ID

41347

Descripción

Study ID: 105043/013 Clinical Study ID: 105043/013 Study Title: An Open-Label Study of Argatroban Injection to Evaluate the Safety and Effectiveness in Pediatric Patients Requiring Anticoagulant Alternatives to Heparin (Protocol SKF105043/013) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00039858 Sponsor: GlaxoSmithKline Collaborators: Encysive Pharmaceuticals Phase: Phase 4 Study Recruitment Status: Completed Generic Name: Argatroban Trade Name: N/A Study Indication: Thrombosis This Study evaluates the safety and the efficacy of i.v. Argatroban treatment in paediatric patients which require anticoagulants but aren't suitable for Heparin treatment. The study consists of screening visit (pre-treatment examination), treatment period of maximum 14 days after reaching therapeutical dose, post-treatment visit (once the treatment is stopped or after 14 days) and a follow-up visit which follows 30 days (+/- 14 days) after clinical resolution of underlying condition or after the end of the 14-day study period. Treatment can be continued after the 14-day study period if needed but such treatment isn't part of this Study. See https://clinicaltrials.gov/ct2/show/NCT00039858 The Chemistry Form has to be filled in twice: first, at the screening visit (withing 96 hours before treatment initiation) and second, within 24 hours of final infusion completion or at the 30-day follow-up visit, whichever comes first.

Link

https://clinicaltrials.gov/ct2/show/NCT00039858

Palabras clave

Versiones (2)
  1. 2020-08-31 2020-08-31 -
  2. 2020-09-02 2020-09-02 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

2 september 2020

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY-NC 4.0
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    Safety and Efficacy of Argatroban in Pediatric Patients, NCT00039858

    Inglés

    Chemistry (pre-/post-treatment)

    1 formularios  
    Administrative Data
    Descripción

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722
    Site #
    Descripción

    Study centre number

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C0600091
    UMLS CUI [1,2]
    C0019994
    Patient #
    Descripción

    patient ID

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C2348585
    Visit Date
    Descripción

    visit date

    Tipo de datos

    date

    Alias
    UMLS CUI [1]
    C1320303
    Investigator Name
    Descripción

    Investigator Name

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C2826892
    Visit Type
    Descripción

    Visit Type

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0545082
    UMLS CUI [1,2]
    C0332307
    Chemistry
    Descripción

    Chemistry

    Alias
    UMLS CUI-1
    C2347783
    Date:
    Descripción

    (dd-mmm-yyyy)

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C0008000
    Time:
    Descripción

    (0000-2359)

    Tipo de datos

    time

    Alias
    UMLS CUI [1,1]
    C0040223
    UMLS CUI [1,2]
    C0008000
    Not Done
    Descripción

    Laboratory procedures not performed - clinical chemistry

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0022885
    UMLS CUI [1,2]
    C0445106
    UMLS CUI [1,3]
    C0008000
    Laboratory Name:
    Descripción

    (Lab name must match name on lab normals.)

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C3258037
    UMLS CUI [1,2]
    C0008000
    Check to indicate copy of associated lab report is attached to CRF.
    Descripción

    Copy of clinical chemistry report attached

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0684224
    UMLS CUI [1,2]
    C0008000
    SGPT (ALT) - Result
    Descripción

    (numeric value only)

    Tipo de datos

    float

    Alias
    UMLS CUI [1]
    C0201836
    SGPT (ALT) - Clinically Significant
    Descripción

    ALT measurement - clinical significance

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0201836
    UMLS CUI [1,2]
    C2826293
    SGPT (ALT) - If clinically significant, please comment
    Descripción

    ALT measurement - comment

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0201836
    UMLS CUI [1,2]
    C0947611
    SGOT (AST) - Result
    Descripción

    (numeric value only)

    Tipo de datos

    float

    Alias
    UMLS CUI [1]
    C0201899
    SGOT (AST) - Clinically Significant
    Descripción

    AST measurement - clinical significance

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0201899
    UMLS CUI [1,2]
    C2826293
    SGOT (AST) - If clinically significant, please comment
    Descripción

    AST measurement - comment

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0201899
    UMLS CUI [1,2]
    C0947611
    Alkaline Phos. - Result
    Descripción

    (numeric value only)

    Tipo de datos

    float

    Alias
    UMLS CUI [1]
    C0201850
    Alkaline Phos. - Clinically Significant
    Descripción

    ALP measurement - clinical significance

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0201850
    UMLS CUI [1,2]
    C2826293
    Alkaline Phos. - If clinically significant, please comment
    Descripción

    ALP measurement - comment

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0201850
    UMLS CUI [1,2]
    C0947611
    Total Bilirubin - Result
    Descripción

