EAST MULTICENTER STUDY DATA COLLECTION TOOL · Placental abnormalities (circle if applicable) Placentia Previa Placental Abruption Placental Accreta Pregnancy complications (circle

EAST MULTICENTER STUDY

DATA COLLECTION TOOL

Multicenter Study: Ultra Massive Transfusion in the Era of Balanced Resuscitation Enrolling Center: _______________________ Enrolling Co-investigator: _______________________ SUBJECT DATA

Study ID

Age

DOB

Sex (M/F)

Race

Latino (Yes/No/Unknown)

Weight (kg)

Height (m)

BMI

Admit Date

ICU Admit Date/Time

PAST MEDICAL HISTORY

Outpatient Medications

Aspirin Yes No

Plavix Yes No

Coumadin Yes No

Rivaroxaban (Xarelto) Yes No

Apixaban (Eliquis) Yes No

Other Anticoagulant Yes No Specify:

Steroid Yes No Specify:

Medical History

Diabetes Yes No AIDS Yes No

Cirrhosis Yes No Stroke Yes No

Liver Failure Yes No MI Yes No

CKD Yes No CHF Yes No

Dialysis Yes No Substance use Yes No

Smoking Yes No Cancer Yes No

Immunocompromised Yes No For cancer=yes, circle any applicable modifiers:

Metastatic Lymphoma Leukemia

TRAUMA PATIENT: YES / NO (if no leave section blank)

Injury Date/Time ED Arrival Date/Time

ED Exit Date/Time Total ED Time (mins)

Injury Data

Mechanism Type Blunt Penetrating

Mechanism GSW multiGSW SW multiSW Assault Crush PVA BVA

MCC MVC Fall Burn Hanging FoundDown Other Unknown

Injury Severity Score (ISS)

AIS

AIS Head ______ AIS Spine ______

AIS Chest _____ AIS Abdomen _____

AIS Extremity ____

Complex Long Bone Fx Yes No Positive FAST Yes No Not performed

Pelvic Fx Yes No Positive CT Abd Fluid Yes No Not performed

ED Vitals

GCS Admit:

Temp (Celsius) Admit: High: Low:

HR Admit: High: Low:

RR Admit: High: Low:

SBP Admit: High: Low:

DBP Admit: High: Low:

MEDICINE/OB/OTHER PATIENTS

Ob/Gyn patient: Yes No (leave section blank if no)

Placental abnormalities (circle if applicable)

Placentia Previa Placental Abruption Placental Accreta

Pregnancy complications (circle if applicable)Pre-eclampsia/Eclampsia

Pre-eclampsia/eclampsia Intrauterine fetal demise Uterine atony Hellp syndrome

Pregnancy history Gravida (#pregnancies)_______ Para (#live births)_______ Number of abortions ________

Internal Medicine/General Surgery/Other

Admission Diagnosis

Medical/Surgical Specialty (At time MTP activation) (Check one)

General Surgery

Transplant Surgery

Cardiothoracic or Vascular surgery

Medical patient

Other: __________

Bleeding Diagnosis (if different than admitting diagnosis)

OUTCOMES AND COMPLICATIONS

Mortality and Discharge data

Vital Status @ 6 hours Alive Dead Vital Status @ 24 hours Alive Dead

Vital Status @ 30 days Alive Dead Vital Status @ discharge Alive Dead

Date/Time of Death (if applicable)

Hospital Discharge Date

Total Hospital Days

ICU Days (to 30)

Vent Days (to 30)

Vent-Free Days (to 30)

Discharge Destination (circle one) Home / SNF / Rehab / AMA / Inc / Transfer / Expired

Venous Thromboembolism

Deep vein thrombosis Yes / No

Pulmonary Embolism Yes / No

OTHER

MI YES / NO

Stroke YES / NO

Acute Renal Failure YES / NO

Sepsis YES / NO

PROCEDURES

EGD Procedures

Start Date/Time Stop Date/Time

Procedure Notes

List procedure(s) CPT codes

IR Procedures


EBL

Procedure Notes


OR Procedures


EBL

Procedure Notes

Was aorta cross clamped in the OR

Yes No Time/Date: Total estimated duration (minutes):


