ID

41354

Beschrijving

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 during the Treatment period after Circuit Prime is administered and whenever a Bolus of Argatroban is administered. Continuous infusions are recorded in a separate form.

Link

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

Trefwoorden

Versies (1)
  1. 03-09-20 03-09-20 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

3 september 2020

DOI

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Licentie

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

Engels

Dosing Information - Circuit Prime and Bolus

1 Formulieren  
Administrative Data
Beschrijving

Administrative Data

Alias
UMLS CUI-1
C1320722
Site #
Beschrijving

Study centre number

Datatype

integer

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

patient ID

Datatype

integer

Alias
UMLS CUI [1]
C2348585
Visit Date
Beschrijving

visit date

Datatype

date

Alias
UMLS CUI [1]
C1320303
Investigator Name
Beschrijving

Investigator Name

Datatype

text

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

Use one instance for every prime or for every nine boluses. Check this box on all instances except for the last one.

Datatype

boolean

Alias
UMLS CUI [1]
C1706499
Instance Number
Beschrijving

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

Datatype

integer

Alias
UMLS CUI [1,1]
C1516308
UMLS CUI [1,2]
C2348184
Dosing Information - Circuit Prime
Beschrijving

Dosing Information - Circuit Prime

Alias
UMLS CUI-1
C0678766
UMLS CUI-2
C1533716
UMLS CUI-3
C3805286
Equipment primed?
Beschrijving

*Protocol violation

Datatype

text

Alias
UMLS CUI [1]
C3805286
**Primed dose: __ μg/__mL
Beschrijving

Part to be filled in: μg **Recommend 50μg/750mL

Datatype

integer

Maateenheden
  • μg
Alias
UMLS CUI [1,1]
C3174092
UMLS CUI [1,2]
C0304229
UMLS CUI [1,3]
C3805286
μg
**Primed dose: __ μg/__mL
Beschrijving

Part to be filled in: mL **Recommend 50μg/750mL

Datatype

integer

Maateenheden
  • mL
Alias
UMLS CUI [1,1]
C3174092
UMLS CUI [1,2]
C0304229
UMLS CUI [1,3]
C3805286
mL
Dosing Information - Bolus
Beschrijving

Dosing Information - Bolus

Alias
UMLS CUI-1
C0678766
UMLS CUI-2
C1533716
UMLS CUI-3
C1511237
Number of bolus administered
Beschrijving

Number of bolus administered

Datatype

text

Alias
UMLS CUI [1,1]
C1511237
UMLS CUI [1,2]
C2348184
Was this bolus administered?
Beschrijving

Please fill in for all nine bolus numbers.

Datatype

text

Alias
UMLS CUI [1,1]
C1511237
UMLS CUI [1,2]
C1521801
*If yes, bolus dose:
Beschrijving

Bolus dose

Datatype

integer

Maateenheden
  • mcg/kg
Alias
UMLS CUI [1]
C1511237
mcg/kg
Start Date:
Beschrijving

(dd-mmm-yyyy)

Datatype

date

Alias
UMLS CUI [1,1]
C1511237
UMLS CUI [1,2]
C0808070
Start Time:
Beschrijving

(0000-2359)

Datatype

time

Alias
UMLS CUI [1,1]
C1511237
UMLS CUI [1,2]
C1301880
Stop Time:
Beschrijving

(0000-2359)

Datatype

time

Alias
UMLS CUI [1,1]
C1511237
UMLS CUI [1,2]
C1522314
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Similar models

Dosing Information - Circuit Prime and Bolus

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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
Dosing Information - Circuit Prime
C0678766 (UMLS CUI-1)
C1533716 (UMLS CUI-2)
C3805286 (UMLS CUI-3)
Item
Equipment primed?
text
C3805286 (UMLS CUI [1])
Circuit priming
Code List
Equipment primed?
CL Item
Yes (Yes)
CL Item
No* (No*)
Priming dose
Item
**Primed dose: __ μg/__mL
integer
C3174092 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C3805286 (UMLS CUI [1,3])
Priming dose
Item
**Primed dose: __ μg/__mL
integer
C3174092 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C3805286 (UMLS CUI [1,3])
Item Group
Dosing Information - Bolus
C0678766 (UMLS CUI-1)
C1533716 (UMLS CUI-2)
C1511237 (UMLS CUI-3)
Item
Number of bolus administered
text
C1511237 (UMLS CUI [1,1])
C2348184 (UMLS CUI [1,2])
Number of bolus administered
Code List
Number of bolus administered
CL Item
initial (initial)
CL Item
second (second)
CL Item
third (third)
CL Item
fourth (fourth)
CL Item
fifth (fifth)
CL Item
sixth (sixth)
CL Item
seventh (seventh)
CL Item
eighth (eighth)
CL Item
ninth (ninth)
Item
Was this bolus administered?
text
C1511237 (UMLS CUI [1,1])
C1521801 (UMLS CUI [1,2])
Bolus administered
Code List
Was this bolus administered?
CL Item
Yes* (Yes*)
CL Item
No (No)
Bolus dose
Item
*If yes, bolus dose:
integer
C1511237 (UMLS CUI [1])
Bolus start date
Item
Start Date:
date
C1511237 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Bolus start time
Item
Start Time:
time
C1511237 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
Bolus stop time
Item
Stop Time:
time
C1511237 (UMLS CUI [1,1])
C1522314 (UMLS CUI [1,2])
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