ID

24467

Description

Pharmacokinetic Study of Fondaparinux in Outpatients With Renal Dysfunction; ODM derived from: https://clinicaltrials.gov/show/NCT00483600

Link

https://clinicaltrials.gov/show/NCT00483600

Keywords

  1. 8/2/17 8/2/17 -
Uploaded on

August 2, 2017

DOI

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License

Creative Commons BY 4.0

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Eligibility Kidney Diseases NCT00483600

Eligibility Kidney Diseases NCT00483600

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
outpatients in the medicine and nephrology clinics who are 18 years or older,
Description

Outpatients | Age

Data type

boolean

Alias
UMLS CUI [1]
C0029921
UMLS CUI [2]
C0001779
outpatients in the medicine and nephrology clinics who have an estimated creatinine clearances between 20-30ml/min,
Description

Outpatients | Creatinine clearance Estimated

Data type

boolean

Alias
UMLS CUI [1]
C0029921
UMLS CUI [2,1]
C0373595
UMLS CUI [2,2]
C0750572
outpatients in the medicine and nephrology clinics who are able to give consent will be included.
Description

Outpatients | Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0029921
UMLS CUI [2]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
anticoagulation therapy for thrombosis or other indication
Description

Anticoagulation Therapy Thrombosis | Indication for Anticoagulation Therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0003281
UMLS CUI [1,2]
C0040053
UMLS CUI [2,1]
C0392360
UMLS CUI [2,2]
C0003281
pregnant or breast-feeding
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
hypersensitivity to fondaparinux
Description

Hypersensitivity fondaparinux

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1098510
subjects also will be excluded if there is concern for an increased risk of bleeding which includes the following:
Description

Bleeding Risk Increased

Data type

boolean

Alias
UMLS CUI [1,1]
C3251812
UMLS CUI [1,2]
C0205217
known bleeding disorder (see section 8. hemostatic assessment)
Description

Blood Coagulation Disorders

Data type

boolean

Alias
UMLS CUI [1]
C0005779
blood transfusion in the past 3 months
Description

Blood Transfusion

Data type

boolean

Alias
UMLS CUI [1]
C0005841
acute ulcer disease with past 3 months
Description

Peptic Ulcer

Data type

boolean

Alias
UMLS CUI [1]
C0030920
platelet count < 120,000 mm3
Description

Platelet Count measurement

Data type

boolean

Alias
UMLS CUI [1]
C0032181
prolonged baseline prothrombin time (pt) or activated partial thromboplastin time (aptt) above upper limit of normal laboratory range
Description

Prothrombin time increased | Activated Partial Thromboplastin Time measurement

Data type

boolean

Alias
UMLS CUI [1]
C0151872
UMLS CUI [2]
C0030605
major trauma or surgery within two weeks prior to enrollment
Description

Major injury | Major surgery

Data type

boolean

Alias
UMLS CUI [1]
C0332677
UMLS CUI [2]
C0679637
history of intracranial hemorrhage
Description

Intracranial Hemorrhages

Data type

boolean

Alias
UMLS CUI [1]
C0151699

Similar models

Eligibility Kidney Diseases NCT00483600

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Outpatients | Age
Item
outpatients in the medicine and nephrology clinics who are 18 years or older,
boolean
C0029921 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Outpatients | Creatinine clearance Estimated
Item
outpatients in the medicine and nephrology clinics who have an estimated creatinine clearances between 20-30ml/min,
boolean
C0029921 (UMLS CUI [1])
C0373595 (UMLS CUI [2,1])
C0750572 (UMLS CUI [2,2])
Outpatients | Informed Consent
Item
outpatients in the medicine and nephrology clinics who are able to give consent will be included.
boolean
C0029921 (UMLS CUI [1])
C0021430 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Anticoagulation Therapy Thrombosis | Indication for Anticoagulation Therapy
Item
anticoagulation therapy for thrombosis or other indication
boolean
C0003281 (UMLS CUI [1,1])
C0040053 (UMLS CUI [1,2])
C0392360 (UMLS CUI [2,1])
C0003281 (UMLS CUI [2,2])
Pregnancy | Breast Feeding
Item
pregnant or breast-feeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Hypersensitivity fondaparinux
Item
hypersensitivity to fondaparinux
boolean
C0020517 (UMLS CUI [1,1])
C1098510 (UMLS CUI [1,2])
Bleeding Risk Increased
Item
subjects also will be excluded if there is concern for an increased risk of bleeding which includes the following:
boolean
C3251812 (UMLS CUI [1,1])
C0205217 (UMLS CUI [1,2])
Blood Coagulation Disorders
Item
known bleeding disorder (see section 8. hemostatic assessment)
boolean
C0005779 (UMLS CUI [1])
Blood Transfusion
Item
blood transfusion in the past 3 months
boolean
C0005841 (UMLS CUI [1])
Peptic Ulcer
Item
acute ulcer disease with past 3 months
boolean
C0030920 (UMLS CUI [1])
Platelet Count measurement
Item
platelet count < 120,000 mm3
boolean
C0032181 (UMLS CUI [1])
Prothrombin time increased | Activated Partial Thromboplastin Time measurement
Item
prolonged baseline prothrombin time (pt) or activated partial thromboplastin time (aptt) above upper limit of normal laboratory range
boolean
C0151872 (UMLS CUI [1])
C0030605 (UMLS CUI [2])
Major injury | Major surgery
Item
major trauma or surgery within two weeks prior to enrollment
boolean
C0332677 (UMLS CUI [1])
C0679637 (UMLS CUI [2])
Intracranial Hemorrhages
Item
history of intracranial hemorrhage
boolean
C0151699 (UMLS CUI [1])

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