ID
41369
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 This Form has to be filled in at the screening visit. Section Pre-Treatment Anticoagulation has to be filled in within 96 hours prior to treatment initiation and additionally, if Heparin was administered, ACT or aPTT have to be measured before Heparin administration. Section Samples for Pre-Treatment PK and Confirmatory HIT Testing, Indication for Argatroban Use has to be filled in within 96 hours before treatment initiation administration. Section Indication for Argatroban Use records the indications on behalf of which is the medicament administered.
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
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Licence
Creative Commons BY-NC 4.0
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Safety and Efficacy of Argatroban in Pediatric Patients, NCT00039858
Anticoagulation, Samples for Pre-Treatment PK and Confirmatory HIT Testing, Indication for Argatroban Use
Description
Pre-Treatment Anticoagulation
Alias
- UMLS CUI-1
- C0003281
- UMLS CUI-2
- C0332152
- UMLS CUI-3
- C2347804
Description
*If Yes, ACT or aPTT results must be from BEFORE heparin was administered. **If No, ACT or aPTT results must be completed up to 96 hours prior to treatment initiation. In either case, PT/INR results must be completed within 96 hours before treatment initiation.
Type de données
text
Alias
- UMLS CUI [1,1]
- C0019134
- UMLS CUI [1,2]
- C0332152
- UMLS CUI [1,3]
- C4684789
Description
(Lab name must match name on lab normals.)
Type de données
text
Alias
- UMLS CUI [1]
- C3258037
Description
Is a copy of the lab report attached?
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0684224
- UMLS CUI [1,2]
- C0587081
Description
(check if test performed)
Type de données
boolean
Alias
- UMLS CUI [1]
- C0030605
Description
(dd-mmm-yyyy)
Type de données
date
Alias
- UMLS CUI [1,1]
- C0030605
- UMLS CUI [1,2]
- C2985720
Description
(0000-2359)
Type de données
time
Alias
- UMLS CUI [1,1]
- C0030605
- UMLS CUI [1,2]
- C1516048
- UMLS CUI [1,3]
- C0040223
Description
(numeric value only)
Type de données
float
Alias
- UMLS CUI [1,1]
- C0030605
- UMLS CUI [1,2]
- C0587081
Description
aPTT - clinical significance
Type de données
text
Alias
- UMLS CUI [1,1]
- C0030605
- UMLS CUI [1,2]
- C2826293
Description
aPPT - comment on clinical significance
Type de données
text
Alias
- UMLS CUI [1,1]
- C1846819
- UMLS CUI [1,2]
- C0947611
- UMLS CUI [1,3]
- C2826293
Description
(check which test was performed)
Type de données
text
Alias
- UMLS CUI [1]
- C0033707
- UMLS CUI [2]
- C0525032
Description
(dd-mmm-yyyy)
Type de données
date
Alias
- UMLS CUI [1,1]
- C0033707
- UMLS CUI [1,2]
- C2985720
- UMLS CUI [2,1]
- C0525032
- UMLS CUI [2,2]
- C2985720
Description
(0000-2359)
Type de données
time
Alias
- UMLS CUI [1,1]
- C0033707
- UMLS CUI [1,2]
- C1516048
- UMLS CUI [1,3]
- C0040223
- UMLS CUI [2,1]
- C0525032
- UMLS CUI [2,2]
- C1516048
- UMLS CUI [2,3]
- C0040223
Description
(numeric value only)
Type de données
float
Alias
- UMLS CUI [1,1]
- C0033707
- UMLS CUI [1,2]
- C0587081
- UMLS CUI [2,1]
- C0525032
- UMLS CUI [2,2]
- C0587081
Description
PT - clinical significance | INR - clinical significance
Type de données
text
Alias
- UMLS CUI [1,1]
- C0033707
- UMLS CUI [1,2]
- C2826293
- UMLS CUI [2,1]
- C0525032
- UMLS CUI [2,2]
- C2826293
Description
PT - comment on clinical significance | INR - comment on clinical significance
Type de données
text
Alias
- UMLS CUI [1,1]
- C0033707
- UMLS CUI [1,2]
- C0947611
- UMLS CUI [1,3]
- C2826293
- UMLS CUI [2,1]
- C0525032
- UMLS CUI [2,2]
- C0947611
- UMLS CUI [2,3]
- C2826293
Description
(check if test performed)
Type de données
boolean
Alias
- UMLS CUI [1]
- C0427611
Description
(dd-mmm-yyyy)
Type de données
date
Alias
- UMLS CUI [1,1]
- C0427611
- UMLS CUI [1,2]
- C2985720
Description
(0000-2359)
Type de données
time
Alias
- UMLS CUI [1,1]
- C0427611
- UMLS CUI [1,2]
- C1516048
- UMLS CUI [1,3]
- C0040223
Description
(numeric value only)
Type de données
float
Alias
- UMLS CUI [1,1]
- C0427611
- UMLS CUI [1,2]
- C0587081
Description
ACT - clinical significance
Type de données
text
Alias
- UMLS CUI [1,1]
- C0427611
- UMLS CUI [1,2]
- C2826293
Description
