0 Ratings
ID

41354

Description

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 during the Treatment period after Circuit Prime is administered and whenever a Bolus of Argatroban is administered. Continuous infusions are recorded in a separate form.

Link

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

Keywords

Versions (1)
  1. 9/3/20 9/3/20 -
Copyright Holder

GlaxoSmithKline

Uploaded on

September 3, 2020

DOI

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License

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

    English

    Dosing Information - Circuit Prime and Bolus

    1 forms  
    Administrative Data
    Description

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722
    Site #
    Description

    Study centre number

    Data type

    integer

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

    patient ID

    Data type

    integer

    Alias
    UMLS CUI [1]
    C2348585
    Visit Date
    Description

    visit date

    Data type

    date

    Alias
    UMLS CUI [1]
    C1320303
    Investigator Name
    Description

    Investigator Name

    Data type

    text

    Alias
    UMLS CUI [1]
    C2826892
    Check if (additional) supplemental instance of this form was used.
    Description

    Use one instance for every prime or for every nine boluses. Check this box on all instances except for the last one.

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1706499
    Instance Number
    Description

    Fill in the instance number, starting from 1. On all instances except for the last one, the preceding box has to be checked.

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1516308
    UMLS CUI [1,2]
    C2348184
    Dosing Information - Circuit Prime
    Description

    Dosing Information - Circuit Prime

    Alias
    UMLS CUI-1
    C0678766
    UMLS CUI-2
    C1533716
    UMLS CUI-3
    C3805286
    Equipment primed?
    Description

    *Protocol violation

    Data type

    text

    Alias
    UMLS CUI [1]
    C3805286
    **Primed dose: __ μg/__mL
    Description

    Part to be filled in: μg **Recommend 50μg/750mL

    Data type

    integer

    Measurement units
    • μg
    Alias
    UMLS CUI [1,1]
    C3174092
    UMLS CUI [1,2]
    C0304229
    UMLS CUI [1,3]
    C3805286
    μg
    **Primed dose: __ μg/__mL
    Description

    Part to be filled in: mL **Recommend 50μg/750mL

    Data type

    integer

    Measurement units
    • mL
    Alias
    UMLS CUI [1,1]
    C3174092
    UMLS CUI [1,2]
    C0304229
    UMLS CUI [1,3]
    C3805286
    mL
    Dosing Information - Bolus
    Description

    Dosing Information - Bolus

    Alias
    UMLS CUI-1
    C0678766
    UMLS CUI-2
    C1533716
    UMLS CUI-3
    C1511237
    Number of bolus administered
    Description

    Number of bolus administered

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1511237
    UMLS CUI [1,2]
    C2348184
    Was this bolus administered?
    Description

    Please fill in for all nine bolus numbers.

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1511237
    UMLS CUI [1,2]
    C1521801
    *If yes, bolus dose:
    Description

    Bolus dose

    Data type

    integer

    Measurement units
    • mcg/kg
    Alias
    UMLS CUI [1]
    C1511237
    mcg/kg
    Start Date:
    Description

    (dd-mmm-yyyy)

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C1511237
    UMLS CUI [1,2]
    C0808070
    Start Time:
    Description

    (0000-2359)

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C1511237
    UMLS CUI [1,2]
    C1301880
    Stop Time:
    Description

    (0000-2359)

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C1511237
    UMLS CUI [1,2]
    C1522314
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    Similar models

    Dosing Information - Circuit Prime and Bolus

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    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])
    Additional form
    Item
    Check if (additional) supplemental instance of this form was used.
    boolean
    C1706499 (UMLS CUI [1])
    CRF Sequential Number
    Item
    Instance Number
    integer
    C1516308 (UMLS CUI [1,1])
    C2348184 (UMLS CUI [1,2])
    Item Group
    Dosing Information - Circuit Prime
    C0678766 (UMLS CUI-1)
    C1533716 (UMLS CUI-2)
    C3805286 (UMLS CUI-3)
    Item
    Equipment primed?
    text
    C3805286 (UMLS CUI [1])
    Circuit priming
    Code List
    Equipment primed?
    CL Item
    Yes (Yes)
    CL Item
    No* (No*)
    Priming dose
    Item
    **Primed dose: __ μg/__mL
    integer
    C3174092 (UMLS CUI [1,1])
    C0304229 (UMLS CUI [1,2])
    C3805286 (UMLS CUI [1,3])
    Priming dose
    Item
    **Primed dose: __ μg/__mL
    integer
    C3174092 (UMLS CUI [1,1])
    C0304229 (UMLS CUI [1,2])
    C3805286 (UMLS CUI [1,3])
    Item Group
    Dosing Information - Bolus
    C0678766 (UMLS CUI-1)
    C1533716 (UMLS CUI-2)
    C1511237 (UMLS CUI-3)
    Item
    Number of bolus administered
    text
    C1511237 (UMLS CUI [1,1])
    C2348184 (UMLS CUI [1,2])
    Number of bolus administered
    Code List
    Number of bolus administered
    CL Item
    initial (initial)
    CL Item
    second (second)
    CL Item
    third (third)
    CL Item
    fourth (fourth)
    CL Item
    fifth (fifth)
    CL Item
    sixth (sixth)
    CL Item
    seventh (seventh)
    CL Item
    eighth (eighth)
    CL Item
    ninth (ninth)
    Item
    Was this bolus administered?
    text
    C1511237 (UMLS CUI [1,1])
    C1521801 (UMLS CUI [1,2])
    Bolus administered
    Code List
    Was this bolus administered?
    CL Item
    Yes* (Yes*)
    CL Item
    No (No)
    Bolus dose
    Item
    *If yes, bolus dose:
    integer
    C1511237 (UMLS CUI [1])
    Bolus start date
    Item
    Start Date:
    date
    C1511237 (UMLS CUI [1,1])
    C0808070 (UMLS CUI [1,2])
    Bolus start time
    Item
    Start Time:
    time
    C1511237 (UMLS CUI [1,1])
    C1301880 (UMLS CUI [1,2])
    Bolus stop time
    Item
    Stop Time:
    time
    C1511237 (UMLS CUI [1,1])
    C1522314 (UMLS CUI [1,2])
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