ID

24467

Descripción

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

Link

https://clinicaltrials.gov/show/NCT00483600

Palabras clave

Versiones (1)
  1. 2/8/17 2/8/17 -
Subido en

2 de agosto de 2017

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Kidney Diseases NCT00483600

Inglés

Eligibility Kidney Diseases NCT00483600

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

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

Outpatients | Age

Tipo de datos

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,
Descripción

Outpatients | Creatinine clearance Estimated

Tipo de datos

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.
Descripción

Outpatients | Informed Consent

Tipo de datos

boolean

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

Exclusion Criteria

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

Anticoagulation Therapy Thrombosis | Indication for Anticoagulation Therapy

Tipo de datos

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
Descripción

Pregnancy | Breast Feeding

Tipo de datos

boolean

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

Hypersensitivity fondaparinux

Tipo de datos

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:
Descripción

Bleeding Risk Increased

Tipo de datos

boolean

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

Blood Coagulation Disorders

Tipo de datos

boolean

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

Blood Transfusion

Tipo de datos

boolean

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

Peptic Ulcer

Tipo de datos

boolean

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

Platelet Count measurement

Tipo de datos

boolean

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

Prothrombin time increased | Activated Partial Thromboplastin Time measurement

Tipo de datos

boolean

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

Major injury | Major surgery

Tipo de datos

boolean

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

Intracranial Hemorrhages

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0151699
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Similar models

Eligibility Kidney Diseases NCT00483600

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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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