ID

41369

Beschreibung

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 This Form has to be filled in at the screening visit. Section Pre-Treatment Anticoagulation has to be filled in within 96 hours prior to treatment initiation and additionally, if Heparin was administered, ACT or aPTT have to be measured before Heparin administration. Section Samples for Pre-Treatment PK and Confirmatory HIT Testing, Indication for Argatroban Use has to be filled in within 96 hours before treatment initiation administration. Section Indication for Argatroban Use records the indications on behalf of which is the medicament administered.

Link

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

Stichworte

Versionen (1)
  1. 14.09.20 14.09.20 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

14. September 2020

DOI

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Lizenz

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

Englisch

Anticoagulation, Samples for Pre-Treatment PK and Confirmatory HIT Testing, Indication for Argatroban Use

1 Formulare  
Administrative Data
Beschreibung

Administrative Data

Alias
UMLS CUI-1
C1320722
Site #
Beschreibung

Study centre number

Datentyp

integer

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

patient ID

Datentyp

integer

Alias
UMLS CUI [1]
C2348585
Visit Date
Beschreibung

visit date

Datentyp

date

Alias
UMLS CUI [1]
C1320303
Investigator Name
Beschreibung

Investigator Name

Datentyp

text

Alias
UMLS CUI [1]
C2826892
Pre-Treatment Anticoagulation
Beschreibung

Pre-Treatment Anticoagulation

Alias
UMLS CUI-1
C0003281
UMLS CUI-2
C0332152
UMLS CUI-3
C2347804
Was heparin being administered prior to study Argatroban administration?
Beschreibung

*If Yes, ACT or aPTT results must be from BEFORE heparin was administered. **If No, ACT or aPTT results must be completed up to 96 hours prior to treatment initiation. In either case, PT/INR results must be completed within 96 hours before treatment initiation.

Datentyp

text

Alias
UMLS CUI [1,1]
C0019134
UMLS CUI [1,2]
C0332152
UMLS CUI [1,3]
C4684789
Laboratory Name:
Beschreibung

(Lab name must match name on lab normals.)

Datentyp

text

Alias
UMLS CUI [1]
C3258037
Check to indicate copy of associated lab report is attached to CRF.
Beschreibung

Is a copy of the lab report attached?

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0684224
UMLS CUI [1,2]
C0587081
aPPT
Beschreibung

(check if test performed)

Datentyp

boolean

Alias
UMLS CUI [1]
C0030605
aPPT - Date
Beschreibung

(dd-mmm-yyyy)

Datentyp

date

Alias
UMLS CUI [1,1]
C0030605
UMLS CUI [1,2]
C2985720
aPPT - Time
Beschreibung

(0000-2359)

Datentyp

time

Alias
UMLS CUI [1,1]
C0030605
UMLS CUI [1,2]
C1516048
UMLS CUI [1,3]
C0040223
aPTT - Result
Beschreibung

(numeric value only)

Datentyp

float

Alias
UMLS CUI [1,1]
C0030605
UMLS CUI [1,2]
C0587081
aPTT - Clinically Significant
Beschreibung

aPTT - clinical significance

Datentyp

text

Alias
UMLS CUI [1,1]
C0030605
UMLS CUI [1,2]
C2826293
aPTT - If clinically significant, please comment
Beschreibung

aPPT - comment on clinical significance

Datentyp

text

Alias
UMLS CUI [1,1]
C1846819
UMLS CUI [1,2]
C0947611
UMLS CUI [1,3]
C2826293
PT or INR
Beschreibung

(check which test was performed)

Datentyp

text

Alias
UMLS CUI [1]
C0033707
UMLS CUI [2]
C0525032
PT or INR - Date
Beschreibung

(dd-mmm-yyyy)

Datentyp

date

Alias
UMLS CUI [1,1]
C0033707
UMLS CUI [1,2]
C2985720
UMLS CUI [2,1]
C0525032
UMLS CUI [2,2]
C2985720
PT or INR - Time
Beschreibung

(0000-2359)

Datentyp

time

Alias
UMLS CUI [1,1]
C0033707
UMLS CUI [1,2]
C1516048
UMLS CUI [1,3]
C0040223
UMLS CUI [2,1]
C0525032
UMLS CUI [2,2]
C1516048
UMLS CUI [2,3]
C0040223
PT or INR - Result
Beschreibung

(numeric value only)

