Early Whole Blood in Patients Requiring Transfusion After Major Trauma
Transfusion of blood products
Enfermedades Cardiovasculares+4
+ Lesiones Accidentales
+ Enfermedades hemáticas y linfáticas
Estudio de Tratamiento
Resumen
Fecha de inicio: 1 de mayo de 2011
Fecha en la que se inscribió al primer participante.Background: The acquired coagulopathy of trauma is responsible for a large percentage of early deaths in civilian trauma practice and is a major cause of battlefield mortality. Widespread recognition has provided a rationale for fundamental changes in the initial management of severely injured patients through prevention of hypothermia, damage control surgery, massive transfusion protocols and early triage to intensive care units for optimized resuscitation. Despite these major advances, hemorrhage remains a leading cause of early death in both civilian trauma and military combat casualty care. However, it is unclear how early whole blood will affect coagulopathy in this cohort of patients as compared to the current standard of care. Objective/Hypothesis: The proposal will assess if patients who require massive transfusion can be accurately predicted early after emergency department arrival and assess if the use of stored whole blood during initial resuscitation will reduce transfusion needs compared to transfusion with component therapy and thus improve outcome. Study Design: As a first step in testing this hypothesis, we will test commonly utilized point of care analysis devices and determine their reliability in predicting transfusion requirements in severely injured trauma patients within 20 minutes after arrival in the emergency department. Furthermore, we will prospectively randomize severely injured patients who require a blood transfusion to receive either stored whole blood and pooled platelets or component therapy (packed red blood cells, fresh frozen plasma, and platelets, our current standard of care) and compare the ability of stored whole blood to reduce transfusion needs and improve clinical outcomes. Relevance: Severe uncontrollable coagulopathy in major trauma patients continues to be a major determinant of trauma mortalities. The proposed effort aims to provide an early, coagulopathy-based prediction model to identify patients at risk for massive transfusion. Moreover, our proposal intends to evaluate early stored whole blood transfusion in this at risk patient population and determine stored whole blood's ability to prevent or control severe coagulopathy compared to standard transfusion care.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 107 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Estudio de Tratamiento
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Cualquier sexo
Sexo biológico de los participantes elegibles para inscribirse.De 18 a 100 años
Rango de edades de los participantes que pueden unirse al estudio.Voluntarios sanos no permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
Inclusion Criteria: 1. 18 years of age or older. 2. Meet Code 3 status; Code 3 is determined by the following criteria (Patients must meet at least one of the following physiologic and/or anatomic criteria): * Physiologic criteria indicating high risk or life threatening injuries * GCS \<10 (Glasgow Coma Scale) * SBP \<90 (Systolic blood pressure) * RR \<10 or \>29 (Respiratory rate) * HR \>120 (Heart rate) * intubated * Base Deficit \> 6 * Anatomic criteria indicating high risk or life threatening injuries * Any penetrating injury to torso, groin, or neck * Amputation proximal to the ankle or wrist * Uncontrolled external hemorrhage * Two or more long bone fractures * Pelvic fracture * Paraplegia or quadriplegia * Combination trauma with burns ≥ 20% BSA (body surface area) 3. Demonstrate evidence of blood loss due to injury, requiring transfusion in the ED. Exclusion Criteria: 1. Death thought to be imminent, suggesting a futile resuscitation effort 2. Known or assumed religious objection to blood products 3. Do not resuscitate order in place 4. Women who present to the ED who are obviously pregnant. 5. Patients who appear to the ED wearing the -opt-out‖ bracelet provided at the community consultation.
Plan de Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.2 grupos de intervención están designados en este estudio
0% de probabilidad de ser asignado al grupo placebo
Grupos de Tratamiento
Grupo I
Comparador ActivoGrupo II
Comparador ActivoObjetivos del Estudio
Objetivos Primarios
Objetivos Secundarios
Centros del Estudio
Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.Este estudio tiene una ubicación
Memorial Hermann Hospital - Texas Medical Center
Houston, United StatesAbrir Memorial Hermann Hospital - Texas Medical Center en Google Maps