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We're sorry but Patient_Recruitment_Template_Vue doesn't work properly without JavaScript enabled. Please enable it to continue. English MENU * English * * About TAP * Participating Study Centers * Your TAP Journey * Meet the Study Team * FAQs * Share This Page The Trauma and Prothrombin Complex Concentrate (TAP) study is a clinical research study for injured people who require a large-volume blood transfusion. TAP is now enrolling patients. ABOUT THE TAP STUDY Thank you for your interest in the TAP study. The TAP study (alternatively called BE1116_3006) is a clinical study of an investigational product called BE1116. BE1116 is a 4-Factor Prothrombin Complex Concentrate (4F-PCC) and is known by its trade names, Kcentra® (US) and Beriplex® (outside the US). Kcentra®/Beriplex® is approved for use to stop or prevent bleeding in some countries but is not specifically approved to treat trauma related bleeding. For that reason, Kcentra®/Beriplex® is an investigational product for this study. The TAP study is a Phase 3 study, which means that the study tests the safety of the treatment and how well it works in a large number of participants. The TAP study is now enrolling patients who have experienced a traumatic injury with acute major bleeding and are predicted to receive a large-volume blood product transfusion. Trauma is the leading cause of death in those under the age of 45. The most common cause of preventable death after injury is bleeding, which is often accompanied by clotting factor abnormalities. This means that people’s bodies have a hard time stopping the bleeding. Some people suffer fatal hemorrhages even with the current best treatment to stop bleeding. This is why CSL Behring is evaluating the investigational product. Kcentra®/Beriplex® contains clotting factors and anticoagulants, and may thus be helpful in patients who have suffered a traumatic injury and acute major bleeding as it promotes clot formation. The purpose of the TAP study is to assess how well a single IV infusion of the investigational product works in helping control or stop bleeding in people with an injury who require a blood transfusion to save their life, with the overall goal of improving survival chances for all such people. The study will compare the health of patients who receive the investigational product with those who receive placebo, a substance that looks like the investigational product but has no medicinally active ingredients. All patients, whether on the investigational product or placebo, will receive the current best standard of care available at their hospital. Because the investigational product must be administered quickly and because most patients cannot consent to a study soon after a serious injury, they may be enrolled without their consent. The study will involve patients aged 15 years and older (≥ 16 in the UK and ≥ 18 in Australia) and they must also weigh 50 kg (110 lbs) or more. Study participation may last up to 30 days. Up to 8000 study patients will take part in the study. The study will take place in approximately 120 study centers around the world. THE FOLLOWING VIDEO PROVIDES MORE INFORMATION ABOUT THE EXCEPTIONS FROM INFORMED CONSENT. Exception from Informed Consent Studies (US Only) In the USA, community disclosure and consultation is required for Exception from Informed Consent (EFIC) studies. The University of Alabama is conducting required EFIC activities for the TAP study. This feature uses Google Maps. If you enable the map, Google may collect some personal data about you, such as your location and information about your browser and device. Please see Google's Privacy Policy for more information. Enable Map PARTICIPATING STUDY CENTERS Please use the map to see other study centers participating in TAP. Search YOUR TAP JOURNEY Your participation in the TAP study may last up to 30 days and consists of the following. Screening Period The purpose of the Screening period is to ensure that you are eligible to take part in the study. Informed consent will usually not be possible in this period, due to the emergency setting, and therefore most study patient enrollments will fall under applicable emergency setting exceptions to the informed consent requirement. However, attempts to collect informed consent will be made, if feasible, in line with applicable law, regulations, and Institutional Review Board (IRB) or Ethics Committee guidance. Study Treatment Period If you are eligible to take part in the study, you might be enrolled and progress to the Study Treatment period. There are two study treatment groups in this study: * Kcentra®/Beriplex® (BE1116) (4-Factor Prothrombin Complex Concentrate) * Placebo Your study treatment group will be selected at random by a computer. You have a one-in-two chance of receiving either Kcentra®/Beriplex® or placebo. Half of the patients enrolled will receive Kcentra®/Beriplex® and half will receive placebo. You will only receive one study treatment. The study is double-blinded, which means that for the entire study, neither you nor the study doctors will know if you have received Kcentra®/Beriplex® or placebo. The placebo looks exactly like Kcentra®/Beriplex® but does not contain any medicinally active drug. Follow-Up Period This period includes a Follow-Up period, where the study team will review your medical records for up to 30 days after your dose of study treatment (Kcentra®/Beriplex® or placebo). The purpose of the Follow-Up period is to assess your health and well-being. The Follow-Up period ends when you leave the hospital. MEET THE STUDY TEAM CSL BEHRING