ID
38093
Beschrijving
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).
Link
https://clinicaltrials.gov/ct2/show/NCT00038961
Trefwoorden
Versies (1)
- 16-09-19 16-09-19 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
16 september 2019
DOI
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Licentie
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
Beschrijving
Specific Medical History/Risk Factors for VTE
Alias
- UMLS CUI-1
- C0262926
- UMLS CUI-2
- C0035648
- UMLS CUI-3
- C1861172
Beschrijving
DVT
Datatype
boolean
Alias
- UMLS CUI [1]
- C0149871
Beschrijving
Pulmonary Embolism
Datatype
boolean
Alias
- UMLS CUI [1]
- C0034065
Beschrijving
Stroke
Datatype
boolean
Alias
- UMLS CUI [1]
- C0038454
Beschrijving
Myocardial Infarction
Datatype
boolean
Alias
- UMLS CUI [1]
- C0027051
Beschrijving
Recent major surgery or trauma
Datatype
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
Beschrijving
If yes, answer next question
Datatype
boolean
Alias
- UMLS CUI [1]
- C1882062
Beschrijving
present at study start for cancer present or treated within the last 6 months
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1882062
- UMLS CUI [1,2]
- C0150312
- UMLS CUI [1,3]
- C2348558
Beschrijving
If yes, answer next question
Datatype
boolean
Alias
- UMLS CUI [1]
- C0021390
Beschrijving
Inflammatory Bowel Disease present at study start
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0021390
- UMLS CUI [1,2]
- C0150312
- UMLS CUI [1,3]
- C2348558
Beschrijving
If yes, answer next question
Datatype
boolean
Alias
- UMLS CUI [1]
- C0024117
Beschrijving
Chronic Obstructive Pulmonary Disease present at study start
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0024117
- UMLS CUI [1,2]
- C0150312
- UMLS CUI [1,3]
- C2348558
Beschrijving
Bed confinement during more than the three days preceding surgery If yes, answer next question
Datatype
boolean
Alias
- UMLS CUI [1]
- C0020944
Beschrijving
Bed confinement during more than the three days preceding surgery
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0020944
- UMLS CUI [1,2]
- C0150312
- UMLS CUI [1,3]
- C2348558
Beschrijving
If yes, answer next question
Datatype
boolean
Alias
- UMLS CUI [1]
- C0009905
Beschrijving
Oral contraceptive use present at study start
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0009905
- UMLS CUI [1,2]
- C0150312
- UMLS CUI [1,3]
- C2348558
Beschrijving
If yes, answer next question
Datatype
boolean
Alias
- UMLS CUI [1]
- C0042345
Beschrijving
Varicose veins present at study start
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0042345
- UMLS CUI [1,2]
- C0150312
- UMLS CUI [1,3]
- C2348558
Beschrijving
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
Datatype
boolean
Alias
- UMLS CUI [1]
- C0398623
Beschrijving
Prothrombotic states or deficiencies of ATIII, deficiencies of or resistance to protein C or protein S, lupus anticoagulant, antiphospholipid antibody etc..
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0398623
- UMLS CUI [1,2]
- C0150312
- UMLS CUI [1,3]
- C2348558
Beschrijving
If yes, answer next question
Datatype
boolean
Alias
- UMLS CUI [1]
- C0018802
Beschrijving
If yes, specify grade at study start
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0018802
- UMLS CUI [1,2]
- C0150312
- UMLS CUI [1,3]
- C2348558
Beschrijving
Congestive Heart Failure NYHA Classification
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0018802
- UMLS CUI [1,2]
- C1275491
Beschrijving
Past medical or surgical history
Alias
- UMLS CUI-1
- C0262926
- UMLS CUI-2
- C0489540
Beschrijving
Past medical or surgical history - Details
Alias
- UMLS CUI-1
- C0262926
- UMLS CUI-2
- C0489540
- UMLS CUI-3
- C1522508
Beschrijving
Past medical or surgical history
Datatype
text
Alias
- UMLS CUI [1]
- C0262926
- UMLS CUI [2]
- C0489540
Beschrijving
Past medical or surgical history: persistent symptoms
Datatype
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
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Medical/Surgical History, VTE Risk Factors
- StudyEvent: ODM
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C0035648 (UMLS CUI-2)
C1861172 (UMLS CUI-3)
C0679637 (UMLS CUI [1,2])
C0332185 (UMLS CUI [1,3])
C0262926 (UMLS CUI [2,1])
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