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ID

38586

Beskrivning

Study ID: 103414 Clinical Study ID: 103414 Study Title: A Multicenter, Randomized, Double-blind, Parallel Group Trial to Demonstrate the Efficacy of Fondaparinux Sodium in Association With Intermittent Pneumatic Compression (IPC) Versus IPC Used Alone for the Prevention of Venous Thromboembolic Events in Subjects at Increased Risk Undergoing Major Abdominal surgery Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00038961 https://clinicaltrials.gov/ct2/show/NCT00038961 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Fondaparinux Sodium Trade Name: Fondaparinux Sodium Study Indication: Thrombosis This phase III placebo-controlled trial studies the efficacy and safety of Fondaparinux as an additional prevention measure of venous thromboembolic events (VTE) in patients above the age of 40 with intermediate or high VTE risk undergoing abdominal surgery. The study consists of a Screening Visit (Visit 0), the baseline visit on Day 1, the day of the surgery (Visit 1), the treatment period (denoted in its entirety as Visit 2) consisting of administration of Fondaparinux (2.5mg subcutaneously once daily) or placebo starting on Day 1 and continuing at least up to Day 5, possibly up to Day 9, in parallel to intermittent pneumatic compression and possibly elastic stockings, followed by a mandatory bilateral venography no longer than 24 hours after study drug cessation, and finally a Follow-up Visit (Visit 3) on Day 30 +/- 2. This form is to be filled in if an autopsy has been performed.

Länk

https://clinicaltrials.gov/ct2/show/NCT00038961

Nyckelord

Versioner (2)
  1. 2019-10-17 2019-10-17 -
  2. 2019-10-25 2019-10-25 - Sarah Riepenhausen
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

25 oktober 2019

DOI

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Licens

Creative Commons BY-NC 3.0
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    Fondaparinux in Addition to Intermittent Pneumatic Compression in Abdominal Surgery Patients at VTE Risk - NCT00038961

    Engelsk

    Autopsy Form

    1 Formulär  
    1. StudyEvent: ODM
      1. Autopsy Form
    Administrative data
    Beskrivning

    Administrative data

    Alias
    UMLS CUI-1
    C1320722
    Country No.
    Beskrivning

    Country No.

    Datatyp

    integer

    Alias
    UMLS CUI [1,1]
    C0454664
    UMLS CUI [1,2]
    C0600091
    Centre No.
    Beskrivning

    Centre No.

    Datatyp

    integer

    Alias
    UMLS CUI [1,1]
    C1301943
    UMLS CUI [1,2]
    C0600091
    Subject No.
    Beskrivning

    Clinical Trial Subject Unique Identifier

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C2348585
    Subject Initials
    Beskrivning

    Subject Initials

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C1997894
    UMLS CUI [1,2]
    C2986440
    Autopsy Form
    Beskrivning

    Autopsy Form

    Alias
    UMLS CUI-1
    C0004398
    Was an autopsy performed?
    Beskrivning

    If yes, complete form.

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0004398
    Date of Autopsy
    Beskrivning

    Date of Autopsy

    Datatyp

    date

    Alias
    UMLS CUI [1]
    C3864942
    Pulmonary Embolism
    Beskrivning

    If yes, specify location

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0034065
    Left pulmonary artery
    Beskrivning

    Pulmonary Embolism in Left pulmonary artery

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0034065
    UMLS CUI [1,2]
    C0226069
    Right pulmonary artery
    Beskrivning

    Pulmonary Embolism in Right pulmonary artery

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0034065
    UMLS CUI [1,2]
    C0226054
    Left lobar arteries
    Beskrivning

    Pulmonary Embolism in Left lobar arteries

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0034065
    UMLS CUI [1,2]
    C0503867
    UMLS CUI [1,3]
    C0205091
    Right lobar arteries
    Beskrivning

    Pulmonary Embolism in Right lobar arteries

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0034065
    UMLS CUI [1,2]
    C0503867
    UMLS CUI [1,3]
    C0205090
    Left segmental arteries
    Beskrivning

    Pulmonary Embolism in Left segmental arteries

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0034065
    UMLS CUI [1,2]
    C0503402
    UMLS CUI [1,3]
    C0205091
    Right segmental arteries
    Beskrivning

    Pulmonary Embolism in Right segmental arteries

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0034065
    UMLS CUI [1,2]
    C0503402
    UMLS CUI [1,3]
    C0205090
    Main pulmonary trunk
    Beskrivning

    Pulmonary Embolism in Main pulmonary trunk

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0034065
    UMLS CUI [1,2]
    C2954153
    Deep Vein Thrombosis
    Beskrivning

    If yes, specify location

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0149871
    Left calf vein
    Beskrivning

