ID

38387

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 the study's laboratory tests: At Screening, Haematology, Biochemistry and - if necessary - a Pregnancy Test are to be performed. This Visit (Visit 0) has to be done during the 7 days before the surgery, or 48 hours if a pregnancy test is needed. At Visit 1, only Haematology is performed. At Visit 2 (Day 3 and/or Day 9 or End of Treatment), both Haematology and Biochemistry are performed. See the respective itemgroups for details. If bleeding has occured, an additional hemoglobin sample is taken at Visit 3 (Follow-Up). Unscheduled tests (including aPTT and PT) can be performed at any time.

Link

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

Stichworte

Versionen (1)
  1. 15.10.19 15.10.19 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

15. Oktober 2019

DOI

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Lizenz

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

Englisch

Laboratory Tests

1 Formulare  
  1. StudyEvent: ODM
    1. Laboratory Tests
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

During Screening (Visit 0) only.

Datentyp

text

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

For Visit 0: No more than 7 days before Day 1 (48 hours if pregnancy test needed)

Datentyp

date

Alias
UMLS CUI [1]
C1320303
Visit Type
Beschreibung

For Visit 0: Fill in Pregnancy Test (if applicable), Haematology and Biochemistry. For Visit 1 (Day 1): Fill in Haematology only. For Visit 2 Day 3: Not applicable if treatment stopped within the last 24 hours -> then use "Visit 2 Day 9 or End of Treatment" instead. Fill in Haematology and Biochemistry. For Visit 2 Day 9 / End of Treatment: Fill in Haematology and Biochemistry. For Visit 3: Only to be used if bleeding has occured, and only Haematology test is performed.

Datentyp

integer

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0332307
Pregnancy Test
Beschreibung

Pregnancy Test

Alias
UMLS CUI-1
C0032976
Pregnancy Test done?
Beschreibung

Pregnancy Test done?

Datentyp

text

Alias
UMLS CUI [1,1]
C0032976
UMLS CUI [1,2]
C0884358
Pregnancy Test: Date of sampling
Beschreibung

Visit 0 (Screening) only, less than 48 hours before Surgery.

Datentyp

date

Alias
UMLS CUI [1,1]
C0032976
UMLS CUI [1,2]
C0011008
Pregnancy Test: Time of sampling
Beschreibung

Pregnancy Test: Time of sampling

Datentyp

time

Alias
UMLS CUI [1,1]
C0032976
UMLS CUI [1,2]
C0870078
UMLS CUI [1,3]
C0040223
Pregnancy Test: Result
Beschreibung

Pregnancy Test: Result

Datentyp

text

Alias
UMLS CUI [1,1]
C0032976
UMLS CUI [1,2]
C1274040
Haematology - Administrative Data
Beschreibung

Haematology - Administrative Data

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C0018941
UMLS CUI-3
C1320722
Not Done? Same laboratory as before?
Beschreibung

Select only one option. If performed but different name/city, give details in next item. This item is not applicable at Visit 0.

Datentyp

integer

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C1272696
UMLS CUI [2,1]
C3258037
UMLS CUI [2,2]
C0442739
UMLS CUI [3,1]
C1882331
UMLS CUI [3,2]
C0008848
UMLS CUI [3,3]
C0442739
Laboratory Name/City
Beschreibung

Laboratory Name/City

Datentyp

text

Alias
UMLS CUI [1]
C3258037
UMLS CUI [2,1]
C1882331
UMLS CUI [2,2]
C0008848
Haematology Date of Sampling
Beschreibung

Haematology Date of Sampling

Datentyp

date

Alias
UMLS CUI [1,1]
C1302413
UMLS CUI [1,2]
C0018941
Haematology Time of Sampling
Beschreibung

Haematology Time of Sampling

Datentyp

time

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0040223
UMLS CUI [1,3]
C0018941
Haematology - Results
Beschreibung

Haematology - Results

Alias
UMLS CUI-1
C0018941
UMLS CUI-2
C1254595
Select Haematology Test
Beschreibung

Fill in entire itemgroup once per test. At Visits 0, 1 and 2 (Day 3 and 9, as applicable), both tests are to be performed. If a haematology test is to be performed at Visit 3, only hemoglobin is tested.

