Case Report Form Version 1.

Inclusion criteria
Medical patients 40 years of age or older Admitted for treatment of a serious medical illness Surgical patients* 18 years of age or older Underwent an operation, which required general or epidural anesthesia, lasting at least 45 minutes Major traumatic event, not requiring a major operation, including closed head injury *Patients admitted to a surgical floor who have not had an operation should be evaluated for eligibility using inclusion criteria for medical patients. Remember to: Use only the forms preprinted with unique Patient Study Numbers Make sure to use the form with the preprinted Patient Study Number that corresponds with the patient assigned that number in the Patient Enrollment Log Use a black pencil (this is highly recommended) Print all information neatly. Fill in each appropriate circle completely. Erase all errors completely Complete all sections for which information is available Do not place identifying patient data (e.g., name) on the form; use only the patient's study number

Please report dates as shown:

Please print neatly within the boxes:

1 5 /MA R/ 2 0 0 6
day month year Please use 3-letter style for month.

1 2 3 4 5 6 7 8 9 0
Please shade circles completely: Correct:

Incorrect:

9 x

ENDORSE Case Report Form - Version 1.0

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Epidemiologic International Day for the Evaluation of Patients at Risk of Venous Thrombosis in the Acute Hospital Care Setting Study
Patient Study Number

Hospital Study Number

(Required)

1. Sex (Required) 3. Weight

Male

Female kg lbs weight missing

2. Year of Birth
(Required)

1 9
in cm height missing

4. Height

5. Date of Survey (today's date) (Required)

6. Date of Hospital Admission (Required)

2 0 0 6
day month* year day month*

2 0 0 6
year

*write in the standard 3 letter abbreviation for the month: JAN, FEB, MAR, APR, MAY, JUN, JUL, AUG, SEP, OCT, NOV, & DEC

7. Medical Conditions a. Medical History Available

Yes

No Obese Contraceptives Chronic Heart Failure

b. Conditions present prior to hospital admission (Fill in all that apply) Previous Venous Thromboembolism Chronic Pulmonary Disease Thrombophilia (laboratory documented) Varicose Veins or Venous Insufficiency Long Term Immobility Pregnancy (within 3 months)

Post-menopausal Hormone Replacement Therapy c. Fill in "Pre Adm" if the condition existed prior to hospital admission. Then Fill in First day each condition was recognized in the hospital Hospital Day Pre At
Adm Adm 2

10 11 12

13 14

Acute Heart Failure (NYHA Class III or IV) Ischemic Stroke Hemorrhagic Stroke Other Cardiovascular Disease Hematologic Diseases Malignancy (active) Acute Non-infectious Respiratory Disease Pulmonary Infection Infection (non-respiratory) Rheumatotologic or Inflammatory Neurologic Renal Endocrine/Metabolic GI/Hepatobiliary Other Medical Condition 8. Admitted with Major Trauma No Head Injury Hip Fracture Other Trauma
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Page 1 of 3 E N D O R S E C a s e R e p o r t F o r m V e r s i o n 1 . 0 2 0 0 6 C e n t e r f o r O u t c o m e s R e s e a r c h U M a s s M e d i c a l S c h o o l W o r c e s t e r , M A 0 1 6 0 5 ( 5 0 8 ) 8 5 6 8 8 3 7 h t t p : / / w w w . o u t c o m e s . o r g Sponsored by an unrestricted educational grant from sanofi aventis

ENDORSE Case Report Form - Version 1.0

1723

Epidemiologic International Day for the Evaluation of Patients at Risk of Venous Thrombosis in the Acute Hospital Care Setting Study
Patient Study Number

9. Surgery (Fill in "Pre Adm" if surgery was performed within 3 months prior to hospital admission. Then fill in day surgery performed in hospital) Hospital Day
At Pre Adm Adm 2

10 11 12

13 14

a. Day Surgery Performed b. Type of the first major operation during the current hospital admission (Check one) Hip Replacement Knee Replacement Hip Fracture c. Was surgery for cancer? Curative Arthroscopy Other Ortho Trauma Colon/Small Bowel Yes No Rectosigmoid Gastric Hepatobiliary Urologic Vascular Thoracic Yes No Gynecologic Other Surgery

Unknown

d. Was it emergency surgery?