    (numeric value only)

    Tipo de datos

    float

    Alias
    UMLS CUI [1]
    C0201913
    Total Bilirubin - Clinically Significant
    Descripción

    Total bilirubin measurement - clinical significance

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0201913
    UMLS CUI [1,2]
    C2826293
    Total Bilirubin - If clinically significant, please comment
    Descripción

    Total bilirubin measurement - comment

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0201913
    UMLS CUI [1,2]
    C0947611
    BUN - Result
    Descripción

    (numeric value only)

    Tipo de datos

    float

    Alias
    UMLS CUI [1]
    C0005845
    BUN - Clinically Significant
    Descripción

    BUN measurement - clinical significance

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0005845
    UMLS CUI [1,2]
    C2826293
    BUN - If clinically significant, please comment
    Descripción

    BUN measurement - comment

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0005845
    UMLS CUI [1,2]
    C0947611
    Chloride - Result
    Descripción

    (numeric value only)

    Tipo de datos

    float

    Alias
    UMLS CUI [1]
    C0201952
    Chloride - Clinically Significant
    Descripción

    Chloride measurement - clinical significance

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0201952
    UMLS CUI [1,2]
    C2826293
    Chloride - If clinically significant, please comment
    Descripción

    Chloride measurement - comment

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0201952
    UMLS CUI [1,2]
    C0947611
    Creatinine - Result
    Descripción

    (numeric value only)

    Tipo de datos

    float

    Alias
    UMLS CUI [1]
    C0201975
    Creatinine - Clinically Significant
    Descripción

    Creatinine measurement - clinical significance

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0201975
    UMLS CUI [1,2]
    C2826293
    Creatinine - If clinically significant, please comment
    Descripción

    Creatinine measurement - comment

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0201975
    UMLS CUI [1,2]
    C0947611
    Glucose - Result
    Descripción

    (numeric value only)

    Tipo de datos

    float

    Alias
    UMLS CUI [1]
    C0337438
    Glucose - Clinically Significant
    Descripción

    Glucose measurement - clinical significance

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0337438
    UMLS CUI [1,2]
    C2826293
    Glucose - If clinically significant, please comment
    Descripción

    Glucose measurement - comment

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0337438
    UMLS CUI [1,2]
    C0947611
    K - Result
    Descripción

    (numeric value only)

    Tipo de datos

    float

    Alias
    UMLS CUI [1]
    C0202194
    K - Clinically Significant
    Descripción

    Potassium measurement - clinical significance

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0202194
    UMLS CUI [1,2]
    C2826293
    K - If clinically significant, please comment
    Descripción

    Potassium measurement - comment

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0202194
    UMLS CUI [1,2]
    C0947611
    Na - Result
    Descripción

    (numeric value only)

    Tipo de datos

    float

    Alias
    UMLS CUI [1]
    C0337443
    Na - Clinically Significant
    Descripción

    Sodium measurement - clinical significance

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0337443
    UMLS CUI [1,2]
    C2826293
    Na - If clinically significant, please comment
    Descripción

    Sodium measurement - comment

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0337443
    UMLS CUI [1,2]
    C0947611
    CO2 - Result
    Descripción

    (numeric value only)

    Tipo de datos

    float

    Alias
    UMLS CUI [1]
    C0201930
    CO2 - Clinically Significant
    Descripción

    Carbon dioxide measurement - clinical significance

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0201930
    UMLS CUI [1,2]
    C2826293
    CO2 - If clinically significant, please comment
    Descripción

    Carbon dioxide measurement - comment

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0201930
    UMLS CUI [1,2]
    C0947611
    Other - Specify:
    Descripción

    (specify test name)

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C2347783
    UMLS CUI [1,2]
    C0205394
    UMLS CUI [1,3]
    C1521902
    Other - Result
    Descripción

    (numeric value only)

    Tipo de datos

    float

    Alias
    UMLS CUI [1,1]
    C2347783
    UMLS CUI [1,2]
    C0205394
    Other - Clinically Significant
    Descripción

    Other clinical chemistry measurement - clinical significance

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C2347783
    UMLS CUI [1,2]
    C0205394
    UMLS CUI [1,3]
    C2826293
    Other - If clinically significant, please comment
    Descripción

    Other clinical chemistry measurement - comment

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C2347783
    UMLS CUI [1,2]
    C0205394
    UMLS CUI [1,3]
    C0947611
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    Similar models

    Chemistry (pre-/post-treatment)

