ID

38093

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 medical/surgical history and risk factors for VTE assessed during 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

Keywords

Versions (1)
  1. 9/16/19 9/16/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

September 16, 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

Medical/Surgical History, VTE Risk Factors

1 forms  
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

No more than 30 days before Day 1 (Surgery)

Data type

date

Alias
UMLS CUI [1]
C1320303
Specific Medical History/Risk Factors for VTE
Description

Specific Medical History/Risk Factors for VTE

Alias
UMLS CUI-1
C0262926
UMLS CUI-2
C0035648
UMLS CUI-3
C1861172
DVT
Description

DVT

Data type

boolean

Alias
UMLS CUI [1]
C0149871
PE
Description

Pulmonary Embolism

Data type

boolean

Alias
UMLS CUI [1]
C0034065
Stroke
Description

Stroke

Data type

boolean

Alias
UMLS CUI [1]
C0038454
Myocardial Infarction
Description

Myocardial Infarction

Data type

boolean

Alias
UMLS CUI [1]
C0027051
Prior major surgery or trauma within the last 12 months
Description

Recent major surgery or trauma

Data type

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0679637
UMLS CUI [1,3]
C0332185
UMLS CUI [2,1]
C0262926
UMLS CUI [2,2]
C0332677
UMLS CUI [2,3]
C0332185
Neoplastic disease
Description

If yes, answer next question

Data type

boolean

Alias
UMLS CUI [1]
C1882062
Neoplastic disease present at study start
Description

present at study start for cancer present or treated within the last 6 months

Data type

boolean

Alias
UMLS CUI [1,1]
C1882062
UMLS CUI [1,2]
C0150312
UMLS CUI [1,3]
C2348558
Inflammatory Bowel Disease
Description

If yes, answer next question

Data type

boolean

Alias
UMLS CUI [1]
C0021390
Inflammatory Bowel Disease present at study start
Description

Inflammatory Bowel Disease present at study start

Data type

boolean

Alias
UMLS CUI [1,1]
C0021390
UMLS CUI [1,2]
C0150312
UMLS CUI [1,3]
C2348558
Chronic Obstructive Pulmonary Disease
Description

If yes, answer next question

Data type

boolean

Alias
UMLS CUI [1]
C0024117
Chronic Obstructive Pulmonary Disease present at study start
Description

Chronic Obstructive Pulmonary Disease present at study start

Data type

boolean

Alias
UMLS CUI [1,1]
C0024117
UMLS CUI [1,2]
C0150312
UMLS CUI [1,3]
C2348558
Immobilization
Description

Bed confinement during more than the three days preceding surgery If yes, answer next question

Data type

boolean

Alias
UMLS CUI [1]
C0020944
Immobilization present at study start
Description

Bed confinement during more than the three days preceding surgery

Data type

boolean

Alias
UMLS CUI [1,1]
C0020944
UMLS CUI [1,2]
C0150312
UMLS CUI [1,3]
C2348558
Oral contraceptive use
Description

If yes, answer next question

Data type

boolean

Alias
UMLS CUI [1]
C0009905
Oral contraceptive use present at study start
Description

Oral contraceptive use present at study start

Data type

boolean

Alias
UMLS CUI [1,1]
C0009905
UMLS CUI [1,2]
C0150312
UMLS CUI [1,3]
C2348558
Varicose veins
Description

If yes, answer next question

Data type

boolean

Alias
UMLS CUI [1]
C0042345
Varicose veins present at study start
Description

Varicose veins present at study start

Data type

boolean

Alias
UMLS CUI [1,1]
C0042345
UMLS CUI [1,2]
C0150312
UMLS CUI [1,3]
C2348558
Prothrombotic states
Description

Prothrombotic states or deficiencies of ATIII, deficiencies of or resistance to protein C or protein S, lupus anticoagulant, antiphospholipid antibody etc.. If yes, answer next question

Data type

boolean

Alias
UMLS CUI [1]
C0398623
Prothrombotic states present at study start
Description

Prothrombotic states or deficiencies of ATIII, deficiencies of or resistance to protein C or protein S, lupus anticoagulant, antiphospholipid antibody etc..

