ID
41370
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 HIT History Form has to be filled in at the screening visit. It is used to record details of prior Heparin Induced Thrombocytopaenia. To be completed within 7 days before treatment initiation.
Link
https://clinicaltrials.gov/ct2/show/NCT00039858
Keywords
Versions (1)
- 9/14/20 9/14/20 -
Copyright Holder
GlaxoSmithKline
Uploaded on
September 14, 2020
DOI
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License
Creative Commons BY-NC 4.0
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Safety and Efficacy of Argatroban in Pediatric Patients, NCT00039858
HIT History
- StudyEvent: ODM
Description
If ‘YES’ was answered for Inclusion Criterion 2a, please give details of the HIT diagnosis and heparin exposure as follows:
Alias
- UMLS CUI-1
- C0272285
- UMLS CUI-2
- C0332157
- UMLS CUI-3
- C0019134
Description
(dd-mmm-yyyy)
Data type
date
Alias
- UMLS CUI [1]
- C2316983
Description
Platelet Count decrease after heparin initiation
Data type
text
Alias
- UMLS CUI [1,1]
- C0392386
- UMLS CUI [1,2]
- C0687676
- UMLS CUI [1,3]
- C1704686
- UMLS CUI [1,4]
- C0019134
Description
Thrombosis associated with HIT
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0040053
- UMLS CUI [1,2]
- C0332281
- UMLS CUI [1,3]
- C0272285
Description
*If ‘Yes’, indicate test, date completed, and results: (Check all that apply; note enrollment is not contingent on receipt of results. Complete this form when results are available.)
Data type
text
Alias
- UMLS CUI [1,1]
- C0272285
- UMLS CUI [1,2]
- C0430022
- UMLS CUI [1,3]
- C0750484
Description
HPF4 ELISA
Data type
boolean
Alias
- UMLS CUI [1,1]
- C4512079
- UMLS CUI [1,2]
- C0014441
Description
(dd-mmm-yyyy)
Data type
date
Alias
- UMLS CUI [1,1]
- C4512079
- UMLS CUI [1,2]
- C0014441
- UMLS CUI [1,3]
- C0011008
Description
HPF4 ELISA Result
Data type
text
Alias
- UMLS CUI [1,1]
- C4512079
- UMLS CUI [1,2]
- C0014441
- UMLS CUI [1,3]
- C0456984
Description
SRA
Data type
boolean
Alias
- UMLS CUI [1]
- C3506382
Description
(dd-mmm-yyyy)
Data type
date
Alias
- UMLS CUI [1,1]
- C3506382
- UMLS CUI [1,2]
- C0011008
Description
SRA Result
Data type
text
Alias
- UMLS CUI [1,1]
- C3506382
- UMLS CUI [1,2]
- C0456984
Description
HIPA
Data type
boolean
Alias
- UMLS CUI [1]
- C0919798
Description
(dd-mmm-yyyy)
Data type
date
Alias
- UMLS CUI [1,1]
- C0919798
- UMLS CUI [1,2]
- C0011008
Description
HIPA Result
Data type
text
Alias
- UMLS CUI [1,1]
- C0919798
- UMLS CUI [1,2]
- C0456984
Description
HIT confirmatory diagnostic test, other
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0272285
- UMLS CUI [1,2]
- C0430022
- UMLS CUI [1,3]
- C0750484
- UMLS CUI [1,4]
- C0205394
Description
HIT confirmatory diagnostic test, other, specify
Data type
text
Alias
- UMLS CUI [1,1]
- C0272285
- UMLS CUI [1,2]
- C0430022
- UMLS CUI [1,3]
- C0750484
- UMLS CUI [1,4]
- C0205394
- UMLS CUI [1,5]
- C1521902
Description
(dd-mmm-yyyy)
Data type
date
Alias
- UMLS CUI [1,1]
- C0272285
- UMLS CUI [1,2]
- C0430022
- UMLS CUI [1,3]
- C0750484
- UMLS CUI [1,4]
- C0205394
- UMLS CUI [1,5]
- C0011008
Description
HIT confirmatory diagnostic test, other, result
Data type
text
Alias
- UMLS CUI [1,1]
- C0272285
- UMLS CUI [1,2]
- C0430022
- UMLS CUI [1,3]
- C0750484
- UMLS CUI [1,4]
- C0205394
- UMLS CUI [1,5]
- C0456984
Description
If ‘YES’ was answered for Inclusion Criterion 2b, please give details of the most recent positive HIT test history and prior heparin exposure as follows:
Alias
- UMLS CUI-1
- C1513491
- UMLS CUI-2
- C0272285
- UMLS CUI-3
- C0456984
Description
(dd-mmm-yyyy)
Data type
date
Alias
- UMLS CUI [1,1]
- C0430022
- UMLS CUI [1,2]
- C0272285
- UMLS CUI [1,3]
- C0011008
Description
Which HIT test was done? (Check all that apply, enter date and results; note enrollment is not contingent on receipt of results.)
