ID

28194

Description

Eligibility form Prüfung der Eignung zur Studienteilnahme NCT02905539 A Randomized, Double-blind Comparative Study Comparing Ferric Carboxymaltose (Ferinject) and Iron Isomaltoside 1000 (Monofer) for Iron Substitution in Iron-deficiency Anemia Quelle: Prof. Dr. med. Gunnar Heine Universitätsklinikum des Saarlandes

Keywords

Versions (3)
  1. 7/9/17 7/9/17 -
  2. 12/28/17 12/28/17 -
  3. 9/20/21 9/20/21 -
Copyright Holder

Saarland University

Uploaded on

December 28, 2017

DOI

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License

Creative Commons BY-NC 3.0
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Eligibility HOMe aFers 1 NCT02905539

German English

Eligibility HOMe aFers 1 NCT02905539

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
Written informed consent,
Description

Written informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Female,
Description

Female

Data type

boolean

Alias
UMLS CUI [1]
C0015780
Gynecological blood losses,
Description

Gynaecological blood losses

Data type

boolean

Alias
UMLS CUI [1,1]
C0018417
UMLS CUI [1,2]
C3163616
Age ≥ 18 years,
Description

Age ≥ 18 years

Data type

boolean

Alias
UMLS CUI [1]
C0001779
Iron deficiency anemia,
Description

Iron deficiency anemia

Data type

boolean

Alias
UMLS CUI [1]
C0162316
Hemoglobin < 12,0 g/dl,
Description

Hemoglobin < 12.0 g/dl

Data type

boolean

Alias
UMLS CUI [1]
C0019046
Serum-Ferritin 100 ng/ml or Serum-Ferritin 300 ng/ml and Transferrin-saturation 30 %,
Description

Serum ferritin and transferrin saturation

Data type

boolean

Alias
UMLS CUI [1]
C0696113
UMLS CUI [2]
C1277709
Intolerance to or inefficacy of an oral iron supplement
Description

Intolerance to or inefficacy of an oral iron supplement

Data type

boolean

Alias
UMLS CUI [1,1]
C3537005
UMLS CUI [1,2]
C1744706
UMLS CUI [2,1]
C3537005
UMLS CUI [2,2]
C0235828
Estimated Glomerular Filtration Rate > 15 ml/min/1.73 m²
Description

eGFR > 15 mL/min/1.73 m^2

Data type

boolean

Alias
UMLS CUI [1]
C3811844
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
Healthy Volunteers
Description

Healthy Volunteers

Data type

boolean

Alias
UMLS CUI [1]
C1708335
Known hypersensitivity to MonoFer or FERINJECT,
Description

Hypersensitivity to MonoFer or FERINJECT

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C2985193
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C2984025
Severe, known hypersensitivity to other intravenous iron preparations,
Description

Severe hypersensitivity to other intravenous iron preparations

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C4305398
Plasma Phosphate < 2.5 mg/dl at screening,
Description

Plasma phosphate < 2.5 mg/dL

Data type

boolean

Alias
UMLS CUI [1]
C0523826
Hemochromatosis,
Description

Haemochromatosis

Data type

boolean

Alias
UMLS CUI [1]
C0018995
Untreated hyperparathyroidism,
Description

Untreated hyperparathyroidism

Data type

boolean

Alias
UMLS CUI [1,1]
C0020502
UMLS CUI [1,2]
C0332155
Renal replacement therapy/kidney transplantation,
Description

Renal replacement therapy

Data type

boolean

Alias
UMLS CUI [1]
C0206074
UMLS CUI [2]
C0022671
Active malignant disease, disease-free survival for less than 5 years,
Description

Active malignant disease

Data type

boolean

Alias
UMLS CUI [1,1]
C0205177
UMLS CUI [1,2]
C0006826
Intravenous iron administration within the last 30 days,
Description

Intravenous iron administration within the last 30 days

Data type

boolean

Alias
UMLS CUI [1]
C4305398
Treatment with erythropoietin or erythropoietin-stimulating agents, transfusion of red blood cells, radiotherapy or chemotherapy within the last 60 days,
Description

Treatment with erythropoietin or erythropoisis stimulating agents, red blood cell transfusion, radiotherapy, chemotherapy within the last 60 days

Data type

boolean

Alias
UMLS CUI [1]
C0014822
UMLS CUI [2]
C1959590
UMLS CUI [3]
C0086252
UMLS CUI [4]
C1384668
UMLS CUI [5]
C3665472
Surgery under anesthetic within the last 10 days,
Description

Surgery under anesthetic within the last 10 days

Data type

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C0002932
Alanine transaminase (ALT) or aspartate transaminase (AST) > 1.5 fold above levels in healthy individuals,
Description

ASAT or ALAT 1.5-fold increased

Data type

boolean

Alias
UMLS CUI [1]
C0201899
UMLS CUI [2]
C0201836
Acute febrile infections within the last 7 days,
Description

