ID

37653

Description

Management of Major Bleeding Events in Atrial Fibrillation Patients Using Pradaxa; ODM derived from: https://clinicaltrials.gov/show/NCT02149303

Link

https://clinicaltrials.gov/show/NCT02149303

Keywords

Versions (1)
  1. 8/14/19 8/14/19 -
Copyright Holder

See clinicaltrials.gov

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August 14, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Atrial Fibrillation NCT02149303

English

Eligibility Atrial Fibrillation NCT02149303

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
greater than or equal to 18 years of age;
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
confirmed diagnosis of non valvular atrial fibrillation (nvaf) (diagnosis of af is considered confirmed if there is medical chart documentation that the patient has atrial fibrillation or af or the icd-9 or icd-10 code for af is documented);
Description

Atrial Fibrillation

Data type

boolean

Alias
UMLS CUI [1]
C0004238
nvaf is defined as follows: nonvalvular atrial fibrillation is restricted to cases in which the rhythm disturbance occurs in the absence of rheumatic mitral stenosis or a prosthetic heart valve.
Description

Atrial Fibrillation | Cardiac Arrhythmia | Rheumatic mitral stenosis Absent | Heart Valve Prosthesis Absent

Data type

boolean

Alias
UMLS CUI [1]
C0004238
UMLS CUI [2]
C0003811
UMLS CUI [3,1]
C0264766
UMLS CUI [3,2]
C0332197
UMLS CUI [4,1]
C0018825
UMLS CUI [4,2]
C0332197
documentation that the patient presented to an emergency department/emergency room (ed/er) for a major bleeding event (index event);
Description

Hemorrhage Event Major | Clinic Visit Emergency department

Data type

boolean

Alias
UMLS CUI [1,1]
C0019080
UMLS CUI [1,2]
C0441471
UMLS CUI [1,3]
C0205164
UMLS CUI [2,1]
C0008952
UMLS CUI [2,2]
C0562508
major bleeding is defined by international society on thrombosis and haemostasis (isth) as:
Description

Hemorrhage Major Definition

Data type

boolean

Alias
UMLS CUI [1,1]
C0019080
UMLS CUI [1,2]
C0205164
UMLS CUI [1,3]
C1704788
fatal bleeding and/or
Description

Hemorrhage Fatal

Data type

boolean

Alias
UMLS CUI [1,1]
C0019080
UMLS CUI [1,2]
C1302234
symptomatic bleeding in a critical area/organ such as intracranial, intraspinal, intraocular, retroperitoneal, intra-articular or pericardial, or intramuscular with compartment syndrome, and/or
Description

Symptomatic bleeding Area Critical | Area Intracranial | Area Intraspinal | Area Intraocular | Retroperitoneal Space | Area Intra-articular | Area Pericardial | Area Intramuscular | Compartment syndromes

Data type

boolean

Alias
UMLS CUI [1,1]
C4324376
UMLS CUI [1,2]
C0205146
UMLS CUI [1,3]
C1511545
UMLS CUI [2,1]
C0205146
UMLS CUI [2,2]
C0524466
UMLS CUI [3,1]
C0205146
UMLS CUI [3,2]
C1283188
UMLS CUI [4,1]
C0205146
UMLS CUI [4,2]
C3282905
UMLS CUI [5]
C0035359
UMLS CUI [6,1]
C0205146
UMLS CUI [6,2]
C0442108
UMLS CUI [7,1]
C0205146
UMLS CUI [7,2]
C0031050
UMLS CUI [8,1]
C0205146
UMLS CUI [8,2]
C0442117
UMLS CUI [9]
C0009492
bleeding causing a fall in hemoglobin of 20g per liter or more, or leading to transfusion of 2 or more units of whole blood or red blood cells
Description

Hemorrhage Causing Hemoglobin drop | Hemorrhage Causing Transfusion whole blood (___ units) | Hemorrhage Causing Red Blood Cell Transfusion

Data type

boolean

Alias
UMLS CUI [1,1]
C0019080
UMLS CUI [1,2]
C0678227
UMLS CUI [1,3]
C0162119
UMLS CUI [2,1]
C0019080
UMLS CUI [2,2]
C0678227
UMLS CUI [2,3]
C3645956
UMLS CUI [3,1]
C0019080
UMLS CUI [3,2]
C0678227
UMLS CUI [3,3]
C0086252
documentation that the index event occurred in a patient who reported having taken at least one dose of dabigatran within the 5 days prior to the index event.
Description

