ID
4570
Descripción
ODM derived from http://clinicaltrials.gov/show/NCT00327379
Link
http://clinicaltrials.gov/show/NCT00327379
Palabras clave
Versiones (2)
- 11/12/13 11/12/13 - Martin Dugas
- 17/9/21 17/9/21 -
Subido en
11 de diciembre de 2013
DOI
Para solicitar uno, por favor iniciar sesión.
Licencia
Creative Commons BY 4.0
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Eligibility NCT00327379 Postoperative Hemorrhage
Eligibility
- StudyEvent: Eligibility
Descripción
Exclusion Criteria
Alias
- UMLS CUI 2011AA
- CL425201
Descripción
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.
Tipo de datos
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
Descripción
Subjects with a known or suspected allergy to aprotinin.
Tipo de datos
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
Descripción
Subjects with sepsis or a known bone infection.
Tipo de datos
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
Descripción
Subjects with known bone malignancy.
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C0260447
- ICD-10-CM Version 2010
- Z85.830
- ICD-9-CM Version 2011
- V10.81
Descripción
Subjects with a creatinine clearance <30mL/min as calculated by the Cockcroft-Gault formula.
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C2711451
- SNOMED CT 2011_0131
- 442407001
- UMLS CUI 2011AA
- C0444686
- SNOMED CT 2011_0131
- 258090004
Descripción
Subjects with a history of bleeding diathesis or known coagulation factor deficiency.
Tipo de datos
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
Descripción
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.
Tipo de datos
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
Descripción
Subjects who refuse to receive allogenic blood products for religious or other reasons.
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C1411169
- UMLS CUI 2011AA
- CL428796
- MedDRA 14.1
- 10071089
Descripción
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).
Tipo de datos
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
Descripción
Subjects who have participated in an investigational drug study within the past 30 days.
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C2348568
- HL7 V3 2006_05
- PART
- UMLS CUI 2011AA
- C0013230
Descripción
Subjects with a history of deep vein thrombosis or pulmonary embolism.
Tipo de datos
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
Descripción
Subjects who are pregnant or breast feeding.
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C0549206
- MedDRA 14.1
- 10036586
- UMLS CUI 2011AA
- C0006147
- MedDRA 14.1
- 10006247
Descripción
Women of childbearing potential in whom the possibility of pregnancy cannot be excluded by a negative serum pregnancy test at screening.
Tipo de datos
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
Descripción
Women of childbearing potential who are not using a reliable method of contraception.
Tipo de datos
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
Descripción
Planned use of other antifibrinolytic agents.
Tipo de datos
boolean
Alias
- UMLS CUI 2011AA
- C0003304
- SNOMED CT 2011_0131
- 75064004
Descripción
Subjects on chronic anticoagulant treatment with Vit K antagonists that cannot be temporarily discontinued for the surgical procedure (as per local practices).
Tipo de datos
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
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