Update: Bleeding out is the most common cause of preventable death after injury. 

That’s why researchers at Northeast Georgia Medical Center in Gainesville are asking for community input on whether they should participate in an international study to examine whether a blood-clotting drug, given to patients soon after they arrive in the emergency department, can improve survival.

“The researchers are asking for feedback from the NGMC community about this study to help determine whether the community wants us to participate in this study,” NGMC Gainesville said in a news release Friday. 

If the community feedback is positive and an independent review board approves the study at NGMC, the hospital will participate in the trial. NGMC was recently verified as a Level 1 trauma center, which allows it to participate in trials like these. 

The catch is that most people who participate will be unable to provide their consent before the blood-clotting drug is administered. If you want to opt-out, you can request a special bracelet by calling 205-934-5890 or emailing cis@uabmc.edu.

“Patients in this study will have suffered a serious and potentially life-threatening injury, causing significant blood loss, and requiring immediate lifesaving interventions,” NGMC said. “These types of injuries occur unexpectedly, and it will not be possible for most people to sign up to participate ahead of time.”

The drug is called Kcentra, a common blood-clotting drug used when treating trauma patients who are on blood-thinning medications, such as those with atrial fibrillation or those who have previously suffered a stroke. 

“We use this on a daily basis multiple times, both in trauma patients and other patients that need their blood thinners reversed very quickly,” Timothy Stevens, a trauma surgeon at NGMC, said in an interview. 

“There is evidence that Kcentra may reduce the chance of dying in injured patients who are not on blood-thinning medications,” Stevens said. “If we can determine that Kcentra is safe and effective for trauma patients, we can transform the standard of care for bleeding trauma patients and save thousands of lives.”

Stevens said on average NGMC sees 30-40 trauma patients per year, meaning 90-120 patients would be enrolled over the course of the three-year trial. 

The TAP trial — called the Trauma and Prothrombin Complex Concentrate Trial — will evaluate the effectiveness of Kcentra in seriously injured patients who require a large blood transfusion. The drug will be additive, meaning patients who receive it will still undergo all the usual procedures used to stop blood loss. 

“The standard treatment of injured patients who are bleeding involves the transfusion of different types of blood products, as well as the use of medications to help the blood clot better, along with surgery to stop the bleeding,” Stevens said. “But even with these treatments up to 30% of patients suffering from a serious traumatic injury die.” 

The TAP trial will be conducted in about 120 leading trauma centers in several countries and will include 8,000 patients, making it the second-largest trauma trial ever conducted. The trial will begin between early 2023 and last until 2026, and is funded by CSL Behring, a global biopharmaceutical company that manufactures blood-clotting drugs. 

You can share your thoughts in an anonymous survey at nghs.com/tap-study.

NGMC will also hold virtual community forums to answer questions about the trial. You can join here. 

• 12 p.m., Monday, March 13 

• 6 p.m., Thursday, March 16

Previous story: Bleeding out is the most common cause of preventable death after injury. 

That’s why researchers at Northeast Georgia Medical Center in Gainesville are asking for community input on whether they should participate in an international study to examine whether a new blood-clotting drug, given to patients soon after they arrive in the emergency department, can improve survival.

“The researchers are asking for feedback from the NGMC community about this study to help determine whether the community wants us to participate in this study,” NGMC Gainesville said in a news release Friday. 

If the community feedback is positive and an independent review board approves the study at NGMC, the hospital will participate in the trial. NGMC was recently verified as a Level 1 trauma center, which allows it to participate in trials like these. 

The catch is that most people who participate will be unable to provide their consent before the blood-clotting drug is administered. If you want to opt-out, you can request a special bracelet that will let hospital staff know that you do not consent to receiving the drug. 

“Patients in this study will have suffered a serious and potentially life-threatening injury, causing significant blood loss, and requiring immediate lifesaving interventions,” NGMC said. “These types of injuries occur unexpectedly, and it will not be possible for most people to sign up to participate ahead of time.”

The drug is called Kcentra, an FDA-approved blood-clotting drug. 

“There is evidence that Kcentra may reduce the chance of dying in injured patients who are not on blood-thinning medications,” said Timothy Stevens, a trauma surgeon at NGMC. “If we can determine that Kcentra is safe and effective for trauma patients, we can transform the standard of care for bleeding trauma patients and save thousands of lives.”

The TAP trial — called the Trauma and Prothrombin Complex Concentrate Trial — will evaluate the effectiveness of Kcentra in seriously injured patients who require a large blood transfusion. The drug will be additive, meaning patients who receive it will still undergo all the usual procedures used to stop blood loss. 

“The standard treatment of injured patients who are bleeding involves the transfusion of different types of blood products, as well as the use of medications to help the blood clot better, along with surgery to stop the bleeding,” Stevens said. “But even with these treatments up to 30% of patients suffering from a serious traumatic injury die.” 

The TAP trial will be conducted in about 120 leading trauma centers in several countries and will include 8,000 patients, making it the second-largest trauma trial ever conducted. The trial will begin between early 2023 and last until 2026, and is funded by CSL Behring, a global biopharmaceutical company that manufactures blood-clotting drugs. 

You can share your thoughts in an anonymous survey at nghs.com/tap-study.

NGMC will also hold virtual community forums to answer questions about the trial. You can join here. 

• 12 p.m., Monday, March 13 

• 6 p.m., Thursday, March 16