Datentyp

float

Alias
UMLS CUI [1,1]
C0033707
UMLS CUI [1,2]
C0587081
UMLS CUI [2,1]
C0525032
UMLS CUI [2,2]
C0587081
PT or INR - Clinically Significant
Beschreibung

PT - clinical significance | INR - clinical significance

Datentyp

text

Alias
UMLS CUI [1,1]
C0033707
UMLS CUI [1,2]
C2826293
UMLS CUI [2,1]
C0525032
UMLS CUI [2,2]
C2826293
PT or INR - If clinically significant, please comment
Beschreibung

PT - comment on clinical significance | INR - comment on clinical significance

Datentyp

text

Alias
UMLS CUI [1,1]
C0033707
UMLS CUI [1,2]
C0947611
UMLS CUI [1,3]
C2826293
UMLS CUI [2,1]
C0525032
UMLS CUI [2,2]
C0947611
UMLS CUI [2,3]
C2826293
ACT
Beschreibung

(check if test performed)

Datentyp

boolean

Alias
UMLS CUI [1]
C0427611
ACT - Date
Beschreibung

(dd-mmm-yyyy)

Datentyp

date

Alias
UMLS CUI [1,1]
C0427611
UMLS CUI [1,2]
C2985720
ACT - Time
Beschreibung

(0000-2359)

Datentyp

time

Alias
UMLS CUI [1,1]
C0427611
UMLS CUI [1,2]
C1516048
UMLS CUI [1,3]
C0040223
ACT - Result
Beschreibung

(numeric value only)

Datentyp

float

Alias
UMLS CUI [1,1]
C0427611
UMLS CUI [1,2]
C0587081
ACT - Clinically Significant
Beschreibung

ACT - clinical significance

Datentyp

text

Alias
UMLS CUI [1,1]
C0427611
UMLS CUI [1,2]
C2826293
ACT - If clinically significant, please comment
Beschreibung

ACT - comment on clinical significance

Datentyp

text

Alias
UMLS CUI [1,1]
C0427611
UMLS CUI [1,2]
C0947611
UMLS CUI [1,3]
C2826293
Samples for Pre-Treatment PK and Confirmatory HIT Testing
Beschreibung

Samples for Pre-Treatment PK and Confirmatory HIT Testing

Alias
UMLS CUI-1
C0200345
UMLS CUI-2
C0031328
UMLS CUI-3
C0919799
Pre-treatment PK sample collected?
Beschreibung

Pharmacokinetic sample collection pre-treatment

Datentyp

text

Alias
UMLS CUI [1,1]
C0200345
UMLS CUI [1,2]
C0031328
UMLS CUI [1,3]
C2709094
*Date Collected:
Beschreibung

(dd-mmm-yyyy)

Datentyp

date

Alias
UMLS CUI [1,1]
C1302413
UMLS CUI [1,2]
C0031328
*Time Collected:
Beschreibung

(0000-2359)

Datentyp

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0200345
UMLS CUI [1,3]
C0031328
*Check to indicate PK sample sent to GSK
Beschreibung

Pharmacokinetic sample sent to sponsor

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2347796
UMLS CUI [1,2]
C0031328
UMLS CUI [1,3]
C0370003
UMLS CUI [1,4]
C1515023
Confirmatory HIT testing sample collected (only if “Yes” was answered for Inclusion Criteria 2a, 2b, or 2c)?
Beschreibung

Confirmatory HIT testing sample collection

Datentyp

text

Alias
UMLS CUI [1,1]
C0200345
UMLS CUI [1,2]
C0919799
UMLS CUI [1,3]
C0750484
*Date Collected:
Beschreibung

(dd-mmm-yyyy)

Datentyp

date

Alias
UMLS CUI [1,1]
C1302413
UMLS CUI [1,2]
C0919799
*Time Collected:
Beschreibung

(0000-2359)

Datentyp

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0200345
UMLS CUI [1,3]
C0919799
*Check to indicate confirmatory HIT sample sent to central lab
Beschreibung

HIT testing sample sent to central lab

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1880016
UMLS CUI [1,2]
C0919799
UMLS CUI [1,3]
C0370003
UMLS CUI [1,4]
C1515023
Indication for Argatroban Use
Beschreibung