Ob/Gyn Procedures: Delivery

Delivery Type Vaginal Cesarean Emergent? Yes No


EBL

Procedure Notes


Other Procedures

REBOA

Yes No Date/Time: Location: ED/OR/Other (specify:______) Total duration of balloon occlusion (minutes):

RESUSCITATIVE THORACOTOMY

Yes No Date/Time: Location: ED/OR/Other (specify:______) Aorta cross clamped: Yes No

Time of aortic cross clamping: Total duration of aortic cross clamping (minutes):

Chest tube insertion Yes No

Senstaken-Blakemore Tube Yes No

Minnesota Tube Yes No

MTP Data – Please fill out one per activation Activation Number:

MTP Data

Activation Information

Activation Location

Activation Date/Time

Termination Date/Time

Fluid Administration

Pre- MTP

Pre-hospital Products Given

Pre-MTP Products Given, in hospital All Locations, 24h prior to MTP

PRBC PRBC

FFP FFP

Plts Plts

Cryo Cryo

Crystalloid Crystalloid

Colloid Colloid

Prehospital TXA Pre MTP TXA

MTP Data

Products Given Hours 0-6


PRBC PRBC

FFP FFP

Plts Plts

Cryo Cryo


Colloid Colloid



pRBCs pRBCs

FFP FFP

Plts Plts

Cryo Cryo


Colloid Colloid

Total Fluid

Administration

MTP

pRBCs

FFP

Plts

Cryo

Crystalloid

Colloid

Hemostatic Medications

KCentra or other 3 or 4 factor concentrate RiaSTAP or other Fibrinogen

Concentrate

First Dose Date/Time First Dose Date/Time

Dosage Dosage

Number of Doses Number of Doses

Specify agent used: Specify agent used:

Tranexamic acid Factor VII

First Dose Date/Time First Dose Date/Time

Dosage Dosage

Number of Doses Number of Doses

Calcium Gluconate Calcium Chloride

Date/Time First Dose Date/Time First Dose

Dosage Dosage

Total Grams Given Total Grams Given

Physiologic and Laboratory Parameters:

At time of MTP Activation

Hemoglobin Calcium

Platelet Count Ionized Calcium

INR SBP

PTT DBP

pH HR

Base Excess Temp (Celsius)

Lactate RR

Sodium Intubated (Y/N)

Potassium Use of vasopressors (Y/N)

TEG: Yes / No

TEG CK R ___ K ___ α ___ MA ___ LY30 ___

TEG CRT ACT ___ R ___ K ___ α ___ MA ___ LY30 ___

ROTEM: Yes / No

INTEM CT __ CFT __ α __ A10 __ A20 __ MCF __ CLI30 __ ML __

HEPTEM CT __ CFT __ α __ A10 __ A20 __ MCF __ CLI30 __ ML __

EXTEM CT __ CFT __ α __ A10 __ A20 __ MCF __ CLI30 __ ML __

FIBTEM CT __ CFT __ α __ A10 __ A20 __ MCF __ CLI30 __ ML __

APTEM CT __ CFT __ α __ A10 __ A20 __ MCF __ CLI30 __ ML __

6 hours after MTP Activation (record closest value within 1 hour)

Hemoglobin Calcium


INR BP (systolic/Diastolic)

PTT HR

pH Temp (Celsius)

Base Excess RR

Lactate Intubated (Y/N)

Sodium Use of vasopressors (Y/N)

Potassium

TEG: Yes / No TEG CK R ___ K ___ α ___ MA ___ LY30 ___ TEG CRT ACT ___ R ___ K ___ α ___ MA ___ LY30 ___

ROTEM: Yes / No INTEM CT __ CFT __ α __ A10 __ A20 __ MCF __ CLI30 __ ML __




APTEM CT __ CFT __ α __ A10 __ A20 __ MCF __ CLI30 __ML __


Hemoglobin Calcium



PTT HR

pH Temp (Celsius)

Base Excess RR



Potassium

TEG: Yes / No TEG CK R ___ K ___ α ___ MA ___ LY30 ___








Hemoglobin Calcium



PTT HR

pH Temp (Celsius)

Base Excess RR



Potassium

TEG: Yes / No TEG CK R ___ K ___ α ___ MA ___ LY30 ___








Hemoglobin Calcium



PTT HR

pH Temp (Celsius)

