ID

38418

Beschreibung

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 diagnostics (in particular imaging) used to assess a suspected pulmnoary embolism and is to be filled in as appropriate during the study.

Link

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

Stichworte

Versionen (1)
  1. 16.10.19 16.10.19 -
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GlaxoSmithKline

Hochgeladen am

16. Oktober 2019

DOI

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Fondaparinux in Addition to Intermittent Pneumatic Compression in Abdominal Surgery Patients at VTE Risk - NCT00038961

Englisch

Assessment of Suspected Pulmonary Embolism

1 Formulare  
Administrative data
Beschreibung

Administrative data

Alias
UMLS CUI-1
C1320722
Country No.
Beschreibung

Country No.

Datentyp

integer

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

Centre No.

Datentyp

integer

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

Clinical Trial Subject Unique Identifier

Datentyp

integer

Alias
UMLS CUI [1]
C2348585
Subject Initials
Beschreibung

Subject Initials

Datentyp

text

Alias
UMLS CUI [1,1]
C1997894
UMLS CUI [1,2]
C2986440
General Pulmonary Embolism Information
Beschreibung

General Pulmonary Embolism Information

Alias
UMLS CUI-1
C1508263
UMLS CUI-2
C0034065
Date of first clinical signs/symptoms of PE
Beschreibung

Date of first PE signs/symptoms

Datentyp

date

Alias
UMLS CUI [1,1]
C0034065
UMLS CUI [1,2]
C0574845
UMLS CUI [1,3]
C0037088
Perfusion and/or Ventilation Lung Scan
Beschreibung

Perfusion and/or Ventilation Lung Scan

Alias
UMLS CUI-1
C0203702
PE Assessment Imaging Modality
Beschreibung

If test performed, record date.

Datentyp

text

Alias
UMLS CUI [1,1]
C0034065
UMLS CUI [1,2]
C0220825
UMLS CUI [1,3]
C1275506
Date of PE Assessment
Beschreibung

Date of PE Assessment

Datentyp

date

Alias
UMLS CUI [1,1]
C0034065
UMLS CUI [1,2]
C0220825
UMLS CUI [1,3]
C0011008
Result
Beschreibung

High probability defect(s) is taken as evidence of PE. Study treatment if ongoing, must be discontinued. Non-high probability defect(s): If the mandatory venography has not yet been done: perform first an Ultrasonography. If negative, continue study drug until mandatory venography. If positive, confirm diagnosis with a venography or a pulmonary angiography. If the mandatory venography has been done: perform a venography or a pulmonary angiography. If no defect(s), the subject should continue study treatment if still ongoing

Datentyp

text

Alias
UMLS CUI [1,1]
C0034065
UMLS CUI [1,2]
C0220825
UMLS CUI [1,3]
C1274040
Ultrasonography
Beschreibung

Ultrasonography

Alias
UMLS CUI-1
C0041618
Not done
Beschreibung

If done, record date

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0041618
UMLS CUI [1,2]
C1272696
Date performed
Beschreibung

Ultrasonography date

Datentyp

date

Alias
UMLS CUI [1,1]
C0041618
UMLS CUI [1,2]
C0011008
Ultrasonography Result of Left Common Femoral
Beschreibung

Ultrasonography Result of Left Common Femoral

Datentyp

text

Alias
UMLS CUI [1,1]
C0041618
UMLS CUI [1,2]
C1275667
UMLS CUI [1,3]
C0205091
UMLS CUI [1,4]
C1274040
Ultrasonography Result of Left Popliteal
Beschreibung

Ultrasonography Result of Left Popliteal

Datentyp

text

Alias
UMLS CUI [1,1]
C0041618
UMLS CUI [1,2]
C0032652
UMLS CUI [1,3]
C0205091
UMLS CUI [1,4]
C1274040
Ultrasonography Result of Right Common Femoral
Beschreibung

