COLORADO MULTIPLE INSTITUTIONAL REVIEW BOARD



wCOMIRB ProtocolCOLORADO MULTIPLE INSTITUTIONAL REVIEW BOARDCAMPUS BOX F-490 TELEPHONE: 303-724-1055 Fax: 303-724-0990Protocol #: 19-0542Project Title:Evaluation of Angioembolization for liver injuries with CT identified blush: A Western Trauma Association Multicenter Study.Principal Investigator: Dr. Laura Harmon MDVersion Date: 4/26/2019Hypotheses and Specific AimsHypotheses: 1) Angioembolization (AE) for liver injuries with blush (i.e. active bleeding) seen on computerized tomography (CT) scan completed within the first two hours after arrival improves survival and decreases need for operative intervention.Specific Aims: Specific aim 1: To define the efficacy and complication rate of hepatic angioembolization in patients with active bleeding from hepatic injuries documented on computed tomography imaging in the stable trauma patientSpecific aim 2: Determine transfusion requirements, complication rates, time to recovery, and need for further interventions following angioembolization done for blush/extravasation identified on CT. II. Background and SignificanceCurrent algorithms for the operative and non-operative management of hepatic trauma result in improved morbidity and mortality compared to historical operative management from the 1970s and 1980s. (WTA Critical Decisions) PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Lb3phcjwvQXV0aG9yPjxZZWFyPjIwMTE8L1llYXI+PFJl

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ADDIN EN.CITE.DATA 1,2In the National?Trauma?Data Bank 2002 to 2008, 3,627 patients had liver injury. Early operative management occurred in 20%, while initial NOM occurred in 73% of patients. Of these, 93% had successful NOM, and 7% had failed NOM. The rate of attempted and failed NOM increased during the study period. Increasing age, male sex, increasing ISS, decreasing Glasgow Coma Scale (GCS) score, hypotension, and hepatic angioembolization were independent predictors of failed NOM. Failed NOM was an independent predictor of mortality. (Polanco J Trauma Acute Care Surgery 2013) ADDIN EN.CITE <EndNote><Cite><Author>Polanco</Author><Year>2013</Year><RecNum>17094</RecNum><DisplayText><style face="superscript">3</style></DisplayText><record><rec-number>17094</rec-number><foreign-keys><key app="EN" db-id="55vdtt2ry0wp0weefrnx52wtvp9zpfs5eevd">17094</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Polanco, P. M.</author><author>Brown, J. B.</author><author>Puyana, J. C.</author><author>Billiar, T. R.</author><author>Peitzman, A. B.</author><author>Sperry, J. L.</author></authors></contributors><auth-address>From the Division of General Surgery and Trauma, Department of Surgery, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania.</auth-address><titles><title>The swinging pendulum: a national perspective of nonoperative management in severe blunt liver injury</title><secondary-title>J Trauma Acute Care Surg</secondary-title><alt-title>The journal of trauma and acute care surgery</alt-title></titles><periodical><full-title>J Trauma Acute Care Surg</full-title></periodical><pages>590-5</pages><volume>75</volume><number>4</number><keywords><keyword>Adult</keyword><keyword>Databases, Factual</keyword><keyword>Female</keyword><keyword>Humans</keyword><keyword>Injury Severity Score</keyword><keyword>Liver/*injuries/surgery</keyword><keyword>Logistic Models</keyword><keyword>Male</keyword><keyword>Middle Aged</keyword><keyword>Retrospective Studies</keyword><keyword>Treatment Outcome</keyword><keyword>United States</keyword><keyword>Wounds, Nonpenetrating/mortality/surgery/*therapy</keyword><keyword>Young Adult</keyword></keywords><dates><year>2013</year><pub-dates><date>Oct</date></pub-dates></dates><isbn>2163-0763 (Electronic)&#xD;2163-0755 (Linking)</isbn><accession-num>24064870</accession-num><urls><related-urls><url>. Preliminary Studies/Progress ReportThe majority of reports on the use of AE are small, retrospective (< 50 patients) series with reported efficacy of 77-100%. (Green et al JTACS 2016) PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5HcmVlbjwvQXV0aG9yPjxZZWFyPjIwMTY8L1llYXI+PFJl

