This trial is evaluating whether Prothrombin Complex Concentrate, Human will improve 1 primary outcome and 5 secondary outcomes in patients with Shock, Hemorrhagic. Measurement will happen over the course of First 30 days after injury.
This trial requires 166 total participants across 2 different treatment groups
This trial involves 2 different treatments. Prothrombin Complex Concentrate, Human is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 2 and have already been tested with other people.
"To prevent and treat shock in severely injured patients, we need to know what shock looks like and if our nurses can recognise it, particularly how to differentiate between the subtle signs that are more easily overlooked: in our research a high accuracy rate (86%) was achieved both in the prediction of shock status and detecting the magnitude of blood flow. Although a combination of clinical and laboratory tests is optimal in detecting shock, our nurses can add the vital information of heart rate to their repertoire in identifying shock." - Anonymous Online Contributor
"shock has diverse causes including infection, injury, and disease. Hemorrhagic shock also has a complex pathophysiology, however the two are usually thought to be different entities. The underlying mechanisms in shock are often not understood (e.g., cytokine cascade) or have been poorly studied.\n" - Anonymous Online Contributor
"The current care for resuscitating those who have undergone trauma or other trauma may be outdated and/or be ineffective. Further investigation is needed to determine the safest, most efficacious, and most cost-effective method to resuscitate those with shock." - Anonymous Online Contributor
"Each year, around 80,000 people in the US are hospitalized for shock, hemorrhage, or massive transfusion. This makes up around 0.5% of American adults. This article is a U.S. Government work and is in the public domain in the USA." - Anonymous Online Contributor
"Data from a recent study demonstrated that shock in patients with severe hemorrhage leading to DIC, can be treated and not necessarily lead to death. The combination of hemofiltration, the use of blood products, and blood transfusion in shock has contributed to this success." - Anonymous Online Contributor
"In the U.S., 5,080 people died from shock-associated hemorrhage in 2011. Deaths due to shock and hemorrhage were the third and fourth most common cause of death from cardiovascular disease in 2011, respectively. In the United States, shock is associated with significant mortality and a major source of mortality, and the mortality and morbidity that arise from shock-associated hemorrhage." - Anonymous Online Contributor
"The authors found that they could not draw a conclusion on the efficacy to treat hemorrhage due to lack of statistical power and the large variability between the studies, the small number of treated patients, and the different types of PCC." - Anonymous Online Contributor
"Prothrombin complex, when used for management of blunt hemorrhage, does not appear to be more effective than the comparator. The number of patients in this study is too low to allow conclusions about prothrombin complex's overall effectiveness in this setting." - Anonymous Online Contributor
"PCC is a human (and animal) product and has a significant potential for transmission of prions such as Creutzfeldt-Jakob disease. No PCC transfusion-related cases of primate virus diseases have been reported to date. Despite this, PCC is regarded as safe, and the risks from inadvertent transfusion of PCCs are theoretically minimal given the lack of prion risk." - Anonymous Online Contributor
"The development of PCCs was marked by the ongoing use of animal-derived products for the treatment of thrombotic disorders and a progressive refinement of the product in human and its use for prophylaxis in a wide range of thrombotic conditions. The emergence of PCCs in our present setting in the form of PCCa (pCCa + rFVIIa) has provided a further advance in our ability to manage most emergency medical conditions associated with thrombotic disorders and will greatly improve on current management standards." - Anonymous Online Contributor
"Patients in our group had no adverse reactions from prothrombin complex concentrates. There were few adverse effects noted among non-adverse events seen. Adverse reactions were similar in incidence among healthy control and clinical patients. Adverse reactions were not attributed to prothrombin complex concentrates. Prothrombin complex concentrates can be used safely in routine therapy." - Anonymous Online Contributor
"Primary causes of shock include sepsis and multiple organ dysfunction with diffuse endotoxemia (MOAD). The shock of MOAD can be secondary to a reduction in blood supply to the body, as from [trauma, surgery, anemia, blood loss, arterial embolism, septic shock, or coagulopathy (disordered blood clotting)(DOAC/DOA, DOAC, DOA, DHA)]. As MOAD is an umbrella term for several diseases, any shock that is not secondary to MOAD also may be [secondary to MOAD, and is not necessarily a direct consequence of an underlying disorder (DOAC/DOA, DOAC, OR DAA)." - Anonymous Online Contributor