ID
38092
Descripción
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 basic demographic data, Informed Consent and vital signs taken at 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
Palabras clave
Versiones (1)
- 16/9/19 16/9/19 -
Titular de derechos de autor
GlaxoSmithKline
Subido en
16 de septiembre de 2019
DOI
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Licencia
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
Demography, Informed Consent, Vital Signs
- StudyEvent: ODM
Descripción
Demography
Alias
- UMLS CUI-1
- C0011298
Descripción
Informed Consent Date
Tipo de datos
date
Alias
- UMLS CUI [1]
- C2985782
Descripción
Date of birth
Tipo de datos
date
Alias
- UMLS CUI [1]
- C0421451
Descripción
Sex
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0079399
Descripción
If other, specify
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C0034510
Descripción
Specify other race
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0034510
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C2348235
Descripción
Vital Signs
Alias
- UMLS CUI-1
- C0518766
Similar models
Demography, Informed Consent, Vital Signs
- StudyEvent: ODM
C0600091 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,2])
C2986440 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])