Re-analysis of the PolyHeme Phase III trial dataset: Lessons for future haemoglobin-based oxygen carrier trauma trials.

Introduction: To assist design of future HBOC clinical trials for pre-hospital and prolonged field care, the haemoglobin-based-oxygen carrier (HBOC) Phase III trauma trial database comparing PolyHeme to blood transfusion was re-analysed to identify causes of adverse early outcomes versus the 30-day mortality outcome of the original trial. We questioned if failure of PolyHeme (10 g/dl) to increase haemoglobin concentration and dilutional coagulopathy versus blood, caused higher Day 1 mortality in the PolyHeme arm of the trial.

Methods: New analyses of the original trial database, including Fisher's exact test, examined impact of interval changes in total haemoglobin [THb], coagulation, fluid volumes administered and mortality on Day 1 in the Control (pre-hospital crystalloids, then blood after trauma centre admission) and PolyHeme arms of the trial.

Virtual reality and haptic interfaces for civilian and military open trauma surgery training: A systematic review.

Objective: Virtual (VR), augmented (AR), mixed reality (MR) and haptic interfaces make additional avenues available for surgeon assessment, guidance and training. We evaluated applications for open trauma and emergency surgery to address the question: Have new computer-supported interface developments occurred that could improve trauma training for civilian and military surgeons performing open, emergency, non-laparoscopic surgery?

Design: Systematic literature review.

Setting And Participants: Faculty, University of Maryland School of Medicine, Baltimore.

Comparison of massive and emergency transfusion prediction scoring systems after trauma with a new Bleeding Risk Index score applied in-flight.

Background: Assessment of blood consumption (ABC), shock index (SI), and Revised Trauma Score (RTS) are used to estimate the need for blood transfusion and triage. We compared Bleeding Risk Index (BRI) score calculated with trauma patient noninvasive vital signs and hypothesized that prehospital BRI has better performance compared with ABC, RTS, and SI for predicting the need for emergent and massive transfusion (MT).

Methods: We analyzed 2-year in-flight data from adult trauma patients transported directly to a Level I trauma center via helicopter.

Enhanced Training Benefits of Video Recording Surgery With Automated Hand Motion Analysis.

Background: Hand motion analysis by video recording during surgery has potential for evaluation of surgical performance. The aim was to identify how technical skill during open surgery can be measured unobtrusively by video recording during a surgical procedure. We hypothesized that procedural-step timing, hand movements, instrument use and Shannon entropy differ with expertise and training and are concordant with a performance-based validated individual procedure score.

Prehospital Point of Care Testing for the Early Detection of Shock and Prediction of Lifesaving Interventions.

Introduction: Early diagnosis and treatment are essential for enhancing outcomes for the traumatically injured. In this prospective prehospital observational study, we hypothesized that a variety of laboratory results measured in the prehospital environment would predict both the presence of early shock and the need for lifesaving interventions (LSIs) for adult patients with traumatic injuries.

Methods: Adult trauma patients flown by a helicopter emergency medical service were prospectively enrolled.

Scoping Evidence Review on Training and Skills Assessment for Open Emergency Surgery.

Objective: Scope evidence on technical performance metrics for open emergency surgery. Identify surgical performance metrics and procedures used in trauma training courses.

Design: Structured literature searches of electronic databases were conducted from January 2010 to December 2019 to identify systematic reviews of tools to measure surgical skills employed in vascular or trauma surgery evaluation and training.

Critical errors in infrequently performed trauma procedures after training.

Background: Critical errors increase postoperative morbidity and mortality. A trauma readiness index was used to evaluate critical errors in 4 trauma procedures. In comparison to practicing and expert surgeon benchmarks, we hypothesized that pretraining trauma readiness index including both vascular and nonvascular trauma surgical procedures can identify residents who will make critical errors.

Handheld Tissue Oximetry for the Prehospital Detection of Shock and Need for Lifesaving Interventions: Technology in Search of an Indication?

Improved prehospital methods for assessing the need for lifesaving interventions (LSIs) are needed to gain critical lead time in the care of the injured. We hypothesized that threshold values using prehospital handheld tissue oximetry would detect occult shock and predict LSI requirements. This was a prospective observational study of adult trauma patients emergently transported by helicopter.

Efficacy of Trauma Surgery Technical Skills Training Courses.

Objective: Because open surgical skills training for trauma is limited in clinical practice, trauma skills training courses were developed to fill this gap, The aim of this report is to find supporting evidence for efficacy of these courses. The questions addressed are: What courses are available and is there robust evidence of benefit?

