Current clinical trials being conducted at the TTMRC
MAssive Transfusion in Children (MATIC-2) (Co-Principle Investigators, Philip C. Spinella, Christine M. Leeper, Stephen R. Wisniewski, Abdus Wahed): is the first randomized trial to use an approach known as a “platform trial” in traumatically injured children or adults. Typical trials compare only one intervention to standard care, but, in practice, doctors give multiple therapies and drugs at the same time. Platform trials test multiple therapies at once against standard of care, which allows scientists to determine which bundle of care is most effective and safe. Platform trials also allow scientists to change the study interventions based on data collected during the trial. A platform trial can adapt to either add or remove treatments to determine the bundle of care that best improves outcomes.
Chilled Platelet Study (CHIPS) (Principal Investigator, Philip C. Spinella; Co-Investigators, Marie Steiner and Nicole Zantek)
The Chilled Platelet Study (CHIPS), is a phase III, multicenter, randomized, double blinded, adaptive, non-inferiority, storage duration ranging trial in 1000 cardiac surgery patients with active bleeding. The adaptive trial design will allow for a maximum storage duration of up to 21 days in the cold storage group. The control group will be room temperature stored platelets with a maximum of 5-7 days, and the primary outcome is a well validated 5-point bleeding score. The trial is expected to begin in the fall of 2021. The trial may lead to the amendment of the license for platelets to allow for cold storage of apheresis platelets for up to 21 days of storage.
Trauma And PCC Study (TAP) (Principle Investigator, Christine M. Leeper) Trauma and PCC (TAP) trial (Site Principal Investigator: Dr. Leeper): The TAP trial is being conducted to see whether prothrombin complex concentrate (PCC or Kcentra) reduces the chances of death after injury in adults. The aim of the TAP trial is to formally evaluate the effectiveness of Kcentra®, in addition to all standard care, in injured patients predicted to require a large volume blood transfusion. UPMC is participating as one of 140 hospitals to involve a total of us to 8,000 patients. More information about TAP can be found here.
The Linking Investigations in Trauma and Emergency Services (LITES) (Principal Investigators: Dr. Sperry, Dr. Guyette and Dr. Wisniewski): is a research Network of US Trauma Systems and Centers with the capability to conduct prospective, multicenter, injury care and outcomes research of relevance to the Department of Defense (DoD).
- Task Order 0001: Linking Investigations in Trauma and Emergency Services (LITES): This study is being done to characterize the epidemiology of moderate and severe physical injury in the U.S. and across the LITES Network and investigate regional variations of presenting characteristics, management practices, and attributable outcomes.
- Task Order 0002: Shock, Whole blood and Assessment of TBI (SWAT): This study is being done to see if giving whole blood instead of blood components (plasma, platelets, packed red blood cells) early in the course of treatment would help improve outcomes of severely injured patients that lose a lot of blood (hypovolemic shock).
- Prehospital Airway Control Trial (PACT): This study is being done to compare different ways of helping people with traumatic injuries breathe.
Completed Trials
Prehospital Air Medical Plasma (PAMPer) Trial (Principal Investigators: Dr. Sperry, D. Gillespie, Dr. Smith and Dr. Soose): This research study is designed to determine the effect of infusing 2 units of AB (universal donor) plasma during air medical (helicopter) transport on 30 day mortality in patients with hemorrhagic shock as compared to standard medical care. We will also examine the effects of plasma on other clinical outcomes (clotting measurements on arrival to the trauma center, total blood transfusion requirements during the first 24 hours, the development of multiple organ failure, hospital-acquired infection, acute lung injury (ALI) and transfusion-related acute lung injury (TRALI)).
Study of Tranexamic acid during Air and ground Medical Prehospital transport (STAAMP) trial. (Principal Investigators: Dr. Sperry, Dr. Guyette and Dr. Wisniewski ): This study will determine the effect of infusing tranexamic acid during pre-hospital emergency medical transport (EMS) on 30-day mortality in patients at risk of bleeding as compared to placebo. We will also examine the effects of tranexamic acid on other clinical outcomes (clotting measurements on arrival to the trauma center, total blood transfusion requirements during the first 24 hours, the development of multiple organ failure, hospital-acquired infection, acute lung injury (ALI) and abnormal clotting throughout the body.
Strategies to Promote ResiliencY study (SPRY) (Principal Investigators: Dr Neal, Dr. Angus and Dr. Seymour) This multi-disciplinary, ITTC-funded double-blind randomized clinical trial is designed to evaluate the effectiveness of metformin on improving surgical outcomes among older nondiabetic adults, or among younger patients with significant frailty/comorbidity, who are scheduled for elective surgery at UPMC. Using elective surgery as a surrogate model for accelerated aging and inflammation and with a primary study endpoint of hospital free days (HFD) at 90 days, we hypothesize those taking metformin will experience more HFD at 90 days compared to those taking placebo.
We need help from our community!
Bleeding out is the most common cause of preventable death after injury. We are participating in an international study to see if a blood clotting drug, given soon after arrival in the emergency department, can improve survival.
Please join our virtual community forum discussing the Trauma And Prothrombin Complex Concentrate (TAP) Trial.
For more information regarding this study please click the link here.