ID
38093
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 contains medical/surgical history and risk factors for VTE assessed during the Screening Visit (Visit 0). This form can be filled in starting 30 days before the surgery, whereas the laboratory tests which also need to be performed during Screening have to be done in the 7 days before the surgery (in a different form).
Länk
https://clinicaltrials.gov/ct2/show/NCT00038961
Nyckelord
Versioner (1)
- 2019-09-16 2019-09-16 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
16 september 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
Medical/Surgical History, VTE Risk Factors
- StudyEvent: ODM
Beskrivning
Specific Medical History/Risk Factors for VTE
Alias
- UMLS CUI-1
- C0262926
- UMLS CUI-2
- C0035648
- UMLS CUI-3
- C1861172
Beskrivning
DVT
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0149871
Beskrivning
Pulmonary Embolism
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0034065
Beskrivning
Stroke
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0038454
Beskrivning
Myocardial Infarction
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0027051
Beskrivning
Recent major surgery or trauma
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0679637
- UMLS CUI [1,3]
- C0332185
- UMLS CUI [2,1]
- C0262926
- UMLS CUI [2,2]
- C0332677
- UMLS CUI [2,3]
- C0332185
Beskrivning
If yes, answer next question
Datatyp
boolean
Alias
- UMLS CUI [1]
- C1882062
Beskrivning
present at study start for cancer present or treated within the last 6 months
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1882062
- UMLS CUI [1,2]
- C0150312
- UMLS CUI [1,3]
- C2348558
Beskrivning
If yes, answer next question
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0021390
Beskrivning
Inflammatory Bowel Disease present at study start
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0021390
- UMLS CUI [1,2]
- C0150312
- UMLS CUI [1,3]
- C2348558
Beskrivning
If yes, answer next question
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0024117
Beskrivning
Chronic Obstructive Pulmonary Disease present at study start
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0024117
- UMLS CUI [1,2]
- C0150312
- UMLS CUI [1,3]
- C2348558
Beskrivning
Bed confinement during more than the three days preceding surgery If yes, answer next question
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0020944
Beskrivning
Bed confinement during more than the three days preceding surgery
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0020944
- UMLS CUI [1,2]
- C0150312
- UMLS CUI [1,3]
- C2348558
Beskrivning
If yes, answer next question
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0009905
Beskrivning
Oral contraceptive use present at study start
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0009905
- UMLS CUI [1,2]
- C0150312
- UMLS CUI [1,3]
- C2348558
Beskrivning
If yes, answer next question
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0042345
Beskrivning
Varicose veins present at study start
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0042345
- UMLS CUI [1,2]
- C0150312
- UMLS CUI [1,3]
- C2348558
Beskrivning
Prothrombotic states or deficiencies of ATIII, deficiencies of or resistance to protein C or protein S, lupus anticoagulant, antiphospholipid antibody etc.. If yes, answer next question
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0398623
Beskrivning
Prothrombotic states or deficiencies of ATIII, deficiencies of or resistance to protein C or protein S, lupus anticoagulant, antiphospholipid antibody etc..
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0398623
- UMLS CUI [1,2]
- C0150312
- UMLS CUI [1,3]
- C2348558
Beskrivning
If yes, answer next question
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0018802
Beskrivning
If yes, specify grade at study start
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0018802
- UMLS CUI [1,2]
- C0150312
- UMLS CUI [1,3]
- C2348558
Beskrivning
Congestive Heart Failure NYHA Classification
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0018802
- UMLS CUI [1,2]
- C1275491
Beskrivning
Past medical or surgical history
Alias
- UMLS CUI-1
- C0262926
- UMLS CUI-2
- C0489540
Beskrivning
Past medical or surgical history - Details
Alias
- UMLS CUI-1
- C0262926
- UMLS CUI-2
- C0489540
- UMLS CUI-3
- C1522508
Beskrivning
Past medical or surgical history
Datatyp
text
Alias
- UMLS CUI [1]
- C0262926
- UMLS CUI [2]
- C0489540
Beskrivning
Past medical or surgical history: persistent symptoms
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C1457887
- UMLS CUI [1,3]
- C0205322
- UMLS CUI [2,1]
- C0489540
- UMLS CUI [2,2]
- C1457887
- UMLS CUI [2,3]
- C0205322
Similar models
Medical/Surgical History, VTE Risk Factors
- StudyEvent: ODM
C0600091 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,2])
C2986440 (UMLS CUI [1,2])
C0035648 (UMLS CUI-2)
C1861172 (UMLS CUI-3)
C0679637 (UMLS CUI [1,2])
C0332185 (UMLS CUI [1,3])
C0262926 (UMLS CUI [2,1])
C0332677 (UMLS CUI [2,2])
C0332185 (UMLS CUI [2,3])
C0150312 (UMLS CUI [1,2])
C2348558 (UMLS CUI [1,3])
C0150312 (UMLS CUI [1,2])
C2348558 (UMLS CUI [1,3])
C0150312 (UMLS CUI [1,2])
C2348558 (UMLS CUI [1,3])
C0150312 (UMLS CUI [1,2])
C2348558 (UMLS CUI [1,3])
C0150312 (UMLS CUI [1,2])
C2348558 (UMLS CUI [1,3])
C0150312 (UMLS CUI [1,2])
C2348558 (UMLS CUI [1,3])
C0150312 (UMLS CUI [1,2])
C2348558 (UMLS CUI [1,3])
C0150312 (UMLS CUI [1,2])
C2348558 (UMLS CUI [1,3])
C1275491 (UMLS CUI [1,2])
C0489540 (UMLS CUI-2)
C0262926 (UMLS CUI [1,2])
C0205394 (UMLS CUI [2,1])
C0489540 (UMLS CUI [2,2])
C0489540 (UMLS CUI-2)
C1522508 (UMLS CUI-3)
C0489540 (UMLS CUI [2])
C1457887 (UMLS CUI [1,2])
C0205322 (UMLS CUI [1,3])
C0489540 (UMLS CUI [2,1])
C1457887 (UMLS CUI [2,2])
C0205322 (UMLS CUI [2,3])