ID

28369

Beschrijving

Fibrinogen and Bleeding After Cardiac Surgery; ODM derived from: https://clinicaltrials.gov/show/NCT00968045

Link

https://clinicaltrials.gov/show/NCT00968045

Trefwoorden

Versies (1)
  1. 08-01-18 08-01-18 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

8 januari 2018

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Complications NCT00968045

Engels

Eligibility Complications NCT00968045

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
males and females
Beschrijving

Gender

Datatype

boolean

Alias
UMLS CUI [1]
C0079399
age 18 years and above
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
patients eligible for a first-time coronary artery bypass(cabg) surgery with a preoperative fibrinogen plasma concentration under 3,8 g/l
Beschrijving

Patients eligible Coronary Artery Bypass Surgery Firstly | Plasma fibrinogen level Preoperative

Datatype

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1548635
UMLS CUI [1,3]
C0010055
UMLS CUI [1,4]
C1279901
UMLS CUI [2,1]
C2082368
UMLS CUI [2,2]
C0445204
signed informed consent to participate in the study
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients undergoing redo surgery
Beschrijving

Repeat Surgery

Datatype

boolean

Alias
UMLS CUI [1]
C0035110
clinical or laboratory signs of bleeding disorder
Beschrijving

Clinical Signs Blood Coagulation Disorders | Laboratory Signs Blood Coagulation Disorders

Datatype

boolean

Alias
UMLS CUI [1,1]
C3540840
UMLS CUI [1,2]
C0005779
UMLS CUI [2,1]
C0022877
UMLS CUI [2,2]
C0311392
UMLS CUI [2,3]
C0005779
clinical or laboratory signs of significant liver disease, or,other significant disease or condition which in the investigators judgment interfere with hemostasis
Beschrijving

Clinical Signs Liver disease | Laboratory Signs Liver disease | Disease Interferes with Hemostasis | Condition Interferes with Hemostasis

Datatype

boolean

Alias
UMLS CUI [1,1]
C3540840
UMLS CUI [1,2]
C0023895
UMLS CUI [2,1]
C0022877
UMLS CUI [2,2]
C0311392
UMLS CUI [2,3]
C0023895
UMLS CUI [3,1]
C0012634
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C0019116
UMLS CUI [4,1]
C0348080
UMLS CUI [4,2]
C0521102
UMLS CUI [4,3]
C0019116
any medications with agents which may interfere with hemostasis within 14 days prior to study start. clopidogrel and warfarin are withdrawn at least 24 hours before surgery. oral aspirin is allowed co-medication.
Beschrijving

Pharmaceutical Preparations Interfere with Hemostasis | Clopidogrel Withdrawn | Warfarin Withdrawn | Oral Aspirin allowed

Datatype

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0019116
UMLS CUI [2,1]
C0070166
UMLS CUI [2,2]
C0424092
UMLS CUI [3,1]
C0043031
UMLS CUI [3,2]
C0424092
UMLS CUI [4,1]
C0732305
UMLS CUI [4,2]
C0683607
administration of other investigational drugs within eight weeks preceding the preentry examination
Beschrijving

Investigational New Drugs

Datatype

boolean

Alias
UMLS CUI [1]
C0013230
pregnant or lactating women
Beschrijving

Pregnancy | Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
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Similar models

Eligibility Complications NCT00968045

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Gender
Item
males and females
boolean
C0079399 (UMLS CUI [1])
Age
Item
age 18 years and above
boolean
C0001779 (UMLS CUI [1])
Patients eligible Coronary Artery Bypass Surgery Firstly | Plasma fibrinogen level Preoperative
Item
patients eligible for a first-time coronary artery bypass(cabg) surgery with a preoperative fibrinogen plasma concentration under 3,8 g/l
boolean
C0030705 (UMLS CUI [1,1])
C1548635 (UMLS CUI [1,2])
C0010055 (UMLS CUI [1,3])
C1279901 (UMLS CUI [1,4])
C2082368 (UMLS CUI [2,1])
C0445204 (UMLS CUI [2,2])
Informed Consent
Item
signed informed consent to participate in the study
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Repeat Surgery
Item
patients undergoing redo surgery
boolean
C0035110 (UMLS CUI [1])
Clinical Signs Blood Coagulation Disorders | Laboratory Signs Blood Coagulation Disorders
Item
clinical or laboratory signs of bleeding disorder
boolean
C3540840 (UMLS CUI [1,1])
C0005779 (UMLS CUI [1,2])
C0022877 (UMLS CUI [2,1])
C0311392 (UMLS CUI [2,2])
C0005779 (UMLS CUI [2,3])
Clinical Signs Liver disease | Laboratory Signs Liver disease | Disease Interferes with Hemostasis | Condition Interferes with Hemostasis
Item
clinical or laboratory signs of significant liver disease, or,other significant disease or condition which in the investigators judgment interfere with hemostasis
boolean
C3540840 (UMLS CUI [1,1])
C0023895 (UMLS CUI [1,2])
C0022877 (UMLS CUI [2,1])
C0311392 (UMLS CUI [2,2])
C0023895 (UMLS CUI [2,3])
C0012634 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C0019116 (UMLS CUI [3,3])
C0348080 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C0019116 (UMLS CUI [4,3])
Pharmaceutical Preparations Interfere with Hemostasis | Clopidogrel Withdrawn | Warfarin Withdrawn | Oral Aspirin allowed
Item
any medications with agents which may interfere with hemostasis within 14 days prior to study start. clopidogrel and warfarin are withdrawn at least 24 hours before surgery. oral aspirin is allowed co-medication.
boolean
C0013227 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0019116 (UMLS CUI [1,3])
C0070166 (UMLS CUI [2,1])
C0424092 (UMLS CUI [2,2])
C0043031 (UMLS CUI [3,1])
C0424092 (UMLS CUI [3,2])
C0732305 (UMLS CUI [4,1])
C0683607 (UMLS CUI [4,2])
Investigational New Drugs
Item
administration of other investigational drugs within eight weeks preceding the preentry examination
boolean
C0013230 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
pregnant or lactating women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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