Northeast Georgia Medical Center is asking for public input on whether it should participate in an international study into whether a blood clotting drug can improve survival for trauma patients experiencing significant blood loss.
NGMC said in a press release the study would look into whether Kcentra, an FDA-approved blood clotting drug, could help increase the chance of survival in trauma patients who are experiencing significant blood loss. Kcentra is currently used to reverse the effects of medications given to "thin" the blood for patients who experience bleeding and/or require surgery.
The Trauma and Prothrombin Complex Concentrate, or TAP Trial, will evaluate the effectiveness of Kcentra in addition to all standard care in injured patients predicted to require a large volume blood transfusion.
“There is evidence that Kcentra may reduce the chance of dying in injured patients who are not on blood-thinning medications,” Dr. Timothy Stevens, a trauma surgeon at NGMC said. "We know that in trauma patients, bleeding is essentially the number one cause of death that we can try to prevent. We also know that in trauma patients, they have severe changes to their ability to clot. The hope is that in trauma patients, [Kcentra] will have the same effect to help their body's inability to clot normally."
Patients in the study will have suffered a serious and potentially life-threatening injury, causing significant blood loss.
"These types of injuries occur unexpectedly, and it will not be possible for most people to sign up to participate ahead of time," the NGMC press release said. "Most patients will be unconscious, unable to speak or hear, and too sick to consent to immediate treatment, or participation in the study."
If the medical center receives positive feedback from the community and an independent review board approves the study at NGMC, then NGMC will participate in the trial.
"Community members who do not want to participate can request a bracelet indicating this," the release said "If feasible, doctors will consent patients who fit the study criteria. If consent is not feasible, patients who fit the criteria will be automatically enrolled without their individual consent if they are not wearing an opt-out bracelet."
Community members are encouraged to fill out an anonymous online survey to provide thoughts on whether NGMC should or should not participate in the study. That survey can be found at this link.
NGMC will also hold virtual community forums on March 13 at noon and March 16 at 6 p.m. These forums aim to educate the community and answer questions regarding the trial. You can find more information and links for the virtual community forums by clicking here.
The trial will start in early 2023 and will last until 2026. It is funded by CSL Behring, a global biotherapeutics leader.
