Mark D. Cipolle

Practice Management Guidelines for the Prevention of Venous Thromboembolism in Trauma Patients: The EAST Practice Management Guidelines Work Group

These original guidelines were developed by interested trauma surgeons in 1997 for the EAST Web site (www.eas- t.org), where a brief summary of four guidelines was pub- lished. A revised, complete, and significantly edited practice management guidelines for the prevention of venous throm- boembolism in trauma patients is presented herein. The step-by-step process of practice management guide- line development, as outlined by the Agency for Health Care Policy and Research (AHCPR), has been used as the meth- odology for the development of these guidelines. 2 Briefly, the first step in guideline development is a classification of sci- entific evidence. A Class I study is a prospective, randomized controlled trial. A Class II study is a clinical study with prospectively collected data or large retrospective analyses with reliable data. A Class III study is retrospective data, expert opinion, or a case report. Once the evidence is classi- fied, it can be used to make recommendations. A Level I recommendation is convincingly justifiable on the basis of the scientific information alone. Usually, such a recommen- dation is made on the basis of a preponderance of Class I data, but some strong Class II data can be used. A Level II rec- ommendation means the recommendation is reasonably jus- tifiable, usually on the basis of a preponderance of Class II data. If there are not enough Class I data to support a Level I recommendation, they may be used to support a Level II recommendation. A Level III recommendation is generally only supported by Class III data. These practice guidelines address eight different areas of practice management as they relate to the prevention and diagnosis of venous thromboembolism in trauma patients. There are few Level I recommendations because there is a paucity of Class I data in the area of trauma literature. We believe it is important to highlight areas where future inves- tigation may bring about definitive Level I recommendations.

Clinical practice guideline: red blood cell transfusion in adult trauma and critical care.

Objective: To develop a clinical practice guideline for red blood cell transfusion in adult trauma and critical care. Design: Meetings, teleconferences and electronic-based communication to achieve grading of the published evidence, discussion and consensus among the entire committee members. Methods: This practice management guideline was developed by a joint taskforce of EAST (Eastern Association for Surgery of Trauma) and the American College of Critical Care Medicine (ACCM) of the Society of Critical Care Medicine (SCCM). We performed a comprehensive literature review of the topic and graded the evidence using scientific assessment methods employed by the Canadian and U.S. Preventive Task Force (Grading of Evidence, Class I, II, III; Grading of Recommendations, Level I, II, III). A list of guideline recommendations was compiled by the members of the guidelines committees for the two societies. Following an extensive review process by external reviewers, the final guideline manuscript was reviewed and approved by the EAST Board of Directors, the Board of Regents of the ACCM and the Council of SCCM. Results: Key recommendations are listed by category, including (A) Indications for RBC transfusion in the general critically ill patient; (B) RBC transfusion in sepsis; (C) RBC transfusion in patients at risk for or with acute lung injury and acute respiratory distress syndrome; (D) RBC transfusion in patients with neurologic injury and diseases; (E) RBC transfusion risks; (F) Alternatives to RBC transfusion; and (G) Strategies to reduce RBC transfusion. Conclusions: Evidence-based recommendations regarding the use of RBC transfusion in adult trauma and critical care will provide important information to critical care practitioners.

Human Polymerized Hemoglobin for the Treatment of Hemorrhagic Shock when Blood Is Unavailable: The USA Multicenter Trial

