0 Evaluaciones
ID

41369

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 This Form has to be filled in at the screening visit. Section Pre-Treatment Anticoagulation has to be filled in within 96 hours prior to treatment initiation and additionally, if Heparin was administered, ACT or aPTT have to be measured before Heparin administration. Section Samples for Pre-Treatment PK and Confirmatory HIT Testing, Indication for Argatroban Use has to be filled in within 96 hours before treatment initiation administration. Section Indication for Argatroban Use records the indications on behalf of which is the medicament administered.

Link

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

Palabras clave

Versiones (1)
  1. 2020-09-14 2020-09-14 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

14 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

    Anticoagulation, Samples for Pre-Treatment PK and Confirmatory HIT Testing, Indication for Argatroban Use

    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
    Pre-Treatment Anticoagulation
    Descripción

    Pre-Treatment Anticoagulation

    Alias
    UMLS CUI-1
    C0003281
    UMLS CUI-2
    C0332152
    UMLS CUI-3
    C2347804
    Was heparin being administered prior to study Argatroban administration?
    Descripción

    *If Yes, ACT or aPTT results must be from BEFORE heparin was administered. **If No, ACT or aPTT results must be completed up to 96 hours prior to treatment initiation. In either case, PT/INR results must be completed within 96 hours before treatment initiation.

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0019134
    UMLS CUI [1,2]
    C0332152
    UMLS CUI [1,3]
    C4684789
    Laboratory Name:
    Descripción

    (Lab name must match name on lab normals.)

    Tipo de datos

    text

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

    Is a copy of the lab report attached?

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0684224
    UMLS CUI [1,2]
    C0587081
    aPPT
    Descripción

    (check if test performed)

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0030605
    aPPT - Date
    Descripción

    (dd-mmm-yyyy)

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C0030605
    UMLS CUI [1,2]
    C2985720
    aPPT - Time
    Descripción

    (0000-2359)

    Tipo de datos

    time

    Alias
    UMLS CUI [1,1]
    C0030605
    UMLS CUI [1,2]
    C1516048
    UMLS CUI [1,3]
    C0040223
    aPTT - Result
    Descripción

    (numeric value only)

    Tipo de datos

    float

    Alias
    UMLS CUI [1,1]
    C0030605
    UMLS CUI [1,2]
    C0587081
    aPTT - Clinically Significant
    Descripción

    aPTT - clinical significance

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0030605
    UMLS CUI [1,2]
    C2826293
    aPTT - If clinically significant, please comment
    Descripción

    aPPT - comment on clinical significance

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C1846819
    UMLS CUI [1,2]
    C0947611
    UMLS CUI [1,3]
    C2826293
    PT or INR
    Descripción

    (check which test was performed)

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C0033707
    UMLS CUI [2]
    C0525032
    PT or INR - Date
    Descripción

    (dd-mmm-yyyy)

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C0033707
    UMLS CUI [1,2]
    C2985720
    UMLS CUI [2,1]
    C0525032
    UMLS CUI [2,2]
    C2985720
    PT or INR - Time
    Descripción

    (0000-2359)

    Tipo de datos

    time

    Alias
    UMLS CUI [1,1]
    C0033707
    UMLS CUI [1,2]
    C1516048
    UMLS CUI [1,3]
    C0040223
    UMLS CUI [2,1]
    C0525032
    UMLS CUI [2,2]
    C1516048
    UMLS CUI [2,3]
    C0040223
    PT or INR - Result
    Descripción

    (numeric value only)

    Tipo de datos

    float

    Alias
    UMLS CUI [1,1]
    C0033707
    UMLS CUI [1,2]
    C0587081
    UMLS CUI [2,1]
    C0525032
    UMLS CUI [2,2]
    C0587081
    PT or INR - Clinically Significant
    Descripción

    PT - clinical significance | INR - clinical significance

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0033707
    UMLS CUI [1,2]
    C2826293
    UMLS CUI [2,1]
    C0525032
    UMLS CUI [2,2]
    C2826293
    PT or INR - If clinically significant, please comment
    Descripción

    PT - comment on clinical significance | INR - comment on clinical significance

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0033707
    UMLS CUI [1,2]
    C0947611
    UMLS CUI [1,3]
    C2826293
    UMLS CUI [2,1]
    C0525032
    UMLS CUI [2,2]
    C0947611
    UMLS CUI [2,3]
    C2826293
    ACT
    Descripción

    (check if test performed)

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0427611
    ACT - Date
    Descripción

    (dd-mmm-yyyy)