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ADDIN EN.CITE.DATA 4This group recently completed a multicenter review of hepatic angioembolization cases across four trauma hospitals (1 Level 1 and 3 Level 2 trauma centers) in the Colorado front range region across eight years (publication submitted for approval). 30 patients were identified as having received hepatic angioembolization using ICD9/10 coding.Hepatic AE was found to be highly effective with no reported mortality.However, morbidity was significant with 43% liver-related complication rate and 35% readmission rate.No comparison group was utilized to determine whether limited mortality and heightened morbidity were due to hepatic AE or other aspects of care.IV. Research MethodsA. Outcome Measure(s)Primary outcome:The primary outcomes of interest for this study are mortality and morbidity (liver-related and unrelated complications) following the use of non-interventional management versus hepatic angioembolization for liver injuries in the patient who is candidate for non-operative management.Secondary outcomes:Rate of liver-related procedures (operative, endoscopic, and radiographic interventions), hospital readmissions within 30 days, ICU days, ventilator days, time to recover (clearance of acidosis) hospital length of stay, transfusion requirements, and factors predictive for need for management with angioembolization in liver injuries and factors predictive of failure of hepatic angioembolizaition.B. Description of Population to be Enrolled. This prospective multicenter study will enroll all patients treated at participating centers with trauma related hepatic injuries. Inclusion criteria: Identification of hepatic blush or extravasation on CT imaging done within 2 hours after arrivalExclusion criteria: Hepatic injuries unrelated to trauma (e.g. iatrogenic, hemorrhage secondary to rupture of mass)Transfers into trauma center: defined as subjects evaluated at an outside hospital prior to arrival at your trauma centerPregnancyHistory of cirrhosis C. Study Design and Research Methods. The University of Colorado Hospital will be the lead site in this multicenter study. This study will be a prospective, observational study. The time period for this study is June 10th 2019 – June 10th 2021. The total expected duration of this study will be 24 months.Participating centers will submit this protocol, and all study materials, to their respective institutional review board (IRB). A letter of approval will be submitted to the lead site prior to contributing data.After IRB approval, sites will enroll subjects after determining they meet inclusion criteria, and have an absence of exclusion criteria. After subject identification, the treating trauma provider will complete a brief case report form (CRF). The CRF will allow all sites to prospectively identify subjects, but also provide rational for pursuing one treatment option vs. another (i.e. non-operative/non-interventional management, endovascular interventions, operative interventions, etc.). CRFs will not be submitted to the lead site, but will be retained by each contributing center, and subsequently destroyed after the completion of the study. Each center will follow their own policies and procedures regarding the retention and destruction of source documents. Case Report Form variables- to be completed by treatment team provider for each subject enrolled (separately attached).Inclusion CriteriaIdentification of hepatic blush or extravasation on CT imaging done within 2 hours after arrivalAbsence of Exclusion CriteriaHepatic injuries unrelated to traumaPregnancyKnown history of cirrhosisTransfers into trauma centerInitial management Observation only (admission without IR or OR intervention)Hepatic angiography with angioembolization Hepatic angiography without angioembolizationCombined IR with immediate OR intervention afterOther: __________________________________Reason for IR interventionExtravasation/ blush on CTOngoing transfusion requirements after attempt at non-operative managementEmpiric therapy after subject deteriorationOther:__________________________________Reason for Operative interventionCT findings suggestive of complex liver injuryFailure of hemorrhage control after initial angioembolization (ongoing extravasation after attempts at angioembolization) Attempt at angiography with inability to identify