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])
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])