Base Excess RR



Potassium

TEG: Yes / No

TEG CK R ___ K ___ α ___ MA ___ LY30 ___


ROTEM: Yes / No

INTEM CT __ CFT __ α __ A10 __ A20 __ MCF __ CLI30 __ ML __




APTEM CT __ CFT __ α __ A10 __ A20 __ MCF __ CLI30 __ ML __

ARDS Adjudication

Lowest P/F Ratio Date/Time Lowest P/F

Denver MOF Score (Measured 48 hours after ICU admission)

P/F in ICU at 48hr

Total Bilirubin in ICU at 48hr

Creatinine (umol/L) in ICU at 48hr

Cardiac Inotropes

None 1 inotrope at small dose Any inotrope at moderate does, or >1 inotrope Any inotrope at high dose, or >2 agents moderate doses

Variables for Apache III Score (Measured 48 hours after ICU admission)

Pulse

Mean BP

RR

paO2

paCO2

pH

FiO2

Hematocrit

WBC Count

Urine Output (ml/day)

Serum BUN

Serum Albumin

Serum Sodium

Serum Glucose

Glasgow coma scale (at 48 hours)

EAST MULTICENTER STUDY

DATA DICTIONARY

Ultra Massive Transfusion in the Era of Balanced Resuscitation Data Entry Points and appropriate definitions / clarifications:

Entry space Definition / Instructions

Subject Data Study ID Please enter patients study ID number Age Age of patient enrolled DOB Date of birth of patient enrolled Sex Biological sex of patient enrolled (male/female) Race List patient race: American Indian or Alaska Native Asian Black or African American Native Hawaiian or Pacific Islander White or Caucasian Other Unknown Latino Does patient identify as Latino (Yes/No/unknown) Weight List weight in kilograms (kg) Height List height in meters (m) Body Mass index Patient’s body mass index, if only height/weight available use formula

weight(kg)/height(meters) Admit Date Admission date (mm/dd/yyyy) of the patient enrolled ICU Admit Date/Time Admission date/time (mm/dd/yyyy/24hh/mm) of the patient to the

intensive care unit (ICU) Past Medical History Outpatient Medications Was the patient listed as taking any of the following medications?

Aspirin Plavix (Clopidogrel)

Coumadin (warfarin) Rivaroxaban (Xarelto) Apixaban (Eliquis) Other anticoagulant? Please specify Steroid (oral or intravenous, please do not include topical, intraarticular or inhaled)

Medical History Answer all Yes or No Diabetes Inclusive or type I and II, insulin and non-insulin dependent Cirrhosis Does patient have a history of cirrhosis (from any cause) listed in

records? Liver failure Does patient have a history of liver failure (i.e. hospitalizations for

decompensated cirrhosis, acute hepatitis)? CKD Include any stage (1-5) of chronic kidney disease Dialysis Is the patient dialysis dependent (count both peritoneal or hemodialysis)? Smoking Was the patient an active tobacco smoker Immunocompromised Does the patient have an immunocompromised status? AIDS Does the patient have HIV with history of AIDS defining illness or CD4

count <200? Stroke Inclusive of all stroke types (ischemic, hemorrhagic, or transient ischemia

attack (TIA)) MI Myocardial Infarction (MI) (include both non-ST elevation and ST

elevation type MI) CHF History of congestive heart failure, any class Substance use Was patient using or have a history of using any of the following: Alcohol (abuse or use disorder) Illicit drugs Cancer Does patient have a history of malignant cancer (any type- solid or hematological)?

For cancer yes, circle if metastatic, lymphoma, or leukemia applicable modifiers (to be used for apache III score)

TRAUMA PATIENT Yes/No was traumatic injury the primary diagnosis? (if no, leave rest of

this section blank)

Injury Date/Time Time and date on which patient was injured prior to arrival ED Arrival Date/Time Time and date of arrival to the Emergency Department (ED) ED Exit Date/Time Time and date of leaving the ED

Total ED Time (mins) Total time spent in the ED in minutes Injury Data Mechanism type What was the primary mechanism of injury? Blunt or Penetrating? Mechanism Single choice for best description of Mechanism

