ID

17707

Description

Study documentation part: Investigation between T0 and T1 – Platelet checks for intervention group, VTETumor02. This is a prospective, randomized, controlled, unicentric, open study on prophylactic treatment of thromboembolism with Enoxaparin in non-surgical oncology patients under systemic antineoplastic therapy. Principal Investigator Prof. Dr. Max E. Scheulen, Clinic and Polyclinic for Internal medicine (Tumor research), University Hospital of Essen, Germany. EudraCT number: 2007-002036-28, Version 0.6 vom 06.08.09.

Keywords

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  1. 9/28/16 9/28/16 -
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September 28, 2016

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Creative Commons BY-NC 3.0
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Investigation between T0 and T1 – Platelet checks for intervention group VTETumor02 Prophylactic Treatment of Thromboembolism with Enoxaparin EudraCT number: 2007-002036-28

German

Investigation between T0 and T1 – Platelet checks for intervention group

1 forms  
Massnahmen für Patienten des Therapiearms
Description

Massnahmen für Patienten des Therapiearms

Alias
UMLS CUI-1
C0013227
UMLS CUI-2
C2986530
Patienten-Nr.:
Description

Patient ID

Data type

integer

Alias
UMLS CUI [1]
C1269815
Datum der Thrombozytenmessung kurz vor der 1.Injektion
Description

date Platelet Count measurement

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0032181
Thrombozytenwert kurz vor der 1.Injektion
Description

Platelet Count measurement

Data type

float

Measurement units
  • µl
Alias
UMLS CUI [1]
C0032181
µl
Thrombozytenwert < 50.000 µl, Ausschluss?
Description

Platelet Count measurement; Exclusion

Data type

boolean

Alias
UMLS CUI [1]
C0032181
UMLS CUI [2]
C2828389
Datum der 1.Enoxaparininjektion
Description

date Enoxaparin

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0206460
Datum: 1 Tag nach der 1.Injektion
Description

date

Data type

date

Alias
UMLS CUI [1]
C0011008
Thrombozytenwert 1 Tag nach der 1.Injektion
Description

Platelet Count measurement

Data type

float

Measurement units
  • µl
Alias
UMLS CUI [1]
C0032181
µl
Falls < 50.000 µl HIT- Test pos.?
Description

Heparin-induced thrombocytopenia test

Data type

boolean

Alias
UMLS CUI [1]
C0919799
Maßnahmen
Description

measures

Data type

text

Alias
UMLS CUI [1,1]
C1608430
UMLS CUI [1,2]
C0677850
Datum: 3 Tage nach der 1.Injektion
Description

date

Data type

date

Alias
UMLS CUI [1]
C0011008
Thrombozytenwert 3 Tage nach der 1.Injektion
Description

Platelet Count measurement

Data type

float

Measurement units
  • µl
Alias
UMLS CUI [1]
C0032181
µl
Falls < 50.000 µl HIT- Test pos.?
Description

Heparin-induced thrombocytopenia test

Data type

boolean

Alias
UMLS CUI [1]
C0919799
Maßnahmen
Description

measures

Data type

text

Alias
UMLS CUI [1,1]
C1608430
UMLS CUI [1,2]
C0677850
Datum: 6 Tage nach der 1.Injektion
Description

date

Data type

date

Alias
UMLS CUI [1]
C0011008
Thrombozytenwert 6 Tage nach der 1.Injektion
Description

Platelet Count measurement

Data type

float

Measurement units
  • µl
Alias
UMLS CUI [1]
C0032181
µl
Falls < 50.000 µl HIT- Test pos.?
Description

Heparin-induced thrombocytopenia test

Data type

boolean

Alias
UMLS CUI [1]
C0919799
Maßnahmen
Description

measures

Data type

text

Alias
UMLS CUI [1,1]
C1608430
UMLS CUI [1,2]
C0677850
Datum: 9 Tage nach der 1.Injektion
Description

date

Data type

date

Alias
UMLS CUI [1]
C0011008
Thrombozytenwert 9 Tage nach der 1.Injektion
Description

Platelet Count measurement

Data type

float

Measurement units
  • µl
Alias
UMLS CUI [1]
C0032181
µl
Falls < 50.000 µl HIT- Test pos.?
Description