Data type

boolean

Alias
UMLS CUI [1,1]
C0398623
UMLS CUI [1,2]
C0150312
UMLS CUI [1,3]
C2348558
Congestive Heart Failure
Description

If yes, answer next question

Data type

boolean

Alias
UMLS CUI [1]
C0018802
Congestive Heart Failure present at study start
Description

If yes, specify grade at study start

Data type

boolean

Alias
UMLS CUI [1,1]
C0018802
UMLS CUI [1,2]
C0150312
UMLS CUI [1,3]
C2348558
Congestive Heart Failure NYHA Classification
Description

Congestive Heart Failure NYHA Classification

Data type

integer

Alias
UMLS CUI [1,1]
C0018802
UMLS CUI [1,2]
C1275491
Past medical or surgical history
Description

Past medical or surgical history

Alias
UMLS CUI-1
C0262926
UMLS CUI-2
C0489540
Please record past medical or surgical history other than those described on the previous page.
Description

If yes, give details in following repeating itemgroup

Data type

text

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C0262926
UMLS CUI [2,1]
C0205394
UMLS CUI [2,2]
C0489540
Past medical or surgical history - Details
Description

Past medical or surgical history - Details

Alias
UMLS CUI-1
C0262926
UMLS CUI-2
C0489540
UMLS CUI-3
C1522508
Past medical or surgical history
Description

Past medical or surgical history

Data type

text

Alias
UMLS CUI [1]
C0262926
UMLS CUI [2]
C0489540
Persistence of symptoms
Description

Past medical or surgical history: persistent symptoms

Data type

text

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C1457887
UMLS CUI [1,3]
C0205322
UMLS CUI [2,1]
C0489540
UMLS CUI [2,2]
C1457887
UMLS CUI [2,3]
C0205322
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Similar models

