Microsoft word - 988023-000 rev 002 syncardia tah-t and other smooth surface device antithrombotic management protocol.doc

SynCardia TAH-t and Other Smooth Surface Device Paul Nolan, PharmD Professor of Pharmacy Practice and Science University Medical Center, Tucson, Arizona ISHLT Affiliate Event April 26, 2007
These guidelines were developed based on the experience in the PMA pivotal clinical trial of the
SynCardia TAH-t and subsequent smooth surface device usage.
The following antithrombotic regimen is recommended for the management of the TAH-t and other
smooth surface implanted devices. The management of this regimen will evolve as the patient’s condition
stabilizes and end-organ function recovers.

Heparin to Coumadin Transition Criteria:
After implant of the TAH-t, the patient is treated with Heparin until the end-organ (e.g. Kidney and liver) function approaches normal values and the nutritional status improves, as indicated by a pre-albumin >20 mg/dL and a serum albumin >2.8 mg/dL. Coumadin therapy can be started when these levels are attained. It is not uncommon to have the patient treated with Heparin for at least one month.
Antithrombotic Prophylaxis Regimen:
The following antithrombotic prophylaxis regimen is recommended after a TAH-t implanted patient has transitioned from heparin. A multi-drug approach is used to promote optimal antithrombotic prophylaxis in the SynCardia TAH-t patient. Specific dosages will be guided by the patient’s laboratory data. Coumadin® (Warfarin) administered once a day in the evening. (Use of brand name product should be encouraged in management of the patient on Coumadin therapy.) Aspirin one to two tablets a day (chewable—non-enteric coated) If ordered once a day, the dose is to be administered in the evening. If ordered twice a day, the doses are to be administered morning and evening, approximately 12 hours apart. Dipyridamole (Persantine®) administered three times a day. Pentoxifylline (Trental®) administered three times. (Dipyridamole and Pentoxifylline dosages should be staggered to minimize the occurrence of nausea.)
Dietary Supplement Regimen:
The following vitamin supplements are recommended. (These supplements should be tailored to the unique needs of the patient). 1. Vitamin B-12 1,000 mcg one to two times a day. Multivitamin +/- Multimineral tablet once to twice a day. Iron Sulfate 325 mg two to three times a day To promote optimal nutrition, it is recommended that a supplement containing Omega 3 fatty acids (e.g. Oxepa® while tube feeding and then ProSure®) be administered every day. Additional Pertinent Medications:
Erythropoetin (Epogen®) 20,000-60,000 units (administered 1-3 times per week)

See other side for Laboratory Data Monitoring and Evaluation

SynCardia Systems Inc and Paul Nolan, PharmD 2007-2010 Laboratory Data for Monitoring and Evaluation:
It is recommended that the following laboratory tests be obtained daily initially, then per hospital standard of care. Micro-technique should be used whenever possible. Laboratory Test
Known As
Thromboelastograph ( R, K, MA, CI ,Angle) Platelet Aggregation Studies (ADP, Collagen, Goal: Suppression of ADP, Epinephrine, and Arachidonic Acid-induced platelet aggregation, accompanied by normal response to Collagen-induced platelet aggregation. Prothrombin Time Hematocrit HCT Hemoglobin Hgb Platelet Count Potassium K+ Sodium Na+ Serum Creatinine Calcium CA+ Magnesium Mg+ Phosphorus PO4 Serum Albumin Direct Bilirubin (conjugated bilirubin) Fibrinogen Fibrinogen Fibrin Degradation Fragment SynCardia Systems Inc and Paul Nolan, PharmD 2007-2010

Source: http://www.perfusion.ws/Vads/syncardia/Antithrombotic%20Management%20Protocol.pdf