0 Bedömningar
ID

41356

Beskrivning

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 whether such samples are drawn during the Study Period. Study Protocol specifies when such Samples should be drawn.

Länk

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

Nyckelord

Versioner (1)
  1. 3/9/20 3/9/20 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

3 de septiembre de 2020

DOI

För en begäran logga in.

Licens

Creative Commons BY-NC 4.0
Modellkommentarer :

Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.

Tillbaka till modellkommentarer
Itemgroup-kommentar för :

Item-kommentar för :

  • Senaste
  • Äldsta
  • Önskad
  • Senaste
    • Senaste
    • Äldsta
    • Önskad

    Inga kommentarer

    Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.

    Safety and Efficacy of Argatroban in Pediatric Patients, NCT00039858

    Engelsk

    Pharmacokinetic Samples and Pharmacodynamic (ACT/aPTT) Samples and Results

    1 Formulär  
    Administrative Data
    Beskrivning

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722 (Administrative documentation)
    SNOMED
    405624007
    Site #
    Beskrivning

    Study centre number

    Datatyp

    integer

    Alias
    UMLS CUI [1,1]
    C0600091 (Identifier)
    SNOMED
    118522005
    LOINC
    LP31795-5
    UMLS CUI [1,2]
    C0019994 (Hospitals)
    Patient #
    Beskrivning

    patient ID

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C2348585 (Clinical Trial Subject Unique Identifier)
    Visit Date
    Beskrivning

    visit date

    Datatyp

    date

    Alias
    UMLS CUI [1]
    C1320303 (Date of visit)
    SNOMED
    406543005
    Investigator Name
    Beskrivning

    Investigator Name

    Datatyp

    text

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

    Use one instance for every ten samples/sample sets. Check this box on all instances except for the last one.

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C1706499 (Additional Information Report)
    Instance Number
    Beskrivning

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

    Datatyp

    integer

    Alias
    UMLS CUI [1,1]
    C1516308 (Case Report Form)
    UMLS CUI [1,2]
    C2348184 (Sequence Number)
    Pharmacokinetic Samples and Pharmacodynamic (ACT/aPTT) Samples and Results
    Beskrivning

    Pharmacokinetic Samples and Pharmacodynamic (ACT/aPTT) Samples and Results

    Alias
    UMLS CUI-1
    C0031328 (Pharmacokinetic aspects)
    UMLS CUI-2
    C0851347 (Pharmacodynamics)
    UMLS CUI-3
    C0370003 (Specimen)
    SNOMED
    123038009
    LOINC
    LP7593-9
    UMLS CUI-4
    C1274040 (Result)
    SNOMED
    394617004
    UMLS CUI-5
    C1274040 (Result)
    SNOMED
    394617004
    UMLS CUI-6
    C0427611 (Activated clotting time measurement)
    SNOMED
    69874005
    LOINC
    LP207644-8
    UMLS CUI-7
    C0030605 (Activated Partial Thromboplastin Time measurement)
    SNOMED
    42525009
    Sample Number
    Beskrivning

    Pharmacokinetics sample number | Pharmacodynamics sample number

    Datatyp

    integer

    Alias
    UMLS CUI [1,1]
    C0031328 (Pharmacokinetic aspects)
    UMLS CUI [1,2]
    C1299222 (Sample identification number)
    SNOMED
    372274003
    UMLS CUI [2,1]
    C0851347 (Pharmacodynamics)
    UMLS CUI [2,2]
    C1299222 (Sample identification number)
    SNOMED
    372274003
    Dose Administration Type / Sample Collection Timepoint (enter code below)
    Beskrivning

    Dose Administration Type / Sample Collection Timepoint

    Datatyp

    integer

    Alias
    UMLS CUI [1,1]
    C3174092 (Medication dose)
    LOINC
    LP116765-1
    UMLS CUI [1,2]
    C0455708 (Administration type)
    SNOMED
    276213000
    UMLS CUI [2,1]
    C0200345 (Specimen Collection)
    SNOMED
    17636008
    UMLS CUI [2,2]
    C2348792 (Timepoint)
    Collection Date:
    Beskrivning

    (dd-mmm-yyyy)

