ID
38090
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 unusual bleeding events and is to be filled in as appropriate during the study.
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
Voor een aanvraag inloggen.
Licentie
Creative Commons BY-NC 3.0
Model Commentaren :
Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.
Itemgroep Commentaren voor :
Item Commentaren voor :
U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.
Fondaparinux in Addition to Intermittent Pneumatic Compression in Abdominal Surgery Patients at VTE Risk - NCT00038961
Unusual Bleeding Form
- StudyEvent: ODM
Beschrijving
Unusual Bleeding
Alias
- UMLS CUI-1
- C0019080
- UMLS CUI-2
- C2700116
Beschrijving
Onset date of bleeding
Datatype
date
Alias
- UMLS CUI [1,1]
- C0019080
- UMLS CUI [1,2]
- C0574845
Beschrijving
If yes, complete transfusion form
Datatype
boolean
Alias
- UMLS CUI [1]
- C0005841
Beschrijving
if yes, specify in next item
Datatype
boolean
Alias
- UMLS CUI [1]
- C0035110
Beschrijving
if applicable
Datatype
text
Alias
- UMLS CUI [1,1]
- C1521902
- UMLS CUI [1,2]
- C0035110
Beschrijving
If yes, specify
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C0184661
- UMLS CUI [1,3]
- C0332850
Beschrijving
if applicable
Datatype
text
Alias
- UMLS CUI [1,1]
- C1521902
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C0184661
- UMLS CUI [1,4]
- C0332850
Beschrijving
Bleeding AE form Numbers
Alias
- UMLS CUI-1
- C0019080
- UMLS CUI-2
- C1300638
- UMLS CUI-3
- C0684224
- UMLS CUI-4
- C0877248
Beschrijving
Bleeding AE form number
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1300638
- UMLS CUI [1,2]
- C0877248
- UMLS CUI [1,3]
- C0684224
- UMLS CUI [1,4]
- C0019080
Beschrijving
only applicable if more than one AE form related to this bleeding Only select for one number
Datatype
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])