source of hemorrhageOperation due to injuries unrelated to liver (e.g. intestinal perforation)Evacuation of hematomaAbdominal compartment syndromeOther: ___________________________________In addition to the CRF, centers will also review trauma registry and medical records for the following data: Trauma Center CharacteristicsTrauma level verification (Level 1, 2, 3, or 4)Verification by state, American College of Surgeons, or bothTwenty-four-hour interventional radiology capabilities DemographicsAgeSexRaceInsurance statusArrival time/dateVital signs upon arrival (admission blood pressure [systolic and diastolic], heart rate, respiratory rate, and temperature)Mechanism of injury (e.g. MVC, auto v ped, GSW, stab)Date and time of injury if knownLevel of trauma team response (activations/red, alert/yellow, other)Alcohol use (Yes/No)Abbreviated Injury Scale (AIS) scores for each body region: (head/neck, face, chest, abdomen/pelvis, extremities, external)Admission GCSInjury Severity Score (ISS)Blunt versus penetrating traumaAAST Liver Injury GradeDisposition from ED (OR, ICU, ward transfer, death)Hospital length of stay (LOS)ICU LOSVentilator DaysDisposition Date and TimeDisposition location (home, skilled nursing facility (snf), rehab, transfer, death)Use of anticoagulant medications prior to arrival (i.e. Coumadin, Eliquis, etc.)Use of antiplatelets prior to arrival (Aspirin, Plavix)Trauma registry co-morbiditiesTrauma registry complicationsPatient Arrival Hemodynamics and Lab ValuesArrival CBC (HGB/HCT, WBC, platelet]Arrival BMP (Na, K, Cl, BUN, Cr, glucose, calcium) Arrival blood gas (pH, paO2, paCO2, bicarbonate) and lactateArrival liver function tests (AST, ALT, alkaline phosphatase, total protein, total bilirubin, direct bilirubin, albumin)Arrival coagulation labs [INR, PTT]], Blood Product Administration: Blood product use at 4 hours and 24 hours (pRBC, plasma, platelet, cryo, TXA, , PCC)Emergency department interventionsChest tube placementCentral line placementED thoracotomyREBOA placementFocused assessment with sonography in trauma (FAST) exam findings.Other ImagingComputerized tomography (CT) findingsLiver injuries on CTLaceration SizeAAST-OIS scoreContusionSizeBlush/extravasation on CT (yes/no)Any medical imaging complete prior to discharge, but after liver injury stabilizationType of imaging: CT Scan, ultrasound, magnetic resonance imagingTiming of imaging in relation to hospital discharge Findings of liver related complications: Biloma, perihepatic abscess, hepatic necrosis, portal vein thrombosis, Arteriovenous (AV) fistula, hemobilia fistula Angioembolization DataIdentification of hemorrhage on angiography (yes/no)Embolization yes/noType of embolization (coils, gelfoam, plug, other)Artery embolized – main branch artery, segmental, subsegmentalDate and time of procedure.Location of injury within the hepatic vasculature.Outcome of angiographyNo embolizationEmbolization with angiographic findings of successful hemorrhage controlEmbolization without findings of successful hemorrhage controlOtherIf embolization not done, why not?Unable to access target vesselExtravasation stopped spontaneouslyPatient decompensated prior to embolizationConcern for insufficient blood flow post-embolizationOther: _________________________________Operative DataWhat surgical interventions were undertaken for liver injury (packing, stapling, balloon tamponade, use of clotting agent, suture ligation, hepatic resection, other) during initial admissionDate and time of operative interventionsOther surgical interventions (thoracic procedure, extremity orthopedic, extremity vascular, neurosurgical intervention, bowel resection, abdominal vascular repair, solid organ interventions [e.g. splenectomy, nephrectomy], urologic intervention) – obtained from trauma registryComplications and Readmission Data (only re-admission data within the first 30 days after discharge will be collected)Liver related complications during initial hospital stay hepatic necrosis, hepatic abscess, biloma, bile leak, perihepatic fluid collectionAV fistula, hemobilia fistulaLiver related complications noted at readmission hepatic necrosis, hepatic abscess, biloma, bile leak, perihepatic fluid collectionAV fistula, hemobilia fistulaIntervention for liver