Datentyp

text

Alias
UMLS CUI [1]
C0018941
Haematology Test done?
Beschreibung

Haematology Test done?

Datentyp

text

Alias
UMLS CUI [1,1]
C0018941
UMLS CUI [1,2]
C0884358
Haematology Test Value
Beschreibung

Haematology Test Value

Datentyp

float

Alias
UMLS CUI [1,1]
C0018941
UMLS CUI [1,2]
C1274040
Haematology Test Unit
Beschreibung

If other unit is used, specify in next item

Datentyp

integer

Alias
UMLS CUI [1,1]
C0018941
UMLS CUI [1,2]
C1519795
If other unit, specify
Beschreibung

Specify Other Haematology Test Unit

Datentyp

text

Alias
UMLS CUI [1,1]
C3845569
UMLS CUI [1,2]
C0018941
UMLS CUI [1,3]
C1519795
Biochemistry - Administrative Data
Beschreibung

Biochemistry - Administrative Data

Alias
UMLS CUI-1
C1320722
UMLS CUI-2
C0005477
Same laboratory as above
Beschreibung

If no, give details in next item

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3258037
UMLS CUI [1,2]
C0442739
UMLS CUI [2,1]
C1882331
UMLS CUI [2,2]
C0008848
UMLS CUI [2,3]
C0442739
Laboratory Name/City
Beschreibung

Laboratory Name/City

Datentyp

text

Alias
UMLS CUI [1]
C3258037
UMLS CUI [2,1]
C1882331
UMLS CUI [2,2]
C0008848
Biochemistry Date of Sampling
Beschreibung

Biochemistry Date of Sampling

Datentyp

date

Alias
UMLS CUI [1,1]
C1302413
UMLS CUI [1,2]
C0005477
Biochemistry Time of Sampling
Beschreibung

Biochemistry Time of Sampling

Datentyp

time

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0040223
UMLS CUI [1,3]
C0005477
Biochemistry - Results
Beschreibung

Biochemistry - Results

Alias
UMLS CUI-1
C0005477
UMLS CUI-2
C1254595
Select Biochemistry Test
Beschreibung

At Visit 0, all three tests are to be performed. At Visit 2 Day 3, only Creatinine is tested. At Visit 2 Day 9 or End of Treatment, only ASAT and ALAT are tested. Biochemistry Tests are not performed at Visit 1 or 3.

Datentyp

integer

Alias
UMLS CUI [1,1]
C0005477
UMLS CUI [1,2]
C0022885
Biochemistry Test done?
Beschreibung

Biochemistry Test done?

Datentyp

text

Alias
UMLS CUI [1,1]
C0005477
UMLS CUI [1,2]
C0022885
UMLS CUI [1,3]
C0884358
Biochemistry Test Value
Beschreibung

Biochemistry Test Value

Datentyp

float

Alias
UMLS CUI [1,1]
C0005477
UMLS CUI [1,2]
C0022885
UMLS CUI [1,3]
C1274040
Biochemistry Test Unit
Beschreibung

If other unit is used, specify in next item

Datentyp

integer

Alias
UMLS CUI [1,1]
C0005477
UMLS CUI [1,2]
C0022885
UMLS CUI [1,3]
C1519795
If other unit, specify
Beschreibung

Specify Other Biochemistry Test Unit

Datentyp

text

Alias
UMLS CUI [1,1]
C3845569
UMLS CUI [1,2]
C0005477
UMLS CUI [1,3]
C0022885
UMLS CUI [1,4]
C1519795
Unscheduled Laboratory Tests
Beschreibung

Unscheduled Laboratory Tests

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C3854240
Laboratory Test
Beschreibung

Laboratory Test

Datentyp

text

Alias
UMLS CUI [1]
C0022885
Date and Time of Sampling
Beschreibung

Date and Time of Sampling

Datentyp

datetime

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C1264639
Laboratory Test Value
Beschreibung