    Deep Vein Thrombosis in Left calf

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0149871
    UMLS CUI [1,2]
    C0230445
    UMLS CUI [1,3]
    C0205091
    Right calf vein
    Beskrivning

    Deep Vein Thrombosis in Right calf

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0149871
    UMLS CUI [1,2]
    C0230445
    UMLS CUI [1,3]
    C0205090
    Left popliteal vein
    Beskrivning

    Deep Vein Thrombosis in Left popliteal vein

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0149871
    UMLS CUI [1,2]
    C0835016
    Right popliteal vein
    Beskrivning

    Deep Vein Thrombosis in Right popliteal vein

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0149871
    UMLS CUI [1,2]
    C0835015
    Left femoral vein
    Beskrivning

    Deep Vein Thrombosis in Left femoral vein

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0149871
    UMLS CUI [1,2]
    C0739301
    Right femoral vein
    Beskrivning

    Deep Vein Thrombosis in Right femoral vein

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0149871
    UMLS CUI [1,2]
    C0739300
    Left iliac vein
    Beskrivning

    Deep Vein Thrombosis in Left iliac vein

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0149871
    UMLS CUI [1,2]
    C4520258
    Right iliac vein
    Beskrivning

    Deep Vein Thrombosis in Right iliac vein

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0149871
    UMLS CUI [1,2]
    C4520257
    Inferior vena cava
    Beskrivning

    Deep Vein Thrombosis in Inferior vena cava

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0149871
    UMLS CUI [1,2]
    C0042458
    Other Thrombosis (venous and/or arterial)
    Beskrivning

    If yes, specify

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0205394
    UMLS CUI [1,2]
    C0042487
    UMLS CUI [2,1]
    C0151942
    UMLS CUI [2,2]
    C0205394
    Specify other venous/arterial thrombosis
    Beskrivning

    if applicable

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C1521902
    UMLS CUI [1,2]
    C0205394
    UMLS CUI [1,3]
    C0042487
    UMLS CUI [2,1]
    C1521902
    UMLS CUI [2,2]
    C0205394
    UMLS CUI [2,3]
    C0151942
    Hemorrhage(s)
    Beskrivning

    if yes specify

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0019080
    Specify Hemorrhage(s)
    Beskrivning

    if applicable

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0019080
    UMLS CUI [1,2]
    C1521902
    Other Findings
    Beskrivning

    if yes specify

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C1335151
    Specify other Findings
    Beskrivning

    if applicable

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C1521902
    UMLS CUI [1,2]
    C1335151
    Investigator's signature
    Beskrivning

    Investigator's signature

    Alias
    UMLS CUI-1
    C2346576
    Investigator's signature
    Beskrivning

    "I, the undersigned, certify that I have carefully examined all entries on the CRF for this subject.To the best of my knowledge, all information is correct."

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C2346576
    Investigator's signature date
    Beskrivning

    Investigator's signature date

    Datatyp

    date

    Alias
    UMLS CUI [1,1]
    C2346576
    UMLS CUI [1,2]
    C0011008
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    Similar models

