Overview

The Division of Trauma, Critical Care & Acute Care Surgery at OHSU is leading a multi-center study to test whether people who have life threatening injuries do better after receiving a drug called Kcentra, or Prothrombin Complex Concentrate. Kcentra is currently used in the reversal of blood thinners like warfarin in patients with bleeding or who need immediate surgery. It is believed it will also help stop severe bleeding in people with traumatic injuries. This study will be conducted in 3 US cities, including Portland.

People will be enrolled shortly after injury and before arriving at one of the participating hospitals by the medics responding to the scene of injury. When medics determine that a person can be included based on mechanism of injury, low blood pressure (systolic blood pressure < 70 mmHg), and transport to one of the participating hospitals, patients will be randomized to receive either a bolus of Kcentra or a placebo (plain salt water). All other treatments will be the same. People who choose not to participate will receive all of the standard of care treatments determined by the medics and physicians.

Consent Information

Normally, before someone joins a research study, it is discussed with him or her in detail. Also, a consent form that lists the purposes of the study, the possible benefits, and the risks from being in the study is reviewed with the person. If the person agrees to join the study, the consent form is signed. In most cases, this takes place before any study procedures are done or treatment is given. This process is called "informed consent" and ensures that the person volunteered for the research study only after being given the information necessary to make an informed decision.

For this study, investigators will not be able to get written informed consent from each study participant, due to them having life threatening injuries. Instead, the investigators will try to inform the community about the study and address any concerns or questions before the study is approved to begin. We will do this by:

• This website
• Community meetings
• Online and mailed surveys
• Newspapers and Newsletters

People have the choice to opt-out of this study by contacting the investigators at OHSU. Each person will be provided a “No study” bracelet. This will inform medics and physicians that a person does not want to be enrolled in any study without providing informed consent first.

If you have questions, please contact us via email at traumare@ohsu.edu (note that the confidentiality of email communications cannot be guaranteed) or at (503) 494-8481 where you will be able to leave a voice message. You can expect to receive a reply within 3 business days.