ID

13746

Description

Coronary Artery Bypass graft surgery in patients with Asymptomatic Carotid Stenosis. A randomized controlled clinical trial. Short title: "CABACS" DRKS Number:DRKS00000521 IRSCTN Number:ISRCTN13486906 Phase:Therapeutic confirmatory(Phase III) Head of clinical trial: Prof. Dr. med. Christian Weimar University Duisburg-Essen Phone: 0201/723-6503 Fax: 0201/723-6948 e-mail: christian.weimar@uk-essen.de University Hospital Essen Hospital for Neurology Hufelandstr. 55 45122 Essen Trial coordinator: Dr. med. Stephan Knipp Phone: 0201/723-4915 Fax: 0201/723-5451 e-mail: stephan.knipp@uk-essen.de University Duisburg-Essen University Hospital Essen Hospital for thoracic- and cardiovascular surgery Hufelandstr. 55 45122 Essen Data Management: Anja Marr Phone: 0201/92239-257 Fax: 0201/92239-333 o. 0201/723-5933 e-mail: anja.marr@uk-essen.de University Hospital Essen Center for clinical trials Essen c/o IMIBE Hufelandstr. 55 45122 Essen Monitoring: Dipl.-Biol. Konstantinos Bilbilis Phone: 0201/92239-252 Fax: 0201/92239-310 e-mail: konstantinos.bilbilis@uk-essen.de University Hospital Essen Center for clinical trials Essen c/o IMIBE Hufelandstr. 55 45122 Essen

Keywords

  1. 3/2/16 3/2/16 -
Uploaded on

March 2, 2016

DOI

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License

Creative Commons BY-NC 3.0

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Coronary Artery Bypass graft surgery in patients with Asymptomatic Carotid Stenosis DRKS00000521

CABACS Case Report Form [Hospital discharge]

Postoperative progress
Description

Postoperative progress

Days patient was in intensive care
Description

Intensive care time

Data type

integer

Measurement units
  • days
Alias
UMLS CUI [1,1]
C0085559
UMLS CUI [1,2]
C0040223
days
Patient mobilization after surgery
Description

Mobilization

Data type

integer

Alias
UMLS CUI [1]
C0300926
Mediastinitis
Description

Mediastinitis

Data type

boolean

Alias
UMLS CUI [1]
C0025064
Resuscitation
Description

Resuscitation

Data type

boolean

Alias
UMLS CUI [1]
C0007203
Myocardial infarction
Description

Myocardial infarction

Data type

boolean

Alias
UMLS CUI [1]
C0027051
Low Cardiac Output
Description

Low Cardiac Output

Data type

integer

Alias
UMLS CUI [1]
C0007166
Reason for revision thoracotomy
Description

Reason for revision thoracotomy

Data type

integer

Alias
UMLS CUI [1,1]
C0039991
UMLS CUI [1,2]
C1527075
UMLS CUI [1,3]
C0566251
Respiratory insufficiency
Description

Respiratory insufficiency

Data type

integer

Alias
UMLS CUI [1]
C0035229
Cerebrovascular accident until hospital discharge?
Description

Cerebrovascular accident

Data type

boolean

Alias
UMLS CUI [1]
C0038454
Duration of cerebrovascular accident
Description

Duration of cerebrovascular accident

Data type

integer

Alias
UMLS CUI [1,1]
C0038454
UMLS CUI [1,2]
C0449238
Rankin severity score of neurological deficit after cerebrovascular accident (duration longer than 24 hours)
Description

Modified Rankin Scale

Data type

integer

Alias
UMLS CUI [1]
C2984908
Psychosyndrome
Description

Psychosyndrome

Data type

integer

Alias
UMLS CUI [1]
C0679479
Gastrointestinal complications that required treatment
Description

Gastrointestinal complications

Data type

integer

Alias
UMLS CUI [1]
C0161819
Serum creatinine after surgery
Description

Creatinine, Serum

Data type

float

Measurement units
  • mg/dL
Alias
UMLS CUI [1]
C0201976
mg/dL
Serum Creatinine
Description

Creatinine, Serum

Data type

integer

Measurement units
  • μmol/l
Alias
UMLS CUI [1]
C0201976
μmol/l
Postoperative dialysis
Description