Indication for Argatroban Use

Alias
UMLS CUI-1
C3146298
UMLS CUI-2
C0048470
Cardiac catherization
Beschreibung

Cardiac catherization

Datentyp

boolean

Alias
UMLS CUI [1]
C0018795
Cardiac surgery
Beschreibung

Cardiac surgery

Datentyp

boolean

Alias
UMLS CUI [1]
C0018821
VAD
Beschreibung

Artificial ventricle

Datentyp

boolean

Alias
UMLS CUI [1]
C0085842
ECMO
Beschreibung

ECMO

Datentyp

boolean

Alias
UMLS CUI [1]
C0015357
Hemodialysis
Beschreibung

Hemodialysis

Datentyp

boolean

Alias
UMLS CUI [1]
C0019004
CVVH
Beschreibung

CVVH

Datentyp

boolean

Alias
UMLS CUI [1]
C0472684
Clinical condition requiring continuous infusion therapy
Beschreibung

Clinical condition requiring continuous infusion therapy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C1511497
Other
Beschreibung

Other clinical condition

Datentyp

boolean

Alias
UMLS CUI [1]
C3843040
Other, specify:
Beschreibung

Other clinical condition - specify

Datentyp

text

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C1521902
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Ähnliche Modelle

Anticoagulation, Samples for Pre-Treatment PK and Confirmatory HIT Testing, Indication for Argatroban Use

