ID

20257

Beschreibung

The Epidemiology of Bleeding and Clotting in Patients Undergoing Heart Transplantation, Coronary Artery Bypass Graft Surgery,or Implantation of Left Ventricular Assist Devices; ODM derived from: https://clinicaltrials.gov/show/NCT01481012

Link

https://clinicaltrials.gov/show/NCT01481012

Stichworte

Versionen (1)
  1. 16.02.17 16.02.17 -
Hochgeladen am

16. Februar 2017

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Congestive Heart Failure NCT01481012

Englisch

Eligibility Congestive Heart Failure NCT01481012

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. signed informed consent, release of medical information, and hipaa forms;
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
2. age greater than or equal to 18 years;
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
3. male, postmenopausal female, or female who may become pregnant but is using adequate contraceptive precautions (defined as oral contraceptive, intrauterine devices, surgical contraception or a combination of a condom and a spermicide), with negative pregnancy test;
Beschreibung

Gender | Postmenopausal state | Possible pregnancy Contraceptive methods | Contraceptives, Oral | Intrauterine Devices | Surgical Contraception | Female Condoms | Vaginal Spermicides | Possible pregnancy Pregnancy test negative

Datentyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0232970
UMLS CUI [3,1]
C0425965
UMLS CUI [3,2]
C0700589
UMLS CUI [4]
C0009905
UMLS CUI [5]
C0021900
UMLS CUI [6]
C2985333
UMLS CUI [7]
C0221829
UMLS CUI [8]
C0087145
UMLS CUI [9,1]
C0425965
UMLS CUI [9,2]
C0427780
4. admitted to the clinical center at the time of enrollment;
Beschreibung

Hospital admission

Datentyp

boolean

Alias
UMLS CUI [1]
C0184666
5. approved and scheduled to undergo one of the following within 24 hours of enrollment:
Beschreibung

Procedures Approved and scheduled

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0184661
UMLS CUI [1,2]
C0332317
orthotopic heart transplantation
Beschreibung

Heart Transplantation Orthotopic

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0018823
UMLS CUI [1,2]
C0574893
cabg and/or valve surgery on cpb; these patients must have an lv ejection fraction of ≤35%
Beschreibung

Coronary Artery Bypass Surgery Cardiopulmonary Bypass | Valve surgery Cardiopulmonary Bypass | Left ventricular ejection fraction

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0010055
UMLS CUI [1,2]
C0007202
UMLS CUI [2,1]
C2066019
UMLS CUI [2,2]
C0007202
UMLS CUI [3]
C0428772
implantation of a pulsatile lvad (e.g.thoratec heartmate® i lvad) for destination therapy or bridge to transplantation
Beschreibung

Implantation of left ventricular assist device Pulsatile | Destination Therapy Transplantation

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0397130
UMLS CUI [1,2]
C0034106
UMLS CUI [2,1]
C1521840
UMLS CUI [2,2]
C0087111
UMLS CUI [2,3]
C0040732
implantation of a continuous flow lvad (e.g. heartmate® ii, debakey vad® or ventrassist® lvas) for destination therapy or bridge to transplantation
Beschreibung

Implantation of left ventricular assist device Flow Continuous | Destination Therapy Transplantation

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0397130
UMLS CUI [1,2]
C0806140
UMLS CUI [1,3]
C0549178
UMLS CUI [2,1]
C1521840
UMLS CUI [2,2]
C0087111
UMLS CUI [2,3]
C0040732
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. history of a platelet disorder;
Beschreibung

Platelet Disorder

Datentyp

boolean

Alias
UMLS CUI [1]
C0005818
2. history of a known, or an inherited, or an acquired coagulation disorder in the study subject;
Beschreibung

Blood Coagulation Disorders | Blood Coagulation Disorders, Inherited | Acquired coagulation disorder

Datentyp

boolean

Alias
UMLS CUI [1]
C0005779
UMLS CUI [2]
C0852077
UMLS CUI [3]
C0398622
3. stroke within 30 days prior to enrollment;
Beschreibung

Cerebrovascular accident

Datentyp

boolean

Alias
UMLS CUI [1]
C0038454
4. allergy to heparin or protamine;
Beschreibung

Heparin allergy | Protamine allergy

Datentyp

boolean

Alias
UMLS CUI [1]
C0571776
UMLS CUI [2]
C0571193
5. participation in a clinical investigational intervention trial, with the exception of an investigational vad trial, at the time of enrollment;
Beschreibung

Study Subject Participation Status | Clinical Trial | Clinical Trial Artificial Ventricle

Datentyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0008976
UMLS CUI [3,1]
C0008976
UMLS CUI [3,2]
C0085842
6. received investigational intervention within 30 days of enrollment, with the exception of an investigational vad trial
Beschreibung