BACKGROUND Human polymerized hemoglobin (PolyHeme, Northfield Laboratories) is a universally compatible oxygen carrier developed to treat life-threatening anemia. This multicenter phase III trial was the first US study to assess survival of patients resuscitated with a hemoglobin-based oxygen carrier starting at the scene of injury. STUDY DESIGN Injured patients with a systolic blood pressure</=90 mmHg were randomized to receive field resuscitation with PolyHeme or crystalloid. Study patients continued to receive up to 6 U of PolyHeme during the first 12 hours postinjury before receiving blood. Control patients received blood on arrival in the trauma center. This trial was conducted as a dual superiority/noninferiority primary end point. RESULTS Seven hundred fourteen patients were enrolled at 29 urban Level I trauma centers (79% men; mean age 37.1 years). Injury mechanism was blunt trauma in 48%, and median transport time was 26 minutes. There was no significant difference between day 30 mortality in the as-randomized (13.4% PolyHeme versus 9.6% control) or per-protocol (11.1% PolyHeme versus 9.3% control) cohorts. Allogeneic blood use was lower in the PolyHeme group (68% versus 50% in the first 12 hours). The incidence of multiple organ failure was similar (7.4% PolyHeme versus 5.5% control). Adverse events (93% versus 88%; p=0.04) and serious adverse events (40% versus 35%; p=0.12), as anticipated, were frequent in the PolyHeme and control groups, respectively. Although myocardial infarction was reported by the investigators more frequently in the PolyHeme group (3% PolyHeme versus 1% control), a blinded committee of experts reviewed records of all enrolled patients and found no discernable difference between groups. CONCLUSIONS Patients resuscitated with PolyHeme, without stored blood for up to 6 U in 12 hours postinjury, had outcomes comparable with those for the standard of care. Although there were more adverse events in the PolyHeme group, the benefit-to-risk ratio of PolyHeme is favorable when blood is needed but not available.

Outcome after decompressive craniectomy for the treatment of severe traumatic brain injury.

BACKGROUND Using decompressive craniectomy as part of the treatment regimen for severe traumatic brain injury (STBI) has become more common at our Level I trauma center. This study was designed to examine this practice with particular attention to long-term functional outcome. METHODS A retrospective review of prospectively collected data was performed for patients with STBI admitted from January 1, 2003 to December 31, 2005. Our institution manages patients using the Brain Trauma Foundation Guidelines. Data collected from patients undergoing decompressive craniectomy included: age, Injury Severity Score, admission and follow-up Glasgow Coma Score, timing of, and indication for decompressive craniectomy, and procedure-related complications. The Extended Glasgow Outcome Scale (GOSE) was performed by a experienced trauma clinical research coordinator using a structured phone interview to assess long-term outcome in the survivors. Students t test and chi2 were used to examine differences between groups. RESULTS Forty STBI patients were treated with decompressive craniectomy; 24 were performed primarily in conjunction with urgent evacuation of extra-axial hemorrhage and 16 were performed primarily in response to increased intracranial pressure with 4 of these after an initial craniotomy. Decompressive craniectomy was very effective at lowering intracranial pressure in these 16 patients (35.0 mm Hg +/- 13.5 mm Hg to 14.6 mm Hg +/- 8.7 mm Hg, p = 0.005). Twenty-two decompressive craniectomy patients did not survive to hospital discharge, whereas admission Glasgow Coma Score and admission pupil size and reactivity correlated with outcome, age, and Injury Severity Score did not. At a mean of 11 months (range, 3-26 months) after decompressive craniectomy, 6 survivors had a poor functional outcome (GOSE 1-4), whereas 12 survivors had a good outcome (GOSE 5-8). Therefore, 70% of these patients had an unfavorable outcome (death or severe disability), and 30% had a favorable long-term functional outcome. Fifteen of 18 survivors went on to cranioplasty, whereas 4 of 18 had cerebrospinal infection. CONCLUSION The majority of survivors after decompressive craniectomy have a good functional outcome as analyzed by GOSE. Overall, 30% of patients with STBI who underwent decompressive craniectomy had a favorable long-term outcome. Improving patient selection and optimizing timing of this procedure may further improve outcome in these very severely brain injured patients.

Posttrauma thromboembolism prophylaxis.

PURPOSE The need to study methods of thromboembolism prophylaxis in high-risk trauma patients is well established. The purpose of this study was to evaluate the feasibility of a proposed study design, including current methods of prophylaxis, performance of a risk assessment profile scale, and the use of serial color-flow duplex studies in detecting deep venous thrombosis (DVT). METHODS Patients were enrolled into the study, stratified as to their ability to receive anticoagulation and randomized to low-dose unfractionated heparin, low molecular weight heparin, pneumatic compression devices, or foot pumps with or without vena caval filters. Serial ultrasound scans were performed at designated intervals for 4 weeks. Pulmonary angiograms were obtained for clinical signs or symptoms of pulmonary embolism. RESULTS Fifty-three patients, 32 male and 21 female patients with a mean age of 44 years, completed the study. The incidence of DVT was 43% (23 of 53 patients) and significantly higher in older patients. There were no pulmonary embolisms. Color-flow duplex proved to be a sensitive method for detecting both proximal and distal thrombi. The risk assessment profile for thromboembolism (RAPT) scale identified a group of patients with a high incidence of DVT. However, the occurrence of DVT was not correlated with the magnitude of the RAPT score. CONCLUSION The ability to identify a population with a high incidence of thromboembolism by using the RAPT score to detect asymptomatic DVT, and the suggested advantage of low molecular weight heparin, all support the need for an appropriately powered randomized clinical trial.