Laboratory Test Value

Datentyp

float

Alias
UMLS CUI [1,1]
C1254595
UMLS CUI [1,2]
C0022885
Laboratory Test Unit
Beschreibung

Laboratory Test Unit

Datentyp

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0439148
Laboratory Test: Normal range lower limit
Beschreibung

Laboratory Test: Normal range lower limit

Datentyp

float

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C1272773
Laboratory Test: Normal range upper limit
Beschreibung

Laboratory Test: Normal range upper limit

Datentyp

float

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C1299400
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Ähnliche Modelle

Laboratory Tests

1 Formulare
  1. StudyEvent: ODM
    1. Laboratory Tests
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])
Date of Visit
Item
Date of Visit
date
C1320303 (UMLS CUI [1])
Item
Visit Type
integer
C0545082 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Visit Type
Code List
Visit Type
CL Item
Visit 0 (Screening / pre-operative) (1)
CL Item
Visit 1 (Day 1 / post-operative: Prior to first post-operative injection) (2)
CL Item
Visit 2 (Day 3) (3)
CL Item
Visit 2 (Day 9 or End of Treatment: less than 24 hours from last dose) (4)
CL Item
Visit 3 (Follow-Up) (5)
CL Item
Unscheduled Test (6)
Item Group
Pregnancy Test
C0032976 (UMLS CUI-1)
Item
Pregnancy Test done?
text
C0032976 (UMLS CUI [1,1])
C0884358 (UMLS CUI [1,2])
Pregnancy Test done?
Code List
Pregnancy Test done?
CL Item
Done (D)
CL Item
Not Applicable/Not Done (NA)
Pregnancy Test: Date of sampling
Item
Pregnancy Test: Date of sampling
date
C0032976 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Pregnancy Test: Time of sampling
Item
Pregnancy Test: Time of sampling
time
C0032976 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Item
Pregnancy Test: Result
text
C0032976 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
Pregnancy Test: Result
Code List
Pregnancy Test: Result
CL Item
Positive (P)
CL Item
Negative (N)
Item Group
Haematology - Administrative Data
C0022885 (UMLS CUI-1)
C0018941 (UMLS CUI-2)
C1320722 (UMLS CUI-3)
Item
Not Done? Same laboratory as before?
integer
C0022885 (UMLS CUI [1,1])
C1272696 (UMLS CUI [1,2])
C3258037 (UMLS CUI [2,1])
C0442739 (UMLS CUI [2,2])
C1882331 (UMLS CUI [3,1])
C0008848 (UMLS CUI [3,2])
C0442739 (UMLS CUI [3,3])
Test performed? Laboratory Name/City same as before?
Code List
Not Done? Same laboratory as before?
CL Item
Not done (option not available at Visit 0/Screening) (1)
CL Item
Same laboratory as before (2)
CL Item
Laboratory Name/City different (specify) (3)
Laboratory Name/City
Item
Laboratory Name/City
text
C3258037 (UMLS CUI [1])
C1882331 (UMLS CUI [2,1])
C0008848 (UMLS CUI [2,2])
Haematology Date of Sampling
Item
Haematology Date of Sampling
date
C1302413 (UMLS CUI [1,1])
C0018941 (UMLS CUI [1,2])
Haematology Time of Sampling
Item
Haematology Time of Sampling
time
C0005834 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0018941 (UMLS CUI [1,3])
Item Group
Haematology - Results
C0018941 (UMLS CUI-1)
C1254595 (UMLS CUI-2)
Item
Select Haematology Test
text
C0018941 (UMLS CUI [1])
Haematology Test
Code List
Select Haematology Test
CL Item
Platelet (1)
CL Item
Hemoglobin (2)
Item
Haematology Test done?
text
