ID

16557

Description

Comparing Angiomax to Heparin With Protamine in Patients Undergoing Cardiopulmonary Bypass (CPB); ODM derived from: https://clinicaltrials.gov/show/NCT00079586

Link

https://clinicaltrials.gov/show/NCT00079586

Keywords

Versions (1)
  1. 7/24/16 7/24/16 -
Uploaded on

July 24, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Cardiovascular Disease NCT00079586

English

Eligibility Cardiovascular Disease NCT00079586

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
provide written informed consent before initiation of any study related procedures.
Description

Informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
be at least 18 years of age.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
be scheduled for cabg, cabg and single valve surgery, or isolated single valve surgery on cpb. patients undergoing repeat (redo) cabg are also considered eligible for this study.
Description

Coronary Artery Bypass Surgery Planned | Operative Surgical Procedure heart valve Single | Cardiopulmonary Bypass | Coronary Artery Bypass Surgery Repeat

Data type

boolean

Alias
UMLS CUI [1,1]
C0010055
UMLS CUI [1,2]
C1301732
UMLS CUI [2,1]
C0543467
UMLS CUI [2,2]
C1305961
UMLS CUI [2,3]
C0205171
UMLS CUI [3]
C0007202
UMLS CUI [4,1]
C0010055
UMLS CUI [4,2]
C0205341
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
confirmed pregnancy at time of randomization via ivrs (if woman of child-bearing potential) (urine or serum pregnancy test)
Description

Pregnancy | Childbearing Potential Urine pregnancy test | Childbearing Potential Serum pregnancy test

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0430056
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0430064
cerebrovascular accident within 6 months, or any cerebrovascular accident with a residual neurological deficit.
Description

Cerebrovascular accident | Neurologic Deficit Residual

Data type

boolean

Alias
UMLS CUI [1]
C0038454
UMLS CUI [2,1]
C0521654
UMLS CUI [2,2]
C1609982
intracranial neoplasm, arteriovenous malformation or aneurysm.
Description

Neoplasms, Intracranial | arteriovenous malformation | Aneurysm

Data type

boolean

Alias
UMLS CUI [1]
C1527390
UMLS CUI [2]
C0003857
UMLS CUI [3]
C0002940
dependency on renal dialysis or creatinine clearance <30 ml/min.
Description

Dialysis procedure dependent | Creatinine clearance measurement

Data type

boolean

Alias
UMLS CUI [1,1]
C0011946
UMLS CUI [1,2]
C3244310
UMLS CUI [2]
C0373595
ongoing treatment with warfarin (or other oral anticoagulant) at the time of randomization.
Description

Warfarin | oral anticoagulants

Data type

boolean

Alias
UMLS CUI [1]
C0043031
UMLS CUI [2]
C0354604
patients previously treated with warfarin may be enrolled if warfarin therapy can be safely discontinued and baseline inr is < 1.3 times control in the absence of heparin therapy.
Description

Warfarin | Drug therapy discontinued | International Normalized Ratio | Heparin therapy Absent

Data type

boolean

Alias
UMLS CUI [1]
C0043031
UMLS CUI [2]
C0558681
UMLS CUI [3]
C0525032
UMLS CUI [4,1]
C0522794
UMLS CUI [4,2]
C0332197
known allergy to angiomax or hirudin-derived drugs, or known sensitivity to any component of the product.
Description

Hypersensitivity Angiomax | Hypersensitivity Hirudin and derivatives | Hypersensitivity MEDICATION COMPONENT

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0939677
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C1320115
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0184498
patients receiving clopidogrel (plavix®) within the previous 5 days of randomization
Description

clopidogrel | Plavix

Data type

boolean

Alias
UMLS CUI [1]
C0070166
UMLS CUI [2]
C0633084
patients receiving a glycoprotein iib/iiia inhibitor within the previous 48 hours if abciximab (reopro®) or 24 hours if eptifibatide (integrilin®) or tirofiban (aggrastat®) of randomization.
Description

GP IIB-IIIa inhibitor | abciximab | ReoPro | eptifibatide | Integrilin | tirofiban | Aggrastat

Data type

boolean

Alias
UMLS CUI [1]
C0864559
UMLS CUI [2]
C0288672
UMLS CUI [3]
C0592046
UMLS CUI [4]
C0253563
UMLS CUI [5]
C0950902
UMLS CUI [6]
C0247025
UMLS CUI [7]
C0656369
patients receiving lepirudin (refludan®) or argatroban within the previous 24 hours prior to randomization.
Description

lepirudin | Refludan | argatroban

Data type

boolean

Alias
UMLS CUI [1]
C0772394
UMLS CUI [2]
C0661608
UMLS CUI [3]
C0048470
patients receiving lmwh or thrombolytics within the previous 12 hours or unfractionated heparin within 30 minutes of randomization.
Description

