BRIEF REPORT

Development and Implementation Results of aVenous Thromboembolism Prophylaxis Guidelinein a Tertiary Care Pediatric HospitalArash Mahajerin, MD,a Emily C. Webber, MD,b Jennifer Morris, PharmD,c Kathryn Taylor, PharmD,c Michele Saysana, MDb,d

A B S T R A C TOBJECTIVES: Incidence of pediatric venous thromboembolism (VTE) is increasing due toincreased survival of children with chronic diseases and use of interventions (eg, central venouslines), with VTE risk. Our objective was to create VTE prophylaxis guidelines with targetedidentification of children at high risk to support appropriate mechanical and pharmacologicprophylaxis and integrate into the electronic medical record (EMR) as a hospital-wide qualityimprovement project.

METHODS: Patients aged 12 to 17 years were included. We evaluated institutional data regardingVTE incidence and risk factors. We evaluated literature for populations at high risk for VTE.Guidelines were formulated, and an EMR tool to assess risk and support the guidelines was createdand implemented.

RESULTS: The EMR tool was used to screen 48% of qualified admissions for the first monthand 81% in the final study month. On average, 69.1% of qualified admissions were screenedmonthly during the first 18 months of the program. No adverse events were reported due topharmacologic prophylaxis.

CONCLUSIONS: Many risk factors are common between children and adults and certain pediatricpopulations warrant prophylactic consideration. Pediatric VTE prophylaxis guidelines can besuccessfully implemented into the EMR to identify high-risk populations. Future studies shouldassess the long-term impact of implementation.

aCHOC Children’sSpecialists, CHOC

Children’s, Orange County,Orange, California;

bDepartment ofPediatrics, IndianaUniversity School ofMedicine and Riley

Hospital for Children atIndiana University Health,

Indianapolis, Indiana;cDepartment of

Pharmacy, Riley Hospitalfor Children at Indiana

University Health,Indianapolis, Indiana; and

dMedical Director, RileyQuality and Safety

www.hospitalpediatrics.orgDOI:10.1542/hpeds.2014-0241Copyright © 2015 by the American Academy of Pediatrics

Address correspondence to Arash Mahajerin, MD, MS, CHOC Children’s Specialists, Division of Hematology, 1201 W La Veta Ave, Orange, CA92868. E-mail: amahajerin@choc.org

HOSPITAL PEDIATRICS (ISSN Numbers: Print, 2154-1663; Online, 2154-1671).

FINANCIAL DISCLOSURE: The authors have indicated they have no financial relationships relevant to this article to disclose.

FUNDING: No external funding.

POTENTIAL CONFLICT OF INTEREST: The authors have indicated they have no potential conflicts of interest to disclose.

Dr Mahajerin was previously at Riley Hospital for Children during the development and initial implementation of the guidelines andcontinues to collaborate with Riley Hospital for Children on results and updates.

There are no prior publications or submissions with any overlapping information, including studies and patients.

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The incidence of venous thromboembolism(VTE), including deep vein thrombosis andpulmonary embolism, is increasing intertiary care pediatric hospitals.1 Ourinstitutional data revealed an incidence of71/10 000 admissions from 2005 to 2009 forpatients aged 0 to 18 and 112/10 000admissions for those 12 and older.2 Thehigher adolescent VTE incidence concurswith known bimodal peaks in neonates andadolescents.3,4

The rising incidence is attributed toincreased survival of patients with chronicconditions and increased utilization oflife-saving measures with known VTEassociation (eg, central venous lines[CVL]). Well-established risk factors includeVTE history, thrombophilic state,autoimmune disease with antiphospholipidantibody (APA) positivity, CVL, bacteremiaor other serious bacterial infection,overweight/obesity, estrogen therapy,immobilization $72 hours, chronic totalparenteral nutrition (TPN), and mechanicalventilation.3

We developed a multidisciplinary committeeto formulate VTE prophylaxis guidelines for12- to 17-year-old patients based on ourinstitution’s high VTE incidence in this agegroup. The goals of the group were todevelop a VTE screening and prophylaxisprogram, to monitor utilization of VTEprophylaxis, and to address adverse eventsattributed to these modalities. In this reportwe describe guideline and electronicmedical record (EMR) tool development andutilization.

METHODS

The institution did not require institutionalreview board approval for guidelinedevelopment. We began by reviewingcurrent literature for prophylaxisguidelines in adults and children. Thisincluded the American College of ChestPhysicians Chest guidelines, otherchildren’s hospitals’ guidelines, andinstitutional retrospective data of VTE riskfactors.2,5,6 We also reviewed existinginstitutional pathways for adult VTEprophylaxis, traumatic brain injury, andspinal cord injury and met withrepresentatives from all major medicaland surgical divisions.