STUDY TEAM BRAHM GOLDSTEIN MCR, MD (USA) VP, R&D Hematology and Thrombosis STEVEN SLOAN MD, PhD (USA) Clinical Program Director, Hematology AMY SUEN Pharm.D. (USA) Principal Clinical Scientist, Hematology JEREMY CASEY (USA) Asset Lead, Clinical Portfolio Execution JULIA DELFS (GER) Clinical Program Manager, Clinical Portfolio Execution JAY RICHWOOD (USA) Clinical Program Manager, Clinical Portfolio Execution UNIVERSITY OF ALABAMA AT BIRMINGHAM (UAB) CENTER FOR INJURY SCIENCE TEAM JAN JANSEN, MBBS, PHD Principal Investigator Professor, Division of Trauma & Acute Care Surgery Director, Center for Injury Science University of Alabama at Birmingham JOHN HOLCOMB, MD Principal Investigator Professor, Division of Trauma & Acute Care Surgery Senior Scientist, Center for Injury Science University of Alabama at Birmingham BELLAL JOSEPH, MD Principal Investigator Martin Gluck Professor of Surgery & Vice Chairman, Research University of Arizona Adjunct Scientist, Center for Injury Science, UAB SHANNON STEPHENS, CCEMTP Program Director Executive Director, Center for Injury Science University of Alabama at Birmingham KAREN BROWN, MS Regulatory Manager Center for Injury Science University of Alabama at Birmingham SARAH DUCKERT, MD Social Media Manager Center for Injury Science University of Alabama at Birmingham TANNER COFFMAN, MD Web Content Coordinator Center for Injury Science University of Alabama at Birmingham FAQS WHAT IS A CLINICAL RESEARCH STUDY? A clinical research study is a medical research study involving human participants. It tests the use of a medical procedure, medical device, drug, or other potential treatment, and is led by researchers including study doctors. Clinical studies provide valuable information and may help researchers to understand a condition better and learn how best to treat it, or may lead to new, better treatments. An investigational product must pass three phases of clinical testing before it is approved by a country’s regulatory authority and made available to the public. The TAP study is a Phase 3 study. In this phase, researchers test the safety and effectiveness of an investigational product in a larger group of patients. WHAT IS THE PURPOSE OF THIS STUDY? The purpose of TAP is to assess how well a single IV infusion of Kcentra®/Beriplex® works to improve survival in patients who have suffered a traumatic injury with acute major bleeding. Some people still suffer fatal bleeding even with the current best therapy to stop bleeding. WHAT IS KCENTRA®/BERIPLEX®? Kcentra®/Beriplex® (4-Factor Prothrombin Complex Concentrate) is a blood clotting factor replacement product. It contains clotting factors II, VII, IX, and X, as well as Protein C and Protein S. Kcentra® is a Food and Drug Administration (FDA) approved product. It is currently approved to reverse the effects of drugs given to “thin” the blood in patients who are experiencing bleeding and/or require surgery. Beriplex® is approved for use in other countries, including the United Kingdom and Australia, when prothrombin complex coagulation factors are deficient. Kcentra®/Beriplex® is also known as BE1116. BE1116 is a research/experimental medicine (i.e. investigational product) in this study because it has not been approved to treat patients whose injuries require blood transfusion to help control or stop bleeding and are at high risk of dying. WHO CAN TAKE PART? Anyone who has experienced a traumatic injury and meets the following criteria can take part in the study: * Is at least 15 years old (≥ 16 in the UK and ≥ 18 in Australia) * Weighs at least 50 kg (110 llbs) * Arrives at a trauma center directly from the scene of an accident * Requires a blood transfusion and massive transfusion protocol activation * Is deemed to have acute major bleeding HOW WILL THE STUDY TREATMENT BE GIVEN? The study treatment (Kcentra®/Beriplex® or placebo) will be given as an intravenous (into a vein) infusion, which lasts about 10-15 minutes. The study treatment will be given in addition to all usual care. No care will be withheld because of the research study. WHAT HAPPENS AFTER THE INFUSION HAS BEEN COMPLETED? There are no other research treatments after the infusion has been completed. The patients will be carefully monitored for complications. There are no additional hospital or clinic visits for this research study. After the infusion has been completed, all information will be recorded from the patient’s medical records. WILL ALL PATIENTS RECEIVE KCENTRA®/BERIPLEX®? No. In order to be able to determine whether the investigational product, Kcentra®/Beriplex®, makes a difference, it will be given to half of the patients. The other half will receive a placebo. When an injured patient arrives at the hospital and is deemed to meet the criteria for participation in the TAP study, doctors will open a special pack. The pack will contain either Kcentra®/Beriplex® or placebo. The medical team looking after the patient will not know which of the two the patient received. This will allow the study team to evaluate the results in an unbiased way. WHAT ABOUT SIDE EFFECTS? All medications, both those that are approved and those undergoing clinical studies, may potentially cause side effects – some of these are known, but there could be others that have not previously been observed. Study procedures may also involve risks. The informed consent form that patients and/or their legally authorized representative complete (prior to enrollment or after enrollment for continued participation) will describe/detail any known risks. If any further risks are discovered while the study is ongoing, you will be informed