ID
38088
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 information on the adjudication of the mandatory venography which is performed between Day 5 and 10 (not more than one day after the last study drug dose), i.e. Visit 2, to check for asymptomatic deep vein thrombosis, and is recorded in a seperate 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
Mandatory Venography Adjudication
- StudyEvent: ODM
Beschrijving
Mandatory Venography Adjudication Form
Alias
- UMLS CUI-1
- C0031545
- UMLS CUI-2
- C1514873
- UMLS CUI-3
- C0680730
Beschrijving
Bilateral Venography Date
Datatype
date
Alias
- UMLS CUI [1,1]
- C0031545
- UMLS CUI [1,2]
- C0011008
- UMLS CUI [1,3]
- C0238767
Beschrijving
Either left leg or right leg
Datatype
date
Alias
- UMLS CUI [1,1]
- C0031545
- UMLS CUI [1,2]
- C0011008
- UMLS CUI [1,3]
- C0205091
- UMLS CUI [1,4]
- C1140621
Beschrijving
Either left leg or right leg
Datatype
date
Alias
- UMLS CUI [1,1]
- C0031545
- UMLS CUI [1,2]
- C0011008
- UMLS CUI [1,3]
- C0205090
- UMLS CUI [1,4]
- C1140621
Beschrijving
Venography Adjudication Results
Alias
- UMLS CUI-1
- C0680730
- UMLS CUI-2
- C0031545
- UMLS CUI-3
- C0456984
Beschrijving
Fill in itemgroup for each of the four sites.
Datatype
text
Alias
- UMLS CUI [1,1]
- C0031545
- UMLS CUI [1,2]
- C1515974
Beschrijving
Venography adjudication result
Datatype
text
Alias
- UMLS CUI [1,1]
- C0680730
- UMLS CUI [1,2]
- C0031545
- UMLS CUI [1,3]
- C0456984
Beschrijving
Overall assessment
Alias
- UMLS CUI-1
- C0220825
Beschrijving
Adjudicators
Alias
- UMLS CUI-1
- C0401783
Beschrijving
Adjudicator Signature 1
Datatype
text
Alias
- UMLS CUI [1,1]
- C0401783
- UMLS CUI [1,2]
- C1519316
Beschrijving
Adjudicator Signature 2
Datatype
text
Alias
- UMLS CUI [1,1]
- C0401783
- UMLS CUI [1,2]
- C1519316
Beschrijving
Date of adjudication
Datatype
text
Alias
- UMLS CUI [1]
- C4740194
Similar models
Mandatory Venography Adjudication
- StudyEvent: ODM
C0600091 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,2])
C2986440 (UMLS CUI [1,2])
C1514873 (UMLS CUI-2)
C0680730 (UMLS CUI-3)
C0011008 (UMLS CUI [1,2])
C0238767 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,2])
C0205091 (UMLS CUI [1,3])
C1140621 (UMLS CUI [1,4])
C0011008 (UMLS CUI [1,2])
C0205090 (UMLS CUI [1,3])
C1140621 (UMLS CUI [1,4])
C0031545 (UMLS CUI-2)
C0456984 (UMLS CUI-3)
C0031545 (UMLS CUI [1,2])
C0456984 (UMLS CUI [1,3])
C0947611 (UMLS CUI [1,2])
C1519316 (UMLS CUI [1,2])
C1519316 (UMLS CUI [1,2])