Acute febrile infections within the last 7 days

Data type

boolean

Alias
UMLS CUI [1]
C0948233
Chronic inflammatory diseases requiring a systemic antiinflammatory treatment,
Description

Chronic inflammatory disease

Data type

boolean

Alias
UMLS CUI [1,1]
C3646020
UMLS CUI [1,2]
C1096024
self-reported severe asthma or eczema,
Description

Self-reported severe asthma or eczema

Data type

boolean

Alias
UMLS CUI [1]
C0581126
UMLS CUI [2]
C0013595
Presence of relative contraindications (any allergy, any immunologic or inflammatory disease, history of atopic allergies), for which a treatment with the medicinal investigational products is not deemed indicated by the investigator,
Description

Further contraindication (allergies, immunologic or inflammatory diseases)

Data type

boolean

Alias
UMLS CUI [1]
C0522473
UMLS CUI [2]
C1527304
UMLS CUI [3]
C0021053
UMLS CUI [4]
C1290884
Pregnancy,
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
Women of childbearing potential without an effective method of contraception,
Description

Woman of childbearing potential without effective contraception method

Data type

boolean

Alias
UMLS CUI [1,1]
C4324275
UMLS CUI [1,2]
C0549184
UMLS CUI [1,3]
C0700589
Lactating women,
Description

Lactating women

Data type

boolean

Alias
UMLS CUI [1]
C0006147
Present alcohol or drug dependency,
Description

Present alcohol or drug dependency

Data type

boolean

Alias
UMLS CUI [1]
C0038580
Patients with a history of a psychological illness or seizures,
Description

History of a psychological illness or seizures

Data type

boolean

Alias
UMLS CUI [1]
C0004936
UMLS CUI [2,1]
C0205191
UMLS CUI [2,2]
C1540600
Non-compliance or administration of any investigational drug within 30 days preceding the study start.
Description

Non-compliance or other study participation within the last 30 days

Data type

boolean

Alias
UMLS CUI [1]
C0457432
UMLS CUI [2,1]
C0679823
UMLS CUI [2,2]
C1516648
Result of eligibility criteria verification
Description

Result of eligibility criteria verification

Alias
UMLS CUI-1
C0013893
UMLS CUI-2
C1274040
Eligibility criteria not fulfilled
Description

Eligibility criteria not fulfilled

Data type

boolean

Alias
UMLS CUI [1]
C3242266
Eligbility criteria fulfilled
Description

Eligbility criteria fulfilled

Data type

boolean

Alias
UMLS CUI [1]
C1302261
Administrative data
Description

Administrative data

Alias
UMLS CUI-1
C1320722
Date
Description

Date

Data type

date

Alias
UMLS CUI [1]
C0011008
Investigator name
Description

Investigator name

Data type

text

Alias
UMLS CUI [1]
C2826892
Investigator signature
Description

Investigator signature

Data type

text

Alias
UMLS CUI [1]
C2346576
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Similar models

