ID

41347

Description

Study ID: 105043/013 Clinical Study ID: 105043/013 Study Title: An Open-Label Study of Argatroban Injection to Evaluate the Safety and Effectiveness in Pediatric Patients Requiring Anticoagulant Alternatives to Heparin (Protocol SKF105043/013) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00039858 Sponsor: GlaxoSmithKline Collaborators: Encysive Pharmaceuticals Phase: Phase 4 Study Recruitment Status: Completed Generic Name: Argatroban Trade Name: N/A Study Indication: Thrombosis This Study evaluates the safety and the efficacy of i.v. Argatroban treatment in paediatric patients which require anticoagulants but aren't suitable for Heparin treatment. The study consists of screening visit (pre-treatment examination), treatment period of maximum 14 days after reaching therapeutical dose, post-treatment visit (once the treatment is stopped or after 14 days) and a follow-up visit which follows 30 days (+/- 14 days) after clinical resolution of underlying condition or after the end of the 14-day study period. Treatment can be continued after the 14-day study period if needed but such treatment isn't part of this Study. See https://clinicaltrials.gov/ct2/show/NCT00039858 The Chemistry Form has to be filled in twice: first, at the screening visit (withing 96 hours before treatment initiation) and second, within 24 hours of final infusion completion or at the 30-day follow-up visit, whichever comes first.

Link

https://clinicaltrials.gov/ct2/show/NCT00039858

Keywords

Versions (2)
  1. 8/31/20 8/31/20 -
  2. 9/2/20 9/2/20 -
Copyright Holder

GlaxoSmithKline

Uploaded on

September 2, 2020

DOI

To request one please log in.

License

Creative Commons BY-NC 4.0
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Safety and Efficacy of Argatroban in Pediatric Patients, NCT00039858

English

Chemistry (pre-/post-treatment)

1 forms  
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Site #
Description

Study centre number

Data type

integer

Alias
UMLS CUI [1,1]
C0600091
UMLS CUI [1,2]
C0019994
Patient #
Description

patient ID

Data type

integer

Alias
UMLS CUI [1]
C2348585
Visit Date
Description

visit date

Data type

date

Alias
UMLS CUI [1]
C1320303
Investigator Name
Description

Investigator Name

Data type

text

Alias
UMLS CUI [1]
C2826892
Visit Type
Description

Visit Type

Data type

text

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0332307
Chemistry
Description

Chemistry

Alias
UMLS CUI-1
C2347783
Date:
Description

(dd-mmm-yyyy)

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0008000
Time:
Description

(0000-2359)

Data type

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0008000
Not Done
Description

Laboratory procedures not performed - clinical chemistry

Data type

boolean

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0445106
UMLS CUI [1,3]
C0008000
Laboratory Name:
Description

(Lab name must match name on lab normals.)

Data type

text

Alias
UMLS CUI [1,1]
C3258037
UMLS CUI [1,2]
C0008000
Check to indicate copy of associated lab report is attached to CRF.
Description

Copy of clinical chemistry report attached

Data type

boolean

Alias
UMLS CUI [1,1]
C0684224
UMLS CUI [1,2]
C0008000
SGPT (ALT) - Result
Description

(numeric value only)

Data type

float

Alias
UMLS CUI [1]
C0201836
SGPT (ALT) - Clinically Significant
Description

ALT measurement - clinical significance

Data type

text

Alias
UMLS CUI [1,1]
C0201836
UMLS CUI [1,2]
C2826293
SGPT (ALT) - If clinically significant, please comment
Description

ALT measurement - comment

Data type

text

Alias
UMLS CUI [1,1]
C0201836
UMLS CUI [1,2]
C0947611
SGOT (AST) - Result
Description

(numeric value only)

Data type

float

Alias
UMLS CUI [1]
C0201899
SGOT (AST) - Clinically Significant
Description

AST measurement - clinical significance

Data type

text

Alias
UMLS CUI [1,1]
C0201899
UMLS CUI [1,2]
C2826293
SGOT (AST) - If clinically significant, please comment
Description

AST measurement - comment

Data type

text

Alias
UMLS CUI [1,1]
C0201899
UMLS CUI [1,2]
C0947611
Alkaline Phos. - Result
Description

(numeric value only)

Data type

float

Alias
UMLS CUI [1]
C0201850
Alkaline Phos. - Clinically Significant
Description

ALP measurement - clinical significance

Data type

text

Alias
UMLS CUI [1,1]
C0201850
UMLS CUI [1,2]
C2826293
Alkaline Phos. - If clinically significant, please comment
Description

ALP measurement - comment

Data type

text

Alias
UMLS CUI [1,1]
C0201850
UMLS CUI [1,2]
C0947611
Total Bilirubin - Result
Description

(numeric value only)

Data type

float

Alias
UMLS CUI [1]
C0201913
Total Bilirubin - Clinically Significant
Description

Total bilirubin measurement - clinical significance

Data type

text

Alias
UMLS CUI [1,1]
C0201913
UMLS CUI [1,2]
C2826293
Total Bilirubin - If clinically significant, please comment
Description

