Finding the bleeding edge: 24-hour mortality by unit of blood product transfused in combat casualties from 2002-2020.

Background: Transfusion studies in civilian trauma patients have tried to identify a general futility threshold. We hypothesized that in combat settings there is no general threshold where blood product transfusion becomes unbeneficial to survival in hemorrhaging patients. We sought to assess the relationship between the number of units of blood products transfused and 24-hour mortality in combat casualties.

The Golden Hour of Casualty Care: Rapid Handoff to Surgical Team is Associated With Improved Survival in War-injured US Service Members.

Objective: To examine time from injury to initiation of surgical care and association with survival in US military casualties.

Background: Although the advantage of trauma care within the "golden hour" after an injury is generally accepted, evidence is scarce.

Methods: This retrospective, population-based cohort study included US military casualties injured in Afghanistan and Iraq, January 2007 to December 2015, alive at initial request for evacuation with maximum abbreviated injury scale scores ≥2 and documented 30-day survival status after injury.

The epidemiology and outcomes of prolonged trauma care (EpiC) study: methodology of a prospective multicenter observational study in the Western Cape of South Africa.

Background: Deaths due to injuries exceed 4.4 million annually, with over 90% occurring in low-and middle-income countries. A key contributor to high trauma mortality is prolonged trauma-to-treatment time.

Determining resuscitation outcomes in combat casualties: Design of the Deployed Hemostatic Emergency Resuscitation of Traumatic Exsanguinating Shock (Deployed HEROES) study.

Background: During the course of the recent conflicts, the recommendations for resuscitation practices have evolved, but there has been no comprehensive comparative effectiveness study of these resuscitation strategies. The objective of this study was to describe the development and study design of the Deployed Hemostatic Emergency Resuscitation of Traumatic Exsanguinating Shock (Deployed HEROES) study-the first comprehensive analysis of military resuscitation practices in the deployed environment from October 2001 to October 2019.

Methods: This retrospective cohort study uses the Department of Defense Trauma Registry, Armed Services Blood Program database, and Military Trauma Mortality Review, while abstractors will use Theater Medical Data Store and Web Interface Patient Records to collect transfusion timing data.

Case-control analysis of prehospital death and prolonged field care survival during recent US military combat operations.

Background: Quantification of medical interventions administered during prolonged field care (PFC) is necessary to inform training and planning.

Materials And Methods: Retrospective cohort study of Department of Defense Trauma Registry casualties with maximum Abbreviated Injury Scale (MAIS) score of 2 or greater and prehospital records during combat operations 2007 to 2015; US military nonsurvivors were linked to Armed Forces Medical Examiner System data. Medical interventions administered to survivors of 4 hours to 72 hours of PFC and nonsurvivors who died prehospital were compared by frequency-matching on mechanism (explosive, firearm, other), injury type (penetrating, blunt) and injured body regions with MAIS score of 3 or greater.

Whole blood at the tip of the spear: A retrospective cohort analysis of warm fresh whole blood resuscitation versus component therapy in severely injured combat casualties.

Background: Death from uncontrolled hemorrhage occurs rapidly, particularly among combat casualties. The US military has used warm fresh whole blood during combat operations owing to clinical and operational exigencies, but published outcomes data are limited. We compared early mortality between casualties who received warm fresh whole blood versus no warm fresh whole blood.

A stepped randomized trial to promote colorectal cancer screening in a nationwide sample of U.S. Veterans.

Background: Colorectal cancer (CRC) screening (CRCS) facilitates early detection and lowers CRC mortality.

Objectives: To increase CRCS in a randomized trial of stepped interventions. Step 1 compared three modes of delivery of theory-informed minimal cue interventions.

Evidence-Based and Clinically Relevant Outcomes for Hemorrhage Control Trauma Trials.

Objective: To address the clinical and regulatory challenges of optimal primary endpoints for bleeding patients by developing consensus-based recommendations for primary clinical outcomes for pivotal trials in patients within 6 categories of significant bleeding, (1) traumatic injury, (2) intracranial hemorrhage, (3) cardiac surgery, (4) gastrointestinal hemorrhage, (5) inherited bleeding disorders, and (6) hypoproliferative thrombocytopenia.

Background: A standardized primary outcome in clinical trials evaluating hemostatic products and strategies for the treatment of clinically significant bleeding will facilitate the conduct, interpretation, and translation into clinical practice of hemostasis research and support alignment among funders, investigators, clinicians, and regulators.

Methods: An international panel of experts was convened by the National Heart Lung and Blood Institute and the United States Department of Defense on September 23 and 24, 2019.

A Pilot Trial of Platelets Stored Cold versus at Room Temperature for Complex Cardiothoracic Surgery.

Background: This pilot trial focused on feasibility and safety to provide preliminary data to evaluate the hemostatic potential of cold-stored platelets (2° to 6°C) compared with standard room temperature-stored platelets (20° to 24°C) in adult patients undergoing complex cardiothoracic surgery. This study aimed to assess feasibility and to provide information for future pivotal trials.

Methods: A single center two-stage exploratory pilot study was performed on adult patients undergoing elective or semiurgent complex cardiothoracic surgery.

Association of time to craniectomy with survival in patients with severe combat-related brain injury.

OBJECTIVEIn combat and austere environments, evacuation to a location with neurosurgery capability is challenging. A planning target in terms of time to neurosurgery is paramount to inform prepositioning of neurosurgical and transport resources to support a population at risk. This study sought to examine the association of wait time to craniectomy with mortality in patients with severe combat-related brain injury who received decompressive craniectomy.

Association of Prehospital Blood Product Transfusion During Medical Evacuation of Combat Casualties in Afghanistan With Acute and 30-Day Survival.

