ID
42859
Description
ODM derived from http://clinicaltrials.gov/show/NCT00327379
Lien
http://clinicaltrials.gov/show/NCT00327379
Mots-clés
Versions (2)
- 11/12/2013 11/12/2013 - Martin Dugas
- 17/09/2021 17/09/2021 -
Téléchargé le
17 septembre 2021
DOI
Pour une demande vous connecter.
Licence
Creative Commons BY 4.0
Modèle Commentaires :
Ici, vous pouvez faire des commentaires sur le modèle. À partir des bulles de texte, vous pouvez laisser des commentaires spécifiques sur les groupes Item et les Item.
Groupe Item commentaires pour :
Item commentaires pour :
Vous devez être connecté pour pouvoir télécharger des formulaires. Veuillez vous connecter ou s’inscrire gratuitement.
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.
Type de données
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.
Type de données
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.
Type de données
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.
Type de données
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.
Type de données
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.
Type de données
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
- C0272315
- 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.
Type de données
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.
Type de données
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).
Type de données
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.
Type de données
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.
Type de données
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.
Type de données
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.
Type de données
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.
Type de données
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.
Type de données
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).
Type de données
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)
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)
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)
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)
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)
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)
C0272315 (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)
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)
CL428796 (UMLS CUI 2011AA)
10071089 (MedDRA 14.1)
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)
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)
C0006147 (UMLS CUI 2011AA)
10006247 (MedDRA 14.1)
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)
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)
75064004 (SNOMED CT 2011_0131)
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)