Total bilirubin measurement - comment

Data type

text

Alias
UMLS CUI [1,1]
C0201913
UMLS CUI [1,2]
C0947611
BUN - Result
Description

(numeric value only)

Data type

float

Alias
UMLS CUI [1]
C0005845
BUN - Clinically Significant
Description

BUN measurement - clinical significance

Data type

text

Alias
UMLS CUI [1,1]
C0005845
UMLS CUI [1,2]
C2826293
BUN - If clinically significant, please comment
Description

BUN measurement - comment

Data type

text

Alias
UMLS CUI [1,1]
C0005845
UMLS CUI [1,2]
C0947611
Chloride - Result
Description

(numeric value only)

Data type

float

Alias
UMLS CUI [1]
C0201952
Chloride - Clinically Significant
Description

Chloride measurement - clinical significance

Data type

text

Alias
UMLS CUI [1,1]
C0201952
UMLS CUI [1,2]
C2826293
Chloride - If clinically significant, please comment
Description

Chloride measurement - comment

Data type

text

Alias
UMLS CUI [1,1]
C0201952
UMLS CUI [1,2]
C0947611
Creatinine - Result
Description

(numeric value only)

Data type

float

Alias
UMLS CUI [1]
C0201975
Creatinine - Clinically Significant
Description

Creatinine measurement - clinical significance

Data type

text

Alias
UMLS CUI [1,1]
C0201975
UMLS CUI [1,2]
C2826293
Creatinine - If clinically significant, please comment
Description

Creatinine measurement - comment

Data type

text

Alias
UMLS CUI [1,1]
C0201975
UMLS CUI [1,2]
C0947611
Glucose - Result
Description

(numeric value only)

Data type

float

Alias
UMLS CUI [1]
C0337438
Glucose - Clinically Significant
Description

Glucose measurement - clinical significance

Data type

text

Alias
UMLS CUI [1,1]
C0337438
UMLS CUI [1,2]
C2826293
Glucose - If clinically significant, please comment
Description

Glucose measurement - comment

Data type

text

Alias
UMLS CUI [1,1]
C0337438
UMLS CUI [1,2]
C0947611
K - Result
Description

(numeric value only)

Data type

float

Alias
UMLS CUI [1]
C0202194
K - Clinically Significant
Description

Potassium measurement - clinical significance

Data type

text

Alias
UMLS CUI [1,1]
C0202194
UMLS CUI [1,2]
C2826293
K - If clinically significant, please comment
Description

Potassium measurement - comment

Data type

text

Alias
UMLS CUI [1,1]
C0202194
UMLS CUI [1,2]
C0947611
Na - Result
Description

(numeric value only)

Data type

float

Alias
UMLS CUI [1]
C0337443
Na - Clinically Significant
Description

Sodium measurement - clinical significance

Data type

text

Alias
UMLS CUI [1,1]
C0337443
UMLS CUI [1,2]
C2826293
Na - If clinically significant, please comment
Description

Sodium measurement - comment

Data type

text

Alias
UMLS CUI [1,1]
C0337443
UMLS CUI [1,2]
C0947611
CO2 - Result
Description

(numeric value only)

Data type

float

Alias
UMLS CUI [1]
C0201930
CO2 - Clinically Significant
Description

Carbon dioxide measurement - clinical significance

Data type

text

Alias
UMLS CUI [1,1]
C0201930
UMLS CUI [1,2]
C2826293
CO2 - If clinically significant, please comment
Description

Carbon dioxide measurement - comment

Data type

text

Alias
UMLS CUI [1,1]
C0201930
UMLS CUI [1,2]
C0947611
Other - Specify:
Description

(specify test name)

Data type

text

Alias
UMLS CUI [1,1]
C2347783
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C1521902
Other - Result
Description

(numeric value only)

Data type

float

Alias
UMLS CUI [1,1]
C2347783
UMLS CUI [1,2]
C0205394
Other - Clinically Significant
Description

Other clinical chemistry measurement - clinical significance

Data type

text

Alias
UMLS CUI [1,1]
C2347783
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C2826293
Other - If clinically significant, please comment
Description

Other clinical chemistry measurement - comment

Data type

text

Alias
UMLS CUI [1,1]
C2347783
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C0947611
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Similar models

Chemistry (pre-/post-treatment)