Heparin-induced thrombocytopenia test

Data type

boolean

Alias
UMLS CUI [1]
C0919799
Maßnahmen
Description

measures

Data type

text

Alias
UMLS CUI [1,1]
C1608430
UMLS CUI [1,2]
C0677850
Datum: 12 Tage nach der 1.Injektion
Description

date

Data type

date

Alias
UMLS CUI [1]
C0011008
Thrombozytenwert 12 Tage nach der 1.Injektion
Description

Platelet Count measurement

Data type

float

Measurement units
  • µl
Alias
UMLS CUI [1]
C0032181
µl
Falls < 50.000 µl HIT- Test pos.?
Description

Heparin-induced thrombocytopenia test

Data type

boolean

Alias
UMLS CUI [1]
C0919799
Maßnahmen
Description

measures

Data type

text

Alias
UMLS CUI [1,1]
C1608430
UMLS CUI [1,2]
C0677850
Datum: 15 Tage nach der 1.Injektion
Description

date

Data type

date

Alias
UMLS CUI [1]
C0011008
Thrombozytenwert 15 Tage nach der 1.Injektion
Description

Platelet Count measurement

Data type

float

Measurement units
  • µl
Alias
UMLS CUI [1]
C0032181
µl
Falls < 50.000 µl HIT- Test pos.?
Description

Heparin-induced thrombocytopenia test

Data type

boolean

Alias
UMLS CUI [1]
C0919799
Maßnahmen
Description

measures

Data type

text

Alias
UMLS CUI [1,1]
C1608430
UMLS CUI [1,2]
C0677850
Datum: 18 Tage nach der 1.Injektion
Description

date

Data type

date

Alias
UMLS CUI [1]
C0011008
Thrombozytenwert 18 Tage nach der 1.Injektion
Description

Platelet Count measurement

Data type

float

Measurement units
  • µl
Alias
UMLS CUI [1]
C0032181
µl
Falls < 50.000 µl HIT- Test pos.?
Description

Heparin-induced thrombocytopenia test

Data type

boolean

Alias
UMLS CUI [1]
C0919799
Maßnahmen
Description

measures

Data type

text

Alias
UMLS CUI [1,1]
C1608430
UMLS CUI [1,2]
C0677850
Datum: 21 Tage nach der 1.Injektion
Description

date

Data type

date

Alias
UMLS CUI [1]
C0011008
Thrombozytenwert 21 Tage nach der 1.Injektion
Description

Platelet Count measurement

Data type

float

Measurement units
  • µl
Alias
UMLS CUI [1]
C0032181
µl
Falls < 50.000 µl HIT- Test pos.?
Description

Heparin-induced thrombocytopenia test

Data type

boolean

Alias
UMLS CUI [1]
C0919799
Maßnahmen
Description

measures

Data type

text

Alias
UMLS CUI [1,1]
C1608430
UMLS CUI [1,2]
C0677850
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Similar models