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C0427611
    UMLS CUI [1,2]
    C2985720
    ACT - Time
    Descripción

    (0000-2359)

    Tipo de datos

    time

    Alias
    UMLS CUI [1,1]
    C0427611
    UMLS CUI [1,2]
    C1516048
    UMLS CUI [1,3]
    C0040223
    ACT - Result
    Descripción

    (numeric value only)

    Tipo de datos

    float

    Alias
    UMLS CUI [1,1]
    C0427611
    UMLS CUI [1,2]
    C0587081
    ACT - Clinically Significant
    Descripción

    ACT - clinical significance

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0427611
    UMLS CUI [1,2]
    C2826293
    ACT - If clinically significant, please comment
    Descripción

    ACT - comment on clinical significance

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0427611
    UMLS CUI [1,2]
    C0947611
    UMLS CUI [1,3]
    C2826293
    Samples for Pre-Treatment PK and Confirmatory HIT Testing
    Descripción

    Samples for Pre-Treatment PK and Confirmatory HIT Testing

    Alias
    UMLS CUI-1
    C0200345
    UMLS CUI-2
    C0031328
    UMLS CUI-3
    C0919799
    Pre-treatment PK sample collected?
    Descripción

    Pharmacokinetic sample collection pre-treatment

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0200345
    UMLS CUI [1,2]
    C0031328
    UMLS CUI [1,3]
    C2709094
    *Date Collected:
    Descripción

    (dd-mmm-yyyy)

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C1302413
    UMLS CUI [1,2]
    C0031328
    *Time Collected:
    Descripción

    (0000-2359)

    Tipo de datos

    time

    Alias
    UMLS CUI [1,1]
    C0040223
    UMLS CUI [1,2]
    C0200345
    UMLS CUI [1,3]
    C0031328
    *Check to indicate PK sample sent to GSK
    Descripción

    Pharmacokinetic sample sent to sponsor

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C2347796
    UMLS CUI [1,2]
    C0031328
    UMLS CUI [1,3]
    C0370003
    UMLS CUI [1,4]
    C1515023
    Confirmatory HIT testing sample collected (only if “Yes” was answered for Inclusion Criteria 2a, 2b, or 2c)?
    Descripción

    Confirmatory HIT testing sample collection

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0200345
    UMLS CUI [1,2]
    C0919799
    UMLS CUI [1,3]
    C0750484
    *Date Collected:
    Descripción

    (dd-mmm-yyyy)

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C1302413
    UMLS CUI [1,2]
    C0919799
    *Time Collected:
    Descripción

    (0000-2359)

    Tipo de datos

    time

    Alias
    UMLS CUI [1,1]
    C0040223
    UMLS CUI [1,2]
    C0200345
    UMLS CUI [1,3]
    C0919799
    *Check to indicate confirmatory HIT sample sent to central lab
    Descripción

    HIT testing sample sent to central lab

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C1880016
    UMLS CUI [1,2]
    C0919799
    UMLS CUI [1,3]
    C0370003
    UMLS CUI [1,4]
    C1515023
    Indication for Argatroban Use
    Descripción

    Indication for Argatroban Use

    Alias
    UMLS CUI-1
    C3146298
    UMLS CUI-2
    C0048470
    Cardiac catherization
    Descripción

    Cardiac catherization

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0018795
    Cardiac surgery
    Descripción

    Cardiac surgery

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0018821
    VAD
    Descripción

    Artificial ventricle

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0085842
    ECMO
    Descripción

    ECMO

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0015357
    Hemodialysis
    Descripción

    Hemodialysis

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0019004
    CVVH
    Descripción

    CVVH

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0472684
    Clinical condition requiring continuous infusion therapy
    Descripción

    Clinical condition requiring continuous infusion therapy

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0348080
    UMLS CUI [1,2]
    C1514873
    UMLS CUI [1,3]
    C1511497
    Other
    Descripción

    Other clinical condition

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C3843040
    Other, specify:
    Descripción

    Other clinical condition - specify

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C3843040
    UMLS CUI [1,2]
    C1521902
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    Similar models

    Anticoagulation, Samples for Pre-Treatment PK and Confirmatory HIT Testing, Indication for Argatroban Use

