ID

44331

Description

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

Link

https://clinicaltrials.gov/show/NCT00131872

Keywords

Versions (3)
  1. 9/9/16 9/9/16 -
  2. 9/2/21 9/2/21 -
  3. 9/20/21 9/20/21 -
Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility End Stage Renal Disease NCT00131872

English

Eligibility End Stage Renal Disease NCT00131872

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patient has chronic renal failure and requires vascular access for hemodialysis
Description

Chronic Kidney Failure Requirement vascular access Hemodialysis

Data type

boolean

Alias
UMLS CUI [1,1]
C0022661
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0750138
UMLS CUI [1,4]
C0019004
patient has given informed consent to participate in the trial and is willing to comply with the study protocol
Description

Informed Consent | Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2]
C0525058
patient is male or female, 18 years of age or older
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
the vascular access graft can be placed in the upper extremity (forearm, including across the elbow, or upper arm)
Description

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

Data type

boolean

Alias
UMLS CUI [1,1]
C0398232
UMLS CUI [1,2]
C1140618
UMLS CUI [2,1]
C0398232
UMLS CUI [2,2]
C0016536
UMLS CUI [2,3]
C0332257
UMLS CUI [2,4]
C0013769
UMLS CUI [3,1]
C0398232
UMLS CUI [3,2]
C0446516
patient is undergoing or will undergo hemodialysis at a hospital or hemodialysis center
Description

Hemodialysis, maintenance in hospital | Hemodialysis Hemodialysis Units

Data type

boolean

Alias
UMLS CUI [1]
C0200022
UMLS CUI [2,1]
C0019004
UMLS CUI [2,2]
C0019007
patient has a vein 4 mm or larger to which the graft can be anastomosed
Description

Patient Has Vein Diameter | Anastomosis vascular access graft

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C3539897
UMLS CUI [1,3]
C0042449
UMLS CUI [1,4]
C1301886
UMLS CUI [2,1]
C0677554
UMLS CUI [2,2]
C0493494
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patient is unable to comply with the study follow-up
Description

Clinical Study Follow-up Compliance behavior Limited

Data type

boolean

Alias
UMLS CUI [1,1]
C3274571
UMLS CUI [1,2]
C1321605
UMLS CUI [1,3]
C0439801
patient has a known sensitivity to polyurethane or porcine heparin
Description

Sensitivity Polyurethanes | Sensitivity heparin, porcine

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0032616
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0770546
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
Description

Insertion of graft for vascular access Previous | Insertion of graft for vascular access Investigational Unsuccessful

Data type

boolean

Alias
UMLS CUI [1,1]
C0398232
UMLS CUI [1,2]
C0205156
UMLS CUI [2,1]
C0398232
UMLS CUI [2,2]
C1517586
UMLS CUI [2,3]
C1272705
patient has an immunodeficiency syndrome
Description

Immunologic Deficiency Syndrome

Data type

boolean

Alias
UMLS CUI [1]
C0021051
patient has a prior history of bacterial infection within 8 weeks of implantation of graft
Description

Bacterial Infection

Data type

boolean

Alias
UMLS CUI [1]
C0004623
patient has a severe coagulation disorder
Description

Blood Coagulation Disorder Severe

Data type

boolean

Alias
UMLS CUI [1,1]
C0005779
UMLS CUI [1,2]
C0205082
patient has an elevated platelet count of greater than 1 million
Description

Increased number of platelets

Data type

boolean

Alias
UMLS CUI [1]
C0857460
patient has a history of heparin-induced thrombocytopenia syndrome (hit)
Description

Heparin induced thrombocytopenia (HIT)

Data type

boolean

Alias
UMLS CUI [1]
C0272285
patient is pregnant
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
patient has a fever greater than 100 degrees fahrenheit
Description

Fever Degrees fahrenheit

Data type

boolean

Alias
UMLS CUI [1,1]
C0015967
UMLS CUI [1,2]
C0456628
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Similar models

Eligibility End Stage Renal Disease NCT00131872

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
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])
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])
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])
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])
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])
C0677554 (UMLS CUI [2,1])
C0493494 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
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])
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])
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])
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])
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
C0272285 (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])
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