Patient Cohort to Be Screened andVTE Risk Factors

The 2 risk factors with the largestcontribution to VTE are CVL andimmobility.3,7–9 We determined these2 factors must be present to considerpharmacologic prophylaxis. Mobility has arange of definitions posing a challenge toidentify an accurate standard. AmericanCollege of Chest Physicians guidelines(9th edition) support thromboprophylaxisof chronically immobilized patients (definedby Robinson8 as .30 days) in postacuteor subacute situations, given similar VTEincidence compared with acutely illhospitalized patients.9 For clarity, weidentified acutely “nonambulatory” orchronically nonambulatory patients withdecreased range of motion from baselineand unable to do passive range ofmotion exercises as candidates forthromboprophylaxis. Patients who arechronically nonambulatory but at baselineduring hospitalization did not meet criteriafor VTE thromboprophylaxis considerationfor immobility.

Several pediatric populations have beenpreviously described to have increased VTErisk. Patients with diabetic ketoacidosis orsickle cell anemia and a CVL are atincreased VTE risk.10–12 Two small caseseries demonstrated increased VTE risk inpatients with cystic fibrosis (CF) andBurkholderia cepacia.13,14 The risk of VTE inpatients with inflammatory bowel disease(IBD) is 3 times that of the generalpopulation; approximately two-thirds of IBD-associated VTE occurs during active flaresof disease.15 Patients with congenital heartdisease involving dilated cardiomyopathy,atrial fibrillation, single-ventricle pathology,and/or palliative surgical shunts havehigher VTE incidence.16,17

Certain patients are at high risk for VTEregardless of CVL presence and immobility.These include acute spinal cord injury24 hours postinjury without plan forsurgical intervention or 24 hourspostsurgery,18 traumatic brain injury withstable computed tomography of the head,and 48 hours postprocedure and 72 hourspostinjury,19 and patients 48 hours aftermajor surgery.

Prophylaxis Modalities andContraindications

Literature review recommends intermittentpneumatic compression devices duringwakeful nonambulatory periods. Graduatedcompression stockings are less efficaciousthan intermittent pneumatic compressiondevices.20 Selecting the appropriategraduated compression stocking size for apediatric population is challenging, anderroneous sizing can result in skin damageand increase VTE risk.21 For pharmacologicprophylaxis, we use enoxaparin. Forpatients ,60 kg, we use 0.5 mg/kg per dosesubcutaneous twice daily.22 For patients.60 kg, we use 30 mg subcutaneous twicedaily or 40 mg subcutaneous once daily.9

We determined contraindications (Table 1)by reviewing established contraindications(eg, active bleeding), adult guidelines inour health system, and consensus opinionwith the divisions mentioned previously.We also reviewed American Society ofRegional Anesthesia and Pain Medicine2010 guidelines regarding regionalanesthesia and enoxaparin.23

Adverse Events

All medication-related adverse events,including enoxaparin, are reviewed in astandard process. Adverse bleeding wasdefined via International Society ofThrombosis and Haemostasis majorbleeding criteria,24 and minor bleeding wasdefined as any overt bleeding not fulfillingmajor bleeding criteria but requiringintervention or physician notification.

Final Risk-Stratification

We used a logistic regression modelpreviously published that evaluated riskfactors in a retrospective case-controlstudy of VTE at our institution.2 Subanalysesof adolescents showed retained significanceof risk factors.2 Tier 1 risk factors wereidentified through bivariate analyses andretained significance in a multivariablelogistic regression model: immobilization$72 hours, estrogen therapy, and lengthof stay $7 days.2 Tier 2 risk factors weresignificant by bivariate analyses but didnot retain significance in the multivariatemodel: bacteremia, BMI $85th percentile,chronic TPN, initial ICU admission,

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mechanical ventilation, and other seriousbacterial infections. Specific patientpopulations were included in tier 1:autoimmune disease with APA positivityand acute flare, cardiac disease involvingdilated cardiomyopathy, atrial fibrillation,single-ventricle pathology and palliativesurgical shunts, CF with B cepacia, diabeticketoacidosis, IBD with acute flare, and sicklecell anemia. Personal history of VTE,known thrombophilia, and family historyof VTE, stroke, or myocardial infarction ina first- or second-degree relative ,50 yearsold were considered tier 1.25

Implementation

We created 3 risk groups: high, moderate,and low with a stratification algorithm andthromboprophylaxis recommendations(Fig 1). Guidelines were first implementedin the EMR by using an order set. Specificrisk factors were displayed in plain text.Although this solution supportedthromboprophylaxis orders, it did notsupport risk category documentation.Thus, a more integrated tool was developedthat captured risk category and appliedlogic rules to support the algorithm (Fig 1).