Data type
boolean
Alias
- UMLS CUI [1,1]
- C4512079
- UMLS CUI [1,2]
- C0014441
Description
(dd-mmm-yyyy)
Data type
date
Alias
- UMLS CUI [1,1]
- C4512079
- UMLS CUI [1,2]
- C0014441
- UMLS CUI [1,3]
- C0011008
Description
HPF4 ELISA Result
Data type
text
Alias
- UMLS CUI [1,1]
- C4512079
- UMLS CUI [1,2]
- C0014441
- UMLS CUI [1,3]
- C0456984
Description
SRA
Data type
boolean
Alias
- UMLS CUI [1]
- C3506382
Description
(dd-mmm-yyyy)
Data type
date
Alias
- UMLS CUI [1,1]
- C3506382
- UMLS CUI [1,2]
- C0011008
Description
SRA Result
Data type
text
Alias
- UMLS CUI [1,1]
- C3506382
- UMLS CUI [1,2]
- C0456984
Description
HIPA
Data type
boolean
Alias
- UMLS CUI [1]
- C0919798
Description
(dd-mmm-yyyy)
Data type
date
Alias
- UMLS CUI [1,1]
- C0919798
- UMLS CUI [1,2]
- C0011008
Description
HIPA Result
Data type
text
Alias
- UMLS CUI [1,1]
- C0919798
- UMLS CUI [1,2]
- C0456984
Description
HIT confirmatory diagnostic test, other
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0272285
- UMLS CUI [1,2]
- C0430022
- UMLS CUI [1,3]
- C0750484
- UMLS CUI [1,4]
- C0205394
Description
HIT confirmatory diagnostic test, other, specify
Data type
text
Alias
- UMLS CUI [1,1]
- C0272285
- UMLS CUI [1,2]
- C0430022
- UMLS CUI [1,3]
- C0750484
- UMLS CUI [1,4]
- C0205394
- UMLS CUI [1,5]
- C1521902
Description
(dd-mmm-yyyy)
Data type
date
Alias
- UMLS CUI [1,1]
- C0272285
- UMLS CUI [1,2]
- C0430022
- UMLS CUI [1,3]
- C0750484
- UMLS CUI [1,4]
- C0205394
- UMLS CUI [1,5]
- C0011008
Description
HIT confirmatory diagnostic test, other, result
Data type
text
Alias
- UMLS CUI [1,1]
- C0272285
- UMLS CUI [1,2]
- C0430022
- UMLS CUI [1,3]
- C0750484
- UMLS CUI [1,4]
- C0205394
- UMLS CUI [1,5]
- C0456984
Description
Platelet Count decrease after heparin initiation
Data type
text
Alias
- UMLS CUI [1,1]
- C0392386
- UMLS CUI [1,2]
- C0687676
- UMLS CUI [1,3]
- C1704686
- UMLS CUI [1,4]
- C0019134
Description
Platelet count drop
Data type
boolean
Alias
- UMLS CUI [1]
- C0392386
Description
Platelet count drop
Data type
boolean
Alias
- UMLS CUI [1]
- C0392386
Description
Platelet count drop
Data type
boolean
Alias
- UMLS CUI [1]
- C0392386
Description
Thrombosis associated with HIT
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0040053
- UMLS CUI [1,2]
- C0332281
- UMLS CUI [1,3]
- C0272285
Description
Please fill in the Heparin Exposure section unless YES ticked.
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0332157
- UMLS CUI [1,2]
- C0019134
- UMLS CUI [1,3]
- C1511726
- UMLS CUI [1,4]
- C0439673
- UMLS CUI [2,1]
- C0332157
- UMLS CUI [2,2]
- C0019134
- UMLS CUI [2,3]
- C1511726
- UMLS CUI [2,4]
- C0686905
Description
If ‘YES’ was answered for Inclusion Criterion 2c, please provide details of all previous heparin exposure/data:
Alias
- UMLS CUI-1
- C0205156
- UMLS CUI-2
- C0332157
- UMLS CUI-3
- C0019134
- UMLS CUI-4
- C0205197
Description
Please fill in the Heparin Exposure section unless YES ticked.
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0332157
- UMLS CUI [1,2]
- C0019134
- UMLS CUI [1,3]
- C1511726
- UMLS CUI [1,4]
- C0439673
- UMLS CUI [2,1]
- C0332157
- UMLS CUI [2,2]
- C0019134
- UMLS CUI [2,3]
- C1511726
- UMLS CUI [2,4]
- C0686905
Description
If ‘YES’ was answered for Inclusion Criterion 2d, what was the underlying condition?
