Early Whole Blood in Patients Requiring Transfusion After Major Trauma
Transfusion of blood products
Accidental Injuries+5
+ Cardiovascular Diseases
+ Hematologic Diseases
Treatment Study
Summary
Study start date: May 1, 2011
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.107 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 100 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
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.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
Active ComparatorGroup II
Active ComparatorStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Memorial Hermann Hospital - Texas Medical Center
Houston, United StatesOpen Memorial Hermann Hospital - Texas Medical Center in Google Maps