C0018941 (UMLS CUI [1,1])
C0884358 (UMLS CUI [1,2])
Haematology Test
Code List
Haematology Test done?
CL Item
not done (MD)
CL Item
done (D)
Haematology Test Value
Item
Haematology Test Value
float
C0018941 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
Item
Haematology Test Unit
integer
C0018941 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
Haematology Test Unit
Code List
Haematology Test Unit
CL Item
10^9/L (for Platelets) (1)
CL Item
g/dL (for Hemoglobin) (2)
CL Item
Other unit (3)
Specify Other Haematology Test Unit
Item
If other unit, specify
text
C3845569 (UMLS CUI [1,1])
C0018941 (UMLS CUI [1,2])
C1519795 (UMLS CUI [1,3])
Item Group
Biochemistry - Administrative Data
C1320722 (UMLS CUI-1)
C0005477 (UMLS CUI-2)
Laboratory Name/City same as before
Item
Same laboratory as above
boolean
C3258037 (UMLS CUI [1,1])
C0442739 (UMLS CUI [1,2])
C1882331 (UMLS CUI [2,1])
C0008848 (UMLS CUI [2,2])
C0442739 (UMLS CUI [2,3])
Laboratory Name/City
Item
Laboratory Name/City
text
C3258037 (UMLS CUI [1])
C1882331 (UMLS CUI [2,1])
C0008848 (UMLS CUI [2,2])
Biochemistry Date of Sampling
Item
Biochemistry Date of Sampling
date
C1302413 (UMLS CUI [1,1])
C0005477 (UMLS CUI [1,2])
Biochemistry Time of Sampling
Item
Biochemistry Time of Sampling
time
C0005834 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0005477 (UMLS CUI [1,3])
Item Group
Biochemistry - Results
C0005477 (UMLS CUI-1)
C1254595 (UMLS CUI-2)
Item
Select Biochemistry Test
integer
C0005477 (UMLS CUI [1,1])
C0022885 (UMLS CUI [1,2])
Haematology Test
Code List
Select Biochemistry Test
CL Item
Creatinine (1)
CL Item
ASAT (2)
CL Item
ALAT (3)
Item
Biochemistry Test done?
text
C0005477 (UMLS CUI [1,1])
C0022885 (UMLS CUI [1,2])
C0884358 (UMLS CUI [1,3])
Haematology Test
Code List
Biochemistry Test done?
CL Item
not done (MD)
CL Item
done (D)
Biochemistry Test Value
Item
Biochemistry Test Value
float
C0005477 (UMLS CUI [1,1])
C0022885 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
Item
Biochemistry Test Unit
integer
C0005477 (UMLS CUI [1,1])
C0022885 (UMLS CUI [1,2])
C1519795 (UMLS CUI [1,3])
Haematology Test Unit
Code List
Biochemistry Test Unit
CL Item
mg/dL (for Creatinine) (1)
CL Item
UL (for ASAT and ALAT) (2)
CL Item
Other unit (3)
Specify Other Biochemistry Test Unit
Item
If other unit, specify
text
C3845569 (UMLS CUI [1,1])
C0005477 (UMLS CUI [1,2])
C0022885 (UMLS CUI [1,3])
C1519795 (UMLS CUI [1,4])
Item Group
Unscheduled Laboratory Tests
C0022885 (UMLS CUI-1)
C3854240 (UMLS CUI-2)
Laboratory Test
Item
Laboratory Test
text
C0022885 (UMLS CUI [1])
Date and Time of Sampling
Item
Date and Time of Sampling
datetime
C0005834 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
Laboratory Test Value
Item
Laboratory Test Value
float
C1254595 (UMLS CUI [1,1])
C0022885 (UMLS CUI [1,2])
Laboratory Test Unit
Item
Laboratory Test Unit
text
C0022885 (UMLS CUI [1,1])
C0439148 (UMLS CUI [1,2])
Laboratory Test: Normal range lower limit
Item
Laboratory Test: Normal range lower limit
float
C0022885 (UMLS CUI [1,1])
C1272773 (UMLS CUI [1,2])
Laboratory Test: Normal range upper limit
Item
Laboratory Test: Normal range upper limit
float
C0022885 (UMLS CUI [1,1])
C1299400 (UMLS CUI [1,2])
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