Informed Consent
Item
1. signed informed consent, release of medical information, and hipaa forms;
boolean
C0021430 (UMLS CUI [1])
Age
Item
2. age greater than or equal to 18 years;
boolean
C0001779 (UMLS CUI [1])
Gender | Postmenopausal state | Possible pregnancy Contraceptive methods | Contraceptives, Oral | Intrauterine Devices | Surgical Contraception | Female Condoms | Vaginal Spermicides | Possible pregnancy Pregnancy test negative
Item
3. male, postmenopausal female, or female who may become pregnant but is using adequate contraceptive precautions (defined as oral contraceptive, intrauterine devices, surgical contraception or a combination of a condom and a spermicide), with negative pregnancy test;
boolean
C0079399 (UMLS CUI [1])
C0232970 (UMLS CUI [2])
C0425965 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0009905 (UMLS CUI [4])
C0021900 (UMLS CUI [5])
C2985333 (UMLS CUI [6])
C0221829 (UMLS CUI [7])
C0087145 (UMLS CUI [8])
C0425965 (UMLS CUI [9,1])
C0427780 (UMLS CUI [9,2])
Hospital admission
Item
4. admitted to the clinical center at the time of enrollment;
boolean
C0184666 (UMLS CUI [1])
Procedures Approved and scheduled
Item
5. approved and scheduled to undergo one of the following within 24 hours of enrollment:
boolean
C0184661 (UMLS CUI [1,1])
C0332317 (UMLS CUI [1,2])
Heart Transplantation Orthotopic
Item
orthotopic heart transplantation
boolean
C0018823 (UMLS CUI [1,1])
C0574893 (UMLS CUI [1,2])
Coronary Artery Bypass Surgery Cardiopulmonary Bypass | Valve surgery Cardiopulmonary Bypass | Left ventricular ejection fraction
Item
cabg and/or valve surgery on cpb; these patients must have an lv ejection fraction of ≤35%
boolean
C0010055 (UMLS CUI [1,1])
C0007202 (UMLS CUI [1,2])
C2066019 (UMLS CUI [2,1])
C0007202 (UMLS CUI [2,2])
C0428772 (UMLS CUI [3])
Implantation of left ventricular assist device Pulsatile | Destination Therapy Transplantation
Item
implantation of a pulsatile lvad (e.g.thoratec heartmate® i lvad) for destination therapy or bridge to transplantation
boolean
C0397130 (UMLS CUI [1,1])
C0034106 (UMLS CUI [1,2])
C1521840 (UMLS CUI [2,1])
C0087111 (UMLS CUI [2,2])
C0040732 (UMLS CUI [2,3])
Implantation of left ventricular assist device Flow Continuous | Destination Therapy Transplantation
Item
implantation of a continuous flow lvad (e.g. heartmate® ii, debakey vad® or ventrassist® lvas) for destination therapy or bridge to transplantation
boolean
C0397130 (UMLS CUI [1,1])
C0806140 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,3])
C1521840 (UMLS CUI [2,1])
C0087111 (UMLS CUI [2,2])
C0040732 (UMLS CUI [2,3])
Platelet Disorder
Item
1. history of a platelet disorder;
boolean
C0005818 (UMLS CUI [1])
Blood Coagulation Disorders | Blood Coagulation Disorders, Inherited | Acquired coagulation disorder
Item
2. history of a known, or an inherited, or an acquired coagulation disorder in the study subject;
boolean
C0005779 (UMLS CUI [1])
C0852077 (UMLS CUI [2])
C0398622 (UMLS CUI [3])
Cerebrovascular accident
Item
3. stroke within 30 days prior to enrollment;
boolean
C0038454 (UMLS CUI [1])
Heparin allergy | Protamine allergy
Item
4. allergy to heparin or protamine;
boolean
C0571776 (UMLS CUI [1])
C0571193 (UMLS CUI [2])
Study Subject Participation Status | Clinical Trial | Clinical Trial Artificial Ventricle
Item
5. participation in a clinical investigational intervention trial, with the exception of an investigational vad trial, at the time of enrollment;
boolean
C2348568 (UMLS CUI [1])
C0008976 (UMLS CUI [2])
C0008976 (UMLS CUI [3,1])
C0085842 (UMLS CUI [3,2])
Intervention Investigational | Clinical Trial Artificial Ventricle
Item
6. received investigational intervention within 30 days of enrollment, with the exception of an investigational vad trial
boolean
C0184661 (UMLS CUI [1,1])
C1517586 (UMLS CUI [1,2])
C0008976 (UMLS CUI [2,1])
C0085842 (UMLS CUI [2,2])