related complicationIR placed drain, ERCP +/- endoscopic intervention, otherERCP dataDiagnostic or therapeuticIf diagnostic – leak Y/NTherapeutic – what therapy done?Need for antibiotic post-intervention (yes/no)Readmission data after initial hospitalization (re-admission data will be limited to only readmissions within 30 days of discharge). Days post-discharged, indication for readmission, interventions needed, arrival vital signs days in hospitalD. Description, Risks, and Justification of Procedures and Data Collection Tools. The only risk associated with this prospective observational study is a breach of subject confidentiality. To mitigate this risk, the following steps will be taken:University of Colorado Hospital specific: The lead site, the University of Colorado Hospital, will store all study information on the University of Colorado Department of Surgery’s secure server. That server is managed by an access control list, and behind the University of Colorado Hospital’s firewall.REDCap, a HIPAA compliant research database, will be utilized for this project. CRFs will be stored in a study binder. The binder will be secured in a locked filing cabinet in the trauma services department. Access to the trauma services department is limited by badge access and a digital door lock. Only Dr. Laura Harmon MD and her study team will have access to all sites information within REDCapAll final data will be anonymized prior to publication. Participating center specific:All sites will follow their own institutions policies and procedures to minimize the risk of breach of subject confidentiality Sites will directly input data into a REDCap database hosted by University of Colorado.Each site will be designated as a data access group within REDCap, and they will only be able to see and edit their own data.Sites will be responsible for maintaining a linking document or study binder mapping subjects to their REDCap identification number. There will be no sharing of data between sub-sites. All data submissions will be shared directly with the lead site, the University of Colorado.E. Data Analysis Plan. Continuous variables will be compared using a Student t-test for normally distributed variables and a Mann Whitney U-test for nonparametrically distributed variables. All tests will be two-tailed. Chi-squared and Fisher’s exact tests will be used to compare categorical variables. A P-value < 0.05 will be considered statistically significant. Overall morbidity will include both surgical and medical complications. The overall morbidity will be reflective of the number of patients who had at least 1 complication; that is, patients with more than 1 complication will only be counted once. The Principal Investigator and co-Investigator will procure and analyze the data, which will then be distributed for review by all coauthors. G. Summarize Knowledge to be Gained. The aim of this study is to determine the benefit and risk associated with the use of angioembolization after hepatic trauma, and the types of complications that arise when this treatment is employed to treat hepatic trauma compared to other surgical and non-surgical management paradigms commonly employed in the treatment of hepatic trauma. Additionally, our study team aims to better define the indications for angioembolization of hepatic trauma in today’s contemporary healthcare setting. H. References.1.Kozar RA, Feliciano DV, Moore EE, et al. Western Trauma Association/critical decisions in trauma: operative management of adult blunt hepatic trauma. J Trauma. Jul 2011;71(1):1-5.2.Kozar RA, Moore FA, Moore EE, et al. Western Trauma Association critical decisions in trauma: nonoperative management of adult blunt hepatic trauma. J Trauma. Dec 2009;67(6):1144-1148; discussion 1148-1149.3.Polanco PM, Brown JB, Puyana JC, Billiar TR, Peitzman AB, Sperry JL. The swinging pendulum: a national perspective of nonoperative management in severe blunt liver injury. J Trauma Acute Care Surg. Oct 2013;75(4):590-595.4.Green CS, Bulger EM, Kwan SW. Outcomes and complications of angioembolization for hepatic trauma: A systematic review of the literature. J Trauma Acute Care Surg. Mar 2016;80(3):529-537. ................
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