Multicenter Study: The Incidence of VTE in Trauma Patients ...

EAST MULTICENTER STUDY DATA COLLECTION TOOL

Multicenter Study: The Incidence of VTE in Trauma Patients after TXA administration: A Multicenter Retrospective Study

Enrolling Center: Enrolling Co-investigator:

George Washington University Hospital Lisbi Rivas, MD

Demographics / Injury Variables:

Age: _______ Gender:_______

Mechanism of initial injury:

Blunt:

YES / NO

Penetrating: YES / NO

ISS: _______ AIS Head: _______ AIS Chest: _______ AIS Abdomen: _______

Admission values:

Admit date____ time ____

Hemoglobin: ____ INR: _______PT___ PTT____

Plt count___

TEG results: R____ alpha____ LY30 ____MA___

G____

Emergency Department: blood pressure ______ heart rate ______

Lactate: _______Base Deficit: _______

Comorbidities: DM HTN COPD CHF CAD Stroke H/O MI A-Fib History of DVT /PE

YES / NO YES / NO YES / NO YES / NO YES / NO YES / NO YES / NO YES / NO YES / NO

Management Variables:

TXA: YES / NO

TXA administration: Date___ Time____

TXA total dose in 12 hours____gm

VTE chemoprophylaxis: YES / NO

VTE chemoprophylaxis start: Date___ Time____

# of doses of chemoprophylaxis NOT given over 2 weeks____

Transfusion in first 24 hours

PRBC units: ________________

FFP units:

________________

Platelet units: ________________

Outcomes:

DVT: YES NO DVT diagnosis date _____ time ______

PE: YES NO PE diagnosis date ______ time ______

MI Stroke Renal Failure Multi Organ Failure (MOF)

YES NO YES NO YES NO YES NO

Hospital LOS: _______________days

In hospital mortality

YES NO

ICU LOS: ____________hours

EAST MULTICENTER STUDY DATA DICTIONARY

The Incidence of VTE in Trauma Patients after TXA administration: A Multicenter Retrospective Study ? Data Dictionary

Data Entry Points and appropriate definitions / clarifications:

Entry space

Definition / Instructions

Standard Study Questions

Admit Date

Admission date of the patient enrolled

Admit Time

Admission time of the patient enrolled

Age

Age of patient enrolled

Case Information

Gender

Gender of Patient enrolled

Mechanism of initial Injury

Blunt

Single choice for best description of blunt mechanism (if penetrating mechanism proceed to next data point) Options include: MVC Auto vs. Peds (Pedestrian), Fall Assault MCC (Motorcycle Collision / Crash) Machinery Other

Penetrating

Single choice for best description of penetrating mechanism. Options include: GSW (Gunshot wound) Shotgun (Shotgun wound) Stab (Stab Wound) Other

ISS

Numerical value for calculated ISS

(ISS = Injury Severity Score)

AIS Head

Numerical Value for AIS body region = Head (AIS = Abbreviated Injury Score)

AIS Chest

AIS Abdomen

Admission Lab Values Hemoglobin

Lactate Base Deficit TEG results R, LY30, MA, Alpha, G ED blood pressure ED heart rate

Comorbidities: DM HTN COPD CHF CAD Stroke History of DVT /PE A-fib MI

Numerical Value for AIS body region = Chest (AIS = Abbreviated Injury Score) Numerical Value for AIS body region = Abdomen (AIS = Abbreviated Injury Score)

Admission Hemoglobin value (g/dL)

Admission lactate (mmol/L) Admission Base Deficit (mmol/L) Admission thromboelastography results R time, Lysis at 30 minutes, Maximum Amplitude, Alpha angle, G value Admission blood pressure (mmHg) Admission heart rate (beats per minute)

Diabetes Mellitus (any type) Hypertension Chronic Obstructive Pulmonary Disease Congestive Heart Failure Coronary Artery Disease Stroke History of deep vein thrombosis and or pulmonary embolism History of atrial fibrillation History of myocardial infarction

Management Variables TXA

Prehospital or In hospital administration of tranexamic acid

TXA Administration time

Tranexamic acid dose date and time

VTE chemoprophylaxis

Type of venous thromboembolism chemoprophylaxis given

VTE chemoprophylaxis administration Venous thromboembolism chemoprophylaxis administration date

Date/Time

and time (first dose)

PRBC Units FFP Units Platelet Units Outcomes DVT DVT date/time PE PE date/time MI

Stroke/CVA

PRBC (Packed Red Blood Cells) administered within the initial 24 hour of injury in units

FFP (Fresh Frozen Plasma) administered within the initial 24 hour of injury in units

Platelet volume administered within the initial 24 hour of injury in units

Check if applies. DVT = Deep Vein Thrombosis within 2 weeks from injury Diagnosis must be confirmed radiographically (Ultrasound, Computed tomography, venography, etc.)

Deep vein thrombosis diagnosis date time

Check if applies. PE = Pulmonary embolism within 2 weeks from injury Diagnosis must be confirmed radiographically (Ultrasound, Computed tomography, venography, etc.)

Pulmonary embolism diagnosis date time

Check if applies. An acute myocardial infarction. Diagnosis must be Confirmed: 1. Documentation of ECG changes indicative of acute MI (a. ST elevation >1 mm in two or more contiguous leads b. New left bundle branch block c. New q-wave in two or more contiguous leads) OR 2. New elevation in troponin greater than three times upper level of the reference range in the setting of suspected myocardial ischemia OR 3. Physician diagnosis of myocardial infarction must have occurred during the patient's initial stay at your hospital.

Check if applies. Stroke. Diagnosis must be confirmed: 1. A focal or global neurological deficit of rapid onset and NOT present

on admission. The patient must have at least one of the following symptoms: ? Change in level of consciousness ? Hemiplegia ? Hemiparesis ? Numbness or sensory loss affecting on side of the body ? Dysphasia or aphasia ? Hemianopia ? Amaurosis fugax ? other neurological signs or symptoms consistent with stroke AND: ? Duration of neurological deficit 24 h OR: 2. Duration of deficit ................
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