ACT - comment on clinical significance
Type de données
text
Alias
- UMLS CUI [1,1]
- C0427611
- UMLS CUI [1,2]
- C0947611
- UMLS CUI [1,3]
- C2826293
Description
Samples for Pre-Treatment PK and Confirmatory HIT Testing
Alias
- UMLS CUI-1
- C0200345
- UMLS CUI-2
- C0031328
- UMLS CUI-3
- C0919799
Description
Pharmacokinetic sample collection pre-treatment
Type de données
text
Alias
- UMLS CUI [1,1]
- C0200345
- UMLS CUI [1,2]
- C0031328
- UMLS CUI [1,3]
- C2709094
Description
(dd-mmm-yyyy)
Type de données
date
Alias
- UMLS CUI [1,1]
- C1302413
- UMLS CUI [1,2]
- C0031328
Description
(0000-2359)
Type de données
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0200345
- UMLS CUI [1,3]
- C0031328
Description
Pharmacokinetic sample sent to sponsor
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C2347796
- UMLS CUI [1,2]
- C0031328
- UMLS CUI [1,3]
- C0370003
- UMLS CUI [1,4]
- C1515023
Description
Confirmatory HIT testing sample collection
Type de données
text
Alias
- UMLS CUI [1,1]
- C0200345
- UMLS CUI [1,2]
- C0919799
- UMLS CUI [1,3]
- C0750484
Description
(dd-mmm-yyyy)
Type de données
date
Alias
- UMLS CUI [1,1]
- C1302413
- UMLS CUI [1,2]
- C0919799
Description
(0000-2359)
Type de données
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0200345
- UMLS CUI [1,3]
- C0919799
Description
HIT testing sample sent to central lab
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C1880016
- UMLS CUI [1,2]
- C0919799
- UMLS CUI [1,3]
- C0370003
- UMLS CUI [1,4]
- C1515023
Description
Indication for Argatroban Use
Alias
- UMLS CUI-1
- C3146298
- UMLS CUI-2
- C0048470
Description
Cardiac catherization
Type de données
boolean
Alias
- UMLS CUI [1]
- C0018795
Description
Cardiac surgery
Type de données
boolean
Alias
- UMLS CUI [1]
- C0018821
Description
Artificial ventricle
Type de données
boolean
Alias
- UMLS CUI [1]
- C0085842
Description
ECMO
Type de données
boolean
Alias
- UMLS CUI [1]
- C0015357
Description
Hemodialysis
Type de données
boolean
Alias
- UMLS CUI [1]
- C0019004
Description
CVVH
Type de données
boolean
Alias
- UMLS CUI [1]
- C0472684
Description
Clinical condition requiring continuous infusion therapy
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0348080
- UMLS CUI [1,2]
- C1514873
- UMLS CUI [1,3]
- C1511497
Description
Other clinical condition
Type de données
boolean
Alias
- UMLS CUI [1]
- C3843040
Description
Other clinical condition - specify
Type de données
text
Alias
- UMLS CUI [1,1]
- C3843040
- UMLS CUI [1,2]
- C1521902
Similar models
Anticoagulation, Samples for Pre-Treatment PK and Confirmatory HIT Testing, Indication for Argatroban Use
C0019994 (UMLS CUI [1,2])
C0332152 (UMLS CUI-2)
C2347804 (UMLS CUI-3)
C0332152 (UMLS CUI [1,2])
C4684789 (UMLS CUI [1,3])
C0587081 (UMLS CUI [1,2])
C2985720 (UMLS CUI [1,2])
C1516048 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C0587081 (UMLS CUI [1,2])
C2826293 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,2])
C2826293 (UMLS CUI [1,3])
C2985720 (UMLS CUI [1,2])
C0525032 (UMLS CUI [2,1])
C2985720 (UMLS CUI [2,2])
C1516048 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C0525032 (UMLS CUI [2,1])
C1516048 (UMLS CUI [2,2])
C0040223 (UMLS CUI [2,3])
C0587081 (UMLS CUI [1,2])
C0525032 (UMLS CUI [2,1])
C0587081 (UMLS CUI [2,2])
C2826293 (UMLS CUI [1,2])
C0525032 (UMLS CUI [2,1])
C2826293 (UMLS CUI [2,2])
C0947611 (UMLS CUI [1,2])
C2826293 (UMLS CUI [1,3])
C0525032 (UMLS CUI [2,1])
C0947611 (UMLS CUI [2,2])
C2826293 (UMLS CUI [2,3])
C2985720 (UMLS CUI [1,2])
C1516048 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C0587081 (UMLS CUI [1,2])
C2826293 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,2])
C2826293 (UMLS CUI [1,3])
C0031328 (UMLS CUI-2)
C0919799 (UMLS CUI-3)
C0031328 (UMLS CUI [1,2])
C2709094 (UMLS CUI [1,3])
C0031328 (UMLS CUI [1,2])
C0200345 (UMLS CUI [1,2])
C0031328 (UMLS CUI [1,3])
C0031328 (UMLS CUI [1,2])
C0370003 (UMLS CUI [1,3])
C1515023 (UMLS CUI [1,4])
C0919799 (UMLS CUI [1,2])
C0750484 (UMLS CUI [1,3])
C0919799 (UMLS CUI [1,2])
C0200345 (UMLS CUI [1,2])
C0919799 (UMLS CUI [1,3])
C0919799 (UMLS CUI [1,2])
C0370003 (UMLS CUI [1,3])
C1515023 (UMLS CUI [1,4])
C0048470 (UMLS CUI-2)
C1514873 (UMLS CUI [1,2])
C1511497 (UMLS CUI [1,3])
C1521902 (UMLS CUI [1,2])