TAP Study

Trauma and Prothrombin Complex Concentrate Study (TAP) is a major international research study for injured patients with severe bleeding. Erlanger will participate in this trial.

When severely injured patients are bleeding, their blood may fail to clot. The medication, PCC (Prothrombin Complex Concentrate), given in this study helps blood clot when bleeding won't stop and patients are dying. If the medication works better than placebo, it may help save many lives.

PCC is simply very concentrated clotting factors that help make the blood form clots. These clotting factors are normally found in blood. In severe bleeding, the body runs out of clotting factors.

Since this study is intended only for patients with severe bleeding, it is being performed under special FDA regulations called Exception From Informed Consent (EFIC). When injured patients are severely bleeding, it is not possible to get permission from the patient or family to participate in the study. The patient could bleed to death before this happens.

Why should Erlanger participate in the TAP study?

• When severely injured patients are bleeding, their blood may fail to clot. About 30% of patients with severe traumatic bleeding do not survive.
• The medication, PCC, given in this study helps blood clot when bleeding won’t stop and patients are dying.
• The TAP study is to see whether PCC works to help blood clot in the active blood transfusion phase following severe injury. CSL’s TAP Study will randomize patients to receive PCC or placebo. The placebo is normal saline intravenous fluid. If the medication works better than the placebo, it will help save many lives.

What is PCC and how does it work?

• PCC stands for Prothrombin Complex Concentrate.
• It is simply very concentrated clotting factors that help make the blood form clots.
• These clotting factors are normally found in blood.
• In severe bleeding, the body runs out of clotting factors.

What is special about the TAP study?

• Since this study is intended only for patients with severe bleeding, it is being performed under special FDA regulations called Exception from Informed Consent (EFIC).

More about EFIC

• When injured patients are severely bleeding, it may not be possible to get permission from the patient or family to participate in the study.
• The patient could bleed to death before this happens.

How does EFIC work?

• Exception from Informed Consent Research is performed in emergency circumstances where there is usually not enough time to obtain consent before a treatment is given.
• The FDA requires that people who may become a study participant are educated through Community Consultation and Public Disclosure using TV, radio, newspapers, social media, organizational meetings, and Zoom meetings.
• Erlanger will be conducting multiple public service announcements with question and answer sessions.
• An Opt Out option is available to community members.

Opt out of trauma research option can be found HERE

Take the public opinion survey on exception from informed consent research HERE