Medical/Surgical History, VTE Risk Factors

1 forms
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
Specific Medical History/Risk Factors for VTE
C0262926 (UMLS CUI-1)
C0035648 (UMLS CUI-2)
C1861172 (UMLS CUI-3)
DVT
Item
DVT
boolean
C0149871 (UMLS CUI [1])
Pulmonary Embolism
Item
PE
boolean
C0034065 (UMLS CUI [1])
Stroke
Item
Stroke
boolean
C0038454 (UMLS CUI [1])
Myocardial Infarction
Item
Myocardial Infarction
boolean
C0027051 (UMLS CUI [1])
Recent major surgery or trauma
Item
Prior major surgery or trauma within the last 12 months
boolean
C0262926 (UMLS CUI [1,1])
C0679637 (UMLS CUI [1,2])
C0332185 (UMLS CUI [1,3])
C0262926 (UMLS CUI [2,1])
C0332677 (UMLS CUI [2,2])
C0332185 (UMLS CUI [2,3])
Neoplastic disease
Item
Neoplastic disease
boolean
C1882062 (UMLS CUI [1])
Neoplastic disease present at study start
Item
Neoplastic disease present at study start
boolean
C1882062 (UMLS CUI [1,1])
C0150312 (UMLS CUI [1,2])
C2348558 (UMLS CUI [1,3])
Inflammatory Bowel Disease
Item
Inflammatory Bowel Disease
boolean
C0021390 (UMLS CUI [1])
Inflammatory Bowel Disease present at study start
Item
Inflammatory Bowel Disease present at study start
boolean
C0021390 (UMLS CUI [1,1])
C0150312 (UMLS CUI [1,2])
C2348558 (UMLS CUI [1,3])
Chronic Obstructive Pulmonary Disease
Item
Chronic Obstructive Pulmonary Disease
boolean
C0024117 (UMLS CUI [1])
Chronic Obstructive Pulmonary Disease present at study start
Item
Chronic Obstructive Pulmonary Disease present at study start
boolean
C0024117 (UMLS CUI [1,1])
C0150312 (UMLS CUI [1,2])
C2348558 (UMLS CUI [1,3])
Immobilization
Item
Immobilization
boolean
C0020944 (UMLS CUI [1])
Immobilization present at study start
Item
Immobilization present at study start
boolean
C0020944 (UMLS CUI [1,1])
C0150312 (UMLS CUI [1,2])
C2348558 (UMLS CUI [1,3])
Oral contraceptive use
Item
Oral contraceptive use
boolean
C0009905 (UMLS CUI [1])
Oral contraceptive use present at study start
Item
Oral contraceptive use present at study start
boolean
C0009905 (UMLS CUI [1,1])
C0150312 (UMLS CUI [1,2])
C2348558 (UMLS CUI [1,3])
Varicose veins
Item
Varicose veins
boolean
C0042345 (UMLS CUI [1])
Varicose veins present at study start
Item
Varicose veins present at study start
boolean
C0042345 (UMLS CUI [1,1])
C0150312 (UMLS CUI [1,2])
C2348558 (UMLS CUI [1,3])
Prothrombotic states
Item
Prothrombotic states
boolean
C0398623 (UMLS CUI [1])
Prothrombotic states present at study start
Item
Prothrombotic states present at study start
boolean
C0398623 (UMLS CUI [1,1])
C0150312 (UMLS CUI [1,2])
C2348558 (UMLS CUI [1,3])
Congestive Heart Failure
Item
Congestive Heart Failure
boolean
C0018802 (UMLS CUI [1])
Congestive Heart Failure present at study start
Item
Congestive Heart Failure present at study start
boolean
C0018802 (UMLS CUI [1,1])
C0150312 (UMLS CUI [1,2])
C2348558 (UMLS CUI [1,3])
Item
Congestive Heart Failure NYHA Classification
integer
C0018802 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
Congestive Heart Failure NYHA Classification
Code List
Congestive Heart Failure NYHA Classification
CL Item
No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, or dyspnea (shortness of breath) (1)
CL Item
Slight limitation of physical activity. Comfortable at rest, but ordinary physical activity results in fatigue, palpitation, or dyspnea (shortness of breath) (2)
CL Item
Marked limitation of physical activity. Comfortable at rest, but less than ordinary physical activity causes fatigue, palpitation, or dyspnea (shortness of breath) (3)
CL Item
Unable to carry out any physical activity without discomfort. Symptoms of cardiac insufficiency at rest. If any physical activity is undertaken, discomfort is increased. (4)
Item Group
Past medical or surgical history
C0262926 (UMLS CUI-1)
C0489540 (UMLS CUI-2)
Item
Please record past medical or surgical history other than those described on the previous page.
text
C0205394 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C0205394 (UMLS CUI [2,1])
C0489540 (UMLS CUI [2,2])
Other medical or surgical history?
Code List
Please record past medical or surgical history other than those described on the previous page.
CL Item
Yes (Y)
CL Item
None (N)
Item Group
Past medical or surgical history - Details
C0262926 (UMLS CUI-1)
C0489540 (UMLS CUI-2)
C1522508 (UMLS CUI-3)
Past medical or surgical history
Item
Past medical or surgical history
text
C0262926 (UMLS CUI [1])
C0489540 (UMLS CUI [2])
Item
Persistence of symptoms
text
C0262926 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0205322 (UMLS CUI [1,3])
C0489540 (UMLS CUI [2,1])
C1457887 (UMLS CUI [2,2])
C0205322 (UMLS CUI [2,3])
Medical history; history of surgical procedures; Symptoms, persistent
Code List
Persistence of symptoms
CL Item
Yes (Yes)
CL Item
No (No)
CL Item
Not applicable (Not applicable)
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