e. If surgery was not performed, patient was admitted for: Observation (admitted to a surgical unit, but no surgery scheduled) Elective Surgery (not performed to date) 10. Risk Factors for Bleeding Present at Current Admission (Fill in all that apply) Significant Renal Impairment Intracranial Hemorrhage Low Platelet Count (<100,000 per l) Known Bleeding Disorder (congenital or acquired) Hepatic Impairment (clinically relevant) Bleeding at Hospital Admission 11. Serum Creatinine Level (first) Active Gastroduodenal Ulcer Aspirin on Admission

Continued during this admission

Yes No NSAID on Admission (excluding aspirin)

Continued during this admission

Yes No umol/liter mg/dl

12. Additonal Risk factors for VTE Present Immediately Prior to, or During First 14 Days of Admission (Fill in "Pre Adm" if the condition existed prior to hospital admission. Then Fill in First day each condition was recognized in the hospital) Hospital Day Pre At Risk Factor Adm Adm 2 3 4 5 6 7 8 9 10 11 12 13 14 Admitted to ICU/CCU Central Venous Catheter Mechanical Ventilation Immobile with Bathroom Privileges Complete Immobilization Cancer Therapy (chemo or hormonal) Heparin Induced Thrombocytopenia
Page 2 of 3 E N D O R S E C a s e R e p o r t F o r m V e r s i o n 1 . 0 2 0 0 6 C e n t e r f o r O u t c o m e s R e s e a r c h U M a s s M e d i c a l S c h o o l W o r c e s t e r , M A 0 1 6 0 5 ( 5 0 8 ) 8 5 6 8 8 3 7 h t t p : / / w w w . o u t c o m e s . o r g Sponsored by an unrestricted educational grant from sanofi aventis

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ENDORSE Case Report Form - Version 1.0

1723

Epidemiologic International Day for the Evaluation of Patients at Risk of Venous Thrombosis in the Acute Hospital Care Setting Study
Patient Study Number

13. Anticoagulant VTE Prophylaxis Ordered (Fill in all days that apply. If not ordered, skip to question 16)
Pre At Adm Adm 2

Hospital Day 3 4 5 6 7 8 9 10 11 12 13 14

Low Molecular Weight Heparin Unfractionated Heparin Vitamin K Antagonist (e.g. Warfarin) Fondaparinux (Arixtra) Other Anticoagulants 14. Type of Low Molecular Weight Heparin (LMWH) Enoxaparin (Clexane/Klexane/Lovenox) Dalteparin (Fragmin) 15. Maintenance Dosing of Heparin a. Dose per Injection b. Dosing Regimen Once a Day mg Twice a Day IU IU/kg Three Times per Day Other Nadroparin (Fraxiparin) Tinzaparin (Innohep/Logiparin) Other LMWH

16. Mechanical Prophylaxis (Fill in all that apply)

Given

For surgical patients, when given? PreOp IntraOp PostOp

Intermittent Pneumatic Compression (IPC) Foot Pump (AVI) Graduated Compression Stockings 17. Antiplatelet Agents Given Yes No Unknown Arterial Disease Prevention of DVT/PE Other Unknown

Atrial Fibrillation

18. Therapeutic Anticoagulation Given (as Rx for MI, VTE, AF, etc. - Fill in all days that apply)
Pre At Adm Adm 2

Hospital Day 3 4 5 6 7 8 9 10 11 12 14 13

a. Days Given b. Reason for therapeutic (curative) anticoagulation Myocardial Ischemia (includes UA and MI) DVT/PE Atrial Fibrillation Yes Other (e.g. heart valve) No

19. Today (day of this survey) is the day of hospital discharge (Required)

20. Orders for continued prophylaxis after discharge, or after day 14 of hospital stay Yes No LMWH Unknown UFH Vitamin K Antagonist Other Anticoagulants Mechanical Prophylaxis
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Page 3 of 3 E N D O R S E C a s e R e p o r t F o r m V e r s i o n 1 . 0 2 0 0 6 C e n t e r f o r O u t c o m e s R e s e a r c h U M a s s M e d i c a l S c h o o l W o r c e s t e r , M A 0 1 6 0 5 ( 5 0 8 ) 8 5 6 8 8 3 7 h t t p : / / w w w . o u t c o m e s . o r g Sponsored by an unrestricted educational grant from sanofi aventis