ID
4570
Beschrijving
ODM derived from http://clinicaltrials.gov/show/NCT00327379
Link
http://clinicaltrials.gov/show/NCT00327379
Trefwoorden
Versies (2)
- 11-12-13 11-12-13 - Martin Dugas
- 17-09-21 17-09-21 -
Geüploaded op
11 december 2013
DOI
Voor een aanvraag inloggen.
Licentie
Creative Commons BY 4.0
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Eligibility NCT00327379 Postoperative Hemorrhage
Eligibility
- StudyEvent: Eligibility
Beschrijving
Ausschlusskriterien
Alias
- UMLS CUI 2011AA
- CL425201
Beschrijving
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.
Datatype
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
Beschrijving
Subjects with a known or suspected allergy to aprotinin.
Datatype
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
Beschrijving
Subjects with sepsis or a known bone infection.
Datatype
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
Beschrijving
Subjects with known bone malignancy.
Datatype
boolean
Alias
- UMLS CUI 2011AA
- C0260447
- ICD-10-CM Version 2010
- Z85.830
- ICD-9-CM Version 2011
- V10.81
Beschrijving
Subjects with a creatinine clearance <30mL/min as calculated by the Cockcroft-Gault formula.
Datatype
boolean
Alias
- UMLS CUI 2011AA
- C2711451
- SNOMED CT 2011_0131
- 442407001
- UMLS CUI 2011AA
- C0444686
- SNOMED CT 2011_0131
- 258090004
Beschrijving
Subjects with a history of bleeding diathesis or known coagulation factor deficiency.
Datatype
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
Beschrijving
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.
Datatype
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
Beschrijving
Subjects who refuse to receive allogenic blood products for religious or other reasons.
Datatype
boolean
Alias
- UMLS CUI 2011AA
- C1411169
- UMLS CUI 2011AA
- CL428796
- MedDRA 14.1
- 10071089
Beschrijving
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).
Datatype
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
Beschrijving
Subjects who have participated in an investigational drug study within the past 30 days.
Datatype
boolean
Alias
- UMLS CUI 2011AA
- C2348568
- HL7 V3 2006_05
- PART
- UMLS CUI 2011AA
- C0013230
Beschrijving
Subjects with a history of deep vein thrombosis or pulmonary embolism.
Datatype
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
Beschrijving
Subjects who are pregnant or breast feeding.
Datatype
boolean
Alias
- UMLS CUI 2011AA
- C0549206
- MedDRA 14.1
- 10036586
- UMLS CUI 2011AA
- C0006147
- MedDRA 14.1
- 10006247
Beschrijving
Women of childbearing potential in whom the possibility of pregnancy cannot be excluded by a negative serum pregnancy test at screening.
Datatype
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
Beschrijving
Women of childbearing potential who are not using a reliable method of contraception.
Datatype
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
Beschrijving
Planned use of other antifibrinolytic agents.
Datatype
boolean
Alias
- UMLS CUI 2011AA
- C0003304
- SNOMED CT 2011_0131
- 75064004
Beschrijving
Subjects on chronic anticoagulant treatment with Vit K antagonists that cannot be temporarily discontinued for the surgical procedure (as per local practices).
Datatype
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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