Eligibility HOMe aFers 1 NCT02905539

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion Criteria
C1512693 (UMLS CUI-1)
Written informed consent
Item
Written informed consent,
boolean
C0021430 (UMLS CUI [1])
Female
Item
Female,
boolean
C0015780 (UMLS CUI [1])
Gynaecological blood losses
Item
Gynecological blood losses,
boolean
C0018417 (UMLS CUI [1,1])
C3163616 (UMLS CUI [1,2])
Age ≥ 18 years
Item
Age ≥ 18 years,
boolean
C0001779 (UMLS CUI [1])
Iron deficiency anemia
Item
Iron deficiency anemia,
boolean
C0162316 (UMLS CUI [1])
Hemoglobin < 12.0 g/dl
Item
Hemoglobin < 12,0 g/dl,
boolean
C0019046 (UMLS CUI [1])
Serum ferritin and transferrin saturation
Item
Serum-Ferritin 100 ng/ml or Serum-Ferritin 300 ng/ml and Transferrin-saturation 30 %,
boolean
C0696113 (UMLS CUI [1])
C1277709 (UMLS CUI [2])
Intolerance to or inefficacy of an oral iron supplement
Item
Intolerance to or inefficacy of an oral iron supplement
boolean
C3537005 (UMLS CUI [1,1])
C1744706 (UMLS CUI [1,2])
C3537005 (UMLS CUI [2,1])
C0235828 (UMLS CUI [2,2])
eGFR > 15 mL/min/1.73 m^2
Item
Estimated Glomerular Filtration Rate > 15 ml/min/1.73 m²
boolean
C3811844 (UMLS CUI [1])
Item Group
Exclusion Criteria
C0680251 (UMLS CUI-1)
Healthy Volunteers
Item
Healthy Volunteers
boolean
C1708335 (UMLS CUI [1])
Hypersensitivity to MonoFer or FERINJECT
Item
Known hypersensitivity to MonoFer or FERINJECT,
boolean
C0020517 (UMLS CUI [1,1])
C2985193 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C2984025 (UMLS CUI [2,2])
Severe hypersensitivity to other intravenous iron preparations
Item
Severe, known hypersensitivity to other intravenous iron preparations,
boolean
C0020517 (UMLS CUI [1,1])
C4305398 (UMLS CUI [1,2])
Plasma phosphate < 2.5 mg/dL
Item
Plasma Phosphate < 2.5 mg/dl at screening,
boolean
C0523826 (UMLS CUI [1])
Haemochromatosis
Item
Hemochromatosis,
boolean
C0018995 (UMLS CUI [1])
Untreated hyperparathyroidism
Item
Untreated hyperparathyroidism,
boolean
C0020502 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
Renal replacement therapy
Item
Renal replacement therapy/kidney transplantation,
boolean
C0206074 (UMLS CUI [1])
C0022671 (UMLS CUI [2])
Active malignant disease
Item
Active malignant disease, disease-free survival for less than 5 years,
boolean
C0205177 (UMLS CUI [1,1])
C0006826 (UMLS CUI [1,2])
Intravenous iron administration within the last 30 days
Item
Intravenous iron administration within the last 30 days,
boolean
C4305398 (UMLS CUI [1])
Treatment with erythropoietin or erythropoisis stimulating agents, red blood cell transfusion, radiotherapy, chemotherapy within the last 60 days
Item
Treatment with erythropoietin or erythropoietin-stimulating agents, transfusion of red blood cells, radiotherapy or chemotherapy within the last 60 days,
boolean
C0014822 (UMLS CUI [1])
C1959590 (UMLS CUI [2])
C0086252 (UMLS CUI [3])
C1384668 (UMLS CUI [4])
C3665472 (UMLS CUI [5])
Surgery under anesthetic within the last 10 days
Item
Surgery under anesthetic within the last 10 days,
boolean
C0543467 (UMLS CUI [1,1])
C0002932 (UMLS CUI [1,2])
ASAT or ALAT 1.5-fold increased
Item
Alanine transaminase (ALT) or aspartate transaminase (AST) > 1.5 fold above levels in healthy individuals,
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
Acute febrile infections within the last 7 days
Item
Acute febrile infections within the last 7 days,
boolean
C0948233 (UMLS CUI [1])
Chronic inflammatory disease
Item
Chronic inflammatory diseases requiring a systemic antiinflammatory treatment,
boolean
C3646020 (UMLS CUI [1,1])
C1096024 (UMLS CUI [1,2])
Self-reported severe asthma or eczema
Item
self-reported severe asthma or eczema,
boolean
C0581126 (UMLS CUI [1])
C0013595 (UMLS CUI [2])
Further contraindication (allergies, immunologic or inflammatory diseases)
Item
Presence of relative contraindications (any allergy, any immunologic or inflammatory disease, history of atopic allergies), for which a treatment with the medicinal investigational products is not deemed indicated by the investigator,
boolean
C0522473 (UMLS CUI [1])
C1527304 (UMLS CUI [2])
C0021053 (UMLS CUI [3])
C1290884 (UMLS CUI [4])
Pregnancy
Item
Pregnancy,
boolean
C0032961 (UMLS CUI [1])
Woman of childbearing potential without effective contraception method
Item
Women of childbearing potential without an effective method of contraception,
boolean
C4324275 (UMLS CUI [1,1])
C0549184 (UMLS CUI [1,2])
C0700589 (UMLS CUI [1,3])
Lactating women
Item
Lactating women,
boolean
C0006147 (UMLS CUI [1])
Present alcohol or drug dependency
Item
Present alcohol or drug dependency,
boolean
C0038580 (UMLS CUI [1])
History of a psychological illness or seizures
Item
Patients with a history of a psychological illness or seizures,
boolean
C0004936 (UMLS CUI [1])
C0205191 (UMLS CUI [2,1])
C1540600 (UMLS CUI [2,2])
Non-compliance or other study participation within the last 30 days
Item
Non-compliance or administration of any investigational drug within 30 days preceding the study start.
boolean
C0457432 (UMLS CUI [1])
C0679823 (UMLS CUI [2,1])
C1516648 (UMLS CUI [2,2])
Item Group
C0013893 (UMLS CUI-1)
C1274040 (UMLS CUI-2)
Eligibility criteria not fulfilled
Item
boolean
C3242266 (UMLS CUI [1])
Eligbility criteria fulfilled
Item
boolean
C1302261 (UMLS CUI [1])
Item Group
C1320722 (UMLS CUI-1)
Date
Item
date
C0011008 (UMLS CUI [1])
Investigator name
Item
text
C2826892 (UMLS CUI [1])
Investigator signature
Item
text
C2346576 (UMLS CUI [1])
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