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.
Lien
https://clinicaltrials.gov/ct2/show/NCT00039858
Mots-clés
Versions (1)
- 14/09/2020 14/09/2020 -
Détendeur de droits
GlaxoSmithKline
Téléchargé le
14 septembre 2020
DOI
Pour une demande vous connecter.
Licence
Creative Commons BY-NC 4.0
Modèle Commentaires :
Ici, vous pouvez faire des commentaires sur le modèle. À partir des bulles de texte, vous pouvez laisser des commentaires spécifiques sur les groupes Item et les Item.
Groupe Item commentaires pour :
Item commentaires pour :
Vous devez être connecté pour pouvoir télécharger des formulaires. Veuillez vous connecter ou s’inscrire gratuitement.
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)
Type de données
date
Alias
- UMLS CUI [1]
- C2316983
Description
Platelet Count decrease after heparin initiation
Type de données
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
Type de données
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.)
Type de données
text
Alias
- UMLS CUI [1,1]
- C0272285
- UMLS CUI [1,2]
- C0430022
- UMLS CUI [1,3]
- C0750484
Description
HPF4 ELISA
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C4512079
- UMLS CUI [1,2]
- C0014441
Description
(dd-mmm-yyyy)
Type de données
date
Alias
- UMLS CUI [1,1]
- C4512079
- UMLS CUI [1,2]
- C0014441
- UMLS CUI [1,3]
- C0011008
Description
HPF4 ELISA Result
Type de données
text
Alias
- UMLS CUI [1,1]
- C4512079
- UMLS CUI [1,2]
- C0014441
- UMLS CUI [1,3]
- C0456984
Description
SRA
Type de données
boolean
Alias
- UMLS CUI [1]
- C3506382
Description
(dd-mmm-yyyy)
Type de données
date
Alias
- UMLS CUI [1,1]
- C3506382
- UMLS CUI [1,2]
- C0011008
Description
SRA Result
Type de données
text
Alias
- UMLS CUI [1,1]
- C3506382
- UMLS CUI [1,2]
- C0456984
Description
HIPA
Type de données
boolean
Alias
- UMLS CUI [1]
- C0919798
Description
(dd-mmm-yyyy)
Type de données
date
Alias
- UMLS CUI [1,1]
- C0919798
- UMLS CUI [1,2]
- C0011008
Description
HIPA Result
Type de données
text
Alias
- UMLS CUI [1,1]
- C0919798
- UMLS CUI [1,2]
- C0456984
Description
HIT confirmatory diagnostic test, other
Type de données
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
Type de données
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)
Type de données
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
Type de données
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)
Type de données
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.)
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C4512079
- UMLS CUI [1,2]
- C0014441
Description
(dd-mmm-yyyy)
Type de données
date
Alias
- UMLS CUI [1,1]
- C4512079
- UMLS CUI [1,2]
- C0014441
- UMLS CUI [1,3]
- C0011008
Description
HPF4 ELISA Result
Type de données
text
Alias
- UMLS CUI [1,1]
- C4512079
- UMLS CUI [1,2]
- C0014441
- UMLS CUI [1,3]
- C0456984
Description
SRA
Type de données
boolean
Alias
- UMLS CUI [1]
- C3506382
Description
(dd-mmm-yyyy)
Type de données
date
Alias
- UMLS CUI [1,1]
- C3506382
- UMLS CUI [1,2]
- C0011008
Description
SRA Result
Type de données
text
Alias
- UMLS CUI [1,1]
- C3506382
- UMLS CUI [1,2]
- C0456984
Description
HIPA
Type de données
boolean
Alias
- UMLS CUI [1]
- C0919798
Description
(dd-mmm-yyyy)
Type de données
date
Alias
- UMLS CUI [1,1]
- C0919798
- UMLS CUI [1,2]
- C0011008
Description
HIPA Result
Type de données
text
Alias
- UMLS CUI [1,1]
- C0919798
- UMLS CUI [1,2]
- C0456984
Description
HIT confirmatory diagnostic test, other
Type de données
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
Type de données
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)
Type de données
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
Type de données
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
Type de données
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
Type de données
boolean
Alias
- UMLS CUI [1]
- C0392386
Description
Platelet count drop
Type de données
boolean
Alias
- UMLS CUI [1]
- C0392386
Description
Platelet count drop
Type de données
boolean
Alias
- UMLS CUI [1]
- C0392386
Description
Thrombosis associated with HIT
Type de données
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.
Type de données
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.
Type de données
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
Type de données
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
Type de données
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.
Type de données
text
Alias
- UMLS CUI [1]
- C1512693
Description
Type of heparin
Type de données
text
Alias
- UMLS CUI [1,1]
- C0019134
- UMLS CUI [1,2]
- C0332307
Description
Types of heparin - Comments
Type de données
text
Alias
- UMLS CUI [1,1]
- C0019134
- UMLS CUI [1,2]
- C0332307
- UMLS CUI [1,3]
- C0947611
Description
(dd-mmm-yyyy)
Type de données
date
Alias
- UMLS CUI [1,1]
- C0019134
- UMLS CUI [1,2]
- C0808070
Description
(dd-mmm-yyyy)
Type de données
date
Alias
- UMLS CUI [1,1]
- C0019134
- UMLS CUI [1,2]
- C0806020
Description
Route of heparin admission
Type de données
text
Alias
- UMLS CUI [1,1]
- C0019134
- UMLS CUI [1,2]
- C0013153
Description
Route of heparin admission - other, specify
Type de données
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])