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At Talecris Biotherapeutics, we strive to provide healthcare professionals with the most up-to-date information required for clinical practice. For your convenience, the Clinical Communications professionals at Talecris Biotherapeutics have compiled the most common questions received based upon areas of expertise.
Please feel free to contact Talecris Biotherapeutics' Clinical Communications Department for any additional information.
Click on any question below.
Q1. Does albumin reduce the need for blood transfusions?
A1. Albumin use may reduce the need for blood transfusions by decreasing the amount of excessive bleeding typically associated with use of nonprotein colloids.1
Q2. What is the role of albumin and nonprotein colloids in surgery?
A2. Albumin and nonprotein colloids (hetastarch [6% hydroxyethyl starch] or dextran) are blood volume expanders that are frequently used perioperatively to enhance intravascular blood volume, improve hemodynamics, and reduce the need for blood transfusions.2
Q3. Are there advantages to using albumin versus lower-cost nonprotein colloids during cardiac surgery?
A3. Data has shown that nonprotein colloid volume expanders are associated with impaired hemostasis, platelet dysfunction, and excessive bleeding.3-5
Q4. Does albumin result in less bleeding than alternative agents?
A4. A meta-analysis of 16 trials found that there was a fourfold increase in bleeding when starches were used compared to albumin.6
Q5. What effect does albumin have on mortality?
A5. Albumin has been associated with 25% lower odds of mortality when compared with nonprotein colloid use.7
Q6. Why does albumin have a lesser effect on mortality rates?
A6. Excessive bleeding has been shown to be four times higher when nonprotein colloids are used instead of albumin.8-10 Postoperative bleeding and re-operation increase mortality.11 A study by Sedrakyan et al reported that when albumin was used in lieu of nonprotein colloids, approximately five to six lives were saved for every 1,000 patients who underwent coronary artery bypass graft (CABG) surgery.12
Q7. What are the cost savings of using albumin?
A7. Analysis of cost effectiveness has shown that albumin administration is a cost-effective option.13 The use of albumin results in approximately $52,000 to $54,000 in charges per life saved. Although direct savings have not been taken into account, this estimate compares favorably with a variety of alternative uses of funds in coronary heart disease.14
Q8. Are Talecris Biotherapeutics' manufacturing processes for virus removal validated?
A8. Yes, all steps have been validated according to established guidelines.15 While some steps exist specifically to remove pathogens, other steps lower virus levels as part of the purification process.16
Q9. What are Talecris Biotherapeutics' Plasma Viral Testing procedures?
A9. Talecris Biotherapeutics requires all donated plasma to be screened in an FDA-licensed and approved laboratory for standard tests for viral markers or indications of potential infection.
In addition, Talecris Biotherapeutics uses state-of-the-art nucleic acid testing (NAT) technology to test the plasma units for HIV, HBV, HCV, and parvovirus B19 genetic material. These polymerase chain reaction (PCR)-based tests enable direct detection of viral nucleic acid.
PCR testing helps reduce the "window period" during which infection is present but detectable levels of viral antigens or antibodies have not yet developed.
Q10. How do I request a Certificate of Analysis?
A10. To request a Certificate of Analysis, please contact our Clinical Communication Department at at 1-800-520-2807 (8:30 AM - 5:00 PM Eastern Standard Time). A copy of the document will then be e-mailed or faxed to you.
Q11. Does Talecris Biotherapeutics manufacture a low aluminum albumin formulation for use in the US?
A11. Yes, Talecris Biotherapeutics has a FDA license for low aluminum albumin in a variety of formulations and vial sizes. All Talecris' albumin products are manufactured at our Clayton, North Carolina facility. For more information visit our product information or prescribing information.
References
| 1. |
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Sedrakyan A, Gondek K, Paltiel D, Elefteriades JA. Volume expansion with albumin decreases mortality after coronary artery bypass graft surgery. Chest. 2003;123:1853-1857. |
| 2. |
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Elefteriades JA, Geha, AS, Cohen LS. Patterns of fluid balance: house officer guide to ICU care; fundamentals of management of the heart and lungs. Philadelphia, PA: Lippincott-Raven, 1996; 88-89. |
| 3. |
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Cope JT, Banks D, Mauney MC, et al. Intraoperative hetastarch infusion impairs hemostasis after cardiac operations. Ann Thorac Surg. 1997;63(1):78-82; discussion 82-3. |
| 4. |
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Knutson JE, Deering JA, Hall FW, et al. Does intraoperative hetastarch administration increase blood loss and transfusion requirements after cardiac surgery? Anesth Analg. 2000;90(4):801-807. |
| 5. |
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Belisle S, Hardy JF. Hemorrhage and the use of blood products after adult cardiac operations: myths and realities. Ann Thorac Surg. 1996;62(6):1908-17. |
| 6. |
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Wilkes MM, Navickis RJ, Sibbald WJ. Albumin versus hydroxyethyl starch in cardiopulmonary bypass surgery: a meta-analysis of postoperative bleeding. Ann Thorac Surg. 2001;72:527-534. |
| 7. |
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Sedrakyan A, Gondek K, Paltiel D, Elefteriades JA. Volume expansion with albumin decreases mortality after coronary artery bypass graft surgery. Chest. 2003;123:1853-1857. |
| 8. |
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Cope JT, Banks D, Mauney MC, et al. Intraoperative hetastarch infusion impairs hemostasis after cardiac operations. Ann Thorac Surg. 1997;63(1):78-82; discussion 82-3. |
| 9. |
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Belisle S, Hardy JF. Hemorrhage and the use of blood products after adult cardiac operations: myths and realities. Ann Thorac Surg. 1996;62(6):1908-1917. |
| 10. |
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Wilkes MM, Navickis RJ, Sibbald WJ. Albumin versus hydroxyethyl starch in cardiopulmonary bypass surgery: a meta-analysis of postoperative bleeding. Ann Thorac Surg. 2001;72(2):527-33; discussion 534. |
| 11. |
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Sedrakyan A, Gondek K, Paltiel D, Elefteriades JA. Volume expansion with albumin decreases mortality after coronary artery bypass graft surgery. Chest. 2003;123:1853-1857. |
| 12. |
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Sedrakyan A, Gondek K, Paltiel D, Elefteriades JA. Volume expansion with albumin decreases mortality after coronary artery bypass graft surgery. Chest. 2003;123:1853-1857. |
| 13. |
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Tengs TO, Adams ME, Pliskin JS, et al. Five-hundred life-saving interventions and their cost-effectiveness. Risk Anal. 1995;15(3):369-390. |
| 14. |
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Council of Europe, Public Health Committee. Human Plasma for Fractionation. 1998. Resolution AP-CSP (98) 11. |
| 15. |
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Committee for Proprietary Medicinal Products (CPMP). Note for Guidenance on Virus Validation Studies: The Design, Contribution and Interpretation of Studies Validating the Inactivation and Removal of Viruses. 1996. CPMP BWP/268/95. |
| 16. |
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Remington KM, Petteway SR Jr. Comprehensive pathogen safety management for Plasbumin. Pediatr Crit Care Med. 2001;2(suppl):S23-S27. |
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