Heparin, Low-Molecular-Weight | Fibrinolytic Agents | Unfractionated Heparin

Data type

boolean

Alias
UMLS CUI [1]
C0019139
UMLS CUI [2]
C0016018
UMLS CUI [3]
C2825026
participation in other clinical research studies involving the evaluation of other investigational drugs or devices within 30 days of randomization.
Description

Study Subject Participation Status | Investigational New Drugs Evaluation | Investigational Medical Device Evaluation

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0013230
UMLS CUI [2,2]
C1261322
UMLS CUI [3,1]
C2346570
UMLS CUI [3,2]
C1261322
refusal to undergo blood transfusion should it become necessary.
Description

Blood Transfusion Needed Refused

Data type

boolean

Alias
UMLS CUI [1,1]
C0005841
UMLS CUI [1,2]
C0027552
UMLS CUI [1,3]
C1705116
any other disease or condition, which, in the judgment of the investigator, would place a patient at undue risk by being enrolled in the trial, or cause inability to comply with the trial.
Description

Comorbidity Risk Study Subject Participation Status | Comorbidity Compliance behavior Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0035647
UMLS CUI [1,3]
C2348568
UMLS CUI [2,1]
C0009488
UMLS CUI [2,2]
C1321605
UMLS CUI [2,3]
C1299582
planned surgical procedure in which proximal anastomoses will precede distal anastomoses of the bypass grafts.
Description

Operative Surgical Procedures Planned | Proximal anastomosis preceding Distal anastomosis Bypass grafts

Data type

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C1301732
UMLS CUI [2,1]
C0448963
UMLS CUI [2,2]
C0332152
UMLS CUI [2,3]
C0448964
UMLS CUI [2,4]
C0185098
planned (>1) double (or greater) valve repair-replacement (e.g.: avr-mvr) surgery.
Description

multiple valve surgery replacement of two valves | multiple valve surgery repair of two valves | Replacement of aortic valve | Replacement of mitral valve

Data type

boolean

Alias
UMLS CUI [1]
C2066023
UMLS CUI [2]
C2066020
UMLS CUI [3]
C0003506
UMLS CUI [4]
C0026268
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Similar models