Options Circle one: GSW = gunshot wound multiGSW = multiple gunshot wounds SW = stab wound multiSW = multiple stab wounds Assault = assault with blunt objects Crush = crush injury PVA = pedestrian vs automobile/motor vehicle BVA = bicycle vs automobile/motor vehicle MCC = motorcycle collision MVC = motor vehicle collision MVC (motor vehicle collision) Fall Hanging Burn Found down Other Unknown

ISS Numerical value for calculated ISS (ISS = Injury Severity Score) AIS Head Numerical Value for AIS body region = Chest (AIS = Abbreviated Injury Score) AIS Spine Numerical Value for AIS body region = Chest (AIS = Abbreviated Injury Score) AIS Chest Numerical Value for AIS body region = Chest (AIS = Abbreviated Injury Score) AIS Abdomen Numerical Value for AIS body region = Abdomen (AIS = Abbreviated Injury Score) AIS Extremity Numerical Value for AIS body region = Chest (AIS = Abbreviated Injury Score) GCS Glasgow Coma Scale (3-15, include T to denote intubated status) Complex long bone fx Did patient have a complex (open or comminuted) long bone fracture?

Long bones include: femur, tibia, fibula, humerus, ulna, radius and clavicle

Pelvic fx Did the patient have a pelvic fracture?

Positive FAST Did the patient have a reported positive FAST exam “focused assessment with sonography in trauma”? Yes / No / Not performed

Positive CT abd fluid Did the patient have a CT scan of the abdomen positive for free intraabdominal fluid? Yes / No / Not performed

ED VITALS Fill out trauma patient vital signs in emergency department, on admission

and the high and low values for each: GCS Glasgow coma scale Temp Temperature in Celsius HR Heart rate RR Respiratory rate SBP Systolic blood pressure DBP Diastolic blood pressure MEDICINE/OB/OTHER PATIENTS Ob/gyn patient Was patient’s primary team obstetrics/gynecology at time of MTP

activation? Yes / No If no, leave section blank Placental abnormalities Yes/No were there following conditions diagnosed:

Placenta previa Placental abruption Placental accreta

Pregnancy complications Yes/No were the following pregnancy complications diagnosed:

Pre-eclampsia/eclampsia Intrauterine fetal demise Uterine atony Hellp syndrome

Pregnancy history List number of prior pregnancies (gravida), prior live births (para), and abortions

Internal medicine/ General surgery/other

Fill out this section if patient’s primary team at time of MTP was internal medicine (or medical subspecialty), general surgery (or surgical subspecialty outside of trauma), or other

Admission Diagnosis What was the patient’s admitting diagnosis (write one only) Medical surgical specialty What was the patient’s medical or surgical specialty at the time of MTP

activation? General surgery Transplant surgery Cardiothoracic or vascular surgery Medical specialty (ex: internal medicine, gastroenterology, cardiology) Other: please specify Bleeding diagnosis If different than the patient’s primary admitting diagnosis, list the

diagnosis associated with MTP activation OUTCOMES AND COMPLICATIONS

Mortality and Discharge Data Vital Status at 6 hours Was the patient’s vital status alive or dead 6 hours after MTP activation? Vital Status at 24 hours Was the patient’s vital status alive or dead 24hours after MTP activation? Vital Status at 30 days Was the patient’s vital status alive or dead 30 days after MTP activation? Vital Status at discharge Was the patient’s vital status alive or dead at discharge from hospital? Date/Time of death If applicable, list patient’s date and time of death (mm/dd/yyyy/24hh/mm) Hospital discharge date What was the date of discharge? Total hospital days What was the total duration in days of the admission associated with

MTP? ICU days Free text entry of number of days (up to 30) patient required ICU

admission Vent days Free text entry for number of days (up to 30) during which patient was

intubated Vent free days Free text entry for number of days (up to 30) during which patient was

not intubated Discharge destination Where was the patient discharged to? SNF= skilled nursing facility Rehab=acute rehabilitation center or facility LTAC=long term acute care center or facility AMA=patient left against medical advice Transfer=patient was transferred to another hospital Expired=patient died during the hospitalization Incomplete=discharge data missing Other Venous thromboembolism Deep vein thrombosis Yes/No was the patient diagnosed with DVT (deep vein thrombosis) Pulmonary embolism Yes/No was the patient diagnosed with PE (pulmonary embolism)

DVT and PE Diagnosis must be confirmed radiographically (Ultrasound, Computed tomography, venography, etc.)