Ultrasonography Result of Right Common Femoral

Datentyp

text

Alias
UMLS CUI [1,1]
C0041618
UMLS CUI [1,2]
C1275667
UMLS CUI [1,3]
C0205090
UMLS CUI [1,4]
C1274040
Ultrasonography Result of Right Popliteal
Beschreibung

Ultrasonography Result of Right Popliteal

Datentyp

text

Alias
UMLS CUI [1,1]
C0041618
UMLS CUI [1,2]
C0032652
UMLS CUI [1,3]
C0205090
UMLS CUI [1,4]
C1274040
Venography
Beschreibung

Venography

Alias
UMLS CUI-1
C0031545
Venography Type
Beschreibung

For bilateral/left leg/right leg, record date in next item. For not done/left leg/right leg, record primary reason.

Datentyp

text

Alias
UMLS CUI [1,1]
C0031545
UMLS CUI [1,2]
C0332307
Date performed
Beschreibung

Venography Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0031545
UMLS CUI [1,2]
C0011008
If NOT BILATERAL or NOT DONE, select the primary reason
Beschreibung

if other reason, specify in next item

Datentyp

text

Alias
UMLS CUI [1,1]
C1549995
UMLS CUI [1,2]
C0031545
UMLS CUI [1,3]
C1272696
UMLS CUI [2,1]
C1549995
UMLS CUI [2,2]
C0205092
UMLS CUI [2,3]
C0031545
Specify other reason venography not done/not bilateral
Beschreibung

if applicable

Datentyp

text

Alias
UMLS CUI [1,1]
C1521902
UMLS CUI [1,2]
C3840932
UMLS CUI [1,3]
C0031545
UMLS CUI [1,4]
C1272696
UMLS CUI [2,1]
C1521902
UMLS CUI [2,2]
C3840932
UMLS CUI [2,3]
C0205092
UMLS CUI [2,4]
C0031545
Angiography
Beschreibung

Angiography

Alias
UMLS CUI-1
C0002978
Not done
Beschreibung

if done, record date

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1272696
UMLS CUI [1,2]
C0002978
Date performed
Beschreibung

Angiography date

Datentyp

date

Alias
UMLS CUI [1,1]
C0002978
UMLS CUI [1,2]
C0011008
Spiral CT scan
Beschreibung

Spiral CT scan

Alias
UMLS CUI-1
C0860888
Not done
Beschreibung

if done, record date

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1272696
UMLS CUI [1,2]
C0860888
Date performed
Beschreibung

Spiral CT date

Datentyp

date

Alias
UMLS CUI [1,1]
C0860888
UMLS CUI [1,2]
C0011008
Other tests
Beschreibung

Other tests

Alias
UMLS CUI-1
C0039593
UMLS CUI-2
C0205394
Not done
Beschreibung

if done, record type of test and date

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1272696
UMLS CUI [1,2]
C0039593
UMLS CUI [1,3]
C0205394
Other test, specify
Beschreibung

Specify other test

Datentyp

text

Alias
UMLS CUI [1,1]
C1521902
UMLS CUI [1,2]
C0039593
UMLS CUI [1,3]
C0205394
Date performed
Beschreibung

Other test date

Datentyp

date

Alias
UMLS CUI [1,1]
C0039593
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C0011008
Treatment
Beschreibung

Treatment

Alias
UMLS CUI-1
C0087111
Based on signs and symptoms, and all above detailed examinations, was medication given to treat PE?
Beschreibung

If medication was given, record in the medication form

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013216
UMLS CUI [1,2]
C0034065
UMLS CUI [1,3]
C0566251
UMLS CUI [1,4]
C0037088
UMLS CUI [2,1]
C0013216
UMLS CUI [2,2]
C0034065
UMLS CUI [2,3]
C0566251
UMLS CUI [2,4]
C0220825
Suspected PE fatal
Beschreibung

Suspected PE fatal

Alias
UMLS CUI-1
C0034065
UMLS CUI-2
C1302234
UMLS CUI-3
C0750491
Was the suspected PE fatal?
Beschreibung