Clinical practice guideline: Red blood cell transfusion in adult trauma and critical care*

STATEMENT OF THE PROBLEMRed blood cell (RBC) transfusion is common in critically ill and injured patients. Many studies1–6 have documented the widespread use of RBC transfusion in critically ill patients and the data from these studies from diverse locations in Western Europe, Canada, the United Kin

Preinjury warfarin does not impact outcome in trauma patients.

OBJECTIVE The objective of this study was to determine whether the preinjury condition of anticoagulation had an adverse impact on patients sustaining injury. METHODS A retrospective analysis was performed for prospectively collected registry data from 1995-2000 from all accredited trauma centers in Pennsylvania. The registry was queried for all trauma patients who had anticoagulation therapy as a preinjury condition (PIC). This group served as our experimental cohort. A control cohort (not having warfarin therapy as a PIC) was developed using case-matching techniques for age, sex, Glasgow Coma Scale (GCS), Injury Severity Score (ISS), A Severity Characterization of Trauma (ASCOT) score, and in the head injured patients, International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) diagnoses. Head and non-head injured patients were evaluated separately. The cohorts were examined for 28-day mortality, intensive care unit length of stay (ICU-LOS), hospital length of stay (HOS-LOS), PICs, occurrences, discharge destinations, and functional status at discharge. Chi2 and Students t test were used to evaluate the data; p values < 0.05 were considered significant. RESULTS Two thousand nine hundred forty-two patients were available for analysis. The prevalence of PICs was significantly greater in the warfarin group for both the head and non-head injured populations (p < 0.003 and p < 0.0001, respectively). The incidence of occurrences in the non-head injured population was statistically higher for the warfarin patients (p < 0.001), but showed no difference in the head injured group regardless of warfarin use (p = 0.15). Functional status at discharge demonstrated no clinically significant difference between the warfarin and non-warfarin groups in both head and non-head injured populations. There was no difference in discharge destination in the head injured population; however, in the non-head injured population a greater percentage of non-warfarin patients was discharged to home when compared with the warfarin patients. CONCLUSION Our data suggest that the PIC of anticoagulation with warfarin does not adversely impact mortality or LOS outcomes in both head and non-head injured patients. In non-head injured patients, however, the occurrence rates and discharge destination were different. More research needs to be done to determine whether this is related to anticoagulation or other reasons (i.e., number of PICs). These data should be used when weighing risk/benefit ratios of prescribing chronic anticoagulation.

Use of Admission Glasgow Coma Score, Pupil Size, and Pupil Reactivity to Determine Outcome for Trauma Patients.

BACKGROUND Determination of nonsurvival in trauma patients is difficult because valid prognostic indicators are lacking. It was hypothesized that patients presenting with a Glasgow Coma Score (GCS) of 3 as well as fixed and dilated (FD) pupils do not have a reasonable chance of survival. METHODS From 1999 through 2001, adult trauma patients (age, >14 years) admitted with a GCS of 3 were reviewed. Patients receiving paralytic agents before initial assessment were excluded from analysis. Fixed and dilated pupils were defined as being 4 mm or more in diameter bilaterally and nonreactive to light. In this study, the FD patients were evaluated for survival, resuscitative measures, surgical procedures, length of hospital stay, and organ donation. The non-FD patients were evaluated for survival and length of hospital stay. RESULTS Of the 137 patients evaluated with a GCS of 3, 104 had FD pupils and 33 did not. In the FD group, there were no survivors. On arrival, 28 (37.3%) of the patients were declared dead, and no further interventions were undertaken. Of the 76 patients (62.7%) who underwent further resuscitation, which included 53 surgical procedures, 30 died in the resuscitation bay, 39 within 24 hours, 4 within 48 hours, 2 within 72 hours, and 1 on day 6. There were 18 (23.7%) organ donors. Of the 33 patients without FD pupils, 11 (33%) survived to discharge (mean hospital stay, 21.4 days). Of the 22 nonsurvivors (67%), 10 died in the resuscitation bay, 8 within 24 hours, 1 within 48 hours, 1 on day 4, and 2 on day 6. CONCLUSIONS Patients presenting with a GCS of 3 and FD pupils have no reasonable chance for survival. A significant percentage of these patients can be salvaged for organ donation. This information should be used in deciding to pursue aggressive resuscitation efforts and in discussing prognosis with family. Patients with a GCS of 3 who are not FD should be aggressively resuscitated because many of these patients survive to discharge.