OTHER COMPLICATIONS MI Did the patient have a myocardial infarction (MI) during their

hospitalization? Stoke Did the patient have a stroke during their hospitalization? Acute Renal Failure Acute Renal failure defined for the purpose of this study as elevation of serum creatinine greater or equal to 2.0 mg/dL during hospitalization in patient without antecedent renal dysfunction.

Sepsis Has a confirmed infectious process AND two or more of the following:

1. Body temperature < 36 degrees Celsius (97 F) or > 38 C (100 F) 2. Heart rate > 100 bpm

3. Respiratory rate > 20 breaths per minute or, on blood gas, PaCO2 of less than 32 mm Hg

4. White blood cell count > 4,000 cells/mm3 or > 12,000 cells/mm3

or greater than 10% and forms (immature wbc) PROCEDURES EGD procedures Please list start and stop date and time for esophago-gastroduo-

denoscopy procedures (EGD)/ upper endoscopy, associated procedure notes (what were key findings and therapeutic interventions), and CPT code(s)

IR procedures Please list start and stop date and time for any interventional radiology

(IR) procedures, associated procedure notes (what were key findings and therapeutic interventions), estimated blood loss (EBL) and CPT code(s)

OR procedures Please list start and stop date and time for any operating room (OR)

procedures, associated procedure notes (what were key findings and therapeutic interventions), EBL and CPT code(s)

Was aorta cross clamped? Answer yes or no if aorta was cross clamped during the operation,

provide time/date (if known) and estimated total duration (if known) in minutes of cross clamping

Ob/Gyn procedures Please list start and stop date and time for any obstetrics or gynecology

(Ob/Gyn) procedures, associated procedure notes (what were key findings and therapeutic interventions), EBL and CPT code(s)

Other procedures REBOA Was resuscitative, endovascular, balloon occlusion of the aorta and

location (ED: emergency department; OR: operating room; ICU: intensive care unit). Including date/time and duration of balloon occlusion in minutes

Resuscitative thoracotomy Was resuscitative thoracotomy performed and location (ED: emergency

department; OR: operating room; ICU: intensive care unit), state whether aorta was cross clamped (if so, include date/time and duration of cross clamping in minutes)

Chest tube insertion Was a chest tube placed (Yes/No response) Senstaken-Blakemore Tube Was a Senstaken-Blakemore Tube placed? Minnesota Tube Was a Minnesota Tube placed?

MTP DATA Massive transfusion protocol (MTP) activation data, please fill out one per activation (if multiple activations for same patient during their hospitalization

Activation information Provide location, start date/time and termination date time of MTP Fluid administration Pre MTP Fluid and blood products administered prior to activation of MTP, Including prehospital products PRBC Number of units of packed red blood cells (PRBCS) transfused FFP Number of units of fresh frozen plasma (FFP) transfused Plts Number of units of platelets transfused Cryo Number of units of cryoprecipitate transfused Crystalloid Number of liters of crystalloid administered Colloid Number of liters of colloid administered TXA Specify if tranexamic acid was given MTP Data Products and fluid given during MTP Activation, broken down by

time intervals (0-6 hours, 6-12 hours, 12-18 hours, 18-24 hours) PRBC Number of units of packed red blood cells (PRBCS) transfused FFP Number of units of fresh frozen plasma (FFP) transfused Plts Number of units of platelets transfused Cryo Number of units of cryoprecipitate transfused Crystalloid Number of liters of crystalloid administered Colloid Number of liters of colloid administered Total Fluid administration MTP Total of each component given during the MTP activation Hemostatic Medications List date and time of fist dose for each medication, dosage, and

number of doses given Tranexamic acid Tranexamic acid (TXA) RiaSTAP RiaSTAP or other Fibrinogen concentrate KCentra Kcentra (Prothrombin complex concentrate-PCC) or other 3 or 4 factor