Eligibility Cardiovascular Disease NCT00079586

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Informed consent
Item
provide written informed consent before initiation of any study related procedures.
boolean
C0021430 (UMLS CUI [1])
Age
Item
be at least 18 years of age.
boolean
C0001779 (UMLS CUI [1])
Coronary Artery Bypass Surgery Planned | Operative Surgical Procedure heart valve Single | Cardiopulmonary Bypass | Coronary Artery Bypass Surgery Repeat
Item
be scheduled for cabg, cabg and single valve surgery, or isolated single valve surgery on cpb. patients undergoing repeat (redo) cabg are also considered eligible for this study.
boolean
C0010055 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
C0543467 (UMLS CUI [2,1])
C1305961 (UMLS CUI [2,2])
C0205171 (UMLS CUI [2,3])
C0007202 (UMLS CUI [3])
C0010055 (UMLS CUI [4,1])
C0205341 (UMLS CUI [4,2])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Childbearing Potential Urine pregnancy test | Childbearing Potential Serum pregnancy test
Item
confirmed pregnancy at time of randomization via ivrs (if woman of child-bearing potential) (urine or serum pregnancy test)
boolean
C0032961 (UMLS CUI [1])
C3831118 (UMLS CUI [2,1])
C0430056 (UMLS CUI [2,2])
C3831118 (UMLS CUI [3,1])
C0430064 (UMLS CUI [3,2])
Cerebrovascular accident | Neurologic Deficit Residual
Item
cerebrovascular accident within 6 months, or any cerebrovascular accident with a residual neurological deficit.
boolean
C0038454 (UMLS CUI [1])
C0521654 (UMLS CUI [2,1])
C1609982 (UMLS CUI [2,2])
Neoplasms, Intracranial | arteriovenous malformation | Aneurysm
Item
intracranial neoplasm, arteriovenous malformation or aneurysm.
boolean
C1527390 (UMLS CUI [1])
C0003857 (UMLS CUI [2])
C0002940 (UMLS CUI [3])
Dialysis procedure dependent | Creatinine clearance measurement
Item
dependency on renal dialysis or creatinine clearance <30 ml/min.
boolean
C0011946 (UMLS CUI [1,1])
C3244310 (UMLS CUI [1,2])
C0373595 (UMLS CUI [2])
Warfarin | oral anticoagulants
Item
ongoing treatment with warfarin (or other oral anticoagulant) at the time of randomization.
boolean
C0043031 (UMLS CUI [1])
C0354604 (UMLS CUI [2])
Warfarin | Drug therapy discontinued | International Normalized Ratio | Heparin therapy Absent
Item
patients previously treated with warfarin may be enrolled if warfarin therapy can be safely discontinued and baseline inr is < 1.3 times control in the absence of heparin therapy.
boolean
C0043031 (UMLS CUI [1])
C0558681 (UMLS CUI [2])
C0525032 (UMLS CUI [3])
C0522794 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
Hypersensitivity Angiomax | Hypersensitivity Hirudin and derivatives | Hypersensitivity MEDICATION COMPONENT
Item
known allergy to angiomax or hirudin-derived drugs, or known sensitivity to any component of the product.
boolean
C0020517 (UMLS CUI [1,1])
C0939677 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C1320115 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0184498 (UMLS CUI [3,2])
clopidogrel | Plavix
Item
patients receiving clopidogrel (plavix®) within the previous 5 days of randomization
boolean
C0070166 (UMLS CUI [1])
C0633084 (UMLS CUI [2])
GP IIB-IIIa inhibitor | abciximab | ReoPro | eptifibatide | Integrilin | tirofiban | Aggrastat
Item
patients receiving a glycoprotein iib/iiia inhibitor within the previous 48 hours if abciximab (reopro®) or 24 hours if eptifibatide (integrilin®) or tirofiban (aggrastat®) of randomization.
boolean
C0864559 (UMLS CUI [1])
C0288672 (UMLS CUI [2])
C0592046 (UMLS CUI [3])
C0253563 (UMLS CUI [4])
C0950902 (UMLS CUI [5])
C0247025 (UMLS CUI [6])
C0656369 (UMLS CUI [7])
lepirudin | Refludan | argatroban
Item
patients receiving lepirudin (refludan®) or argatroban within the previous 24 hours prior to randomization.
boolean
C0772394 (UMLS CUI [1])
C0661608 (UMLS CUI [2])
C0048470 (UMLS CUI [3])
Heparin, Low-Molecular-Weight | Fibrinolytic Agents | Unfractionated Heparin
Item
patients receiving lmwh or thrombolytics within the previous 12 hours or unfractionated heparin within 30 minutes of randomization.
boolean
C0019139 (UMLS CUI [1])
C0016018 (UMLS CUI [2])
C2825026 (UMLS CUI [3])
Study Subject Participation Status | Investigational New Drugs Evaluation | Investigational Medical Device Evaluation
Item
participation in other clinical research studies involving the evaluation of other investigational drugs or devices within 30 days of randomization.
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2,1])
C1261322 (UMLS CUI [2,2])
C2346570 (UMLS CUI [3,1])
C1261322 (UMLS CUI [3,2])
Blood Transfusion Needed Refused
Item
refusal to undergo blood transfusion should it become necessary.
boolean
C0005841 (UMLS CUI [1,1])
C0027552 (UMLS CUI [1,2])
C1705116 (UMLS CUI [1,3])
Comorbidity Risk Study Subject Participation Status | Comorbidity Compliance behavior Unable
Item
any other disease or condition, which, in the judgment of the investigator, would place a patient at undue risk by being enrolled in the trial, or cause inability to comply with the trial.
boolean
C0009488 (UMLS CUI [1,1])
C0035647 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C0009488 (UMLS CUI [2,1])
C1321605 (UMLS CUI [2,2])
C1299582 (UMLS CUI [2,3])
Operative Surgical Procedures Planned | Proximal anastomosis preceding Distal anastomosis Bypass grafts
Item
planned surgical procedure in which proximal anastomoses will precede distal anastomoses of the bypass grafts.
boolean
C0543467 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
C0448963 (UMLS CUI [2,1])
C0332152 (UMLS CUI [2,2])
C0448964 (UMLS CUI [2,3])
C0185098 (UMLS CUI [2,4])
multiple valve surgery replacement of two valves | multiple valve surgery repair of two valves | Replacement of aortic valve | Replacement of mitral valve
Item
planned (>1) double (or greater) valve repair-replacement (e.g.: avr-mvr) surgery.
boolean
C2066023 (UMLS CUI [1])
C2066020 (UMLS CUI [2])
C0003506 (UMLS CUI [3])
C0026268 (UMLS CUI [4])
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