ID

38388

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 the subject's surgery on Day 1 (Visit 1).

Link

https://clinicaltrials.gov/ct2/show/NCT00038961

Keywords

Versions (1)
  1. 10/15/19 10/15/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

October 15, 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

English

Details of Operation

1 forms  
  1. StudyEvent: ODM
    1. Details of Operation
Administrative data
Description

Administrative data

Alias
UMLS CUI-1
C1320722
Country No.
Description

Country No.

Data type

integer

Alias
UMLS CUI [1,1]
C0454664
UMLS CUI [1,2]
C0600091
Centre No.
Description

Centre No.

Data type

integer

Alias
UMLS CUI [1,1]
C1301943
UMLS CUI [1,2]
C0600091
Subject No.
Description

Clinical Trial Subject Unique Identifier

Data type

integer

Alias
UMLS CUI [1]
C2348585
Subject Initials
Description

Subject Initials

Data type

text

Alias
UMLS CUI [1,1]
C1997894
UMLS CUI [1,2]
C2986440
Date of Visit
Description

Date of Visit

Data type

date

Alias
UMLS CUI [1]
C1320303
Details of Operation
Description

Details of Operation

Alias
UMLS CUI-1
C0543467
UMLS CUI-2
C1522508
Gastrointestinal
Description

Select all that apply

Data type

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C0012240
Gynecological
Description

Select all that apply

Data type

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C0018417
Urological
Description

Select all that apply

Data type

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C0042077
Other, specify
Description

If yes, specify in next item

Data type

boolean

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C0543467
UMLS CUI [1,3]
C0332307
Specify other type of surgery
Description

Specify other type of surgery

Data type

text

Alias
UMLS CUI [1,1]
C1521902
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C0543467
UMLS CUI [1,4]
C0332307
Cancer surgery?
Description

Cancer surgery?

Data type

boolean

Alias
UMLS CUI [1]
C0920424
Date and time of anesthesia induction
Description

Date/time of anesthesia induction

Data type

datetime

Alias
UMLS CUI [1,1]
C0853212
UMLS CUI [1,2]
C1264639
Time of incision
Description

Time of incision

Data type

time

Alias
UMLS CUI [1]
C2116297
Time of incision closure
Description

Time of wound closure

Data type

time

Alias
UMLS CUI [1,1]
C1883250
UMLS CUI [1,2]
C0040223
General
Description

Select all that apply for Type of Anesthesia

Data type

boolean

Alias
UMLS CUI [1]
C0002915
Spinal/Epidural
Description

Select all that apply for Type of Anesthesia

Data type

boolean

Alias
UMLS CUI [1]
C0002913
UMLS CUI [2]
C0002928
Was any i.v. or central venous line used?
Description

Record all use of heparin including i.v. line flushes, use for central venous line, cell saver, on the Medication Form

Data type

boolean

Alias
UMLS CUI [1]
C2985513
UMLS CUI [2]
C1145640
Was cell saver equipment used?
Description

Record all use of heparin including i.v. line flushes, use for central venous line, cell saver, on the Medication Form

Data type

boolean

Alias
UMLS CUI [1,1]
C1441512
UMLS CUI [1,2]
C0014672
Date and time of removal of Indewelling Intrathecal or Epidural Catheter
Description

if not applicable, select following item

Data type

datetime

Alias
UMLS CUI [1,1]
C1410830
UMLS CUI [1,2]
C2584606
UMLS CUI [1,3]
C1264639
UMLS CUI [2,1]
C1410830
UMLS CUI [2,2]
C0179751
UMLS CUI [2,3]
C1264639
Date and time of removal of Indewelling Intrathecal or Epidural Catheter not applicable
Description

Date/Time removal of inthratecal/epidural catheter not applicable?

Data type

boolean

Alias
UMLS CUI [1,1]
C1272460
UMLS CUI [1,2]
C1410830
UMLS CUI [1,3]
C2584606
UMLS CUI [1,4]
C1264639
UMLS CUI [2,1]
C1272460
UMLS CUI [2,2]
C1410830
UMLS CUI [2,3]
C0179751
UMLS CUI [2,4]
C1264639
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Similar models

Details of Operation

1 forms
  1. StudyEvent: ODM
    1. Details of Operation
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Country No.
Item
Country No.
integer
C0454664 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Centre No.
Item
Centre No.
integer
C1301943 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Clinical Trial Subject Unique Identifier
Item
Subject No.
integer
C2348585 (UMLS CUI [1])
Subject Initials
Item
Subject Initials
text
C1997894 (UMLS CUI [1,1])
C2986440 (UMLS CUI [1,2])
Date of Visit
Item
Date of Visit
date
C1320303 (UMLS CUI [1])
Item Group
Details of Operation
C0543467 (UMLS CUI-1)
C1522508 (UMLS CUI-2)
Type of surgery: Gastrointestinal?
Item
Gastrointestinal
boolean
C0543467 (UMLS CUI [1,1])
C0012240 (UMLS CUI [1,2])
Type of surgery: Gynecological?
Item
Gynecological
boolean
C0543467 (UMLS CUI [1,1])
C0018417 (UMLS CUI [1,2])
Type of surgery: Urological?
Item
Urological
boolean
C0543467 (UMLS CUI [1,1])
C0042077 (UMLS CUI [1,2])
Other type of surgery?
Item
Other, specify
boolean
C0205394 (UMLS CUI [1,1])
C0543467 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,3])
Specify other type of surgery
Item
Specify other type of surgery
text
C1521902 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0543467 (UMLS CUI [1,3])
C0332307 (UMLS CUI [1,4])
Cancer surgery?
Item
Cancer surgery?
boolean
C0920424 (UMLS CUI [1])
Date/time of anesthesia induction
Item
Date and time of anesthesia induction
datetime
C0853212 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
Time of incision
Item
Time of incision
time
C2116297 (UMLS CUI [1])
Time of wound closure
Item
Time of incision closure
time
C1883250 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
General anaesthesia?
Item
General
boolean
C0002915 (UMLS CUI [1])
Spinal/Epidural anaesthesia?
Item
Spinal/Epidural
boolean
C0002913 (UMLS CUI [1])
C0002928 (UMLS CUI [2])
Peripheral/central venous line?
Item
Was any i.v. or central venous line used?
boolean
C2985513 (UMLS CUI [1])
C1145640 (UMLS CUI [2])
Cell saver equipment?
Item
Was cell saver equipment used?
boolean
C1441512 (UMLS CUI [1,1])
C0014672 (UMLS CUI [1,2])
Date/Time removal of inthratecal/epidural catheter
Item
Date and time of removal of Indewelling Intrathecal or Epidural Catheter
datetime
C1410830 (UMLS CUI [1,1])
C2584606 (UMLS CUI [1,2])
C1264639 (UMLS CUI [1,3])
C1410830 (UMLS CUI [2,1])
C0179751 (UMLS CUI [2,2])
C1264639 (UMLS CUI [2,3])
Date/Time removal of inthratecal/epidural catheter not applicable?
Item
Date and time of removal of Indewelling Intrathecal or Epidural Catheter not applicable
boolean
C1272460 (UMLS CUI [1,1])
C1410830 (UMLS CUI [1,2])
C2584606 (UMLS CUI [1,3])
C1264639 (UMLS CUI [1,4])
C1272460 (UMLS CUI [2,1])
C1410830 (UMLS CUI [2,2])
C0179751 (UMLS CUI [2,3])
C1264639 (UMLS CUI [2,4])
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