Design: We performed a systematic review of the training course literature on open trauma surgery procedural skills courses for surgeons using Kirkpatrick's framework for evaluating complex educational interventions. Courses were identified using Pubmed, Google Scholar and other databases.

Blood Transfusion Indicators Following Trauma in the Non-Massively Bleeding Patient.

Background: Establishing transfusion guidelines during trauma resuscitation is challenging. Our objective was to evaluate indications for transfusion in trauma patients who emergently received ≤2 units of red blood cells (RBC) during the first hour of resuscitation.

Methods: A single center retrospective study included non-massively bleeding trauma patients stratified into 2 groups: 1) with a clinical indication for transfusion and 2) with no indication for transfusion.

Cadaver-Based Trauma Procedural Skills Training: Skills Retention 30 Months after Training among Practicing Surgeons in Comparison to Experts or More Recently Trained Residents.

Background: Long-term retention of trauma procedural core-competency skills and need for re-training after a 1-day cadaver-based course remains unknown. We measured and compared technical skills for trauma core competencies at mean 14 months (38 residents), 30 months (35 practicing surgeons), and 46 months (10 experts) after training to determine if skill degradation occurs with time. Technical performance during extremity vascular exposures and lower-extremity fasciotomy in fresh cadavers measured by validated individual procedure score (IPS) was the primary outcome.

Repeat lactate level predicts mortality better than rate of clearance.

Background: Lactate clearance has been developed into a marker of resuscitation in trauma, but no study has compared the predictive power of the various clearance calculations. Our objective was to determine which method of calculating lactate clearance best predicted 24-hour and in-hospital mortality after injury.

Study Design: Retrospective chart review of patients admitted to a Level-1 trauma center directly from the scene of injury from 2010 to 2013 who survived >15min, had an elevated lactate at admission (≥3mmol/L), followed by another measurement within 24h of admission.

Relative Efficacies of HBOC-201 and Polyheme to Increase Oxygen Transport Compared to Blood and Crystalloids.

Background: Because total hemoglobin in circulation ([THb]) is an established predictor of clinical outcomes in anemic individuals, the relative efficacies of resuscitation fluids to increase [THb] can be used to design better hemoglobin-based oxygen carrier (HBOC) clinical trials.

Methods: Expected efficacies of HBOC-201 (13 g Hb/dL) and packed red blood cells (RBCs) (packed red blood cells [pRBCs], 24 g Hb/dL) to increase [THb] were calculated and interpreted in the context of severe adverse events (SAEs) in the HEM-0115 phase III clinical trial.The PolyHeme phase III clinical trial compared the HBOC, PolyHeme (10 g Hb/dL), with crystalloid control prehospital and packed RBCs in hospital.

Users Guide to Pitfalls and Lessons Learned About HBOC-201 During Clinical Trials, Expanded Access, and Clinical Use in 1,701 Patients.

Lessons learned during 1,701 clinical uses of HBOC-201, a polymerized bovine hemoglobin-based oxygen carrier (HBOC), were identified to provide management lessons and training material for future clinical trials and use. HBOC-201 contains 13 g/dL hemoglobin (Hb), is iso-oncotic, stable at 2°C to 30°C with shelf-life of 3 years, requires no cross-matching with half-life of 19 h, and plasma volume distribution. Adverse effects include increased blood pressure, oliguria, gastrointestinal (GI) symptoms, yellow skin and scleral discoloration, decreased pulse oximetry measurements, and transient increases in methemoglobin, hepatic, and pancreatic enzymes.

Head-camera video recordings of trauma core competency procedures can evaluate surgical resident's technical performance as well as colocated evaluators.

Background: Unbiased evaluation of trauma core competency procedures is necessary to determine if residency and predeployment training courses are useful. We tested whether a previously validated individual procedure score (IPS) for individual procedure vascular exposure and fasciotomy (FAS) performance skills could discriminate training status by comparing IPS of evaluators colocated with surgeons to blind video evaluations.

Methods: Performance of axillary artery (AA), brachial artery (BA), and femoral artery (FA) vascular exposures and lower extremity FAS on fresh cadavers by 40 PGY-2 to PGY-6 residents was video-recorded from head-mounted cameras.

Can hyper-realistic physical models of peripheral vessel exposure and fasciotomy replace cadavers for performance assessment?

Background: Work-hour restrictions have reduced operative experience for residents. The Advanced Surgical Skills for Exposure in Trauma (ASSET) course fills this training gap. Cadaver use has limitations including cost and availability.