immediately if those risks may impact you. WHAT IS A “PLACEBO”? If you are enrolled in the study, you will be randomly assigned by a computer to receive either Kcentra®/Beriplex® or placebo. The placebo looks exactly like Kcentra®/Beriplex® but does not contain any medicinally active drug. Placebos are commonly used in clinical studies to help understand if the drug being researched is effective. In this study, half of the patients will take the placebo. Neither you nor the study doctor or nurses will know if you are receiving Kcentra®/Beriplex® or placebo. In the case of an emergency, it is possible for the study doctor to obtain this information. WHAT HAPPENS IF I DECIDE THAT I DON'T WANT TO STAY IN THE STUDY? You are free to leave the study at any time, and this will not affect your future care in any way. Data collected prior to your withdrawal will still be used for the purposes of research in accordance with applicable law. WHAT HOSPITALS CAN TAKE PART? Level I and II trauma centers (in the United States) or equivalent institutions (in other countries) can take part in this study. WHAT IS EMERGENCY CARE RESEARCH? If a person needs urgent treatment but their condition renders them unable to give informed consent, emergency research or research without consent may be started so that the person is still able to receive the required treatment. The study will attempt to obtain consent as soon as possible. In the US, this is known as Exceptions from Informed Consent Research. OVERSIGHT OF THE TAP STUDY The study has been approved by the health authorities, such as the Food and Drug Administration (FDA), in all countries that are participating. In addition, an Independent Data Monitoring Committee will review relevant data as the study progresses and recommend changes or even discontinuation of the study if significant problems arise. WHAT IS EXCEPTION FROM INFORMED CONSENT RESEARCH (EFIC) (US ONLY)? Acute care research is sometimes conducted under Exception from Informed Consent (EFIC) regulations in the United States. In many life-threatening illnesses, patients are unconscious or too sick to provide written or verbal informed consent. The federal EFIC rules were developed in 1996 to allow for the waiver of obtaining and documenting informed consent for a strictly limited class of research. Research carried out under EFIC rules undergoes extremely high levels of scrutiny by multiple agencies to assure that research subjects are afforded every protection available under the law. Research conducted under EFIC rules encompasses research that could not otherwise be conducted because of the nature of illness or injury. Research carried out under EFIC must hold the promise of a new treatment that is at least equal to or better than what is currently available. According to FDA regulations, to qualify for EFIC, the research study must involve participants suffering from a life-threatening disease process or injury for which the current standard of care is associated with a very high failure or mortality rate. In addition, there must be reasonable evidence that the research has the potential to provide real and direct benefit to the patient. Studies must be held to the highest ethical standards. The use of a randomized clinical study such as this is the “gold standard” for determining what works best for people. For treatments that must be given immediately to be effective, EFIC research is considered appropriate by federal regulatory bodies and many ethicists who study this field. The obligation to improve standard treatments that yield poor results in life-threatening conditions is also considered an ethical imperative, as is maintaining individual rights of citizens. In EFIC studies, citizens receive standard treatment in addition to research treatment. To be tested in this fashion, the research treatment has to have shown promise in earlier or smaller studies. Before any EFIC studies are started, the US government requires that participating institutions conduct a process of “Community Consultation and Public Disclosure.” During this process, the study is advertised in communities where the research will take place. Community members are invited to give their own thoughts and comments about the proposed study. The results of these interactions are reported to the Institutional Review Board (IRB) monitoring the research. Additional information is available at the EFIC website of the US Food and Drug Administration and the Code of Federal Regulations. COMMUNITY CONSULTATION & PUBLIC DISCLOSURE (US ONLY) In the US, public disclosures will be performed both prior to study enrollment and at the completion of the study in the form of multimedia press releases organized by CSL Behring. Local sites may also decide to target notification to specific community groups. In the event that the press releases are not widely circulated, advertisements will also be placed on the study website used in the social media campaigns. OPT-OUT BRACELET (US ONLY) If a person in the US does not want to participate in the TAP study, there is an option for them to receive an opt-out bracelet, which, if worn at the time of hospital admission, would exclude them from participating in the study. SHARE THIS PAGE Copy and paste the link below to tell a friend or family member about TAP. Copy Contact Us Copyright © 2023 Advarra, Inc. | Privacy Policy This website would like to use third party cookies to analyze traffic. This analytics data will be anonymized and can’t be used to identify you. For more information, please review our Privacy Policy. Accept I do not accept cookies Click for sound 4:55