Eligibility

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion Criteria
CL425202 (UMLS CUI 2011AA)
age >=18 Years
Item
Age 18 Years and older
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Subjects requiring elective spinal fusion surgery involving 3 to 7 vertebral levels with instrumentation. One vertebral level is defined as encompassing two vertebral bodies and one inter-vertebral disc space, so that a contiguous spinal fusion involving 3 vertebral levels would include 4 vertebral bodies and 3 inter-vertebral disc spaces.
Item
Subjects requiring elective spinal fusion surgery involving 3 to 7 vertebral levels with instrumentation. One vertebral level is defined as encompassing two vertebral bodies and one inter-vertebral disc space, so that a contiguous spinal fusion involving 3 vertebral levels would include 4 vertebral bodies and 3 inter-vertebral disc spaces.
boolean
C0206058 (UMLS CUI 2011AA)
274075007 (SNOMED CT 2011_0131)
10058829 (MedDRA 14.1)
C0919636 (UMLS CUI 2011AA)
10050505 (MedDRA 14.1)
C0446409 (UMLS CUI 2011AA)
263276005 (SNOMED CT 2011_0131)
CL414307 (UMLS CUI 2011AA)
C0223084 (UMLS CUI 2011AA)
3572006 (SNOMED CT 2011_0131)
C1279061 (UMLS CUI 2011AA)
181817002 (SNOMED CT 2011_0131)
C1556138 (UMLS CUI 2011AA)
C0223088 (UMLS CUI 2011AA)
47886009 (SNOMED CT 2011_0131)
Item Group
Exclusion Criteria
CL425201 (UMLS CUI 2011AA)
Subjects with previous exposure to aprotinin in the last 6 months. If the subject has undergone cardiac surgery in the last 6 months, all attempts should be made to ascertain if aprotinin was administered during cardiac surgery. If no records are available, or if the subject received aprotinin, the subject should be excluded.
Item
Subjects with previous exposure to aprotinin in the last 6 months. If the subject has undergone cardiac surgery in the last 6 months, all attempts should be made to ascertain if aprotinin was administered during cardiac surgery. If no records are available, or if the subject received aprotinin, the subject should be excluded.
boolean
C0205156 (UMLS CUI 2011AA)
9130008 (SNOMED CT 2011_0131)
C0332157 (UMLS CUI 2011AA)
24932003 (SNOMED CT 2011_0131)
C0592198 (UMLS CUI 2011AA)
386961008 (SNOMED CT 2011_0131)
C0018821 (UMLS CUI 2011AA)
64915003 (SNOMED CT 2011_0131)
10061026 (MedDRA 14.1)
C1521801 (UMLS CUI 2011AA)
C0347984 (UMLS CUI 2011AA)
371881003 (SNOMED CT 2011_0131)
C0034869 (UMLS CUI 2011AA)
CL411789 (UMLS CUI 2011AA)
Subjects with a known or suspected allergy to aprotinin.
Item
Subjects with a known or suspected allergy to aprotinin.
boolean
C0205309 (UMLS CUI 2011AA)
36692007 (SNOMED CT 2011_0131)
C0750491 (UMLS CUI 2011AA)
415684004 (SNOMED CT 2011_0131)
C0020517 (UMLS CUI 2011AA)
257550005 (SNOMED CT 2011_0131)
T78.40 (ICD-10-CM Version 2010)
C0592198 (UMLS CUI 2011AA)
386961008 (SNOMED CT 2011_0131)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
Subjects with sepsis or a known bone infection.
Item
Subjects with sepsis or a known bone infection.
boolean
C0243026 (UMLS CUI 2011AA)
91302008 (SNOMED CT 2011_0131)
10040047 (MedDRA 14.1)
995.91 (ICD-9-CM Version 2011)
C0205309 (UMLS CUI 2011AA)
36692007 (SNOMED CT 2011_0131)
C2242472 (UMLS CUI 2011AA)
111253001 (SNOMED CT 2011_0131)
M86.9 (ICD-10-CM Version 2010)
730.9 (ICD-9-CM Version 2011)
E11314 (CTCAE 1105E)
Subjects with known bone malignancy.