Event Occurrence | Dabigatran Dose Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C0441471
UMLS CUI [1,2]
C2745955
UMLS CUI [2,1]
C2348066
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C1265611
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
confirmed diagnosis of valvular af (diagnosis of valvular af is considered confirmed if there is medical chart documentation that the patient has valvular af or vaf. in the absence of documentation to indicate whether the patient has non-valvular or valvular af,);
Description

Atrial Fibrillation Involvement with Valve

Data type

boolean

Alias
UMLS CUI [1,1]
C0004238
UMLS CUI [1,2]
C1314939
UMLS CUI [1,3]
C1186983
documentation that the patient was taking dabigatran with a concomitant anticoagulant (contemporaneous parenteral anticoagulant or another oral anticoagulant) within 72 hours of the index event;
Description

Dabigatran with Anticoagulants | Anticoagulants Parenteral | Oral anticoagulants

Data type

boolean

Alias
UMLS CUI [1,1]
C2348066
UMLS CUI [1,2]
C0332287
UMLS CUI [1,3]
C0003280
UMLS CUI [2,1]
C0003280
UMLS CUI [2,2]
C1518896
UMLS CUI [3]
C0354604
the concomitant administration of antiplatelet medications prior to the onset of the index event is not exclusionary;
Description

Antiplatelet Agents Previous allowed

Data type

boolean

Alias
UMLS CUI [1,1]
C0085826
UMLS CUI [1,2]
C0205156
UMLS CUI [1,3]
C0683607
documentation of the patient receiving thrombolytic therapy within 48 hours of the onset of the index event;
Description

Thrombolytic Therapy

Data type

boolean

Alias
UMLS CUI [1]
C0040044
documentation that the patient was enrolled in an interventional investigational or other bi observational clinical trial at the time of the onset of the index event;
Description

Study Subject Participation Status | Interventional Study | Observational Study

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C3274035
UMLS CUI [3]
C1518527
medical record was not retrievable, was missing or empty.
Description

Medical record not available | Medical record lost | Medical Record Empty

Data type

boolean

Alias
UMLS CUI [1]
C1320768
UMLS CUI [2]
C0746463
UMLS CUI [3,1]
C0025102
UMLS CUI [3,2]
C1880497
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Similar models