If yes, specify date of death

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0034065
UMLS CUI [1,2]
C1302234
UMLS CUI [1,3]
C0750491
If yes, specify date of death
Beschreibung

Date of death if fatal PE

Datentyp

date

Alias
UMLS CUI [1,1]
C1148348
UMLS CUI [1,2]
C0034065
UMLS CUI [1,3]
C1302234
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Ähnliche Modelle

Assessment of Suspected Pulmonary Embolism

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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])
Item Group
General Pulmonary Embolism Information
C1508263 (UMLS CUI-1)
C0034065 (UMLS CUI-2)
Date of first PE signs/symptoms
Item
Date of first clinical signs/symptoms of PE
date
C0034065 (UMLS CUI [1,1])
C0574845 (UMLS CUI [1,2])
C0037088 (UMLS CUI [1,3])
Item Group
Perfusion and/or Ventilation Lung Scan
C0203702 (UMLS CUI-1)
Item
PE Assessment Imaging Modality
text
C0034065 (UMLS CUI [1,1])
C0220825 (UMLS CUI [1,2])
C1275506 (UMLS CUI [1,3])
PE Assessment Imaging Modality
Code List
PE Assessment Imaging Modality
CL Item
Not done (Not done)
CL Item
V/Q scan (V/Q scan)
CL Item
Perfusion scan (Perfusion scan)
CL Item
Ventilation scan (Ventilation scan)
Date of PE Assessment
Item
Date of PE Assessment
date
C0034065 (UMLS CUI [1,1])
C0220825 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item
Result
text
C0034065 (UMLS CUI [1,1])
C0220825 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
Results
Code List
Result
CL Item
High probability defect(s) (High probability defect(s))
CL Item
Non high probability defect(s) (Non high probability defect(s))
CL Item
No defect(s) (No defect(s))
Item Group
Ultrasonography
C0041618 (UMLS CUI-1)
Ultrasonography not done
Item
Not done
boolean
C0041618 (UMLS CUI [1,1])
C1272696 (UMLS CUI [1,2])
Ultrasonography date
Item
Date performed
date
C0041618 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Ultrasonography Result of Left Common Femoral
text
C0041618 (UMLS CUI [1,1])
C1275667 (UMLS CUI [1,2])
C0205091 (UMLS CUI [1,3])
C1274040 (UMLS CUI [1,4])
Ultrasonography, Common Femoral vein, left, Result
Code List
Ultrasonography Result of Left Common Femoral
CL Item
Fully compressible/Normal (Fully compressible/Normal)
CL Item
Non compressible (Non compressible)
CL Item
Inadequate (Inadequate)
CL Item
Not done (Not done)
Item
Ultrasonography Result of Left Popliteal
text
C0041618 (UMLS CUI [1,1])
C0032652 (UMLS CUI [1,2])
C0205091 (UMLS CUI [1,3])
C1274040 (UMLS CUI [1,4])
Ultrasonography, Common Femoral vein, left, Result
Code List
Ultrasonography Result of Left Popliteal
CL Item
Fully compressible/Normal (Fully compressible/Normal)
CL Item
Non compressible (Non compressible)
CL Item
Inadequate (Inadequate)
CL Item
Not done (Not done)
Item
Ultrasonography Result of Right Common Femoral
text
C0041618 (UMLS CUI [1,1])
C1275667 (UMLS CUI [1,2])
C0205090 (UMLS CUI [1,3])
C1274040 (UMLS CUI [1,4])
Ultrasonography, Common Femoral vein, left, Result
Code List
Ultrasonography Result of Right Common Femoral
CL Item
Fully compressible/Normal (Fully compressible/Normal)
CL Item
Non compressible (Non compressible)
CL Item
Inadequate (Inadequate)
CL Item
Not done (Not done)
Item
Ultrasonography Result of Right Popliteal
text
C0041618 (UMLS CUI [1,1])
C0032652 (UMLS CUI [1,2])
C0205090 (UMLS CUI [1,3])
