ID
4570
Description
ODM derived from http://clinicaltrials.gov/show/NCT00327379
Link
http://clinicaltrials.gov/show/NCT00327379
Keywords
Versions (2)
- 12/11/13 12/11/13 - Martin Dugas
- 9/17/21 9/17/21 -
Uploaded on
December 11, 2013
DOI
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License
Creative Commons BY 4.0
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Eligibility NCT00327379 Postoperative Hemorrhage
Eligibility
- StudyEvent: Eligibility
Description
Ausschlusskriterien
Alias
- UMLS CUI 2011AA
- CL425201
Description
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.
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0205156
- SNOMED CT 2011_0131
- 9130008
- UMLS CUI 2011AA
- C0332157
- SNOMED CT 2011_0131
- 24932003
- UMLS CUI 2011AA
- C0592198
- SNOMED CT 2011_0131
- 386961008
- UMLS CUI 2011AA
- C0018821
- SNOMED CT 2011_0131
- 64915003
- MedDRA 14.1
- 10061026
- UMLS CUI 2011AA
- C1521801
- UMLS CUI 2011AA
- C0347984
- SNOMED CT 2011_0131
- 371881003
- UMLS CUI 2011AA
- C0034869
- UMLS CUI 2011AA
- CL411789
Description
Subjects with a known or suspected allergy to aprotinin.
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0205309
- SNOMED CT 2011_0131
- 36692007
- UMLS CUI 2011AA
- C0750491
- SNOMED CT 2011_0131
- 415684004
- UMLS CUI 2011AA
- C0020517
- SNOMED CT 2011_0131
- 257550005
- ICD-10-CM Version 2010
- T78.40
- UMLS CUI 2011AA
- C0592198
- SNOMED CT 2011_0131
- 386961008
- UMLS CUI 2011AA
- C0011900
- SNOMED CT 2011_0131
- 439401001
- LOINC Version 232
- MTHU008876
Description
Subjects with sepsis or a known bone infection.
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0243026
- SNOMED CT 2011_0131
- 91302008
- MedDRA 14.1
- 10040047
- ICD-9-CM Version 2011
- 995.91
- UMLS CUI 2011AA
- C0205309
- SNOMED CT 2011_0131
- 36692007
- UMLS CUI 2011AA
- C2242472
- SNOMED CT 2011_0131
- 111253001
- ICD-10-CM Version 2010
- M86.9
- ICD-9-CM Version 2011
- 730.9
- CTCAE 1105E
- E11314
Description
Subjects with known bone malignancy.
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0260447
- ICD-10-CM Version 2010
- Z85.830
- ICD-9-CM Version 2011
- V10.81
Description
Subjects with a creatinine clearance <30mL/min as calculated by the Cockcroft-Gault formula.
Data type
boolean
Alias
- UMLS CUI 2011AA
- C2711451
- SNOMED CT 2011_0131
- 442407001
- UMLS CUI 2011AA
- C0444686
- SNOMED CT 2011_0131
- 258090004
Description
Subjects with a history of bleeding diathesis or known coagulation factor deficiency.
Data type
boolean
Alias
- UMLS CUI 2011AA
- CL421546
- SNOMED CT 2011_0131
- 392521001
- UMLS CUI 2011AA
- C1458140
- SNOMED CT 2011_0131
- 248250000
- MedDRA 14.1
- 10005134
- UMLS CUI 2011AA
- C0205309
- SNOMED CT 2011_0131
- 36692007
- UMLS CUI 2011AA
- C0849773
- SNOMED CT 2011_0131
- 86075001
- MedDRA 14.1
- 10067787
- ICD-9-CM Version 2011
- 286
Description
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.
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0231174
- SNOMED CT 2011_0131
- 76797004
- UMLS CUI 2011AA
- C0205164
- SNOMED CT 2011_0131
- 255603008
- UMLS CUI 2011AA
- C0460002
- SNOMED CT 2011_0131
- 91689009
- UMLS CUI 2011AA
- C0205177
- SNOMED CT 2011_0131
- 55561003
- UMLS CUI 2011AA
- C0750502
- SNOMED CT 2011_0131
- 386134007
- UMLS CUI 2011AA
- C0205476
- SNOMED CT 2011_0131
- 74188005
- UMLS CUI 2011AA
- C0221423
- SNOMED CT 2011_0131
- 39104002
- MedDRA 14.1
- 10040658
- ICD-10-CM Version 2010
- R69
- UMLS CUI 2011AA
- C0085732
- SNOMED CT 2011_0131
- 371150009
- UMLS CUI 2011AA
- C0205197
- SNOMED CT 2011_0131
- 255594003
- UMLS CUI 2011AA
- C0008976
- SNOMED CT 2011_0131
- 110465008
- UMLS CUI 2011AA
- C2348568
Description
Subjects who refuse to receive allogenic blood products for religious or other reasons.
Data type
boolean
Alias
- UMLS CUI 2011AA
- C1411169
- UMLS CUI 2011AA
- CL428796
- MedDRA 14.1
- 10071089
Description
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).