    Datatyp

    date

    Alias
    UMLS CUI [1]
    C1302413 (Specimen collection date)
    SNOMED
    399445004
    Collection Time
    Beskrivning

    (0000-2359)

    Datatyp

    time

    Alias
    UMLS CUI [1]
    C4064021 (specimen collection time)
    ACT or aPTT
    Beskrivning

    Test type

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0022885 (Laboratory Procedures)
    SNOMED
    269814003
    UMLS CUI [1,2]
    C0332307 (Type - attribute)
    SNOMED
    261664005
    ACT or aPTT Result
    Beskrivning

    Test result

    Datatyp

    float

    Måttenheter
    • sec
    Alias
    UMLS CUI [1]
    C0587081 (Laboratory test finding)
    SNOMED
    118246004
    sec
    PK Sample Drawn?
    Beskrivning

    Pharmacokinetics sample drawn

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0031328 (Pharmacokinetic aspects)
    UMLS CUI [1,2]
    C0807979 (Specimen drawn)
    LOINC
    LP29111-9
    Comments
    Beskrivning

    Comment

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C0947611 (Comment)
    LOINC
    LP72293-1
    Tillbaka till toppen

    Similar models

    Pharmacokinetic Samples and Pharmacodynamic (ACT/aPTT) Samples and Results

    1 Formulär
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    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
    Pharmacokinetic Samples and Pharmacodynamic (ACT/aPTT) Samples and Results
    C0031328 (UMLS CUI-1)
    C0851347 (UMLS CUI-2)
    C0370003 (UMLS CUI-3)
    C1274040 (UMLS CUI-4)
    C1274040 (UMLS CUI-5)
    C0427611 (UMLS CUI-6)
    C0030605 (UMLS CUI-7)
    Pharmacokinetics sample number | Pharmacodynamics sample number
    Item
    Sample Number
    integer
    C0031328 (UMLS CUI [1,1])
    C1299222 (UMLS CUI [1,2])
    C0851347 (UMLS CUI [2,1])
    C1299222 (UMLS CUI [2,2])
    Item
    Dose Administration Type / Sample Collection Timepoint (enter code below)
    integer
    C3174092 (UMLS CUI [1,1])
    C0455708 (UMLS CUI [1,2])
    C0200345 (UMLS CUI [2,1])
    C2348792 (UMLS CUI [2,2])
    Dose Administration Type / Sample Collection Timepoint
    Code List
    Dose Administration Type / Sample Collection Timepoint (enter code below)
    CL Item
    5 - 10 min post-bolus (1)
    CL Item
    5 - 10 min post-infusion dose change (2)
    CL Item
    Stable infusion — every 60 min (3)
    CL Item
    Post-infusion — every 60 min until <160 sec (4)
    CL Item
    Additional — at physician’s discretion (5)
    CL Item
    2 hrs post-initial infusion initiation (6)
    CL Item
    2 hrs post-infusion dose change (7)
    CL Item
    Daily — at stable infusion dose (8)
    CL Item
    0.5 - 2 hrs post-infusion termination (9)
    CL Item
    3 - 6 hrs post-infusion termination (10)
    CL Item
    Additional — at physician’s discretion (11)
    Specimen collection date
    Item
    Collection Date:
    date
    C1302413 (UMLS CUI [1])
    Specimen collection time
    Item
    Collection Time
    time
    C4064021 (UMLS CUI [1])
    Item
    ACT or aPTT
    text
    C0022885 (UMLS CUI [1,1])
    C0332307 (UMLS CUI [1,2])
    ACT | aPTT
    Code List
    ACT or aPTT
    CL Item
    ACT (ACT)
    CL Item
    aPTT (aPTT)
    Test result
    Item
    ACT or aPTT Result
    float
    C0587081 (UMLS CUI [1])
    Item
    PK Sample Drawn?
    text
    C0031328 (UMLS CUI [1,1])
    C0807979 (UMLS CUI [1,2])
    PK sample drawn
    Code List
    PK Sample Drawn?
    CL Item
    Yes (Yes)
    CL Item
    No (No)
    Comment
    Item
    Comments
    text
    C0947611 (UMLS CUI [1])
    Tillbaka till toppen 

    Hjälp

    Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

    Watch Tutorial