Hepatic angioembolization in trauma patients: indications and complications.

BACKGROUND Hepatic angiography (HA) and hepatic angioembolization (HAE) are increasingly used to diagnose and treat intrahepatic arterial injuries. This study was performed to review indications, outcomes, and complications of HA/HAE in blunt trauma patients who underwent HAE as adjunct management of hepatic injury. METHODS A retrospective review of consecutive cases of HA/HAE at a Level I trauma center during an 8-year period. Data include demographics, physiologic condition, liver injury grade, HA/HAE indications, outcomes, morbidity, and mortality. RESULTS Seventy-nine patients underwent diagnostic HA; 31 (39%) had subsequent HAE. Fifty-eight hemodynamically stable patients had computerized axial tomographic (CT) scan followed by HA. HA was performed for contrast blush on CT in 30 (52%) of 58 patients, high-grade liver injury in 4 (7%), subsequent hemodynamic instability in 15 (27%), and angiography planned for other purpose in 9 (17%). HA confirmed arterial injury and led to HAE in 50% of patients with contrast blush on CT or high-grade liver injury. HA was negative when performed for hemodynamic instability or for other primary purposes. Twenty-one hemodynamically unstable patients underwent emergent laparotomy followed by postoperative HA with 11 (50%) requiring HAE. Overall mortality in HAE group was 16%, and liver-related morbidity was 29% usually presenting as gallbladder or liver necrosis. CONCLUSION HA/HAE should be used when CT scan suggests associated intrahepatic arterial or high-grade injury in the management of hepatic injuries and should also be considered after laparotomy and perihepatic packing to control inaccessible intrahepatic hemorrhage. Mortality related to HAE is uncommon, but morbidity occurs frequently.

Long-term follow-up of trauma patients with a vena caval filter.

BACKGROUND Venous thromboembolism (VTE) is an important complication in blunt trauma patients. At our Level I trauma center, we had a deep venous thrombosis (DVT) rate of 3.2% from 1993 to 1997 despite an aggressive VTE prophylaxis program. During this time period, we placed vena caval filters (VCF) for both traditional and prophylactic indications. This project was developed to establish a VCF registry for trauma patients to determine the long-term complications of VCF placement. METHODS A letter was sent to all trauma patients who had a VCF placed from 1993 through 1997. Patients were asked to return for a history and physical examination to detect signs and symptoms related to VTE, a duplex ultrasound of the inferior vena cava, and a plain abdominal radiograph to determine filter migration. RESULTS There were 191 VCFs inserted in our trauma population from 1993 to 1997. There were 105 patients (75 male and 30 female) available for evaluation, with a mean follow-up of 28.9 months. Forty-one VCFs were placed in patients with DVT or pulmonary embolism, and 64 were placed in patients for prophylactic indications as per the guidelines developed by the Eastern Association for the Surgery of Trauma. There were no clinically identifiable complications related to insertion of the VCF. There were no pulmonary embolisms detected after VCF insertion. In follow-up, only one filter (0.95%) migrated, and this was minimal (1 cm cephalad). One (0.95%) vena cava was occluded, based on duplex ultrasonography, and 11 patients (10.4%) had signs or symptoms of leg swelling after hospital discharge. Twenty eight (44%) of the 64 patients with prophylactic VCFs developed a DVT after filter placement. CONCLUSION VCFs placed in trauma patients have acceptable short- and long-term complication rates. Consideration should be given to prophylactic VCF placement in patients at high risk for VTE. Randomized controlled trials are needed to evaluate whether VCF insertion increases the risk for subsequent DVT.