    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 Group
    Pre-Treatment Anticoagulation
    C0003281 (UMLS CUI-1)
    C0332152 (UMLS CUI-2)
    C2347804 (UMLS CUI-3)
    Item
    Was heparin being administered prior to study Argatroban administration?
    text
    C0019134 (UMLS CUI [1,1])
    C0332152 (UMLS CUI [1,2])
    C4684789 (UMLS CUI [1,3])
    Heparin administered prior to study
    Code List
    Was heparin being administered prior to study Argatroban administration?
    CL Item
    Yes* (Yes*)
    CL Item
    No** (No**)
    Laboratory Name
    Item
    Laboratory Name:
    text
    C3258037 (UMLS CUI [1])
    Is a copy of the lab report attached?
    Item
    Check to indicate copy of associated lab report is attached to CRF.
    boolean
    C0684224 (UMLS CUI [1,1])
    C0587081 (UMLS CUI [1,2])
    aPPT
    Item
    aPPT
    boolean
    C0030605 (UMLS CUI [1])
    aPPT - Assessment Date
    Item
    aPPT - Date
    date
    C0030605 (UMLS CUI [1,1])
    C2985720 (UMLS CUI [1,2])
    aPPT - Assessment Time
    Item
    aPPT - Time
    time
    C0030605 (UMLS CUI [1,1])
    C1516048 (UMLS CUI [1,2])
    C0040223 (UMLS CUI [1,3])
    aPTT - test result
    Item
    aPTT - Result
    float
    C0030605 (UMLS CUI [1,1])
    C0587081 (UMLS CUI [1,2])
    Item
    aPTT - Clinically Significant
    text
    C0030605 (UMLS CUI [1,1])
    C2826293 (UMLS CUI [1,2])
    aPTT - clinical significance
    Code List
    aPTT - Clinically Significant
    CL Item
    Yes (Yes)
    CL Item
    No (No)
    CL Item
    NA (NA)
    aPPT - comment on clinical significance
    Item
    aPTT - If clinically significant, please comment
    text
    C1846819 (UMLS CUI [1,1])
    C0947611 (UMLS CUI [1,2])
    C2826293 (UMLS CUI [1,3])
    Item
    PT or INR
    text
    C0033707 (UMLS CUI [1])
    C0525032 (UMLS CUI [2])
    PT | INR
    Code List
    PT or INR
    CL Item
    PT (PT)
    CL Item
    INR (INR)
    PT - Assessment Date | INR - Assessment Date
    Item
    PT or INR - Date
    date
    C0033707 (UMLS CUI [1,1])
    C2985720 (UMLS CUI [1,2])
    C0525032 (UMLS CUI [2,1])
    C2985720 (UMLS CUI [2,2])
    PT - Assessment Time | INR - Assessment Time
    Item
    PT or INR - Time
    time
    C0033707 (UMLS CUI [1,1])
    C1516048 (UMLS CUI [1,2])
    C0040223 (UMLS CUI [1,3])
    C0525032 (UMLS CUI [2,1])
    C1516048 (UMLS CUI [2,2])
    C0040223 (UMLS CUI [2,3])
    PT - test result | INR - test result
    Item
    PT or INR - Result
    float
    C0033707 (UMLS CUI [1,1])
    C0587081 (UMLS CUI [1,2])
    C0525032 (UMLS CUI [2,1])
    C0587081 (UMLS CUI [2,2])
    Item
    PT or INR - Clinically Significant
    text
    C0033707 (UMLS CUI [1,1])
    C2826293 (UMLS CUI [1,2])
    C0525032 (UMLS CUI [2,1])
    C2826293 (UMLS CUI [2,2])
    aPTT - clinical significance
    Code List
    PT or INR - Clinically Significant
    CL Item
    Yes (Yes)
    CL Item
    No (No)
    CL Item
    NA (NA)
    PT - comment on clinical significance | INR - comment on clinical significance
    Item
    PT or INR - If clinically significant, please comment
    text
    C0033707 (UMLS CUI [1,1])
    C0947611 (UMLS CUI [1,2])
    C2826293 (UMLS CUI [1,3])
    C0525032 (UMLS CUI [2,1])
    C0947611 (UMLS CUI [2,2])
    C2826293 (UMLS CUI [2,3])
    ACT
    Item
    ACT
    boolean
    C0427611 (UMLS CUI [1])
    ACT - Assessment Date
    Item
    ACT - Date
    date
    C0427611 (UMLS CUI [1,1])
    C2985720 (UMLS CUI [1,2])
    ACT - Assessment Time
    Item
    ACT - Time
    time
    C0427611 (UMLS CUI [1,1])
    C1516048 (UMLS CUI [1,2])
    C0040223 (UMLS CUI [1,3])
    ACT - test result
    Item