Eligibility Atrial Fibrillation NCT02149303

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
greater than or equal to 18 years of age;
boolean
C0001779 (UMLS CUI [1])
Atrial Fibrillation
Item
confirmed diagnosis of non valvular atrial fibrillation (nvaf) (diagnosis of af is considered confirmed if there is medical chart documentation that the patient has atrial fibrillation or af or the icd-9 or icd-10 code for af is documented);
boolean
C0004238 (UMLS CUI [1])
Atrial Fibrillation | Cardiac Arrhythmia | Rheumatic mitral stenosis Absent | Heart Valve Prosthesis Absent
Item
nvaf is defined as follows: nonvalvular atrial fibrillation is restricted to cases in which the rhythm disturbance occurs in the absence of rheumatic mitral stenosis or a prosthetic heart valve.
boolean
C0004238 (UMLS CUI [1])
C0003811 (UMLS CUI [2])
C0264766 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0018825 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
Hemorrhage Event Major | Clinic Visit Emergency department
Item
documentation that the patient presented to an emergency department/emergency room (ed/er) for a major bleeding event (index event);
boolean
C0019080 (UMLS CUI [1,1])
C0441471 (UMLS CUI [1,2])
C0205164 (UMLS CUI [1,3])
C0008952 (UMLS CUI [2,1])
C0562508 (UMLS CUI [2,2])
Hemorrhage Major Definition
Item
major bleeding is defined by international society on thrombosis and haemostasis (isth) as:
boolean
C0019080 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
C1704788 (UMLS CUI [1,3])
Hemorrhage Fatal
Item
fatal bleeding and/or
boolean
C0019080 (UMLS CUI [1,1])
C1302234 (UMLS CUI [1,2])
Symptomatic bleeding Area Critical | Area Intracranial | Area Intraspinal | Area Intraocular | Retroperitoneal Space | Area Intra-articular | Area Pericardial | Area Intramuscular | Compartment syndromes
Item
symptomatic bleeding in a critical area/organ such as intracranial, intraspinal, intraocular, retroperitoneal, intra-articular or pericardial, or intramuscular with compartment syndrome, and/or
boolean
C4324376 (UMLS CUI [1,1])
C0205146 (UMLS CUI [1,2])
C1511545 (UMLS CUI [1,3])
C0205146 (UMLS CUI [2,1])
C0524466 (UMLS CUI [2,2])
C0205146 (UMLS CUI [3,1])
C1283188 (UMLS CUI [3,2])
C0205146 (UMLS CUI [4,1])
C3282905 (UMLS CUI [4,2])
C0035359 (UMLS CUI [5])
C0205146 (UMLS CUI [6,1])
C0442108 (UMLS CUI [6,2])
C0205146 (UMLS CUI [7,1])
C0031050 (UMLS CUI [7,2])
C0205146 (UMLS CUI [8,1])
C0442117 (UMLS CUI [8,2])
C0009492 (UMLS CUI [9])
Hemorrhage Causing Hemoglobin drop | Hemorrhage Causing Transfusion whole blood (___ units) | Hemorrhage Causing Red Blood Cell Transfusion
Item
bleeding causing a fall in hemoglobin of 20g per liter or more, or leading to transfusion of 2 or more units of whole blood or red blood cells
boolean
C0019080 (UMLS CUI [1,1])
C0678227 (UMLS CUI [1,2])
C0162119 (UMLS CUI [1,3])
C0019080 (UMLS CUI [2,1])
C0678227 (UMLS CUI [2,2])
C3645956 (UMLS CUI [2,3])
C0019080 (UMLS CUI [3,1])
C0678227 (UMLS CUI [3,2])
C0086252 (UMLS CUI [3,3])
Event Occurrence | Dabigatran Dose Quantity
Item
documentation that the index event occurred in a patient who reported having taken at least one dose of dabigatran within the 5 days prior to the index event.
boolean
C0441471 (UMLS CUI [1,1])
C2745955 (UMLS CUI [1,2])
C2348066 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Atrial Fibrillation Involvement with Valve
Item
confirmed diagnosis of valvular af (diagnosis of valvular af is considered confirmed if there is medical chart documentation that the patient has valvular af or vaf. in the absence of documentation to indicate whether the patient has non-valvular or valvular af,);
boolean
C0004238 (UMLS CUI [1,1])
C1314939 (UMLS CUI [1,2])
C1186983 (UMLS CUI [1,3])
Dabigatran with Anticoagulants | Anticoagulants Parenteral | Oral anticoagulants
Item
documentation that the patient was taking dabigatran with a concomitant anticoagulant (contemporaneous parenteral anticoagulant or another oral anticoagulant) within 72 hours of the index event;
boolean
C2348066 (UMLS CUI [1,1])
C0332287 (UMLS CUI [1,2])
C0003280 (UMLS CUI [1,3])
C0003280 (UMLS CUI [2,1])
C1518896 (UMLS CUI [2,2])
C0354604 (UMLS CUI [3])
Antiplatelet Agents Previous allowed
Item
the concomitant administration of antiplatelet medications prior to the onset of the index event is not exclusionary;
boolean
C0085826 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0683607 (UMLS CUI [1,3])
Thrombolytic Therapy
Item
documentation of the patient receiving thrombolytic therapy within 48 hours of the onset of the index event;
boolean
C0040044 (UMLS CUI [1])
Study Subject Participation Status | Interventional Study | Observational Study
Item
documentation that the patient was enrolled in an interventional investigational or other bi observational clinical trial at the time of the onset of the index event;
boolean
C2348568 (UMLS CUI [1])
C3274035 (UMLS CUI [2])
C1518527 (UMLS CUI [3])
Medical record not available | Medical record lost | Medical Record Empty
Item
medical record was not retrievable, was missing or empty.
boolean
C1320768 (UMLS CUI [1])
C0746463 (UMLS CUI [2])
C0025102 (UMLS CUI [3,1])
C1880497 (UMLS CUI [3,2])
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