Item
Personal history of malignant neoplasm of bone
boolean
C0260447 (UMLS CUI 2011AA)
Z85.830 (ICD-10-CM Version 2010)
V10.81 (ICD-9-CM Version 2011)
Subjects with a creatinine clearance <30mL/min as calculated by the Cockcroft-Gault formula.
Item
Subjects with a creatinine clearance <30mL/min as calculated by the Cockcroft-Gault formula.
boolean
C2711451 (UMLS CUI 2011AA)
442407001 (SNOMED CT 2011_0131)
C0444686 (UMLS CUI 2011AA)
258090004 (SNOMED CT 2011_0131)
Subjects with a history of bleeding diathesis or known coagulation factor deficiency.
Item
Subjects with a history of bleeding diathesis or known coagulation factor deficiency.
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C1458140 (UMLS CUI 2011AA)
248250000 (SNOMED CT 2011_0131)
10005134 (MedDRA 14.1)
C0205309 (UMLS CUI 2011AA)
36692007 (SNOMED CT 2011_0131)
C0272315 (UMLS CUI 2011AA)
86075001 (SNOMED CT 2011_0131)
10067787 (MedDRA 14.1)
286 (ICD-9-CM Version 2011)
Subjects with failure of a major organ system or any active significant medical illness that in the opinion of the Investigator is likely to affect the subject's ability to complete the study or precludes the subject's participation in the study.
Item
Subjects with failure of a major organ system or any active significant medical illness that in the opinion of the Investigator is likely to affect the subject's ability to complete the study or precludes the subject's participation in the study.
boolean
C0231174 (UMLS CUI 2011AA)
76797004 (SNOMED CT 2011_0131)
C0205164 (UMLS CUI 2011AA)
255603008 (SNOMED CT 2011_0131)
C0460002 (UMLS CUI 2011AA)
91689009 (SNOMED CT 2011_0131)
C0205177 (UMLS CUI 2011AA)
55561003 (SNOMED CT 2011_0131)
C0750502 (UMLS CUI 2011AA)
386134007 (SNOMED CT 2011_0131)
C0205476 (UMLS CUI 2011AA)
74188005 (SNOMED CT 2011_0131)
C0221423 (UMLS CUI 2011AA)
39104002 (SNOMED CT 2011_0131)
10040658 (MedDRA 14.1)
R69 (ICD-10-CM Version 2010)
C0085732 (UMLS CUI 2011AA)
371150009 (SNOMED CT 2011_0131)
C0205197 (UMLS CUI 2011AA)
255594003 (SNOMED CT 2011_0131)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C2348568 (UMLS CUI 2011AA)
Subjects who refuse to receive allogenic blood products for religious or other reasons.
Item
Subjects who refuse to receive allogenic blood products for religious or other reasons.
boolean
C1411169 (UMLS CUI 2011AA)
CL428796 (UMLS CUI 2011AA)
10071089 (MedDRA 14.1)
Subjects whose preoperative red blood cell volume is so low that a blood transfusion would be likely to be given perioperatively (preoperative hematocrit or hemoglobin values <24% or <8 g/dl, respectively).
Item
Subjects whose preoperative red blood cell volume is so low that a blood transfusion would be likely to be given perioperatively (preoperative hematocrit or hemoglobin values <24% or <8 g/dl, respectively).
boolean
C0445204 (UMLS CUI 2011AA)
262068006 (SNOMED CT 2011_0131)
C2711689 (UMLS CUI 2011AA)
441791009 (SNOMED CT 2011_0131)
C0005841 (UMLS CUI 2011AA)
116859006 (SNOMED CT 2011_0131)
10005835 (MedDRA 14.1)
MTHU020992 (LOINC Version 232)
C1518988 (UMLS CUI 2011AA)
C0744727 (UMLS CUI 2011AA)
10018838 (MedDRA 14.1)
R71.0 (ICD-10-CM Version 2010)
C0162119 (UMLS CUI 2011AA)
165397008 (SNOMED CT 2011_0131)
10018884 (MedDRA 14.1)
Subjects who have participated in an investigational drug study within the past 30 days.