    ACT - Result
    float
    C0427611 (UMLS CUI [1,1])
    C0587081 (UMLS CUI [1,2])
    Item
    ACT - Clinically Significant
    text
    C0427611 (UMLS CUI [1,1])
    C2826293 (UMLS CUI [1,2])
    aPTT - clinical significance
    Code List
    ACT - Clinically Significant
    CL Item
    Yes (Yes)
    CL Item
    No (No)
    CL Item
    NA (NA)
    ACT - comment on clinical significance
    Item
    ACT - If clinically significant, please comment
    text
    C0427611 (UMLS CUI [1,1])
    C0947611 (UMLS CUI [1,2])
    C2826293 (UMLS CUI [1,3])
    Item Group
    Samples for Pre-Treatment PK and Confirmatory HIT Testing
    C0200345 (UMLS CUI-1)
    C0031328 (UMLS CUI-2)
    C0919799 (UMLS CUI-3)
    Item
    Pre-treatment PK sample collected?
    text
    C0200345 (UMLS CUI [1,1])
    C0031328 (UMLS CUI [1,2])
    C2709094 (UMLS CUI [1,3])
    Pharmacokinetic sample collection
    Code List
    Pre-treatment PK sample collected?
    CL Item
    Yes* (Yes*)
    CL Item
    No (No)
    Pharmacokinetic sample collection date
    Item
    *Date Collected:
    date
    C1302413 (UMLS CUI [1,1])
    C0031328 (UMLS CUI [1,2])
    Pharmacokinetic sample collection time
    Item
    *Time Collected:
    time
    C0040223 (UMLS CUI [1,1])
    C0200345 (UMLS CUI [1,2])
    C0031328 (UMLS CUI [1,3])
    Pharmacokinetic sample sent to sponsor
    Item
    *Check to indicate PK sample sent to GSK
    boolean
    C2347796 (UMLS CUI [1,1])
    C0031328 (UMLS CUI [1,2])
    C0370003 (UMLS CUI [1,3])
    C1515023 (UMLS CUI [1,4])
    Item
    Confirmatory HIT testing sample collected (only if “Yes” was answered for Inclusion Criteria 2a, 2b, or 2c)?
    text
    C0200345 (UMLS CUI [1,1])
    C0919799 (UMLS CUI [1,2])
    C0750484 (UMLS CUI [1,3])
    Pharmacokinetic sample collection
    Code List
    Confirmatory HIT testing sample collected (only if “Yes” was answered for Inclusion Criteria 2a, 2b, or 2c)?
    CL Item
    Yes* (Yes*)
    CL Item
    No (No)
    CL Item
    N/A (N/A)
    HIT testing sample collection date
    Item
    *Date Collected:
    date
    C1302413 (UMLS CUI [1,1])
    C0919799 (UMLS CUI [1,2])
    HIT testing sample collection time
    Item
    *Time Collected:
    time
    C0040223 (UMLS CUI [1,1])
    C0200345 (UMLS CUI [1,2])
    C0919799 (UMLS CUI [1,3])
    HIT testing sample sent to central lab
    Item
    *Check to indicate confirmatory HIT sample sent to central lab
    boolean
    C1880016 (UMLS CUI [1,1])
    C0919799 (UMLS CUI [1,2])
    C0370003 (UMLS CUI [1,3])
    C1515023 (UMLS CUI [1,4])
    Item Group
    Indication for Argatroban Use
    C3146298 (UMLS CUI-1)
    C0048470 (UMLS CUI-2)
    Cardiac catherization
    Item
    Cardiac catherization
    boolean
    C0018795 (UMLS CUI [1])
    Cardiac surgery
    Item
    Cardiac surgery
    boolean
    C0018821 (UMLS CUI [1])
    Artificial ventricle
    Item
    VAD
    boolean
    C0085842 (UMLS CUI [1])
    ECMO
    Item
    ECMO
    boolean
    C0015357 (UMLS CUI [1])
    Hemodialysis
    Item
    Hemodialysis
    boolean
    C0019004 (UMLS CUI [1])
    CVVH
    Item
    CVVH
    boolean
    C0472684 (UMLS CUI [1])
    Clinical condition requiring continuous infusion therapy
    Item
    Clinical condition requiring continuous infusion therapy
    boolean
    C0348080 (UMLS CUI [1,1])
    C1514873 (UMLS CUI [1,2])
    C1511497 (UMLS CUI [1,3])
    Other clinical condition
    Item
    Other
    boolean
    C3843040 (UMLS CUI [1])
    Other clinical condition - specify
    Item
    Other, specify:
    text
    C3843040 (UMLS CUI [1,1])
    C1521902 (UMLS CUI [1,2])
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