    Autopsy Form

    1 Formulär
    1. StudyEvent: ODM
      1. Autopsy Form
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    Alias
    Item Group
    Administrative data
    C1320722 (UMLS CUI-1)
    Country No.
    Item
    Country No.
    integer
    C0454664 (UMLS CUI [1,1])
    C0600091 (UMLS CUI [1,2])
    Centre No.
    Item
    Centre No.
    integer
    C1301943 (UMLS CUI [1,1])
    C0600091 (UMLS CUI [1,2])
    Clinical Trial Subject Unique Identifier
    Item
    Subject No.
    integer
    C2348585 (UMLS CUI [1])
    Subject Initials
    Item
    Subject Initials
    text
    C1997894 (UMLS CUI [1,1])
    C2986440 (UMLS CUI [1,2])
    Item Group
    Autopsy Form
    C0004398 (UMLS CUI-1)
    Autopsy?
    Item
    Was an autopsy performed?
    boolean
    C0004398 (UMLS CUI [1])
    Date of Autopsy
    Item
    Date of Autopsy
    date
    C3864942 (UMLS CUI [1])
    Pulmonary Embolism
    Item
    Pulmonary Embolism
    boolean
    C0034065 (UMLS CUI [1])
    Pulmonary Embolism in Left pulmonary artery
    Item
    Left pulmonary artery
    boolean
    C0034065 (UMLS CUI [1,1])
    C0226069 (UMLS CUI [1,2])
    Pulmonary Embolism in Right pulmonary artery
    Item
    Right pulmonary artery
    boolean
    C0034065 (UMLS CUI [1,1])
    C0226054 (UMLS CUI [1,2])
    Pulmonary Embolism in Left lobar arteries
    Item
    Left lobar arteries
    boolean
    C0034065 (UMLS CUI [1,1])
    C0503867 (UMLS CUI [1,2])
    C0205091 (UMLS CUI [1,3])
    Pulmonary Embolism in Right lobar arteries
    Item
    Right lobar arteries
    boolean
    C0034065 (UMLS CUI [1,1])
    C0503867 (UMLS CUI [1,2])
    C0205090 (UMLS CUI [1,3])
    Pulmonary Embolism in Left segmental arteries
    Item
    Left segmental arteries
    boolean
    C0034065 (UMLS CUI [1,1])
    C0503402 (UMLS CUI [1,2])
    C0205091 (UMLS CUI [1,3])
    Pulmonary Embolism in Right segmental arteries
    Item
    Right segmental arteries
    boolean
    C0034065 (UMLS CUI [1,1])
    C0503402 (UMLS CUI [1,2])
    C0205090 (UMLS CUI [1,3])
    Pulmonary Embolism in Main pulmonary trunk
    Item
    Main pulmonary trunk
    boolean
    C0034065 (UMLS CUI [1,1])
    C2954153 (UMLS CUI [1,2])
    Deep Vein Thrombosis
    Item
    Deep Vein Thrombosis
    boolean
    C0149871 (UMLS CUI [1])
    Deep Vein Thrombosis in Left calf
    Item
    Left calf vein
    boolean
    C0149871 (UMLS CUI [1,1])
    C0230445 (UMLS CUI [1,2])
    C0205091 (UMLS CUI [1,3])
    Deep Vein Thrombosis in Right calf
    Item
    Right calf vein
    boolean
    C0149871 (UMLS CUI [1,1])
    C0230445 (UMLS CUI [1,2])
    C0205090 (UMLS CUI [1,3])
    Deep Vein Thrombosis in Left popliteal vein
    Item
    Left popliteal vein
    boolean
    C0149871 (UMLS CUI [1,1])
    C0835016 (UMLS CUI [1,2])
    Deep Vein Thrombosis in Right popliteal vein
    Item
    Right popliteal vein
    boolean
    C0149871 (UMLS CUI [1,1])
    C0835015 (UMLS CUI [1,2])
    Deep Vein Thrombosis in Left femoral vein
    Item
    Left femoral vein
    boolean
    C0149871 (UMLS CUI [1,1])
    C0739301 (UMLS CUI [1,2])
    Deep Vein Thrombosis in Right femoral vein
    Item
    Right femoral vein
    boolean
    C0149871 (UMLS CUI [1,1])
    C0739300 (UMLS CUI [1,2])
    Deep Vein Thrombosis in Left iliac vein
    Item
    Left iliac vein
    boolean
    C0149871 (UMLS CUI [1,1])
    C4520258 (UMLS CUI [1,2])
    Deep Vein Thrombosis in Right iliac vein
    Item
    Right iliac vein
    boolean
    C0149871 (UMLS CUI [1,1])
    C4520257 (UMLS CUI [1,2])
    Deep Vein Thrombosis in Inferior vena cava
    Item
    Inferior vena cava
    boolean
    C0149871 (UMLS CUI [1,1])
    C0042458 (UMLS CUI [1,2])
    Other venous/arterial thrombosis
    Item
    Other Thrombosis (venous and/or arterial)
    boolean
    C0205394 (UMLS CUI [1,1])
    C0042487 (UMLS CUI [1,2])
    C0151942 (UMLS CUI [2,1])
    C0205394 (UMLS CUI [2,2])
    Specify other venous/arterial thrombosis
    Item
    Specify other venous/arterial thrombosis
    text
    C1521902 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    C0042487 (UMLS CUI [1,3])
    C1521902 (UMLS CUI [2,1])
    C0205394 (UMLS CUI [2,2])
    C0151942 (UMLS CUI [2,3])
    Hemorrhage
    Item
    Hemorrhage(s)
    boolean
    C0019080 (UMLS CUI [1])
    Specify Hemorrhage
    Item
    Specify Hemorrhage(s)
    text
    C0019080 (UMLS CUI [1,1])
    C1521902 (UMLS CUI [1,2])
    Other findings
    Item
    Other Findings
    boolean
    C1335151 (UMLS CUI [1])
    Specify other findings
    Item
    Specify other Findings
    text
    C1521902 (UMLS CUI [1,1])
    C1335151 (UMLS CUI [1,2])
    Item Group
    Investigator's signature
    C2346576 (UMLS CUI-1)
    Investigator's signature
    Item
    Investigator's signature
    text
    C2346576 (UMLS CUI [1])
    Investigator's signature date
    Item
    Investigator's signature date
    date
    C2346576 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
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