Intervention Investigational | Clinical Trial Artificial Ventricle

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0184661
UMLS CUI [1,2]
C1517586
UMLS CUI [2,1]
C0008976
UMLS CUI [2,2]
C0085842
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Ähnliche Modelle

Eligibility Congestive Heart Failure NCT01481012

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
1. signed informed consent, release of medical information, and hipaa forms;
boolean
C0021430 (UMLS CUI [1])
Age
Item
2. age greater than or equal to 18 years;
boolean
C0001779 (UMLS CUI [1])
Gender | Postmenopausal state | Possible pregnancy Contraceptive methods | Contraceptives, Oral | Intrauterine Devices | Surgical Contraception | Female Condoms | Vaginal Spermicides | Possible pregnancy Pregnancy test negative
Item
3. male, postmenopausal female, or female who may become pregnant but is using adequate contraceptive precautions (defined as oral contraceptive, intrauterine devices, surgical contraception or a combination of a condom and a spermicide), with negative pregnancy test;
boolean
C0079399 (UMLS CUI [1])
C0232970 (UMLS CUI [2])
C0425965 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0009905 (UMLS CUI [4])
C0021900 (UMLS CUI [5])
C2985333 (UMLS CUI [6])
C0221829 (UMLS CUI [7])
C0087145 (UMLS CUI [8])
C0425965 (UMLS CUI [9,1])
C0427780 (UMLS CUI [9,2])
Hospital admission
Item
4. admitted to the clinical center at the time of enrollment;
boolean
C0184666 (UMLS CUI [1])
Procedures Approved and scheduled
Item
5. approved and scheduled to undergo one of the following within 24 hours of enrollment:
boolean
C0184661 (UMLS CUI [1,1])
C0332317 (UMLS CUI [1,2])
Heart Transplantation Orthotopic
Item
orthotopic heart transplantation
boolean
C0018823 (UMLS CUI [1,1])
C0574893 (UMLS CUI [1,2])
Coronary Artery Bypass Surgery Cardiopulmonary Bypass | Valve surgery Cardiopulmonary Bypass | Left ventricular ejection fraction
Item
cabg and/or valve surgery on cpb; these patients must have an lv ejection fraction of ≤35%
boolean
C0010055 (UMLS CUI [1,1])
C0007202 (UMLS CUI [1,2])
C2066019 (UMLS CUI [2,1])
C0007202 (UMLS CUI [2,2])
C0428772 (UMLS CUI [3])
Implantation of left ventricular assist device Pulsatile | Destination Therapy Transplantation
Item
implantation of a pulsatile lvad (e.g.thoratec heartmate® i lvad) for destination therapy or bridge to transplantation
boolean
C0397130 (UMLS CUI [1,1])
C0034106 (UMLS CUI [1,2])
C1521840 (UMLS CUI [2,1])
C0087111 (UMLS CUI [2,2])
C0040732 (UMLS CUI [2,3])
Implantation of left ventricular assist device Flow Continuous | Destination Therapy Transplantation
Item
implantation of a continuous flow lvad (e.g. heartmate® ii, debakey vad® or ventrassist® lvas) for destination therapy or bridge to transplantation
boolean
C0397130 (UMLS CUI [1,1])
C0806140 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,3])
C1521840 (UMLS CUI [2,1])
C0087111 (UMLS CUI [2,2])
C0040732 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Platelet Disorder
Item
1. history of a platelet disorder;
boolean
C0005818 (UMLS CUI [1])
Blood Coagulation Disorders | Blood Coagulation Disorders, Inherited | Acquired coagulation disorder
Item
2. history of a known, or an inherited, or an acquired coagulation disorder in the study subject;
boolean
C0005779 (UMLS CUI [1])
C0852077 (UMLS CUI [2])
C0398622 (UMLS CUI [3])
Cerebrovascular accident
Item
3. stroke within 30 days prior to enrollment;
boolean
C0038454 (UMLS CUI [1])
Heparin allergy | Protamine allergy
Item
4. allergy to heparin or protamine;
boolean
C0571776 (UMLS CUI [1])
C0571193 (UMLS CUI [2])
Study Subject Participation Status | Clinical Trial | Clinical Trial Artificial Ventricle
Item
5. participation in a clinical investigational intervention trial, with the exception of an investigational vad trial, at the time of enrollment;
boolean
C2348568 (UMLS CUI [1])
C0008976 (UMLS CUI [2])
C0008976 (UMLS CUI [3,1])
C0085842 (UMLS CUI [3,2])
Intervention Investigational | Clinical Trial Artificial Ventricle
Item
6. received investigational intervention within 30 days of enrollment, with the exception of an investigational vad trial
boolean
C0184661 (UMLS CUI [1,1])
C1517586 (UMLS CUI [1,2])
C0008976 (UMLS CUI [2,1])
C0085842 (UMLS CUI [2,2])
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