Investigation between T0 and T1 – Platelet checks for intervention group

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Massnahmen für Patienten des Therapiearms
C0013227 (UMLS CUI-1)
C2986530 (UMLS CUI-2)
Patient ID
Item
Patienten-Nr.:
integer
C1269815 (UMLS CUI [1])
date Platelet Count measurement
Item
Datum der Thrombozytenmessung kurz vor der 1.Injektion
date
C0011008 (UMLS CUI [1,1])
C0032181 (UMLS CUI [1,2])
Platelet Count measurement
Item
Thrombozytenwert kurz vor der 1.Injektion
float
C0032181 (UMLS CUI [1])
Platelet Count measurement; Exclusion
Item
Thrombozytenwert < 50.000 µl, Ausschluss?
boolean
C0032181 (UMLS CUI [1])
C2828389 (UMLS CUI [2])
date Enoxaparin
Item
Datum der 1.Enoxaparininjektion
date
C0011008 (UMLS CUI [1,1])
C0206460 (UMLS CUI [1,2])
date
Item
Datum: 1 Tag nach der 1.Injektion
date
C0011008 (UMLS CUI [1])
Platelet Count measurement
Item
Thrombozytenwert 1 Tag nach der 1.Injektion
float
C0032181 (UMLS CUI [1])
Heparin-induced thrombocytopenia test
Item
Falls < 50.000 µl HIT- Test pos.?
boolean
C0919799 (UMLS CUI [1])
measures
Item
Maßnahmen
text
C1608430 (UMLS CUI [1,1])
C0677850 (UMLS CUI [1,2])
date
Item
Datum: 3 Tage nach der 1.Injektion
date
C0011008 (UMLS CUI [1])
Platelet Count measurement
Item
Thrombozytenwert 3 Tage nach der 1.Injektion
float
C0032181 (UMLS CUI [1])
Heparin-induced thrombocytopenia test
Item
Falls < 50.000 µl HIT- Test pos.?
boolean
C0919799 (UMLS CUI [1])
measures
Item
Maßnahmen
text
C1608430 (UMLS CUI [1,1])
C0677850 (UMLS CUI [1,2])
date
Item
Datum: 6 Tage nach der 1.Injektion
date
C0011008 (UMLS CUI [1])
Platelet Count measurement
Item
Thrombozytenwert 6 Tage nach der 1.Injektion
float
C0032181 (UMLS CUI [1])
Heparin-induced thrombocytopenia test
Item
Falls < 50.000 µl HIT- Test pos.?
boolean
C0919799 (UMLS CUI [1])
measures
Item
Maßnahmen
text
C1608430 (UMLS CUI [1,1])
C0677850 (UMLS CUI [1,2])
date
Item
Datum: 9 Tage nach der 1.Injektion
date
C0011008 (UMLS CUI [1])
Platelet Count measurement
Item
Thrombozytenwert 9 Tage nach der 1.Injektion
float
C0032181 (UMLS CUI [1])
Heparin-induced thrombocytopenia test
Item
Falls < 50.000 µl HIT- Test pos.?
boolean
C0919799 (UMLS CUI [1])
measures
Item
Maßnahmen
text
C1608430 (UMLS CUI [1,1])
C0677850 (UMLS CUI [1,2])
date
Item
Datum: 12 Tage nach der 1.Injektion
date
C0011008 (UMLS CUI [1])
Platelet Count measurement
Item
Thrombozytenwert 12 Tage nach der 1.Injektion
float
C0032181 (UMLS CUI [1])
Heparin-induced thrombocytopenia test
Item
Falls < 50.000 µl HIT- Test pos.?
boolean
C0919799 (UMLS CUI [1])
measures
Item
Maßnahmen
text
C1608430 (UMLS CUI [1,1])
C0677850 (UMLS CUI [1,2])
date
Item
Datum: 15 Tage nach der 1.Injektion
date
C0011008 (UMLS CUI [1])
Platelet Count measurement
Item
Thrombozytenwert 15 Tage nach der 1.Injektion
float
C0032181 (UMLS CUI [1])
Heparin-induced thrombocytopenia test
Item
Falls < 50.000 µl HIT- Test pos.?
boolean
C0919799 (UMLS CUI [1])
measures
Item
Maßnahmen
text
C1608430 (UMLS CUI [1,1])
C0677850 (UMLS CUI [1,2])
date
Item
Datum: 18 Tage nach der 1.Injektion
date
C0011008 (UMLS CUI [1])
Platelet Count measurement
Item
Thrombozytenwert 18 Tage nach der 1.Injektion
float
C0032181 (UMLS CUI [1])
Heparin-induced thrombocytopenia test
Item
Falls < 50.000 µl HIT- Test pos.?
boolean
C0919799 (UMLS CUI [1])
measures
Item
Maßnahmen
text
C1608430 (UMLS CUI [1,1])
C0677850 (UMLS CUI [1,2])
date
Item
Datum: 21 Tage nach der 1.Injektion
date
C0011008 (UMLS CUI [1])
Platelet Count measurement
Item
Thrombozytenwert 21 Tage nach der 1.Injektion
float
C0032181 (UMLS CUI [1])
Heparin-induced thrombocytopenia test
Item
Falls < 50.000 µl HIT- Test pos.?
boolean
C0919799 (UMLS CUI [1])
measures
Item
Maßnahmen
text
C1608430 (UMLS CUI [1,1])
C0677850 (UMLS CUI [1,2])
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