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0445204
- SNOMED CT 2011_0131
- 262068006
- UMLS CUI 2011AA
- C2711689
- SNOMED CT 2011_0131
- 441791009
- UMLS CUI 2011AA
- C0005841
- SNOMED CT 2011_0131
- 116859006
- MedDRA 14.1
- 10005835
- LOINC Version 232
- MTHU020992
- UMLS CUI 2011AA
- C1518988
- UMLS CUI 2011AA
- C0744727
- MedDRA 14.1
- 10018838
- ICD-10-CM Version 2010
- R71.0
- UMLS CUI 2011AA
- C0162119
- SNOMED CT 2011_0131
- 165397008
- MedDRA 14.1
- 10018884
Description
Subjects who have participated in an investigational drug study within the past 30 days.
Data type
boolean
Alias
- UMLS CUI 2011AA
- C2348568
- HL7 V3 2006_05
- PART
- UMLS CUI 2011AA
- C0013230
Description
Subjects with a history of deep vein thrombosis or pulmonary embolism.
Data type
boolean
Alias
- UMLS CUI 2011AA
- CL421546
- SNOMED CT 2011_0131
- 392521001
- UMLS CUI 2011AA
- C0149871
- SNOMED CT 2011_0131
- 128053003
- MedDRA 14.1
- 10051055
- ICD-10-CM Version 2010
- I82.40
- UMLS CUI 2011AA
- C0034065
- SNOMED CT 2011_0131
- 59282003
- MedDRA 14.1
- 10037377
- ICD-10-CM Version 2010
- I26
- ICD-9-CM Version 2011
- 415.1
Description
Subjects who are pregnant or breast feeding.
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0549206
- MedDRA 14.1
- 10036586
- UMLS CUI 2011AA
- C0006147
- MedDRA 14.1
- 10006247
Description
Women of childbearing potential in whom the possibility of pregnancy cannot be excluded by a negative serum pregnancy test at screening.
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0043210
- SNOMED CT 2011_0131
- 224526002
- UMLS CUI 2011AA
- C1148523
- UMLS CUI 2011AA
- C0237399
- UMLS CUI 2011AA
- C0332149
- SNOMED CT 2011_0131
- 371930009
- UMLS CUI 2011AA
- CL425201
- UMLS CUI 2011AA
- C0430061
- SNOMED CT 2011_0131
- 166435006
- UMLS CUI 2011AA
- C1409616
Description
Women of childbearing potential who are not using a reliable method of contraception.
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0043210
- SNOMED CT 2011_0131
- 224526002
- UMLS CUI 2011AA
- C1148523
- UMLS CUI 2011AA
- C0237399
- UMLS CUI 2011AA
- C0700589
- SNOMED CT 2011_0131
- 146680009
- MedDRA 14.1
- 10010808
Description
Planned use of other antifibrinolytic agents.
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0003304
- SNOMED CT 2011_0131
- 75064004
Description
Subjects on chronic anticoagulant treatment with Vit K antagonists that cannot be temporarily discontinued for the surgical procedure (as per local practices).
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0205191
- SNOMED CT 2011_0131
- 90734009
- UMLS CUI 2011AA
- C0150457
- SNOMED CT 2011_0131
- 182764009
- MedDRA 14.1
- 10053468
- UMLS CUI 2011AA
- C1096489
- MedDRA 14.1
- 10053755
- UMLS CUI 2011AA
- C0205374
- SNOMED CT 2011_0131
- 14803004
- UMLS CUI 2011AA
- C1444662
- SNOMED CT 2011_0131
- 410546004
- UMLS CUI 2011AA
- C0543467
- SNOMED CT 2011_0131
- 83578000
- MedDRA 14.1
- 10051332
- LOINC Version 232
- MTHU000079
- UMLS CUI 2011AA
- CL415116
- UMLS CUI 2011AA
- C0032893
Similar models
Eligibility
- StudyEvent: Eligibility
397669002 (SNOMED CT 2011_0131)
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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)
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439401001 (SNOMED CT 2011_0131)
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10040047 (MedDRA 14.1)
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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)
Z85.830 (ICD-10-CM Version 2010)
V10.81 (ICD-9-CM Version 2011)
442407001 (SNOMED CT 2011_0131)
C0444686 (UMLS CUI 2011AA)
258090004 (SNOMED CT 2011_0131)
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)
C0849773 (UMLS CUI 2011AA)
86075001 (SNOMED CT 2011_0131)
10067787 (MedDRA 14.1)
286 (ICD-9-CM Version 2011)
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)
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110465008 (SNOMED CT 2011_0131)
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116859006 (SNOMED CT 2011_0131)
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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)
PART (HL7 V3 2006_05)
C0013230 (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)
10036586 (MedDRA 14.1)
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10006247 (MedDRA 14.1)
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C0237399 (UMLS CUI 2011AA)
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371930009 (SNOMED CT 2011_0131)
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C0237399 (UMLS CUI 2011AA)
C0700589 (UMLS CUI 2011AA)
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C0205374 (UMLS CUI 2011AA)
14803004 (SNOMED CT 2011_0131)
C1444662 (UMLS CUI 2011AA)
410546004 (SNOMED CT 2011_0131)
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