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Information:
Fel:
ID
17365
Beskrivning
Study to Evaluate the Performance and Safety of Expedial and Compare it to Expanded Polytetrafluoroethylene (ePTFE) Vascular Access Grafts; ODM derived from: https://clinicaltrials.gov/show/NCT00131872
Länk
https://clinicaltrials.gov/show/NCT00131872
Nyckelord
Versioner (3)
- 2016-09-09 2016-09-09 -
- 2021-09-02 2021-09-02 -
- 2021-09-20 2021-09-20 -
Uppladdad den
9 september 2016
DOI
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Licens
Creative Commons BY 4.0
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Eligibility End Stage Renal Disease NCT00131872
Eligibility End Stage Renal Disease NCT00131872
- StudyEvent: Eligibility
Similar models
Eligibility End Stage Renal Disease NCT00131872
- StudyEvent: Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Chronic Kidney Failure Requirement vascular access Hemodialysis
Item
patient has chronic renal failure and requires vascular access for hemodialysis
boolean
C0022661 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0750138 (UMLS CUI [1,3])
C0019004 (UMLS CUI [1,4])
C1514873 (UMLS CUI [1,2])
C0750138 (UMLS CUI [1,3])
C0019004 (UMLS CUI [1,4])
Informed Consent | Protocol Compliance
Item
patient has given informed consent to participate in the trial and is willing to comply with the study protocol
boolean
C0021430 (UMLS CUI [1])
C0525058 (UMLS CUI [2])
C0525058 (UMLS CUI [2])
Age
Item
patient is male or female, 18 years of age or older
boolean
C0001779 (UMLS CUI [1])
Insertion of graft for vascular access Upper Extremity | Insertion of graft for vascular access Forearm Including Elbow | Insertion of graft for vascular access Upper arm
Item
the vascular access graft can be placed in the upper extremity (forearm, including across the elbow, or upper arm)
boolean
C0398232 (UMLS CUI [1,1])
C1140618 (UMLS CUI [1,2])
C0398232 (UMLS CUI [2,1])
C0016536 (UMLS CUI [2,2])
C0332257 (UMLS CUI [2,3])
C0013769 (UMLS CUI [2,4])
C0398232 (UMLS CUI [3,1])
C0446516 (UMLS CUI [3,2])
C1140618 (UMLS CUI [1,2])
C0398232 (UMLS CUI [2,1])
C0016536 (UMLS CUI [2,2])
C0332257 (UMLS CUI [2,3])
C0013769 (UMLS CUI [2,4])
C0398232 (UMLS CUI [3,1])
C0446516 (UMLS CUI [3,2])
Hemodialysis, maintenance in hospital | Hemodialysis Hemodialysis Units
Item
patient is undergoing or will undergo hemodialysis at a hospital or hemodialysis center
boolean
C0200022 (UMLS CUI [1])
C0019004 (UMLS CUI [2,1])
C0019007 (UMLS CUI [2,2])
C0019004 (UMLS CUI [2,1])
C0019007 (UMLS CUI [2,2])
Patient Has Vein Diameter | Anastomosis vascular access graft
Item
patient has a vein 4 mm or larger to which the graft can be anastomosed
boolean
C0030705 (UMLS CUI [1,1])
C3539897 (UMLS CUI [1,2])
C0042449 (UMLS CUI [1,3])
C1301886 (UMLS CUI [1,4])
C0002805 (UMLS CUI [2,1])
C0493494 (UMLS CUI [2,2])
C3539897 (UMLS CUI [1,2])
C0042449 (UMLS CUI [1,3])
C1301886 (UMLS CUI [1,4])
C0002805 (UMLS CUI [2,1])
C0493494 (UMLS CUI [2,2])
Clinical Study Follow-up Compliance behavior Limited
Item
patient is unable to comply with the study follow-up
boolean
C3274571 (UMLS CUI [1,1])
C1321605 (UMLS CUI [1,2])
C0439801 (UMLS CUI [1,3])
C1321605 (UMLS CUI [1,2])
C0439801 (UMLS CUI [1,3])
Sensitivity Polyurethanes | Sensitivity heparin, porcine
Item
patient has a known sensitivity to polyurethane or porcine heparin
boolean
C0020517 (UMLS CUI [1,1])
C0032616 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0770546 (UMLS CUI [2,2])
C0032616 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0770546 (UMLS CUI [2,2])
Insertion of graft for vascular access Previous | Insertion of graft for vascular access Investigational Unsuccessful
Item
patient has a previous vascular access graft implanted and it is not possible to place the study graft proximal to the existing device and no other sites are available
boolean
C0398232 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0398232 (UMLS CUI [2,1])
C1517586 (UMLS CUI [2,2])
C1272705 (UMLS CUI [2,3])
C0205156 (UMLS CUI [1,2])
C0398232 (UMLS CUI [2,1])
C1517586 (UMLS CUI [2,2])
C1272705 (UMLS CUI [2,3])
Immunologic Deficiency Syndrome
Item
patient has an immunodeficiency syndrome
boolean
C0021051 (UMLS CUI [1])
Bacterial Infection
Item
patient has a prior history of bacterial infection within 8 weeks of implantation of graft
boolean
C0004623 (UMLS CUI [1])
Blood Coagulation Disorder Severe
Item
patient has a severe coagulation disorder
boolean
C0005779 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0205082 (UMLS CUI [1,2])
Increased number of platelets
Item
patient has an elevated platelet count of greater than 1 million
boolean
C0857460 (UMLS CUI [1])
Heparin induced thrombocytopenia (HIT)
Item
patient has a history of heparin-induced thrombocytopenia syndrome (hit)
boolean
C2349404 (UMLS CUI [1])
Pregnancy
Item
patient is pregnant
boolean
C0032961 (UMLS CUI [1])
Fever Degrees fahrenheit
Item
patient has a fever greater than 100 degrees fahrenheit
boolean
C0015967 (UMLS CUI [1,1])
C0456628 (UMLS CUI [1,2])
C0456628 (UMLS CUI [1,2])