ID
38586
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 is to be filled in if an autopsy has been performed.
Lien
https://clinicaltrials.gov/ct2/show/NCT00038961
Mots-clés
Versions (2)
- 17/10/2019 17/10/2019 -
- 25/10/2019 25/10/2019 - Sarah Riepenhausen
Détendeur de droits
GlaxoSmithKline
Téléchargé le
25 octobre 2019
DOI
Pour une demande vous connecter.
Licence
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
Autopsy Form
- StudyEvent: ODM
Description
Autopsy Form
Alias
- UMLS CUI-1
- C0004398
Description
If yes, complete form.
Type de données
boolean
Alias
- UMLS CUI [1]
- C0004398
Description
Date of Autopsy
Type de données
date
Alias
- UMLS CUI [1]
- C3864942
Description
If yes, specify location
Type de données
boolean
Alias
- UMLS CUI [1]
- C0034065
Description
Pulmonary Embolism in Left pulmonary artery
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0034065
- UMLS CUI [1,2]
- C0226069
Description
Pulmonary Embolism in Right pulmonary artery
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0034065
- UMLS CUI [1,2]
- C0226054
Description
Pulmonary Embolism in Left lobar arteries
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0034065
- UMLS CUI [1,2]
- C0503867
- UMLS CUI [1,3]
- C0205091
Description
Pulmonary Embolism in Right lobar arteries
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0034065
- UMLS CUI [1,2]
- C0503867
- UMLS CUI [1,3]
- C0205090
Description
Pulmonary Embolism in Left segmental arteries
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0034065
- UMLS CUI [1,2]
- C0503402
- UMLS CUI [1,3]
- C0205091
Description
Pulmonary Embolism in Right segmental arteries
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0034065
- UMLS CUI [1,2]
- C0503402
- UMLS CUI [1,3]
- C0205090
Description
Pulmonary Embolism in Main pulmonary trunk
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0034065
- UMLS CUI [1,2]
- C2954153
Description
If yes, specify location
Type de données
boolean
Alias
- UMLS CUI [1]
- C0149871
Description
Deep Vein Thrombosis in Left calf
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0149871
- UMLS CUI [1,2]
- C0230445
- UMLS CUI [1,3]
- C0205091
Description
Deep Vein Thrombosis in Right calf
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0149871
- UMLS CUI [1,2]
- C0230445
- UMLS CUI [1,3]
- C0205090
Description
Deep Vein Thrombosis in Left popliteal vein
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0149871
- UMLS CUI [1,2]
- C0835016
Description
Deep Vein Thrombosis in Right popliteal vein
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0149871
- UMLS CUI [1,2]
- C0835015
Description
Deep Vein Thrombosis in Left femoral vein
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0149871
- UMLS CUI [1,2]
- C0739301
Description
Deep Vein Thrombosis in Right femoral vein
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0149871
- UMLS CUI [1,2]
- C0739300
Description
Deep Vein Thrombosis in Left iliac vein
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0149871
- UMLS CUI [1,2]
- C4520258
Description
Deep Vein Thrombosis in Right iliac vein
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0149871
- UMLS CUI [1,2]
- C4520257
Description
Deep Vein Thrombosis in Inferior vena cava
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0149871
- UMLS CUI [1,2]
- C0042458
Description
If yes, specify
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C0042487
- UMLS CUI [2,1]
- C0151942
- UMLS CUI [2,2]
- C0205394
Description
if applicable
Type de données
text
Alias
- UMLS CUI [1,1]
- C1521902
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C0042487
- UMLS CUI [2,1]
- C1521902
- UMLS CUI [2,2]
- C0205394
- UMLS CUI [2,3]
- C0151942
Description
if yes specify
Type de données
boolean
Alias
- UMLS CUI [1]
- C0019080
Description
if applicable
Type de données
text
Alias
- UMLS CUI [1,1]
- C0019080
- UMLS CUI [1,2]
- C1521902
Description
if yes specify
Type de données
boolean
Alias
- UMLS CUI [1]
- C1335151
Description
if applicable
Type de données
text
Alias
- UMLS CUI [1,1]
- C1521902
- UMLS CUI [1,2]
- C1335151
Description
Investigator's signature
Alias
- UMLS CUI-1
- C2346576
Description
"I, the undersigned, certify that I have carefully examined all entries on the CRF for this subject.To the best of my knowledge, all information is correct."
Type de données
text
Alias
- UMLS CUI [1]
- C2346576
Description
Investigator's signature date
Type de données
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
Similar models
Autopsy Form
- StudyEvent: ODM
C0600091 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,2])
C2986440 (UMLS CUI [1,2])
C0226069 (UMLS CUI [1,2])
C0226054 (UMLS CUI [1,2])
C0503867 (UMLS CUI [1,2])
C0205091 (UMLS CUI [1,3])
C0503867 (UMLS CUI [1,2])
C0205090 (UMLS CUI [1,3])
C0503402 (UMLS CUI [1,2])
C0205091 (UMLS CUI [1,3])
C0503402 (UMLS CUI [1,2])
C0205090 (UMLS CUI [1,3])
C2954153 (UMLS CUI [1,2])
C0230445 (UMLS CUI [1,2])
C0205091 (UMLS CUI [1,3])
C0230445 (UMLS CUI [1,2])
C0205090 (UMLS CUI [1,3])
C0835016 (UMLS CUI [1,2])
C0835015 (UMLS CUI [1,2])
C0739301 (UMLS CUI [1,2])
C0739300 (UMLS CUI [1,2])
C4520258 (UMLS CUI [1,2])
C4520257 (UMLS CUI [1,2])
C0042458 (UMLS CUI [1,2])
C0042487 (UMLS CUI [1,2])
C0151942 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C0205394 (UMLS CUI [1,2])
C0042487 (UMLS CUI [1,3])
C1521902 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C0151942 (UMLS CUI [2,3])
C1521902 (UMLS CUI [1,2])
C1335151 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])