Perfadex®

The Gold Standard in Lung Preservation

Perfadex® is a colloid containing, lightly buffered ‘extracellular’ low K+ electro-lyte solution for rapid cooling, perfusion and storage of organs in connection with transplantation.

  • Improves immediate post-transplant lung function (PO2/Fi02ratio)1, 2, 3, 4, 5, 9, 10, 12
  • Reduces 30-day mortality 1, 2, 3, 10, 11 and 1-year mortality13
  • Prevents ischemia-reperfusion injury 1, 2, 6, 7
  • Protects surfactant function8

MECHANISM OF ACTION

The composition of Perfadex® has been specifically formulated to preserve the function and integrity of organs rich in endothelium during flushing and cold ischemic storage prior to trans-plantation and reperfusion. Its colloid component, dextran 40, particularly protects the microvasculare against post-ischemic reperfusion injury, primarily by preventing pathological leukocyte-endothelial interaction. 14, 15 It also prevents edema and counteracts thrombosis.16 Perfadex® is thus an ideal solution for the preservation of vascular grafts, pancreas and lungs in particular. 17 It may also be used as a base or ‘carrier’ solution for other organ-specific electrolytes or active components such as scavengers, immunosuppressants or gene therapy.

COMPOSITION

Each 1,000 ml Perfadex® contains 5% dextran 40 (Mw 40.000), Na+ 138 mmol, K+ 6 mmol, Mg 2+ 0.8 mmol, Cl- 142 mmol, SO 4 2- 0.8 mmol, H2PO 4-plus HPO4 2-0.8 mmol and glucose 5 mmol.

ADDITIVES

At about pH 5.5, shelf-life is 3 years. Adjust to about pH 7.4 shortly before use by addition of 1 mmol THAM/TRIS (trometamol or tromethamine) per litre Perfadex®. The solution should then be chilled and used within 24 hours.

HOW SUPPLIED

Perfadex® is supplied in 1,000 mL or 2,800 mL (PVC bags).

In USA Perfadex® is supplied with THAM.

REF 19001; 8 x 1000 mL
REF 19002; 2 x 2800 mL
REF 19017*; 8 x 1000 mL
REF 19018*; 2 x 2800 mL

*REF number used in the USA

In the USA, the use of Perfadex® for preservation of tissues and organs other than lungs has not been cleared by the FDA.

 

REFERENCES

1. Muller C, et al, transplantation, 1999. 68(8):1139-43.

2. Fischer S, et al, J Thorac. Cardiovasc Surg. 2001. 121(3):594-6

3. Struber M, et al, Eur. J. Cardiothorac. Surg. 2001. 19 (2):190-4.

4. Rabanal J M, et al, Transplant Proc. 2003. ;35(5):1938-9

5. Rega F, et al, 5th Internat Cong lung transplant, Paris, Sept 19-20, 2002.

6. Sakamaki F, et al, Am J Respir Crit Care Med. 1997:156:1073-81

7. Struber M, et al, J Heart Lung Transplant. 1999:18:1:87

8. Struber M, et al, J Thorac Cardiovasc Surg. 2000, 120 (3); 566-72.

9. Inci I et al. J Heart Lung Transplant. 2008 Sep;27(9):1016-22.

10. Oto T et al. Ann Thorac Surg. 2006 Nov;82(5):1842-8.

11. Gamez P et al Arch Bronconeumol. 2005 Jan;41(1):16-19.

12. Okada Y et al. Ann Thorac Cardiovasc Surg. 2006 Feb;12(1):10-4

13. Arnaoutakis GJ et al. J Heart Lung Transplant. 2010 Dec; 29(12): 1380-7

14. Menger M D. Transplant Proceed. 1995, 27; 5: 2863-65

15. Hoffman h et al. Z. Hertz-, Thorax-, Gefässchir. 1997, 11: 108-14

16. Frost -Arner L et al. Microsurgery. 1995, 16: 357-361

17. Keshavjee SH et al. J Thorac Cardiovascular Surg. 1992; 103:314-25