concentrate factor concentrate Factor VII Factor VII (other names: NovoSeven, AryoSeven, rFVIIa) Calcium gluconate Provide date/time and dosage of calcium gluconate administration Calcium chlorate Provide date/time and dosage of calcium gluconate administration Physiologic and lab parameters Provide following laboratory and physiologic parameters for each timepoint (within 1 hour, if no value within 1 hour of timepoint, leave blank) Hemoglobin hemoglobin (g/dL) Platelet count platelet count (thousand/uL) INR International Normalized ratio PTT partial thromboplastin time

pH pH from arterial or venous blood gas if arterial not available Base excess base excess in mmol/L Lactate lactate or lactic acid in mmol/L Sodium Sodium (Na) in mmol/L Potassium Potassium in mmol/L Calcium calcium in mg/dL Ionized calcium ionized calcium or ical in mmol/L SBP systolic blood pressure DBP diastolic blood pressure HR heart rate Temp temperature in Celsius RR respiratory rate Intubated Yes/No was the patient intubated Use of vasopressors Yes/No was the patient receiving vasopressors or cardiac inotropes (yes

includes either continuous or bolus) TEG or ROTEM Was rotational thromboelastography or thromboelastography performed? If yes, provide date and time, and values TEG values TEG CK=TEG citrated +kaolin TEG CRT=citrated + rapid TEG

ACT=activated clotting time in seconds R=reaction time in minutes K= kinetics in minutes α= alpha angle in degrees MA=mean amplitude in millimeters (mm) LY30=percentage lysis at 30 minutes

ROTEM values INTEM= intrinsic channel results HEPTEM=heparinase channel results EXTEM=extrinsic channel results FIBTEM=fibrin channel results APTEM=aprotinin channel results CT=clotting time (seconds) CFT=clot formation time (seconds) α=alpha angle in degrees A10=clot firmness after 10 minutes A20=clot firmness after 20 minutes MCF=maximum clot firmness (mm) CLI30=lysis index after 30 minutes percentage (%) ML= maximum clot lysis (%)

ARDS Adjudication Lowest P/F Ratio What was the lowest P/F ratio recorded, included date/time P= partial pressure of Oxygen from arterial blood gas (paO2) F= fraction inspired oxygen (FiO2- ex: 60% O2 delivery = FiO2 0.60) Denver MOF Score Denver Multisystem Organ Failure score P/F at 48 hr List the first P/F ratio recorded in ICU 48 hours after injury Total Bilirubin at 48hr List the first total bilirubin recorded in ICU 48 hours after injury Creatinine at 48hr List the first creatinine recorded in ICU 48 hours after injury Cardiac Inotropes at 48hr Was the patient requiring cardiac inotropes at following levels?

(references table for doses/levels below) None

1 inotrope at small dose

Any inotrope at moderate does, or >1 inotrope

Any inotrope at high dose, or >2 agents moderate doses Reference for doses (all doses in ug/Kg/Min):

Inotrope Small dose Moderate Dose High Dose

Milrinone <0.3 0.4-0.7 >0.7

Vasopressin <0.03 0.03-0.07 >0.07

Dopamine <6 6-10 >10

Dobutamine <6 6-10 >10

Epinephrine <0.06 0.06-0.15 >0.15

Norepinephrine <0.11 0.11-0.5 >0.5

Phenylephrine <0.6 0.6-0.3 >0.3

Additional Laboratory Variables for Apache III Score Please provide following values at 48 hours after ICU admission: Pulse Heart rate Mean BP Mean blood pressure RR respiratory rate pH pH from arterial blood gas, or venous if arterial sample not available paO2 partial pressure oxygen of arterial blood gas in mmHg paCO2 partial pressure carbon dioxide of arterial blood gas in mmHg FiO2 fraction inspired oxygen at time of above blood gas measurements Hematocrit hematocrit WBC count white blood cell count in thousand cells/uL

Urine output (ml/day) Urine output in milliliters (ml) per day Serum BUN Serum blood urea nitrogen (BUN), in mg/dL Serum Albumin Serum albumin level in g/dL Serum Sodium Serum sodium in mEq/L Serum glucose Serum glucose in mg/dL GCS Provide Glasgow coma scale at 48 hours

Documents

EAST MULTICENTER STUDY DATA COLLECTION TOOL · Placental abnormalities (circle if applicable) Placentia Previa Placental Abruption Placental Accreta Pregnancy complications (circle