ID
38090
Description
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 unusual bleeding events and is to be filled in as appropriate during the study.
Link
https://clinicaltrials.gov/ct2/show/NCT00038961
Keywords
Versions (1)
- 9/16/19 9/16/19 -
Copyright Holder
GlaxoSmithKline
Uploaded on
September 16, 2019
DOI
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License
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
Unusual Bleeding Form
- StudyEvent: ODM
Description
Unusual Bleeding
Alias
- UMLS CUI-1
- C0019080
- UMLS CUI-2
- C2700116
Description
Onset date of bleeding
Data type
date
Alias
- UMLS CUI [1,1]
- C0019080
- UMLS CUI [1,2]
- C0574845
Description
If yes, complete transfusion form
Data type
boolean
Alias
- UMLS CUI [1]
- C0005841
Description
if yes, specify in next item
Data type
boolean
Alias
- UMLS CUI [1]
- C0035110
Description
if applicable
Data type
text
Alias
- UMLS CUI [1,1]
- C1521902
- UMLS CUI [1,2]
- C0035110
Description
If yes, specify
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C0184661
- UMLS CUI [1,3]
- C0332850
Description
if applicable
Data type
text
Alias
- UMLS CUI [1,1]
- C1521902
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C0184661
- UMLS CUI [1,4]
- C0332850
Description
Bleeding AE form Numbers
Alias
- UMLS CUI-1
- C0019080
- UMLS CUI-2
- C1300638
- UMLS CUI-3
- C0684224
- UMLS CUI-4
- C0877248
Description
Bleeding AE form number
Data type
integer
Alias
- UMLS CUI [1,1]
- C1300638
- UMLS CUI [1,2]
- C0877248
- UMLS CUI [1,3]
- C0684224
- UMLS CUI [1,4]
- C0019080
Description
only applicable if more than one AE form related to this bleeding Only select for one number
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1542147
- UMLS CUI [1,2]
- C1300638
- UMLS CUI [1,3]
- C0684224
- UMLS CUI [1,4]
- C0877248
Similar models
Unusual Bleeding Form
- StudyEvent: ODM
C0600091 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,2])
C2986440 (UMLS CUI [1,2])
C0574845 (UMLS CUI [1,2])
C0035110 (UMLS CUI [1,2])
C0184661 (UMLS CUI [1,2])
C0332850 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,2])
C0184661 (UMLS CUI [1,3])
C0332850 (UMLS CUI [1,4])
C1300638 (UMLS CUI-2)
C0684224 (UMLS CUI-3)
C0877248 (UMLS CUI-4)
C0877248 (UMLS CUI [1,2])
C0684224 (UMLS CUI [1,3])
C0019080 (UMLS CUI [1,4])
C1300638 (UMLS CUI [1,2])
C0684224 (UMLS CUI [1,3])
C0877248 (UMLS CUI [1,4])