ID
38349
Beskrivning
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 end of treatment and is to be filled in on Day 9 (or earlier if the treatment has been stopped earlier), which belongs to Visit 2.
Länk
https://clinicaltrials.gov/ct2/show/NCT00038961
Nyckelord
Versioner (2)
- 2019-09-16 2019-09-16 -
- 2019-10-11 2019-10-11 - Sarah Riepenhausen
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
11 oktober 2019
DOI
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Licens
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
End of Treatment
- StudyEvent: ODM
Beskrivning
End of Treatment
Alias
- UMLS CUI-1
- C0087111
- UMLS CUI-2
- C0444930
Beskrivning
Date of last administration
Datatyp
date
Alias
- UMLS CUI [1,1]
- C1762893
- UMLS CUI [1,2]
- C1533734
Beskrivning
Select lack of efficacy in case of suspicion of DVT and/or PE, even if not confirmed, and complete appropriate forms. For Adverse Events, complete AE/SAE forms as well as Bleeding or Death Forms, if appropriate. Specify other main reason in next item.
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1542147
- UMLS CUI [1,2]
- C0566251
- UMLS CUI [1,3]
- C0087111
- UMLS CUI [1,4]
- C0444930
Beskrivning
if applicable
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1521902
- UMLS CUI [1,2]
- C1542147
- UMLS CUI [1,3]
- C3840932
- UMLS CUI [1,4]
- C0087111
- UMLS CUI [1,5]
- C0444930
Beskrivning
Investigator's Signature
Alias
- UMLS CUI-1
- C2346576
Beskrivning
"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."
Datatyp
text
Alias
- UMLS CUI [1]
- C2346576
Beskrivning
Investigator's signature date
Datatyp
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
Similar models
End of Treatment
- StudyEvent: ODM
C0600091 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,2])
C2986440 (UMLS CUI [1,2])
C1533734 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
C0444930 (UMLS CUI [1,4])
C1542147 (UMLS CUI [1,2])
C3840932 (UMLS CUI [1,3])
C0087111 (UMLS CUI [1,4])
C0444930 (UMLS CUI [1,5])
C0011008 (UMLS CUI [1,2])