Dialysis

Data type

integer

Alias
UMLS CUI [1]
C0011946
Did the patient receive RBC transfusions
Description

Red Blood Cell Transfusion

Data type

boolean

Alias
UMLS CUI [1,1]
C0086252
UMLS CUI [1,2]
C0750480
Number of RBC transfusions
Description

Red Blood Cell Transfusion

Data type

integer

Alias
UMLS CUI [1,1]
C0086252
UMLS CUI [1,2]
C0750480
Red blood cell transfusion
Description

RBC transfusion

Data type

integer

Alias
UMLS CUI [1]
C0086252
Number of FFP transfusions
Description

FFP

Data type

integer

Alias
UMLS CUI [1]
C0016709
Platelet concentrate administered
Description

Platelet concentrate

Data type

boolean

Alias
UMLS CUI [1]
C1293886
Cardiac rhythm upon discharge
Description

Cardiac rhythm upon discharge

Data type

integer

Alias
UMLS CUI [1]
C0232187
Patient wears a cardiac pacemaker/defibrillator
Description

Cardiac pacemaker/defibrillator

Data type

integer

Alias
UMLS CUI [1]
C0030163
UMLS CUI [2]
C0162589
Hospital discharge diagnosis: Please give ICD-Codes of all relevant diagnoses at discharge
Description

Hospital discharge diagnosis

Data type

text

Alias
UMLS CUI [1]
C0332144
Date of hospital discharge
Description

Date of hospital discharge

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0586003
Reason for Discharge
Description

Entlassungsgrund

Data type

text

Alias
UMLS CUI [1,1]
C0586003
UMLS CUI [1,2]
C0566251
Date of completion of this form
Description

Date of completion

Data type

date

Alias
UMLS CUI [1]
C0011008
Signature by investigator
Description

Signature

Data type

text

Alias
UMLS CUI [1]
C1519316
Name of Investigator
Description

Name of Investigator

Data type

text

Alias
UMLS CUI [1]
C0008961

Similar models

CABACS Case Report Form [Hospital discharge]