Performance of Vascular Exposure and Fasciotomy Among Surgical Residents Before and After Training Compared With Experts.

Importance: Surgical patient outcomes are related to surgeon skills.

Objective: To measure resident surgeon technical and nontechnical skills for trauma core competencies before and after training and up to 18 months later and to compare resident performance with the performance of expert traumatologists.

Design, Setting, And Participants: This longitudinal study performed from May 1, 2013, through February 29, 2016, at Maryland State Anatomy Board cadaver laboratories included 40 surgical residents and 10 expert traumatologists.

Reliable Collection of Real-Time Patient Physiologic Data from less Reliable Networks: a "Monitor of Monitors" System (MoMs).

Research and practice based on automated electronic patient monitoring and data collection systems is significantly limited by system down time. We asked whether a triple-redundant Monitor of Monitors System (MoMs) to collect and summarize key information from system-wide data sources could achieve high fault tolerance, early diagnosis of system failure, and improve data collection rates. In our Level I trauma center, patient vital signs(VS) monitors were networked to collect real time patient physiologic data streams from 94 bed units in our various resuscitation, operating, and critical care units.

Automated continuous vital signs predict use of uncrossed matched blood and massive transfusion following trauma.

Background: Recognizing the use of uncross-matched packed red blood cells (UnXRBCs) or predicting the need for massive transfusion (MT) in injured patients with hemorrhagic shock can be challenging.A validated predictive model could accelerate decision making regarding transfusion.

Methods: Three transfusion outcomes were evaluated in adult trauma patients admitted to a Level I trauma center during a 4-year period (2009-2012): use of UnXRBC, use of greater than 4 U of packed red blood cells within 4 hours (MT1), and use of equal to or greater than 10 U of packed red blood cells within 24 hours (MT2).

Computer Modelling Using Prehospital Vitals Predicts Transfusion and Mortality.

Objective: Test computer-assisted modeling techniques using prehospital vital signs of injured patients to predict emergency transfusion requirements, number of intensive care days, and mortality, compared to vital signs alone.

Methods: This single-center retrospective analysis of 17,988 trauma patients used vital signs data collected between 2006 and 2012 to predict which patients would receive transfusion, require 3 or more days of intensive care, or die. Standard transmitted prehospital vital signs (heart rate, blood pressure, shock index, and respiratory rate) were used to create a regression model (PH-VS) that was internally validated and evaluated using area under the receiver operating curve (AUROC).

Trends of Hemoglobin Oximetry: Do They Help Predict Blood Transfusion During Trauma Patient Resuscitation?

Background: A noninvasive decision support tool for emergency transfusion would benefit triage and resuscitation. We tested whether 15 minutes of continuous pulse oximetry-derived hemoglobin measurements (SpHb) predict emergency blood transfusion better than conventional oximetry, vital signs, and invasive point-of-admission (POA) laboratory testing. We hypothesized that the trends in noninvasive SpHb features monitored for 15 minutes predict emergency transfusion better than pulse oximetry, shock index (SI = heart rate/systolic blood pressure), or routine POA laboratory measures.

Using an Individual Procedure Score Before and After the Advanced Surgical Skills Exposure for Trauma Course Training to Benchmark a Hemorrhage-Control Performance Metric.

Objective: Test with an individual procedure score (IPS) to assess whether an unpreserved cadaver trauma training course, including upper and lower limb vascular exposure, improves correct identification of surgical landmarks, underlying anatomy, and shortens time to vascular control.

Design: Prospective study of performance of 3 vascular exposure and control procedures (axillary, brachial, and femoral arteries) using IPS metrics by 2 colocated and trained evaluators before and after training with the Advanced Surgical Skills Exposure for Trauma (ASSET) course. IPS, including identification of anatomical landmarks, incisions, underlying structures, and time to completion of each procedure was compared before and after training using repeated measurement models.

Development and validation of trauma surgical skills metrics: Preliminary assessment of performance after training.

Background: Maintaining trauma-specific surgical skills is an ongoing challenge for surgical training programs. An objective assessment of surgical skills is needed. We hypothesized that a validated surgical performance assessment tool could detect differences following a training intervention.

Perception does not equal reality for resident vascular trauma skills.

Background: Experience with the management of vascular trauma by senior surgical residents is increasingly limited. When queried about their understanding of anatomy and ability to perform specific vascular exposures, residents express a moderately high level of confidence. We hypothesized that this perception does not equal reality.