Providers are presented the screening format time of patient admission, with an optionto defer for 24 hours if the admittingprovider does not have enough informationto make an accurate risk assessment.The provider selects risk factors andcontraindications. Logic rules from thealgorithm are applied by the EMR andpresent the risk category and specificprophylaxis recommendations. The providercan select the recommended prophylaxisorders. This tool was implemented onAugust 9, 2013. Rates of screening weretracked by querying the EMR for the numberof qualified admissions per month, numberof risk assessment forms completed,associated risk categories, and orders forprophylaxis interventions. This review isan ongoing, monthly process with the goalof increasing screening rates to $90%.

RESULTSImplementation Outcomes

The study period was defined as the first17 months of EMR tool use. During this time,149 qualified patients, on average, wereadmitted each month and an average of69.1% were screened. Figure 2 shows

screening rates of qualified admissions.The first month rate was 48% and increasedto 81% in the last month. Figure 3 showsthe screened populations’ risk categorydistribution.

Overall, physician orders for mechanicaland pharmacologic prophylaxis increasedin the screened population; however, notall physician orders correlated with thesuggestions from the EMR tool. Afterreconfiguring the report, data on VTEprophylaxis orders were captured for thelast 12 months of the study period. Onaverage, 10.4 patients per month werescreened as moderate risk but 27.3 patientsper month received sequential compressiondevices (SCDs). This suggests SCDs wereordered for patients not screened using theVTE risk assessment tool but met othercriteria per provider discretion. Regardingpharmacologic prophylaxis, the averagenumber of high-risk patients per month(2.4) approximately correlated with theaverage number of patients per month whowere screened and received enoxaparin(2.1). No major or minor adverse bleedingevents related to enoxaparin have beenreported to date, although the rate ofenoxaparin use was low.

In the first year after implementing theEMR screening tool, none of the screenedpatients developed a VTE. In the 12 monthsbefore implementation, there were8 patients who developed a VTE, 3 of whomwere between 12 and 17 years and wouldhave been identified as high risk by theEMR tool. During the first 12 months afterimplementation, 6 patients developed aVTE but all were ,12 years old andtherefore not screened.

DISCUSSION

The objective was to create and implementVTE screening and prophylaxis guidelinesfor hospitalized patients 12 to 17 years.Our results demonstrate successfulguideline development and implementationin a tertiary care children’s hospital. Intervalimprovements continue as part of ongoingoptimization of the screening tool toincrease provider utilization. The 2012Chest guidelines do not address pediatricrisk categorization, except for long-termTPN, hemodialysis, perioperative

TABLE 1 Contraindications to Thromboprophylaxis

Mechanical thromboprophylaxis 1. Bilateral amputee2. Bilateral lower extremity trauma or medical issue3. Peripheral arterial insufficiency

Pharmacologic thromboprophylaxis 1. Anesthesia/analgesia (neuraxial), single dose within past 24 ha

2. Anesthesia/analgesia (neuraxial), within past 6 hb

3. Anticoagulated4. Aspirin or other irreversible platelet inhibitor within past 7 d5. AVM, aneurysm, CNS mass, Moyamoya6. Bleeding (active, major) requiring transfusion, bleeding intovital organ, hemodynamic instability

7. Bleeding disorder/tendency or history of unexplained orspontaneous hemorrhage

8. Blood pressure (increased): SBP or DBP greater than 95thpercentile for age, height, gender

9. Catheter placement (indwelling) epidural/spinala

10. Catheter removal epidural/spinal within past 2 ha,b

11. Coagulopathy: INR .1.5, aPTT $44 s, platelet count ,50 000/mm3, or fibrinogen ,100 g/dL

12. Comfort measures only13. HIT history14. Hepatic disease without known INR15. Neurosurgery, head trauma within 3 d16. Spinal hematoma or spinal stabilization surgery within past

24 h

aPTT activated partial thromboplastin time; AVM, arteriovenous malformation; CNS, central nervous system;DBP, diastolic blood pressure; HIT, heparin-induced thrombocytopenia; INR, international normalized ratio;SBP, systolic blood pressure.a For twice-daily enoxaparin dosing.b For once-daily enoxaparin dosing.

