ID

28194

Beschreibung

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

Stichworte

Versionen (3)
  1. 09.07.17 09.07.17 -
  2. 28.12.17 28.12.17 -
  3. 20.09.21 20.09.21 -
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Saarland University

Hochgeladen am

28. Dezember 2017

DOI

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Creative Commons BY-NC 3.0
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Eligibility HOMe aFers 1 NCT02905539

Deutsch Englisch

Eligibility HOMe aFers 1 NCT02905539

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
Written informed consent,
Beschreibung

Written informed consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Female,
Beschreibung

Female

Datentyp

boolean

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

Gynaecological blood losses

Datentyp

boolean

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

Age ≥ 18 years

Datentyp

boolean

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

Iron deficiency anemia

Datentyp

boolean

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

Hemoglobin < 12.0 g/dl

Datentyp

boolean

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

Serum ferritin and transferrin saturation

Datentyp

boolean

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

Intolerance to or inefficacy of an oral iron supplement

Datentyp

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
Beschreibung

eGFR > 15 mL/min/1.73 m^2

Datentyp

boolean

Alias
UMLS CUI [1]
C3811844
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
Healthy Volunteers
Beschreibung

Healthy Volunteers

Datentyp

boolean

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

Hypersensitivity to MonoFer or FERINJECT

Datentyp

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,
Beschreibung

Severe hypersensitivity to other intravenous iron preparations

Datentyp

boolean

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

Plasma phosphate < 2.5 mg/dL

Datentyp

boolean

Alias
UMLS CUI [1]
C0523826
Hemochromatosis,
Beschreibung

Haemochromatosis

Datentyp

boolean

Alias
UMLS CUI [1]
C0018995
Untreated hyperparathyroidism,
Beschreibung

Untreated hyperparathyroidism

Datentyp

boolean

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

Renal replacement therapy

Datentyp

boolean

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

Active malignant disease

Datentyp

boolean

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

Intravenous iron administration within the last 30 days

Datentyp

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,
Beschreibung

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

Datentyp

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,
Beschreibung

Surgery under anesthetic within the last 10 days

Datentyp

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,
Beschreibung

ASAT or ALAT 1.5-fold increased

Datentyp

boolean

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

Acute febrile infections within the last 7 days

Datentyp

boolean

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

Chronic inflammatory disease

Datentyp

boolean

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

Self-reported severe asthma or eczema

Datentyp

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,
Beschreibung

Further contraindication (allergies, immunologic or inflammatory diseases)

Datentyp

boolean

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

Pregnancy

Datentyp

boolean

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

Woman of childbearing potential without effective contraception method

Datentyp

boolean

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

Lactating women

Datentyp

boolean

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

Present alcohol or drug dependency

Datentyp

boolean

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

History of a psychological illness or seizures

Datentyp

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.
Beschreibung

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

Datentyp

boolean

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

Result of eligibility criteria verification

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

Eligibility criteria not fulfilled

Datentyp

boolean

Alias
UMLS CUI [1]
C3242266
Eligbility criteria fulfilled
Beschreibung

Eligbility criteria fulfilled

Datentyp

boolean

Alias
UMLS CUI [1]
C1302261
Administrative data
Beschreibung

Administrative data

Alias
UMLS CUI-1
C1320722
Date
Beschreibung

Date

Datentyp

date

Alias
UMLS CUI [1]
C0011008
Investigator name
Beschreibung

Investigator name

Datentyp

text

Alias
UMLS CUI [1]
C2826892
Investigator signature
Beschreibung

Investigator signature

Datentyp

text

Alias
UMLS CUI [1]
C2346576
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Ähnliche Modelle

Eligibility HOMe aFers 1 NCT02905539

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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