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Study centre number
Item
Site #
integer
C0600091 (UMLS CUI [1,1])
C0019994 (UMLS CUI [1,2])
patient ID
Item
Patient #
integer
C2348585 (UMLS CUI [1])
visit date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Investigator Name
Item
Investigator Name
text
C2826892 (UMLS CUI [1])
Item
Visit Type
text
C0545082 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Visit Type
Code List
Visit Type
CL Item
Pre-Treatment (Pre-Treatment)
CL Item
Post-Treatment (Post-Treatment)
Item Group
Chemistry
C2347783 (UMLS CUI-1)
Date of clinical chemistry
Item
Date:
date
C0011008 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
Time of clinical chemistry
Item
Time:
time
C0040223 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
Laboratory procedures not performed - clinical chemistry
Item
Not Done
boolean
C0022885 (UMLS CUI [1,1])
C0445106 (UMLS CUI [1,2])
C0008000 (UMLS CUI [1,3])
Laboratory name - clinical chemistry
Item
Laboratory Name:
text
C3258037 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
Copy of clinical chemistry report attached
Item
Check to indicate copy of associated lab report is attached to CRF.
boolean
C0684224 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
ALT measurement
Item
SGPT (ALT) - Result
float
C0201836 (UMLS CUI [1])
Item
SGPT (ALT) - Clinically Significant
text
C0201836 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
ALT measurement - clinical significance
Code List
SGPT (ALT) - Clinically Significant
CL Item
Yes (Yes)
CL Item
No (No)
ALT measurement - comment
Item
SGPT (ALT) - If clinically significant, please comment
text
C0201836 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
AST measurement
Item
SGOT (AST) - Result
float
C0201899 (UMLS CUI [1])
Item
SGOT (AST) - Clinically Significant
text
C0201899 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
ALT measurement - clinical significance
Code List
SGOT (AST) - Clinically Significant
CL Item
Yes (Yes)
CL Item
No (No)
AST measurement - comment
Item
SGOT (AST) - If clinically significant, please comment
text
C0201899 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
ALP measurement
Item
Alkaline Phos. - Result
float
C0201850 (UMLS CUI [1])
Item
Alkaline Phos. - Clinically Significant
text
C0201850 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
ALT measurement - clinical significance
Code List
Alkaline Phos. - Clinically Significant
CL Item
Yes (Yes)
CL Item
No (No)
ALP measurement - comment
Item
Alkaline Phos. - If clinically significant, please comment
text
C0201850 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
Total bilirubin measurement
Item
Total Bilirubin - Result
float
C0201913 (UMLS CUI [1])
Item
Total Bilirubin - Clinically Significant
text
C0201913 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
ALT measurement - clinical significance
Code List
Total Bilirubin - Clinically Significant
CL Item
Yes (Yes)
CL Item
No (No)
Total bilirubin measurement - comment
Item
Total Bilirubin - If clinically significant, please comment
text
C0201913 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
BUN measurement
Item
BUN - Result
float
C0005845 (UMLS CUI [1])
Item
BUN - Clinically Significant
text
C0005845 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
ALT measurement - clinical significance
Code List
BUN - Clinically Significant
CL Item
Yes (Yes)
CL Item
No (No)
BUN measurement - comment
Item
BUN - If clinically significant, please comment
text
C0005845 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
Chloride measurement
Item
Chloride - Result
float
C0201952 (UMLS CUI [1])
Item
Chloride - Clinically Significant
text
C0201952 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
ALT measurement - clinical significance
Code List
Chloride - Clinically Significant
CL Item
Yes (Yes)
CL Item
No (No)
Chloride measurement - comment
Item
Chloride - If clinically significant, please comment
text
C0201952 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
Creatinine measurement
Item
Creatinine - Result
float
C0201975 (UMLS CUI [1])
Item
Creatinine - Clinically Significant
text
C0201975 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
ALT measurement - clinical significance
Code List
Creatinine - Clinically Significant
CL Item
Yes (Yes)
CL Item
No (No)
Creatinine measurement - comment
Item
Creatinine - If clinically significant, please comment
text
C0201975 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
Glucose measurement
Item
Glucose - Result
float
C0337438 (UMLS CUI [1])
Item
Glucose - Clinically Significant
text
C0337438 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
ALT measurement - clinical significance
Code List
Glucose - Clinically Significant
CL Item
Yes (Yes)
CL Item
No (No)
Glucose measurement - comment
Item
Glucose - If clinically significant, please comment
text
C0337438 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
Potassium measurement
Item
K - Result
float
C0202194 (UMLS CUI [1])
Item
K - Clinically Significant
text
C0202194 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
ALT measurement - clinical significance
Code List
K - Clinically Significant
CL Item
Yes (Yes)
CL Item
No (No)
Potassium measurement - comment
Item
K - If clinically significant, please comment
text
C0202194 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
Sodium measurement
Item
Na - Result
float
C0337443 (UMLS CUI [1])
Item
Na - Clinically Significant
text
C0337443 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
ALT measurement - clinical significance
Code List
Na - Clinically Significant
CL Item
Yes (Yes)
CL Item
No (No)
Sodium measurement - comment
Item
Na - If clinically significant, please comment
text
C0337443 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
Carbon dioxide measurement
Item
CO2 - Result
float
C0201930 (UMLS CUI [1])
Item
CO2 - Clinically Significant
text
C0201930 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
ALT measurement - clinical significance
Code List
CO2 - Clinically Significant
CL Item
Yes (Yes)
CL Item
No (No)
Carbon dioxide measurement - comment
Item
CO2 - If clinically significant, please comment
text
C0201930 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
Other clinical chemistry - specify
Item
Other - Specify:
text
C2347783 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
Other clinical chemistry measurement - result
Item
Other - Result
float
C2347783 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Other clinical chemistry measurement - clinical significance
Item
Other - Clinically Significant
text
C2347783 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2826293 (UMLS CUI [1,3])
Other clinical chemistry measurement - comment
Item
Other - If clinically significant, please comment
text
C2347783 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,3])
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