Item
Subjects who have participated in an investigational drug study within the past 30 days.
boolean
C2348568 (UMLS CUI 2011AA)
PART (HL7 V3 2006_05)
C0013230 (UMLS CUI 2011AA)
Subjects with a history of deep vein thrombosis or pulmonary embolism.
Item
Subjects with a history of deep vein thrombosis or pulmonary embolism.
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0149871 (UMLS CUI 2011AA)
128053003 (SNOMED CT 2011_0131)
10051055 (MedDRA 14.1)
I82.40 (ICD-10-CM Version 2010)
C0034065 (UMLS CUI 2011AA)
59282003 (SNOMED CT 2011_0131)
10037377 (MedDRA 14.1)
I26 (ICD-10-CM Version 2010)
415.1 (ICD-9-CM Version 2011)
Subjects who are pregnant or breast feeding.
Item
Subjects who are pregnant or breast feeding.
boolean
C0549206 (UMLS CUI 2011AA)
10036586 (MedDRA 14.1)
C0006147 (UMLS CUI 2011AA)
10006247 (MedDRA 14.1)
Women of childbearing potential in whom the possibility of pregnancy cannot be excluded by a negative serum pregnancy test at screening.
Item
Women of childbearing potential in whom the possibility of pregnancy cannot be excluded by a negative serum pregnancy test at screening.
boolean
C0043210 (UMLS CUI 2011AA)
224526002 (SNOMED CT 2011_0131)
C1148523 (UMLS CUI 2011AA)
C0237399 (UMLS CUI 2011AA)
C0332149 (UMLS CUI 2011AA)
371930009 (SNOMED CT 2011_0131)
CL425201 (UMLS CUI 2011AA)
C0430061 (UMLS CUI 2011AA)
166435006 (SNOMED CT 2011_0131)
C1409616 (UMLS CUI 2011AA)
Women of childbearing potential who are not using a reliable method of contraception.
Item
Women of childbearing potential who are not using a reliable method of contraception.
boolean
C0043210 (UMLS CUI 2011AA)
224526002 (SNOMED CT 2011_0131)
C1148523 (UMLS CUI 2011AA)
C0237399 (UMLS CUI 2011AA)
C0700589 (UMLS CUI 2011AA)
146680009 (SNOMED CT 2011_0131)
10010808 (MedDRA 14.1)
Planned use of other antifibrinolytic agents.
Item
Antifibrinolytic Agents
boolean
C0003304 (UMLS CUI 2011AA)
75064004 (SNOMED CT 2011_0131)
Subjects on chronic anticoagulant treatment with Vit K antagonists that cannot be temporarily discontinued for the surgical procedure (as per local practices).
Item
Subjects on chronic anticoagulant treatment with Vit K antagonists that cannot be temporarily discontinued for the surgical procedure (as per local practices).
boolean
C0205191 (UMLS CUI 2011AA)
90734009 (SNOMED CT 2011_0131)
C0150457 (UMLS CUI 2011AA)
182764009 (SNOMED CT 2011_0131)
10053468 (MedDRA 14.1)
C1096489 (UMLS CUI 2011AA)
10053755 (MedDRA 14.1)
C0205374 (UMLS CUI 2011AA)
14803004 (SNOMED CT 2011_0131)
C1444662 (UMLS CUI 2011AA)
410546004 (SNOMED CT 2011_0131)
C0543467 (UMLS CUI 2011AA)
83578000 (SNOMED CT 2011_0131)
10051332 (MedDRA 14.1)
MTHU000079 (LOINC Version 232)
CL415116 (UMLS CUI 2011AA)
C0032893 (UMLS CUI 2011AA)
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