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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 Group
Pre-Treatment Anticoagulation
C0003281 (UMLS CUI-1)
C0332152 (UMLS CUI-2)
C2347804 (UMLS CUI-3)
Item
Was heparin being administered prior to study Argatroban administration?
text
C0019134 (UMLS CUI [1,1])
C0332152 (UMLS CUI [1,2])
C4684789 (UMLS CUI [1,3])
Heparin administered prior to study
Code List
Was heparin being administered prior to study Argatroban administration?
CL Item
Yes* (Yes*)
CL Item
No** (No**)
Laboratory Name
Item
Laboratory Name:
text
C3258037 (UMLS CUI [1])
Is a copy of the lab report attached?
Item
Check to indicate copy of associated lab report is attached to CRF.
boolean
C0684224 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
aPPT
Item
aPPT
boolean
C0030605 (UMLS CUI [1])
aPPT - Assessment Date
Item
aPPT - Date
date
C0030605 (UMLS CUI [1,1])
C2985720 (UMLS CUI [1,2])
aPPT - Assessment Time
Item
aPPT - Time
time
C0030605 (UMLS CUI [1,1])
C1516048 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
aPTT - test result
Item
aPTT - Result
float
C0030605 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
Item
aPTT - Clinically Significant
text
C0030605 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
aPTT - clinical significance
Code List
aPTT - Clinically Significant
CL Item
Yes (Yes)
CL Item
No (No)
CL Item
NA (NA)
aPPT - comment on clinical significance
Item
aPTT - If clinically significant, please comment
text
C1846819 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
C2826293 (UMLS CUI [1,3])
Item
PT or INR
text
C0033707 (UMLS CUI [1])
C0525032 (UMLS CUI [2])
PT | INR
Code List
PT or INR
CL Item
PT (PT)
CL Item
INR (INR)
PT - Assessment Date | INR - Assessment Date
Item
PT or INR - Date
date
C0033707 (UMLS CUI [1,1])
C2985720 (UMLS CUI [1,2])
C0525032 (UMLS CUI [2,1])
C2985720 (UMLS CUI [2,2])
PT - Assessment Time | INR - Assessment Time
Item
PT or INR - Time
time
C0033707 (UMLS CUI [1,1])
C1516048 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C0525032 (UMLS CUI [2,1])
C1516048 (UMLS CUI [2,2])
C0040223 (UMLS CUI [2,3])
PT - test result | INR - test result
Item
PT or INR - Result
float
C0033707 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
C0525032 (UMLS CUI [2,1])
C0587081 (UMLS CUI [2,2])
Item
PT or INR - Clinically Significant
text
C0033707 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C0525032 (UMLS CUI [2,1])
C2826293 (UMLS CUI [2,2])
aPTT - clinical significance
Code List
PT or INR - Clinically Significant
CL Item
Yes (Yes)
CL Item
No (No)
CL Item
NA (NA)
PT - comment on clinical significance | INR - comment on clinical significance
Item
PT or INR - If clinically significant, please comment
text
C0033707 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
C2826293 (UMLS CUI [1,3])
C0525032 (UMLS CUI [2,1])
C0947611 (UMLS CUI [2,2])
C2826293 (UMLS CUI [2,3])
ACT
Item
ACT
boolean
C0427611 (UMLS CUI [1])
ACT - Assessment Date
Item
ACT - Date
date
C0427611 (UMLS CUI [1,1])
C2985720 (UMLS CUI [1,2])
ACT - Assessment Time
Item
ACT - Time
time
C0427611 (UMLS CUI [1,1])
C1516048 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
ACT - test result
Item
ACT - Result
float
C0427611 (UMLS CUI [1,1])
C0587081 (UMLS CUI [1,2])
Item
ACT - Clinically Significant
text
C0427611 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
aPTT - clinical significance
Code List
ACT - Clinically Significant
CL Item
Yes (Yes)
CL Item
No (No)
CL Item
NA (NA)
ACT - comment on clinical significance
Item
ACT - If clinically significant, please comment
text
C0427611 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
C2826293 (UMLS CUI [1,3])
Item Group
Samples for Pre-Treatment PK and Confirmatory HIT Testing
C0200345 (UMLS CUI-1)
C0031328 (UMLS CUI-2)
C0919799 (UMLS CUI-3)
Item
Pre-treatment PK sample collected?
text
C0200345 (UMLS CUI [1,1])
C0031328 (UMLS CUI [1,2])
C2709094 (UMLS CUI [1,3])
Pharmacokinetic sample collection
Code List
Pre-treatment PK sample collected?
CL Item
Yes* (Yes*)
CL Item
No (No)
Pharmacokinetic sample collection date
Item
*Date Collected:
date
C1302413 (UMLS CUI [1,1])
C0031328 (UMLS CUI [1,2])
Pharmacokinetic sample collection time
Item
*Time Collected:
time
C0040223 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C0031328 (UMLS CUI [1,3])
Pharmacokinetic sample sent to sponsor
Item
*Check to indicate PK sample sent to GSK
boolean
C2347796 (UMLS CUI [1,1])
C0031328 (UMLS CUI [1,2])
C0370003 (UMLS CUI [1,3])
C1515023 (UMLS CUI [1,4])
Item
Confirmatory HIT testing sample collected (only if “Yes” was answered for Inclusion Criteria 2a, 2b, or 2c)?
text
C0200345 (UMLS CUI [1,1])
C0919799 (UMLS CUI [1,2])
C0750484 (UMLS CUI [1,3])
Pharmacokinetic sample collection
Code List
Confirmatory HIT testing sample collected (only if “Yes” was answered for Inclusion Criteria 2a, 2b, or 2c)?
CL Item
Yes* (Yes*)
CL Item
No (No)
CL Item
N/A (N/A)
HIT testing sample collection date
Item
*Date Collected:
date
C1302413 (UMLS CUI [1,1])
C0919799 (UMLS CUI [1,2])
HIT testing sample collection time
Item
*Time Collected:
time
C0040223 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C0919799 (UMLS CUI [1,3])
HIT testing sample sent to central lab
Item
*Check to indicate confirmatory HIT sample sent to central lab
boolean
C1880016 (UMLS CUI [1,1])
C0919799 (UMLS CUI [1,2])
C0370003 (UMLS CUI [1,3])
C1515023 (UMLS CUI [1,4])
Item Group
Indication for Argatroban Use
C3146298 (UMLS CUI-1)
C0048470 (UMLS CUI-2)
Cardiac catherization
Item
Cardiac catherization
boolean
C0018795 (UMLS CUI [1])
Cardiac surgery
Item
Cardiac surgery
boolean
C0018821 (UMLS CUI [1])
Artificial ventricle
Item
VAD
boolean
C0085842 (UMLS CUI [1])
ECMO
Item
ECMO
boolean
C0015357 (UMLS CUI [1])
Hemodialysis
Item
Hemodialysis
boolean
C0019004 (UMLS CUI [1])
CVVH
Item
CVVH
boolean
C0472684 (UMLS CUI [1])
Clinical condition requiring continuous infusion therapy
Item
Clinical condition requiring continuous infusion therapy
boolean
C0348080 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C1511497 (UMLS CUI [1,3])
Other clinical condition
Item
Other
boolean
C3843040 (UMLS CUI [1])
Other clinical condition - specify
Item
Other, specify:
text
C3843040 (UMLS CUI [1,1])
C1521902 (UMLS CUI [1,2])
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