Alias
- UMLS CUI-1
- C0272375
- UMLS CUI-2
- C4722602
- UMLS CUI-3
- C0348080
Description
Underlying condition of antithrombin III deficiency
Data type
text
Alias
- UMLS CUI [1,1]
- C0272375
- UMLS CUI [1,2]
- C4722602
- UMLS CUI [1,3]
- C0348080
Description
Alternative anticoagulation required | Other underlying disease, specify
Data type
text
Alias
- UMLS CUI [1,1]
- C0003281
- UMLS CUI [1,2]
- C1523987
- UMLS CUI [1,3]
- C1514873
- UMLS CUI [2,1]
- C4722602
- UMLS CUI [2,2]
- C0012634
- UMLS CUI [2,3]
- C0205394
- UMLS CUI [2,4]
- C1521902
Description
Heparin Exposure
Alias
- UMLS CUI-1
- C0332157
- UMLS CUI-2
- C0019134
Description
Please select to which criterion is the following data related. If one entry is related to multiple criteria, please fill in multiple times to include all of them.
Data type
text
Alias
- UMLS CUI [1]
- C1512693
Description
Type of heparin
Data type
text
Alias
- UMLS CUI [1,1]
- C0019134
- UMLS CUI [1,2]
- C0332307
Description
Types of heparin - Comments
Data type
text
Alias
- UMLS CUI [1,1]
- C0019134
- UMLS CUI [1,2]
- C0332307
- UMLS CUI [1,3]
- C0947611
Description
(dd-mmm-yyyy)
Data type
date
Alias
- UMLS CUI [1,1]
- C0019134
- UMLS CUI [1,2]
- C0808070
Description
(dd-mmm-yyyy)
Data type
date
Alias
- UMLS CUI [1,1]
- C0019134
- UMLS CUI [1,2]
- C0806020
Description
Route of heparin admission
Data type
text
Alias
- UMLS CUI [1,1]
- C0019134
- UMLS CUI [1,2]
- C0013153
Description
Route of heparin admission - other, specify
Data type
text
Alias
- UMLS CUI [1,1]
- C0019134
- UMLS CUI [1,2]
- C0013153
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [1,4]
- C1521902
Similar models
HIT History
- StudyEvent: ODM
C0019994 (UMLS CUI [1,2])
C0332157 (UMLS CUI-2)
C0019134 (UMLS CUI-3)
C0687676 (UMLS CUI [1,2])
C1704686 (UMLS CUI [1,3])
C0019134 (UMLS CUI [1,4])
C0332281 (UMLS CUI [1,2])
C0272285 (UMLS CUI [1,3])
C0430022 (UMLS CUI [1,2])
C0750484 (UMLS CUI [1,3])
C0014441 (UMLS CUI [1,2])
C0014441 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0014441 (UMLS CUI [1,2])
C0456984 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0430022 (UMLS CUI [1,2])
C0750484 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
C0430022 (UMLS CUI [1,2])
C0750484 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
C1521902 (UMLS CUI [1,5])
C0430022 (UMLS CUI [1,2])
C0750484 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
C0011008 (UMLS CUI [1,5])
C0430022 (UMLS CUI [1,2])
C0750484 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
C0456984 (UMLS CUI [1,5])
C0272285 (UMLS CUI-2)
C0456984 (UMLS CUI-3)
C0272285 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0014441 (UMLS CUI [1,2])
C0014441 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0014441 (UMLS CUI [1,2])
C0456984 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0430022 (UMLS CUI [1,2])
C0750484 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
C0430022 (UMLS CUI [1,2])
C0750484 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
C1521902 (UMLS CUI [1,5])
C0430022 (UMLS CUI [1,2])
C0750484 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
C0011008 (UMLS CUI [1,5])
C0430022 (UMLS CUI [1,2])
C0750484 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
C0456984 (UMLS CUI [1,5])
C0687676 (UMLS CUI [1,2])
C1704686 (UMLS CUI [1,3])
C0019134 (UMLS CUI [1,4])
C0332281 (UMLS CUI [1,2])
C0272285 (UMLS CUI [1,3])
C0019134 (UMLS CUI [1,2])
C1511726 (UMLS CUI [1,3])
C0439673 (UMLS CUI [1,4])
C0332157 (UMLS CUI [2,1])
C0019134 (UMLS CUI [2,2])
C1511726 (UMLS CUI [2,3])
C0686905 (UMLS CUI [2,4])
C0332157 (UMLS CUI-2)
C0019134 (UMLS CUI-3)
C0205197 (UMLS CUI-4)
C0019134 (UMLS CUI [1,2])
C1511726 (UMLS CUI [1,3])
C0439673 (UMLS CUI [1,4])
C0332157 (UMLS CUI [2,1])
C0019134 (UMLS CUI [2,2])
C1511726 (UMLS CUI [2,3])
C0686905 (UMLS CUI [2,4])
C4722602 (UMLS CUI-2)
C0348080 (UMLS CUI-3)
C4722602 (UMLS CUI [1,2])
C0348080 (UMLS CUI [1,3])
C1523987 (UMLS CUI [1,2])
C1514873 (UMLS CUI [1,3])
C4722602 (UMLS CUI [2,1])
C0012634 (UMLS CUI [2,2])
C0205394 (UMLS CUI [2,3])
C1521902 (UMLS CUI [2,4])
C0332307 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,3])
C0808070 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
C0013153 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C1521902 (UMLS CUI [1,4])