ID

41467

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 - See https://clinicaltrials.gov/ct2/show/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. The Transfusion Record has to be filled in whenever any bleeding occurs during the Study.

Link

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

Palabras clave

Versiones (1)
  1. 20/10/20 20/10/20 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

20 de octubre de 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

Transfusion Record

1 formularios  
  1. StudyEvent: ODM
    1. Transfusion Record
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 11 transfusions administered. 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
Was a transfusion given during the Argatroban treatment period?
Descripción

Was a transfusion given during the Argatroban treatment period?

Alias
UMLS CUI-1
C1879316
UMLS CUI-2
C0347984
UMLS CUI-3
C0008976
Was a transfusion given during the Argatroban treatment period?
Descripción

If Yes, please complete below.

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1879316
UMLS CUI [1,2]
C0347984
UMLS CUI [1,3]
C0008976
Transfusion Record
Descripción

Transfusion Record

Alias
UMLS CUI-1
C1879316
Blood Component Code
Descripción

Blood component administered in transfusion

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0005841
UMLS CUI [1,2]
C1705248
Transfusion Start Date
Descripción

(dd-mmm-yyyy)

Tipo de datos

date

Alias
UMLS CUI [1,1]
C1879316
UMLS CUI [1,2]
C0808070
Start Time
Descripción

(0000-2359)

Tipo de datos

time

Alias
UMLS CUI [1,1]
C1879316
UMLS CUI [1,2]
C1301880
Transfusion Stop Date
Descripción

(dd-mmm-yyyy)

Tipo de datos

date

Alias
UMLS CUI [1,1]
C1879316
UMLS CUI [1,2]
C0806020
Stop Time
Descripción

(0000-2359)

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1879316
UMLS CUI [1,2]
C1522314
# of units or cc transfused
Descripción

Quantity of transfusion

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1879316
UMLS CUI [1,2]
C1265611
Units or cc
Descripción

Units of transfusion quantity

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1519795
UMLS CUI [1,2]
C1879316
UMLS CUI [1,3]
C1265611
Reason for Transfusion
Descripción

Reason for transfusion

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C1879316
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Similar models

Transfusion Record

1 formularios
  1. StudyEvent: ODM
    1. Transfusion Record
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
Was a transfusion given during the Argatroban treatment period?
C1879316 (UMLS CUI-1)
C0347984 (UMLS CUI-2)
C0008976 (UMLS CUI-3)
Transfusion during clinical trial
Item
Was a transfusion given during the Argatroban treatment period?
boolean
C1879316 (UMLS CUI [1,1])
C0347984 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Item Group
Transfusion Record
C1879316 (UMLS CUI-1)
Item
Blood Component Code
integer
C0005841 (UMLS CUI [1,1])
C1705248 (UMLS CUI [1,2])
Blood component administered in transfusion
Code List
Blood Component Code
CL Item
Whole Blood  (1)
CL Item
Cryoprecipitate (2)
CL Item
Platelets (3)
CL Item
PRBC (4)
CL Item
FFP (5)
CL Item
Autotransfusion (6)
CL Item
Other (specify under Reason for Transfusion) (7)
Transfusion start date
Item
Transfusion Start Date
date
C1879316 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Transfusion start time
Item
Start Time
time
C1879316 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
Transfusion stop date
Item
Transfusion Stop Date
date
C1879316 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Transfusion stop time
Item
Stop Time
text
C1879316 (UMLS CUI [1,1])
C1522314 (UMLS CUI [1,2])
Quantity of transfusion
Item
# of units or cc transfused
integer
C1879316 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
Item
Units or cc
text
C1519795 (UMLS CUI [1,1])
C1879316 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
Units of transfusion quantity
Code List
Units or cc
CL Item
units (units)
CL Item
cc's (cc's)
Reason for transfusion
Item
Reason for Transfusion
text
C0392360 (UMLS CUI [1,1])
C1879316 (UMLS CUI [1,2])
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