C1274040 (UMLS CUI [1,4])
Ultrasonography, Common Femoral vein, left, Result
Code List
Ultrasonography Result of Right Popliteal
CL Item
Fully compressible/Normal (Fully compressible/Normal)
CL Item
Non compressible (Non compressible)
CL Item
Inadequate (Inadequate)
CL Item
Not done (Not done)
Item Group
Venography
C0031545 (UMLS CUI-1)
Item
Venography Type
text
C0031545 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Venography Type
Code List
Venography Type
CL Item
Not done (ND)
CL Item
Bilateral (BI)
CL Item
Left leg (L)
CL Item
Right leg (R)
Venography Date
Item
Date performed
date
C0031545 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
If NOT BILATERAL or NOT DONE, select the primary reason
text
C1549995 (UMLS CUI [1,1])
C0031545 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
C1549995 (UMLS CUI [2,1])
C0205092 (UMLS CUI [2,2])
C0031545 (UMLS CUI [2,3])
Venography; Indication
Code List
If NOT BILATERAL or NOT DONE, select the primary reason
CL Item
Failed venous access (Failed venous access)
CL Item
Subject refused/withdrew consent (Subject refused/withdrew consent)
CL Item
Subject amputee (Subject amputee)
CL Item
Other, specify (Other, specify)
Specify other reason venography not done/unilateral
Item
Specify other reason venography not done/not bilateral
text
C1521902 (UMLS CUI [1,1])
C3840932 (UMLS CUI [1,2])
C0031545 (UMLS CUI [1,3])
C1272696 (UMLS CUI [1,4])
C1521902 (UMLS CUI [2,1])
C3840932 (UMLS CUI [2,2])
C0205092 (UMLS CUI [2,3])
C0031545 (UMLS CUI [2,4])
Item Group
Angiography
C0002978 (UMLS CUI-1)
Angiography not done?
Item
Not done
boolean
C1272696 (UMLS CUI [1,1])
C0002978 (UMLS CUI [1,2])
Angiography date
Item
Date performed
date
C0002978 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
Spiral CT scan
C0860888 (UMLS CUI-1)
Spiral CT scan not done?
Item
Not done
boolean
C1272696 (UMLS CUI [1,1])
C0860888 (UMLS CUI [1,2])
Spiral CT date
Item
Date performed
date
C0860888 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
Other tests
C0039593 (UMLS CUI-1)
C0205394 (UMLS CUI-2)
Other tests not done?
Item
Not done
boolean
C1272696 (UMLS CUI [1,1])
C0039593 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
Specify other test
Item
Other test, specify
text
C1521902 (UMLS CUI [1,1])
C0039593 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
Other test date
Item
Date performed
date
C0039593 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item Group
Treatment
C0087111 (UMLS CUI-1)
Medication for PE treatment given due to signs/symptoms/examinations?
Item
Based on signs and symptoms, and all above detailed examinations, was medication given to treat PE?
boolean
C0013216 (UMLS CUI [1,1])
C0034065 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
C0037088 (UMLS CUI [1,4])
C0013216 (UMLS CUI [2,1])
C0034065 (UMLS CUI [2,2])
C0566251 (UMLS CUI [2,3])
C0220825 (UMLS CUI [2,4])
Item Group
Suspected PE fatal
C0034065 (UMLS CUI-1)
C1302234 (UMLS CUI-2)
C0750491 (UMLS CUI-3)
Suspected PE fatal?
Item
Was the suspected PE fatal?
boolean
C0034065 (UMLS CUI [1,1])
C1302234 (UMLS CUI [1,2])
C0750491 (UMLS CUI [1,3])
Date of death if fatal PE
Item
If yes, specify date of death
date
C1148348 (UMLS CUI [1,1])
C0034065 (UMLS CUI [1,2])
C1302234 (UMLS CUI [1,3])
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