person in the study. However, there is not enough time to do a full “informed consent” process as above.
We will do everything we can to contact the patient’s legal representatives or family when he/she arrives at Harborview to inform them of the study. Once the subject is awake, the study team will explain the study and ask for written consent.
Because we will do this study without informed consent, we have consulted the local community about the study and addressed any concerns or questions before the study begins. We have done this by:
- Posting this website
- Having community meetings
- Doing surveys
- Putting notices in newspapers and Newsletters
The results of these meetings and surveys did not change the research. People that were in the meetings asked for clarification about enrollment, whether the study will cost the patients any money, how to opt out, and what kinds of emergencies might be included.
You have the choice to opt-out of this study by contacting the investigators at Harborview Medical Center. If you do not want to be in the study, we will give you a bracelet that says, “No study”. This will tell the EMT’s doctors that you do not want to be enrolled in any study without providing informed consent first. So far, we have not received any requests for bracelets.
If you have questions, please contact us via email at boost3uw.edu or at (206) 540-0748 and leave a voice message. We will reply within 3 business days.
Below are links to the presentation done for community groups. There is also a survey for your feedback and comments. The form to request an opt-out bracelet is there as well. There is additional information on the National Institutes of Health (NIH) clinical trial website listed below.
Prehospital Kcentra for Hemorrhagic Shock Study Consent Form for Continued Participation Form PDF >>
Prehospital Kcentra for Hemorrhagic Shock Study Information Sheet for Continued Participation PDF >>