CUSTODIOL HTK Solution        Heart       Pancreas        Kidney       Liver

Liver Transplantation

Clinical Trials Compared CUSTODIOL® (HTK Solution) to University of Wisconsin (UW)Solution in
Adult Liver Transplantation1,8,9

Biliary Complications Following Liver Transplantation in the Model for End-Stage LiverDiseases Era:
Effect of Donor, Recipient and Technical Factors9

Among this study are findings in 256 decreased donor liver transplants. The bile leak rate was 18% and stricture rate 23%. Use of histidine-tryptophan ketoglutarate (HTK) versus University of Wisconsin (UW) solution was protective.

* Graft function in the first 5 days postimplant was characterized on the basis of blood chemistry as Good (GOT-max <1000 U/L, spontaneous PT ratio >50%); Fair (GOT 1000-2500 U/L, clotting factor support <2 days); Poor (GOT >2500 U/L, clotting factor support >2 days)

† PDF = Initial Poor function & Primary Non Function

Custodiol® HTK in Extended Criteria Liver Donors

This study presents experience in a large number of SCD and ECD (698) adult cadaveric liver transplants.10

All liver enzymes were measured and graphed at 1, 7, 14 and 30 days post-transplant. Livers preserved with HTK have a higher initial AST and ALD in SCD and (P)ECD livers, whereas the UW-preserved livers have a higher AST and ALT in old donor livers. In all groups, these differences disappear by postoperative day 7.10

• HTK has a much lower viscosity that may result in better penetration of the microcirculation for a better flush. This may lead to a lower rate of biliary complications and may provide a more thorough flush.10

• HTK is protective against biliary complications when compared to UW.10

• ...patient and graft survival between UW preserved and HTK preserved ECD livers are equivalent...10

* (P)EC = Physiologic extended criteria donors
ViaSpan is a registered trademark of Barr Laboratories, Inc.
CUSTODIOL is a registered trademark of Dr. Franz Köhler Chemie GmbH,
Alsbach-Hähnlein, Germany.

References

1. Data on file. Essential Pharmaceuticals, LLC.

2. Erhard J, Lange R, Scherer R, et al. Comparison of histidine-tryptophan- ketoglutarate (HTK) solution versus University of Wisconsin (UW) solution for organ preservation in human liver transplantation. A prospective, randomized study. Transplant Int. 1994;7:177-181

3. Gebhard MM,, Kirlum HJ, Schlegel C. Organ preservation with the solution HTK. In: Hesse UJ, de Hemptinne B, eds. Organ Preservation with HTK and UW Solution: Update on Clinical Use and Experimental Studies. Lengerich, Germany: Pabst Science Publishers; 1999:75-87.

4. Ringe B, Braun F, Moritz M, Zeldin G, Soriano H, Meyers W. Safety and efficacy of living donor liver preservation with HTK solution. Transplant Proc. 2005;37:316-319.

5. Lynch RJ, Kubus J, Chenault RH, Pelletier SJ, Campbell DA, and Englesbe MJ. Comparison of Histidine-Trytophan-ketogluterate and University of Wisconsin Preservation in renal Transplantation. American Journal of Transplantation. 2008;8:567-573.

6. Agarwal A, Murdock P, Fridell JA. Comparison of histidine-tryptophan- ketoglutarate (HTK) solution and University of Wisconsin solution in prolonged cold preservation of kidney allografts. Transplantation. 2006;81:480-482.

7. Agarwal A, Powelson JA, Goggins WC, Milgrom ML, and Fridell JA. Organ preservation with histidine-tryptophan-ketoglutarate solution in clinical pancreas transplantation: an update of the Indiana University Experience. Transplant Proceedings. 2008;40:498-501

8. Pokorny H, Grünberger T, Rockenschaub S, et al. Liver transplantation with HTK perfused organs—a multicenter study. Transplantation. 2002;74:36-37. Abstract

9. Welling TH, Heidt DG, Englesbe MJ, Magee JC, et al. Biliary complications following liver transplantation in the model for end-stage liver disease era: effect of donor, recipient, and technical factors. Liver Transpl. 2008;14:73-80

10. Mangus RS, Fridell JA, Vianna RM, Milgrom MA, et al. Comparison of histidine-tryptophan-ketoglutarate solution (HTK) and University of Wisconsin solution (UW) in extended criteria liver donors. Liver Transpl. 2008;14:365-373.5. (Brown)

11. Becker T, Ringe B, Nyibata M, Meyer zu Vilsendorf A, Schrem H, Lück R, et al. Pancreas transplantation with histidine-tryptophanketoglutarate (HTK) solution and University of Wisconsin (UW) solution: is there a difference? Journal of the Pancreas (Online) 2007;8(3):304-311.

12. Potdar S, Malck S, Eghtesad B, et al: Initial experience using histidine- tryptophan-ketogluterate solution in clinical pancreas transplantation. Clin Transplant 18:661, 2004

13. Englesbe MJ, Moyer A, Kim DY et al: Early Pancreas transplant outcomes with histidine-tryptophan-ketogluterate preservation: a multicenter study. Transplantation 82:136, 2006

14. Weiselthaler GM, Chevtchik O, Konestschny R, et al. Improved graft function using a new myocardial preservation solution: Celsior. Preliminary data from a randomized prospective study. Transplant Proc. 1999;31:2067-2068.

15. CUSTODIOL® [package insert]. Newtown, PA: Essential Pharmaceuticals, LLC;2006.

16. Ackerman J, Gross W, Mory M, Schaefer M, Gebhard, MM. Celsior versus Custodiol® : Early postichemic recovery after cardioplegia and ischemia at 5°C. Ann Thorac Surg. 2002;74:522-529.

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