    1 formularios
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de datos
    Alias
    Item Group
    Administrative Data
    C1320722 (UMLS CUI-1)
    Study centre number
    Item
    Site #
    integer
    C0600091 (UMLS CUI [1,1])
    C0019994 (UMLS CUI [1,2])
    patient ID
    Item
    Patient #
    integer
    C2348585 (UMLS CUI [1])
    visit date
    Item
    Visit Date
    date
    C1320303 (UMLS CUI [1])
    Investigator Name
    Item
    Investigator Name
    text
    C2826892 (UMLS CUI [1])
    Item
    Visit Type
    text
    C0545082 (UMLS CUI [1,1])
    C0332307 (UMLS CUI [1,2])
    Visit Type
    Code List
    Visit Type
    CL Item
    Pre-Treatment (Pre-Treatment)
    CL Item
    Post-Treatment (Post-Treatment)
    Item Group
    Chemistry
    C2347783 (UMLS CUI-1)
    Date of clinical chemistry
    Item
    Date:
    date
    C0011008 (UMLS CUI [1,1])
    C0008000 (UMLS CUI [1,2])
    Time of clinical chemistry
    Item
    Time:
    time
    C0040223 (UMLS CUI [1,1])
    C0008000 (UMLS CUI [1,2])
    Laboratory procedures not performed - clinical chemistry
    Item
    Not Done
    boolean
    C0022885 (UMLS CUI [1,1])
    C0445106 (UMLS CUI [1,2])
    C0008000 (UMLS CUI [1,3])
    Laboratory name - clinical chemistry
    Item
    Laboratory Name:
    text
    C3258037 (UMLS CUI [1,1])
    C0008000 (UMLS CUI [1,2])
    Copy of clinical chemistry report attached
    Item
    Check to indicate copy of associated lab report is attached to CRF.
    boolean
    C0684224 (UMLS CUI [1,1])
    C0008000 (UMLS CUI [1,2])
    ALT measurement
    Item
    SGPT (ALT) - Result
    float
    C0201836 (UMLS CUI [1])
    Item
    SGPT (ALT) - Clinically Significant
    text
    C0201836 (UMLS CUI [1,1])
    C2826293 (UMLS CUI [1,2])
    ALT measurement - clinical significance
    Code List
    SGPT (ALT) - Clinically Significant
    CL Item
    Yes (Yes)
    CL Item
    No (No)
    ALT measurement - comment
    Item
    SGPT (ALT) - If clinically significant, please comment
    text
    C0201836 (UMLS CUI [1,1])
    C0947611 (UMLS CUI [1,2])
    AST measurement
    Item
    SGOT (AST) - Result
    float
    C0201899 (UMLS CUI [1])
    Item
    SGOT (AST) - Clinically Significant
    text
    C0201899 (UMLS CUI [1,1])
    C2826293 (UMLS CUI [1,2])
    ALT measurement - clinical significance
    Code List
    SGOT (AST) - Clinically Significant
    CL Item
    Yes (Yes)
    CL Item
    No (No)
    AST measurement - comment
    Item
    SGOT (AST) - If clinically significant, please comment
    text
    C0201899 (UMLS CUI [1,1])
    C0947611 (UMLS CUI [1,2])
    ALP measurement
    Item
    Alkaline Phos. - Result
    float
    C0201850 (UMLS CUI [1])
    Item
    Alkaline Phos. - Clinically Significant
    text
    C0201850 (UMLS CUI [1,1])
    C2826293 (UMLS CUI [1,2])
    ALT measurement - clinical significance
    Code List
    Alkaline Phos. - Clinically Significant
    CL Item
    Yes (Yes)
    CL Item
    No (No)
    ALP measurement - comment
    Item
    Alkaline Phos. - If clinically significant, please comment
    text
    C0201850 (UMLS CUI [1,1])
    C0947611 (UMLS CUI [1,2])
    Total bilirubin measurement
    Item
    Total Bilirubin - Result
    float
    C0201913 (UMLS CUI [1])
    Item
    Total Bilirubin - Clinically Significant
    text
    C0201913 (UMLS CUI [1,1])
    C2826293 (UMLS CUI [1,2])
    ALT measurement - clinical significance
    Code List
    Total Bilirubin - Clinically Significant
    CL Item
    Yes (Yes)
    CL Item
    No (No)
    Total bilirubin measurement - comment
    Item
    Total Bilirubin - If clinically significant, please comment
    text
    C0201913 (UMLS CUI [1,1])
    C0947611 (UMLS CUI [1,2])
    BUN measurement
    Item
    BUN - Result
    float
    C0005845 (UMLS CUI [1])
    Item
    BUN - Clinically Significant
    text
    C0005845 (UMLS CUI [1,1])
    C2826293 (UMLS CUI [1,2])
    ALT measurement - clinical significance
    Code List
    BUN - Clinically Significant
    CL Item
    Yes (Yes)
    CL Item
    No (No)
