ID
41370
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 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
Stichworte
Versionen (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
HIT History
- StudyEvent: ODM
Beschreibung
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
Beschreibung
(dd-mmm-yyyy)
Datentyp
date
Alias
- UMLS CUI [1]
- C2316983
Beschreibung
Platelet Count decrease after heparin initiation
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0392386
- UMLS CUI [1,2]
- C0687676
- UMLS CUI [1,3]
- C1704686
- UMLS CUI [1,4]
- C0019134
Beschreibung
Thrombosis associated with HIT
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0040053
- UMLS CUI [1,2]
- C0332281
- UMLS CUI [1,3]
- C0272285
Beschreibung
*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.)
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0272285
- UMLS CUI [1,2]
- C0430022
- UMLS CUI [1,3]
- C0750484
Beschreibung
HPF4 ELISA
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C4512079
- UMLS CUI [1,2]
- C0014441
Beschreibung
(dd-mmm-yyyy)
Datentyp
date
Alias
- UMLS CUI [1,1]
- C4512079
- UMLS CUI [1,2]
- C0014441
- UMLS CUI [1,3]
- C0011008
Beschreibung
HPF4 ELISA Result
Datentyp
text
Alias
- UMLS CUI [1,1]
- C4512079
- UMLS CUI [1,2]
- C0014441
- UMLS CUI [1,3]
- C0456984
Beschreibung
SRA
Datentyp
boolean
Alias
- UMLS CUI [1]
- C3506382
Beschreibung
(dd-mmm-yyyy)
Datentyp
date
Alias
- UMLS CUI [1,1]
- C3506382
- UMLS CUI [1,2]
- C0011008
Beschreibung
SRA Result
Datentyp
text
Alias
- UMLS CUI [1,1]
- C3506382
- UMLS CUI [1,2]
- C0456984
Beschreibung
HIPA
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0919798
Beschreibung
(dd-mmm-yyyy)
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0919798
- UMLS CUI [1,2]
- C0011008
Beschreibung
HIPA Result
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0919798
- UMLS CUI [1,2]
- C0456984
Beschreibung
HIT confirmatory diagnostic test, other
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0272285
- UMLS CUI [1,2]
- C0430022
- UMLS CUI [1,3]
- C0750484
- UMLS CUI [1,4]
- C0205394
Beschreibung
HIT confirmatory diagnostic test, other, specify
Datentyp
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
Beschreibung
(dd-mmm-yyyy)
Datentyp
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
Beschreibung
HIT confirmatory diagnostic test, other, result
Datentyp
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
Beschreibung
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
Beschreibung
(dd-mmm-yyyy)
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0430022
- UMLS CUI [1,2]
- C0272285
- UMLS CUI [1,3]
- C0011008
Beschreibung
Which HIT test was done? (Check all that apply, enter date and results; note enrollment is not contingent on receipt of results.)
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C4512079
- UMLS CUI [1,2]
- C0014441
Beschreibung
(dd-mmm-yyyy)
Datentyp
date
Alias
- UMLS CUI [1,1]
- C4512079
- UMLS CUI [1,2]
- C0014441
- UMLS CUI [1,3]
- C0011008
Beschreibung
HPF4 ELISA Result
Datentyp
text
Alias
- UMLS CUI [1,1]
- C4512079
- UMLS CUI [1,2]
- C0014441
- UMLS CUI [1,3]
- C0456984
Beschreibung
SRA
Datentyp
boolean
Alias
- UMLS CUI [1]
- C3506382
Beschreibung
(dd-mmm-yyyy)
Datentyp
date
Alias
- UMLS CUI [1,1]
- C3506382
- UMLS CUI [1,2]
- C0011008
Beschreibung
SRA Result
Datentyp
text
Alias
- UMLS CUI [1,1]
- C3506382
- UMLS CUI [1,2]
- C0456984
Beschreibung
HIPA
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0919798
Beschreibung
(dd-mmm-yyyy)
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0919798
- UMLS CUI [1,2]
- C0011008
Beschreibung
HIPA Result
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0919798
- UMLS CUI [1,2]
- C0456984
Beschreibung
HIT confirmatory diagnostic test, other
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0272285
- UMLS CUI [1,2]
- C0430022
- UMLS CUI [1,3]
- C0750484
- UMLS CUI [1,4]
- C0205394
Beschreibung
HIT confirmatory diagnostic test, other, specify
Datentyp
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
Beschreibung
(dd-mmm-yyyy)
Datentyp
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
Beschreibung
HIT confirmatory diagnostic test, other, result
Datentyp
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
Beschreibung
Platelet Count decrease after heparin initiation
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0392386
- UMLS CUI [1,2]
- C0687676
- UMLS CUI [1,3]
- C1704686
- UMLS CUI [1,4]
- C0019134
Beschreibung
Platelet count drop
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0392386
Beschreibung
Platelet count drop
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0392386
Beschreibung
Platelet count drop
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0392386
Beschreibung
Thrombosis associated with HIT
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0040053
- UMLS CUI [1,2]
- C0332281
- UMLS CUI [1,3]
- C0272285
Beschreibung
Please fill in the Heparin Exposure section unless YES ticked.
Datentyp
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
Beschreibung
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
Beschreibung
Please fill in the Heparin Exposure section unless YES ticked.
Datentyp
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
Beschreibung
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
Beschreibung
Underlying condition of antithrombin III deficiency
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0272375
- UMLS CUI [1,2]
- C4722602
- UMLS CUI [1,3]
- C0348080
Beschreibung
Alternative anticoagulation required | Other underlying disease, specify
Datentyp
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
Beschreibung
Heparin Exposure
Alias
- UMLS CUI-1
- C0332157
- UMLS CUI-2
- C0019134
Beschreibung
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.
Datentyp
text
Alias
- UMLS CUI [1]
- C1512693
Beschreibung
Type of heparin
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0019134
- UMLS CUI [1,2]
- C0332307
Beschreibung
Types of heparin - Comments
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0019134
- UMLS CUI [1,2]
- C0332307
- UMLS CUI [1,3]
- C0947611
Beschreibung
(dd-mmm-yyyy)
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0019134
- UMLS CUI [1,2]
- C0808070
Beschreibung
(dd-mmm-yyyy)
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0019134
- UMLS CUI [1,2]
- C0806020
Beschreibung
Route of heparin admission
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0019134
- UMLS CUI [1,2]
- C0013153
Beschreibung
Route of heparin admission - other, specify
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0019134
- UMLS CUI [1,2]
- C0013153
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [1,4]
- C1521902
Ähnliche Modelle
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])