ID

41356

Descripción

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 whether such samples are drawn during the Study Period. Study Protocol specifies when such Samples should be drawn.

Link

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

Palabras clave

Versiones (1)
  1. 9/3/20 9/3/20 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

September 3, 2020

DOI

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Licencia

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

Inglés

Pharmacokinetic Samples and Pharmacodynamic (ACT/aPTT) Samples and Results

1 formularios  
Administrative Data
Descripción

Administrative Data

Alias
UMLS CUI-1
C1320722
Site #
Descripción

Study centre number

Tipo de datos

integer

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

patient ID

Tipo de datos

integer

Alias
UMLS CUI [1]
C2348585
Visit Date
Descripción

visit date

Tipo de datos

date

Alias
UMLS CUI [1]
C1320303
Investigator Name
Descripción

Investigator Name

Tipo de datos

text

Alias
UMLS CUI [1]
C2826892
Check if (additional) supplemental instance of this form was used.
Descripción

Use one instance for every ten samples/sample sets. Check this box on all instances except for the last one.

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1706499
Instance Number
Descripción

Fill in the instance number, starting from 1. On all instances except for the last one, the preceding box has to be checked.

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1516308
UMLS CUI [1,2]
C2348184
Pharmacokinetic Samples and Pharmacodynamic (ACT/aPTT) Samples and Results
Descripción

Pharmacokinetic Samples and Pharmacodynamic (ACT/aPTT) Samples and Results

Alias
UMLS CUI-1
C0031328
UMLS CUI-2
C0851347
UMLS CUI-3
C0370003
UMLS CUI-4
C1274040
UMLS CUI-5
C1274040
UMLS CUI-6
C0427611
UMLS CUI-7
C0030605
Sample Number
Descripción

Pharmacokinetics sample number | Pharmacodynamics sample number

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C1299222
UMLS CUI [2,1]
C0851347
UMLS CUI [2,2]
C1299222
Dose Administration Type / Sample Collection Timepoint (enter code below)
Descripción

Dose Administration Type / Sample Collection Timepoint

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C3174092
UMLS CUI [1,2]
C0455708
UMLS CUI [2,1]
C0200345
UMLS CUI [2,2]
C2348792
Collection Date:
Descripción

(dd-mmm-yyyy)

Tipo de datos

date

Alias
UMLS CUI [1]
C1302413
Collection Time
Descripción

(0000-2359)

Tipo de datos

time

Alias
UMLS CUI [1]
C4064021
ACT or aPTT
Descripción

Test type

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0332307
ACT or aPTT Result
Descripción

Test result

Tipo de datos

float

Unidades de medida
  • sec
Alias
UMLS CUI [1]
C0587081
sec
PK Sample Drawn?
Descripción

Pharmacokinetics sample drawn

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0031328
UMLS CUI [1,2]
C0807979
Comments
Descripción

Comment

Tipo de datos

text

Alias
UMLS CUI [1]
C0947611
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Similar models

Pharmacokinetic Samples and Pharmacodynamic (ACT/aPTT) Samples and Results

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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])
Additional form
Item
Check if (additional) supplemental instance of this form was used.
boolean
C1706499 (UMLS CUI [1])
CRF Sequential Number
Item
Instance Number
integer
C1516308 (UMLS CUI [1,1])
C2348184 (UMLS CUI [1,2])
Item Group
Pharmacokinetic Samples and Pharmacodynamic (ACT/aPTT) Samples and Results
C0031328 (UMLS CUI-1)
C0851347 (UMLS CUI-2)
C0370003 (UMLS CUI-3)
C1274040 (UMLS CUI-4)
C1274040 (UMLS CUI-5)
C0427611 (UMLS CUI-6)
C0030605 (UMLS CUI-7)
Pharmacokinetics sample number | Pharmacodynamics sample number
Item
Sample Number
integer
C0031328 (UMLS CUI [1,1])
C1299222 (UMLS CUI [1,2])
C0851347 (UMLS CUI [2,1])
C1299222 (UMLS CUI [2,2])
Item
Dose Administration Type / Sample Collection Timepoint (enter code below)
integer
C3174092 (UMLS CUI [1,1])
C0455708 (UMLS CUI [1,2])
C0200345 (UMLS CUI [2,1])
C2348792 (UMLS CUI [2,2])
Dose Administration Type / Sample Collection Timepoint
Code List
Dose Administration Type / Sample Collection Timepoint (enter code below)
CL Item
5 - 10 min post-bolus (1)
CL Item
5 - 10 min post-infusion dose change (2)
CL Item
Stable infusion — every 60 min (3)
CL Item
Post-infusion — every 60 min until <160 sec (4)
CL Item
Additional — at physician’s discretion (5)
CL Item
2 hrs post-initial infusion initiation (6)
CL Item
2 hrs post-infusion dose change (7)
CL Item
Daily — at stable infusion dose (8)
CL Item
0.5 - 2 hrs post-infusion termination (9)
CL Item
3 - 6 hrs post-infusion termination (10)
CL Item
Additional — at physician’s discretion (11)
Specimen collection date
Item
Collection Date:
date
C1302413 (UMLS CUI [1])
Specimen collection time
Item
Collection Time
time
C4064021 (UMLS CUI [1])
Item
ACT or aPTT
text
C0022885 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
ACT | aPTT
Code List
ACT or aPTT
CL Item
ACT (ACT)
CL Item
aPTT (aPTT)
Test result
Item
ACT or aPTT Result
float
C0587081 (UMLS CUI [1])
Item
PK Sample Drawn?
text
C0031328 (UMLS CUI [1,1])
C0807979 (UMLS CUI [1,2])
PK sample drawn
Code List
PK Sample Drawn?
CL Item
Yes (Yes)
CL Item
No (No)
Comment
Item
Comments
text
C0947611 (UMLS CUI [1])
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