Download - Expedited Review Approval
Human Research Protection ProgramInstitutional Review Board (IRB)
Expedited Review Approval
Principal InvestigatorRachael Callcut MD
Co-Principal InvestigatorLucy Kornblith MD
Type of Submission: Modification FormStudy Title: A Review of Massive Transfusion Protocol Activation Practices at San Francisco
General Hospital
IRB #: 11-07155Reference #: 265692Committee of Record: Parnassus PanelStudy Risk Assignment: Minimal
Approval Date: 11/15/2019 Expiration Date: 03/19/2020
IRB Comments: All changes to a study must receive UCSF IRB approval before they are implemented. Follow the modification request instructions. The only exception to the requirement for prior UCSF IRB review and approval is when the changes are necessary to eliminate apparent immediate hazards to the subject (45 CFR 46.103.b.4, 21 CFR 56.108.a). In such cases, report the actions taken by following these instructions.
Expiration Notice: The iRIS system will generate an email notification eight weeks prior to the expiration of this study’s approval. However, it is your responsibility to ensure that an application for continuing review approval has been submitted by the required time. In addition, you are required to submit a study closeout report at the completion of the project.
Documents Reviewed and Approved with this Submission: Consent Documents
Other Study Documents Study Document Title Version # Version Date Outcome data_dictionary_Ultramassive Transfusion Proposal
Version 1.0 10/24/2019 Approved
data_collection_tool_Ultramassive Transfusion
Version 1.0 10/24/2019 Approved
Proposal EAST UMT Proposal final
Version 1.0 10/24/2019 Approved
For a list of all currently approved documents, follow these steps: Go to My Studies and open the study – Click on Informed Consent to obtain a list of approved consent documents and Other Study Documents for a list of other approved documents.
San Francisco Veterans Affairs Medical Center (SFVAMC): If the SFVAMC is engaged in this research, you must secure approval of the VA Research & Development Committee in addition to UCSF IRB approval and follow all applicable VA and other federal requirements. The UCSF IRB website has more information.
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 centimeters (cm) Body Mass index Patient’s body mass index, if only height/weight available use formula
weight(kg)/height(meters)^2 Admit Date/Time Admission date/time (mm/dd/yyyy) of the patient enrolled ED Arrival Date/Time ED Arrival Date/Time (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, leukemia, or solid tumor 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 (hemolysis, elevated liver enzymes, low platelets) Other: specify
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 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 Provide date/time/dosage of calcium gluconate or chloride 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
EAST MULTICENTER STUDY
DATA COLLECTION TOOL Multicenter Study: Ultra Massive Transfusion in the Era of Balanced Resuscitation Enrolling Center and Co-Investigator: _______________________ SUBJECT DATA Study ID
Age
DOB
Sex (M/F)
Race
Latino (Yes/No/Unknown)
Weight (kg)
Height (cm)
BMI
ED Arrival Date/Time
Admit Date/Time
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:
Statin Yes No
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 and Data 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 Other: ______________
Pregnancy history Gravida (#pregnancies)_______ Para (#live births)_______ Number of abortions ________
Internal Medicine/General Surgery/Other
Medical or Surgical subspecialty patient: Yes No (leave section blank if no)
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 Start Date/Time Stop Date/Time EBL
Procedure Notes
List procedure(s) CPT codes
OR Procedures Start Date/Time Stop Date/Time
EBL
Procedure Notes
Was aorta cross clamped in the OR
Yes No Time/Date: Total estimated duration (minutes):
List procedure(s) CPT codes
Ob/Gyn Procedures: Delivery
Delivery Type Vaginal Cesarean Emergent? Yes No
Start Date/Time Stop Date/Time
EBL
Procedure Notes
List procedure(s) CPT codes
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
Products Given Hours 6-12
PRBC PRBC FFP FFP Plts Plts Cryo Cryo Crystalloid Crystalloid Colloid Colloid
Products Given Hours 12-18
Products Given Hours 18-24
pRBCs pRBCs FFP FFP Plts Plts Cryo Cryo Crystalloid Crystalloid Colloid Colloid
Total Fluid Administration
MTP
pRBCs FFP
Plts
Cryo
Crystalloid
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
Platelet Count Ionized 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 __
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 __
12 hours after MTP Activation (record closest value within 1 hour) Hemoglobin Calcium
Platelet Count Ionized 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 __
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 __
18 hours after MTP Activation (record closest value within 1 hour) Hemoglobin Calcium
Platelet Count Ionized 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 __
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 __
24 hours after MTP Activation (record closest value within 1 hour)
Hemoglobin Calcium
Platelet Count Ionized 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 __
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 __
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