ID

23428

Description

Responsible Party: Maria J.G.T. Vehreschild, Principal Investigator, University of Cologne ClinicalTrials.gov Identifier: NCT01544686 History of Changes Other Study ID Numbers: DRKS00003368 Study First Received: February 22, 2012 Last Updated: December 8, 2015 Antimicrobial Catheter Securement Dressings for the Prevention of Cvc-related Bloodstream Infections in Cancer Patients (COAT) ODM derived from: https://clinicaltrials.gov/ct2/show/NCT01544686

Link

https://clinicaltrials.gov/ct2/show/NCT01544686

Keywords

Versions (1)
  1. 7/4/17 7/4/17 -
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July 4, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Bloodstream Infection in Cancer Patient DRKS00003368 NCT01544686 DRKS00003368

English

Eligibility Bloodstream Infection in Cancer Patient NCT01544686 DRKS00003368

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
Patients receiving a central venous catheter for chemotherapy of AML or ALL
Description

Central venous catheter for Chemotherapy

Data type

boolean

Alias
UMLS CUI [1,1]
C1145640
UMLS CUI [1,2]
C0392920
Patients receiving a central venous catheter for high-dose chemotherapy with consecutive autologous stem cell transplantation or any other condition with an expected duration of chemotherapy-associated neutropenia of at least 5 days and an expected duration of central venous catheter use of at least 10 days
Description

Central Venous Catheter Duration

Data type

boolean

Alias
UMLS CUI [1,1]
C1145640
UMLS CUI [1,2]
C0449238
Age >= 18 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
Healthy Volunteers
Description

Control Group

Data type

boolean

Alias
UMLS CUI [1]
C0009932
Condition with an expected duration of chemotherapy-associated neutropenia of at less than 5 days and an expected duration of central venous catheter use of less than 10 days
Description

Expected duration of Neutropenia or Central Venous Catheter

Data type

boolean

Alias
UMLS CUI [1,1]
C0449238
UMLS CUI [1,2]
C1517001
UMLS CUI [1,3]
C0027947
UMLS CUI [2,1]
C0449238
UMLS CUI [2,2]
C1517001
UMLS CUI [2,3]
C1145640
Use of a central venous catheter with antimicrobial coating other than chlorhexidine and/or silver-sulfadiazine
Description

Central Venous Catheter wit antimicrobial coating

Data type

boolean

Alias
UMLS CUI [1,1]
C0180522
UMLS CUI [1,2]
C1145640
Limited venous status, impeding acquisition of peripheral blood cultures in case of febrile neutropenia
Description

Venous status

Data type

boolean

Alias
UMLS CUI [1]
C0042449
Patients previously enrolled in the study
Description

Study Partricipation Status

Data type

boolean

Alias
UMLS CUI [1]
C2348568
Tunneled central venous catheters
Description

Tunneled central venous catheters

Data type

boolean

Alias
UMLS CUI [1]
C0878969
Shaldon catheters
Description

Shaldon catheters

Data type

boolean

Alias
UMLS CUI [1]
C0085590
CVC insertion via the V. femoralis
Description

Central Venous Catheter in Femoral vein

Data type

boolean

Alias
UMLS CUI [1,1]
C0085590
UMLS CUI [1,2]
C0015809
Fever (T > 37.8°C) related to a suspected or confirmed bacterial infection at randomization
Description

Fever

Data type

boolean

Alias
UMLS CUI [1]
C0015967
Known allergic/hypersensitivity reaction to any compounds of the treatment
Description

Hypersensitivity to Study Drug

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0304229
Legal incapacity or limited legal capacity
Description

Legal capacity

Data type

boolean

Alias
UMLS CUI [1]
C0683673
Medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or sign meaningful informed consent
Description

Comorbidity, Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0009488
UMLS CUI [2]
C0021430
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Similar models

Eligibility Bloodstream Infection in Cancer Patient NCT01544686 DRKS00003368

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion Criteria
C1512693 (UMLS CUI-1)
Central venous catheter for Chemotherapy
Item
Patients receiving a central venous catheter for chemotherapy of AML or ALL
boolean
C1145640 (UMLS CUI [1,1])
C0392920 (UMLS CUI [1,2])
Central Venous Catheter Duration
Item
Patients receiving a central venous catheter for high-dose chemotherapy with consecutive autologous stem cell transplantation or any other condition with an expected duration of chemotherapy-associated neutropenia of at least 5 days and an expected duration of central venous catheter use of at least 10 days
boolean
C1145640 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Age
Item
Age >= 18 years
boolean
C0001779 (UMLS CUI [1])
Item Group
Exclusion Criteria
C0680251 (UMLS CUI-1)
Control Group
Item
Healthy Volunteers
boolean
C0009932 (UMLS CUI [1])
Expected duration of Neutropenia or Central Venous Catheter
Item
Condition with an expected duration of chemotherapy-associated neutropenia of at less than 5 days and an expected duration of central venous catheter use of less than 10 days
boolean
C0449238 (UMLS CUI [1,1])
C1517001 (UMLS CUI [1,2])
C0027947 (UMLS CUI [1,3])
C0449238 (UMLS CUI [2,1])
C1517001 (UMLS CUI [2,2])
C1145640 (UMLS CUI [2,3])
Central Venous Catheter wit antimicrobial coating
Item
Use of a central venous catheter with antimicrobial coating other than chlorhexidine and/or silver-sulfadiazine
boolean
C0180522 (UMLS CUI [1,1])
C1145640 (UMLS CUI [1,2])
Venous status
Item
Limited venous status, impeding acquisition of peripheral blood cultures in case of febrile neutropenia
boolean
C0042449 (UMLS CUI [1])
Study Partricipation Status
Item
Patients previously enrolled in the study
boolean
C2348568 (UMLS CUI [1])
Tunneled central venous catheters
Item
Tunneled central venous catheters
boolean
C0878969 (UMLS CUI [1])
Shaldon catheters
Item
Shaldon catheters
boolean
C0085590 (UMLS CUI [1])
Central Venous Catheter in Femoral vein
Item
CVC insertion via the V. femoralis
boolean
C0085590 (UMLS CUI [1,1])
C0015809 (UMLS CUI [1,2])
Fever
Item
Fever (T > 37.8°C) related to a suspected or confirmed bacterial infection at randomization
boolean
C0015967 (UMLS CUI [1])
Hypersensitivity to Study Drug
Item
Known allergic/hypersensitivity reaction to any compounds of the treatment
boolean
C0020517 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Legal capacity
Item
Legal incapacity or limited legal capacity
boolean
C0683673 (UMLS CUI [1])
Comorbidity, Informed Consent
Item
Medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or sign meaningful informed consent
boolean
C0009488 (UMLS CUI [1])
C0021430 (UMLS CUI [2])
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