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management in specific surgical diseases(eg, cardiac defects), and some acquireddefects (eg, coronary artery aneurysm inKawasaki disease).9,22 Children’s Hospitalof Philadelphia published guidelines foradolescents with 14 years as a cutoff andrequired altered mobility and presence of1 other risk factor for pharmacologicprophylaxis consideration.6 Our guidelinesdiffered in using logistic regression toevaluate the relative strength of riskfactors.2 Another key difference was CVLas an additional prerequisite forpharmacologic thromboprophylaxis. Thisadditional step created a more tiered

risk-stratification to prevent overutilizationof enoxaparin.

Challenges to guideline adoption are welldemonstrated. A recent study evaluatingthromboprophylaxis in the PICU foundutilization was different than recommendationsby institutional guidelines.26 The authorssuggest multiple reasons, but foremostwas lack of evidence of efficacy andunderestimation of VTE risk in pediatrics.In acknowledgment of these issues, thescreening tool is optional and staffwere educated periodically to increaseawareness about incidence and risk of VTE.

We recognize limitations to our study. First,the guidelines target adolescents and maynot be generalizable to other high-riskpatient cohorts (eg, neonates). Second,there is existing debate regarding knownVTE risk factors, such as mobility and CVL,making it difficult to reach consensus forguideline definition. The definition ofimmobility for patients who are chronicallynonambulatory was vexed by minimalscientific data. We excluded those able toreceive physical therapy, but there isconflicting evidence regarding whetherpassive physical therapy reduces VTEincidence.27,28 Multiple studies cite CVL as

FIGURE 1 VTE risk assessment and prophylaxis algorithm. ASCI, acute spinal cord injury; EVD, external ventricular drain; hx, history; ICP,intracranial pressure; LOS, length of stay; MI, myocardial infarction; PNS, pediatric neurosurgery; TBI, traumatic brain injury. aDilatedcardiomyopathy, atrial fibrillation, single ventricle pathology, and palliative surgical shunts.

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the most significant VTE risk factor, butprevious research on pharmacologicprophylaxis for pediatric patients with CVLhas not consistently shown benefit.However, many of these studies usedpharmacologic prophylaxis in restrictedpatient populations (eg, cancer29 or infantsafter cardiac surgery30), with 1 broad-basedtrial (Prophylaxis of Thromboembolism inKids Trial [PROTEKT]) closed prematurelydue to poor accrual and lack of benefit.31

It remains to be seen whether broad-basedVTE prophylaxis programs will demonstratebenefit for VTE (CVL-related or not), but earlyevidence suggests potential.32 Third, due toVTE complexity, not all high-risk conditions,such as nephrotic syndrome, wereintegrated into the initial guideline andupdating is required. Last, we included tier2 risk factors despite lack of significance inour own single-institution multivariateanalysis.2 Other pediatric and adult studies

have shown significance of these factors.3,5

Including these risk factors allowed formore accurate risk stratification. Therefore,we required presence of at least 2 toprevent overemphasis and overutilization ofpharmacologic prophylaxis. Finally, theoptional completion of the screening toolinhibits reliability of the screening process.Additionally, the ability of the EMR to promptVTE rescreening later in hospitalization isbeing addressed to optimize compliance.

FIGURE 2 Percentage of qualified inpatients screened.

FIGURE 3 Distribution of screened patients.

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These EMR optimizations will enhanceaccuracy of the data captured and improvereliability of the guidelines and EMR tool.

Future review will assess the impact ofthese changes, evaluate VTE incidence andsafety events, and incorporate futurefeedback from providers to continue toreach our goal of 90% screening. Furtherstudies are needed to evaluate the relativevalue of VTE screening and prophylaxis inpreventing VTE in hospitalized adolescents.As more hospitals develop and implementVTE screening tools, the resulting aggregatedata will help facilitate larger scale,multisite studies to truly evaluate theefficacy of VTE screening and prophylaxisinterventions.

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DOI: 10.1542/hpeds.2014-0241 originally published online January 1, 2015; 2015;5;630Hospital Pediatrics 

SaysanaArash Mahajerin, Emily C. Webber, Jennifer Morris, Kathryn Taylor and Michele

Prophylaxis Guideline in a Tertiary Care Pediatric HospitalDevelopment and Implementation Results of a Venous Thromboembolism

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Prophylaxis Guideline in a Tertiary Care Pediatric HospitalDevelopment and Implementation Results of a Venous Thromboembolism

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