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Postoperative progress
Intensive care time
Item
Days patient was in intensive care
integer
C0085559 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Item
Patient mobilization after surgery
integer
C0300926 (UMLS CUI [1])
Code List
Patient mobilization after surgery
CL Item
not mobilized (0)
CL Item
mobilized the first day after surgery (1)
CL Item
mobilized the second day after surgery (2)
CL Item
mobilized the third day after surgery (3)
CL Item
can not be assessed (4)
Mediastinitis
Item
Mediastinitis
boolean
C0025064 (UMLS CUI [1])
Resuscitation
Item
Resuscitation
boolean
C0007203 (UMLS CUI [1])
Myocardial infarction
Item
Myocardial infarction
boolean
C0027051 (UMLS CUI [1])
Item
Low Cardiac Output
integer
C0007166 (UMLS CUI [1])
Code List
Low Cardiac Output
CL Item
no (0)
CL Item
yes, treated conservatively (1)
CL Item
yes,IABP (2)
CL Item
yes,other mechanical circulatory support (3)
Item
Reason for revision thoracotomy
integer
C0039991 (UMLS CUI [1,1])
C1527075 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
Code List
Reason for revision thoracotomy
CL Item
no revision thoracotomy/no further reason (0)
CL Item
hemorrhage/hematoma (1)
CL Item
low cardiac output (2)
CL Item
tamponade (3)
CL Item
complications with the graft/ischemia (4)
CL Item
wound infection/mediastinitis (5)
CL Item
dissection (6)
CL Item
prosthetic dysfunction (7)
CL Item
unstable sternum (8)
CL Item
chylothorax (9)
CL Item
other reason (10)
Item
Respiratory insufficiency
integer
C0035229 (UMLS CUI [1])
Code List
Respiratory insufficiency
CL Item
no (0)
CL Item
yes, with forced respiration therapy (1)
CL Item
yes, reintubation or prolonged artificial respiration (2)
CL Item
yes,tracheotomy (3)
Cerebrovascular accident
Item
Cerebrovascular accident until hospital discharge?
boolean
C0038454 (UMLS CUI [1])
Item
Duration of cerebrovascular accident
integer
C0038454 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Code List
Duration of cerebrovascular accident
CL Item
up to 24 hours (1)
CL Item
longer than 24 hours up to 72 hours (2)
CL Item
longer than 72 hours (3)
Item
Rankin severity score of neurological deficit after cerebrovascular accident (duration longer than 24 hours)
integer
C2984908 (UMLS CUI [1])
Code List
Rankin severity score of neurological deficit after cerebrovascular accident (duration longer than 24 hours)
CL Item
No symptoms at all (0)
CL Item
No significant disability despite symptoms; able to carry out all usual duties and activities (1)
CL Item
Slight disability; unable to carry out all previous activities but able to look after own affairs without assistance (2)
CL Item
Moderate disability; requiring some help but able to walk without assistance (3)
CL Item
Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance (4)
CL Item
Severe disability; bedridden, incontinent, and requiring constant nursing care and attention (5)
CL Item
Death (6)
Item
Psychosyndrome
integer
C0679479 (UMLS CUI [1])
Code List
Psychosyndrome
CL Item
no (0)
CL Item
yes, transitory without treatment (1)
CL Item
yes, relevant with treatment (2)
Item
Gastrointestinal complications that required treatment
integer
C0161819 (UMLS CUI [1])
Code List
Gastrointestinal complications that required treatment
CL Item
No (0)
CL Item
Yes,conservatively (1)
CL Item
Yes,with intervention (2)
CL Item
Yes,laparotomy (3)
Creatinine, Serum
Item
Serum creatinine after surgery
float
C0201976 (UMLS CUI [1])
Creatinine, Serum
Item
Serum Creatinine
integer
C0201976 (UMLS CUI [1])
Item
Postoperative dialysis
integer
C0011946 (UMLS CUI [1])
Code List
Postoperative dialysis
CL Item
No (0)
CL Item
acute (1)
CL Item
chronic (2)
Red Blood Cell Transfusion
Item
Did the patient receive RBC transfusions
boolean
C0086252 (UMLS CUI [1,1])
C0750480 (UMLS CUI [1,2])
Red Blood Cell Transfusion
Item
Number of RBC transfusions
integer
C0086252 (UMLS CUI [1,1])
C0750480 (UMLS CUI [1,2])
Item
Red blood cell transfusion
integer
C0086252 (UMLS CUI [1])
Code List
Red blood cell transfusion
CL Item
exact number of transfusions unknown, but at least one (1)
CL Item
unknown (2)
FFP
Item
Number of FFP transfusions
integer
C0016709 (UMLS CUI [1])
Platelet concentrate
Item
Platelet concentrate administered
boolean
C1293886 (UMLS CUI [1])
Item
Cardiac rhythm upon discharge
integer
C0232187 (UMLS CUI [1])
Code List
Cardiac rhythm upon discharge
CL Item
Sinus rhythm (1)
CL Item
Atrial fibrillation (2)
CL Item
patient deceased/no cardiac rhythm (3)
CL Item
other cardiac rhythm (4)
Item
Patient wears a cardiac pacemaker/defibrillator
integer
C0030163 (UMLS CUI [1])
C0162589 (UMLS CUI [2])
Code List
Patient wears a cardiac pacemaker/defibrillator
CL Item
No (0)
CL Item
Yes, pacemaker (1)
CL Item
Yes, defibrillator (2)
Hospital discharge diagnosis
Item
Hospital discharge diagnosis: Please give ICD-Codes of all relevant diagnoses at discharge
text
C0332144 (UMLS CUI [1])
Date of hospital discharge
Item
Date of hospital discharge
date
C0011008 (UMLS CUI [1,1])
C0586003 (UMLS CUI [1,2])
Entlassungsgrund
Item
Reason for Discharge
text
C0586003 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
Date of completion
Item
Date of completion of this form
date
C0011008 (UMLS CUI [1])
Signature
Item
Signature by investigator
text
C1519316 (UMLS CUI [1])
Name of Investigator
Item
Name of Investigator
text
C0008961 (UMLS CUI [1])

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