    BUN measurement - comment
    Item
    BUN - If clinically significant, please comment
    text
    C0005845 (UMLS CUI [1,1])
    C0947611 (UMLS CUI [1,2])
    Chloride measurement
    Item
    Chloride - Result
    float
    C0201952 (UMLS CUI [1])
    Item
    Chloride - Clinically Significant
    text
    C0201952 (UMLS CUI [1,1])
    C2826293 (UMLS CUI [1,2])
    ALT measurement - clinical significance
    Code List
    Chloride - Clinically Significant
    CL Item
    Yes (Yes)
    CL Item
    No (No)
    Chloride measurement - comment
    Item
    Chloride - If clinically significant, please comment
    text
    C0201952 (UMLS CUI [1,1])
    C0947611 (UMLS CUI [1,2])
    Creatinine measurement
    Item
    Creatinine - Result
    float
    C0201975 (UMLS CUI [1])
    Item
    Creatinine - Clinically Significant
    text
    C0201975 (UMLS CUI [1,1])
    C2826293 (UMLS CUI [1,2])
    ALT measurement - clinical significance
    Code List
    Creatinine - Clinically Significant
    CL Item
    Yes (Yes)
    CL Item
    No (No)
    Creatinine measurement - comment
    Item
    Creatinine - If clinically significant, please comment
    text
    C0201975 (UMLS CUI [1,1])
    C0947611 (UMLS CUI [1,2])
    Glucose measurement
    Item
    Glucose - Result
    float
    C0337438 (UMLS CUI [1])
    Item
    Glucose - Clinically Significant
    text
    C0337438 (UMLS CUI [1,1])
    C2826293 (UMLS CUI [1,2])
    ALT measurement - clinical significance
    Code List
    Glucose - Clinically Significant
    CL Item
    Yes (Yes)
    CL Item
    No (No)
    Glucose measurement - comment
    Item
    Glucose - If clinically significant, please comment
    text
    C0337438 (UMLS CUI [1,1])
    C0947611 (UMLS CUI [1,2])
    Potassium measurement
    Item
    K - Result
    float
    C0202194 (UMLS CUI [1])
    Item
    K - Clinically Significant
    text
    C0202194 (UMLS CUI [1,1])
    C2826293 (UMLS CUI [1,2])
    ALT measurement - clinical significance
    Code List
    K - Clinically Significant
    CL Item
    Yes (Yes)
    CL Item
    No (No)
    Potassium measurement - comment
    Item
    K - If clinically significant, please comment
    text
    C0202194 (UMLS CUI [1,1])
    C0947611 (UMLS CUI [1,2])
    Sodium measurement
    Item
    Na - Result
    float
    C0337443 (UMLS CUI [1])
    Item
    Na - Clinically Significant
    text
    C0337443 (UMLS CUI [1,1])
    C2826293 (UMLS CUI [1,2])
    ALT measurement - clinical significance
    Code List
    Na - Clinically Significant
    CL Item
    Yes (Yes)
    CL Item
    No (No)
    Sodium measurement - comment
    Item
    Na - If clinically significant, please comment
    text
    C0337443 (UMLS CUI [1,1])
    C0947611 (UMLS CUI [1,2])
    Carbon dioxide measurement
    Item
    CO2 - Result
    float
    C0201930 (UMLS CUI [1])
    Item
    CO2 - Clinically Significant
    text
    C0201930 (UMLS CUI [1,1])
    C2826293 (UMLS CUI [1,2])
    ALT measurement - clinical significance
    Code List
    CO2 - Clinically Significant
    CL Item
    Yes (Yes)
    CL Item
    No (No)
    Carbon dioxide measurement - comment
    Item
    CO2 - If clinically significant, please comment
    text
    C0201930 (UMLS CUI [1,1])
    C0947611 (UMLS CUI [1,2])
    Other clinical chemistry - specify
    Item
    Other - Specify:
    text
    C2347783 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    C1521902 (UMLS CUI [1,3])
    Other clinical chemistry measurement - result
    Item
    Other - Result
    float
    C2347783 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    Other clinical chemistry measurement - clinical significance
    Item
    Other - Clinically Significant
    text
    C2347783 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    C2826293 (UMLS CUI [1,3])
    Other clinical chemistry measurement - comment
    Item
    Other - If clinically significant, please comment
    text
    C2347783 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    C0947611 (UMLS CUI [1,3])
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