Importance: Prehospital blood product transfusion in trauma care remains controversial due to poor-quality evidence and cost. Sequential expansion of blood transfusion capability after 2012 to deployed military medical evacuation (MEDEVAC) units enabled a concurrent cohort study to focus on the timing as well as the location of the initial transfusion.

Objective: To examine the association of prehospital transfusion and time to initial transfusion with injury survival.

Assessing protocol adherence in a clinical trial with ordered treatment regimens: Quantifying the pragmatic, randomized optimal platelet and plasma ratios (PROPPR) trial experience.

Background: Medication dispensing errors are common in clinical trials, and have a significant impact on the quality and validity of a trial. Therefore, the definition, calculation and evaluation of such errors are important for supporting a trial's conclusions. A variety of medication dispensing errors can occur.

Ideal hemoglobin transfusion target for resuscitation of massive-transfusion patients.

Background: Overtransfusion of packed red blood cells is known to increase the risk of death in stable patients. With the delineation of minimum transfusion ratios in hemorrhaging patients complete, attention must be turned to the other end of the massive transfusion spectrum-that of defining the maximum transfusion of packed red blood cells. We aimed to define the ideal hemoglobin range 24 hours after anatomic hemostasis associated with the lowest mortality.

Recurrent event frailty models reduced time-varying and other biases in evaluating transfusion protocols for traumatic hemorrhage.

Objective: Transfusion research seeks to improve survival for severely injured and hemorrhaging patients using optimal plasma and platelet ratios over red blood cells (RBCs). However, most published studies comparing different ratios are plagued with serious bias and ignore time-varying effects. We applied joint recurrent event frailty models to increase validity and clinical utility.

Cardiovascular Disease Risk Factors in Hispanic Adolescents in South Texas.

Objectives: Despite a national crisis of increased prevalence of obesity and type 2 diabetes mellitus in adolescents, especially among Hispanics, there is a paucity of data on health indicators among farmworker adolescents and their peers. The main aim of this study was to estimate the prevalence of cardiovascular disease risk factors in a population of Hispanic adolescent students in south Texas. The study also aimed to compare the prevalence of these risk factors between students enrolled in the Migrant Education Program (MEP) and other students, and between boys and girls.

Damage-control resuscitation and emergency laparotomy: Findings from the PROPPR study.

Background: The Pragmatic Randomized Optimal Platelet and Plasma Ratios (PROPPR) trial has demonstrated that damage-control resuscitation, a massive transfusion strategy targeting a balanced delivery of plasma-platelet-red blood cell in a ratio of 1:1:1, results in improved survival at 3 hours and a reduction in deaths caused by exsanguination in the first 24 hours compared with a 1:1:2 ratio. In light of these findings, we hypothesized that patients receiving 1:1:1 ratio would have improved survival after emergency laparotomy.

Methods: Severely injured patients predicted to receive a massive transfusion admitted to 12 Level I North American trauma centers were randomized to 1:1:1 versus 1:1:2 as described in the PROPPR trial.

A joint latent class model for classifying severely hemorrhaging trauma patients.

Background: In trauma research, "massive transfusion" (MT), historically defined as receiving ≥10 units of red blood cells (RBCs) within 24 h of admission, has been routinely used as a "gold standard" for quantifying bleeding severity. Due to early in-hospital mortality, however, MT is subject to survivor bias and thus a poorly defined criterion to classify bleeding trauma patients.

Methods: Using the data from a retrospective trauma transfusion study, we applied a latent-class (LC) mixture model to identify severely hemorrhaging (SH) patients.

Statistical Machines for Trauma Hospital Outcomes Research: Application to the PRospective, Observational, Multi-Center Major Trauma Transfusion (PROMMTT) Study.

Improving the treatment of trauma, a leading cause of death worldwide, is of great clinical and public health interest. This analysis introduces flexible statistical methods for estimating center-level effects on individual outcomes in the context of highly variable patient populations, such as those of the PRospective, Observational, Multi-center Major Trauma Transfusion study. Ten US level I trauma centers enrolled a total of 1,245 trauma patients who survived at least 30 minutes after admission and received at least one unit of red blood cells.

A joint latent class analysis for adjusting survival bias with application to a trauma transfusion study.

There is no clear classification rule to rapidly identify trauma patients who are severely hemorrhaging and may need substantial blood transfusions. Massive transfusion (MT), defined as the transfusion of at least 10 units of red blood cells within 24 h of hospital admission, has served as a conventional surrogate that has been used to develop early predictive algorithms and establish criteria for ordering an MT protocol from the blood bank. However, the conventional MT rule is a poor proxy, because it is likely to misclassify many severely hemorrhaging trauma patients as they could die before receiving the 10th red blood cells transfusion.

Estimating the ratio of multivariate recurrent event rates with application to a blood transfusion study.

In comparative effectiveness studies of multicomponent, sequential interventions like blood product transfusion (plasma, platelets, red blood cells) for trauma and critical care patients, the timing and dynamics of treatment relative to the fragility of a patient's condition is often overlooked and underappreciated. While many hospitals have established massive transfusion protocols to ensure that physiologically optimal combinations of blood products are rapidly available, the period of time required to achieve a specified massive transfusion standard (e.g.

Alternative end points for trauma studies: A survey of academic trauma surgeons.

Introduction: Changing the epidemiology of trauma makes traditional end points like 30-day mortality less than ideal. Many alternative end points have been suggested; however, they are not yet accepted by the trauma community or regulatory bodies. This study characterizes opinions about the adequacy of accepted end points of studies of trauma and the appropriateness of several novel end points.