-
Steven K Takemoto,
Wolfgang Arns,
Suphamai Bunnapradist,
Louis P Garrison, Lluis Guirado,
Zoltan Kalo,
Gabriel Oniscu,
Gerhard Opelz,
Maria Piera Scolari,
Sergio Stefoni,
Magdi Yaqoob,
Daniel C Brennan
[show abstract]
[hide abstract]
ABSTRACT: Transplantation offers a unique opportunity to demonstrate the complementary roles of randomized controlled trials and outcome research. The surgery and collaboration necessary for the transplant procedure makes randomization and blinding difficult. Because essentially every recipient is included in a transplant registry, sampling bias is minimized. Regulatory agencies generally do not consider outcomes research when assessing efficacy of new drugs or medical interventions. This workgroup summary examines the suitability of outcomes research to complement results of randomized controlled trials and related issues: efficacy versus effectiveness, internal versus external validity, data types, limitations, and analysis methodologies. Many advances in outcomes research have been pioneered in transplantation. A case is made for regulatory and reimbursement authorities to use outcomes research when making efficacy, effectiveness, and coverage decisions in transplantation.
Transplantation 08/2008; 86(1):18-25. · 4.00 Impact Factor
-
[show abstract]
[hide abstract]
ABSTRACT: Bacterial infections are frequent in cadaveric organ donors and can be transmitted to the transplantation recipient, which could have devastating consequences for the recipients if adequate preventive measures are not adopted. From the 355 consecutive brain dead cadaveric organ donors procured at our center in the last four years, 2000-2003, four of them (1.1%) had bacterial endocarditis as cause of death. The bacteria responsible for the endocarditis were Staphylococcus epidermidis, coagulase-negative Staphylococcus, Staphylococcus hominis and Streptococcus viridans, respectively. We performed five kidney and two liver transplantations on seven recipients. All donors and recipients received antibiotic treatment against the germ causing the respective endocarditis. Infection by the bacteria responsible for the endocarditis in the respective donors was not transmitted to any of the recipients. Six of the seven recipients were alive with normal-functioning grafts after between 13 and 24 months' follow-up. Transplantectomy was performed on one kidney recipient due to thrombosis of the renal vein of the graft not related to the endocarditis. Liver and kidney transplantation from donors dying from bacterial endocarditis can be performed without causing the transmission of infection to the recipient or the dysfunction of the graft.
American Journal of Transplantation 05/2005; 5(4 Pt 1):781-7. · 6.39 Impact Factor
-
[show abstract]
[hide abstract]
ABSTRACT: At the moment, controversy has arisen about immunosuppression in aged kidney transplant recipients. We present our results on the efficacy and safety of induction treatment based on tacrolimus (FK506) and mycophenolate mofetil (MMF).
We performed 72 transplants in patients of 60 years or older. Induction treatment consisted on (FK 506) 0.1 mg/kg/day and MMF 2 gr/day. Antilymphocyte serum was administered with delayed graft function. A total of 54 patients received kidneys from donors over 60 years old.
Cold ischemia time was 16.4 h (S=5.7). Delayed graft function occurred in 35 patients (48.6%). Acute rejection was observed in nine patients (12.5%). Opportunistic infections were found in 19 patients (26.4%). Seven patients died due to sudden death (1), acute myocardial infarction (1), stroke (1), infection (3), and neoplasm (1). At 1, 2, and 3 years, serum creatinine was 145, 163, and 156 mmol/l; patient survival 93%, 90%, and 90%; graft survival 93%, 90%, and 87%; and death-censored graft survival 100%, 100%, and 97%, respectively.
These immunosuppressive guidelines appear to be efficacious and safe in kidney transplant in elderly recipients.
International Immunopharmacology 02/2005; 5(1):129-31. · 2.38 Impact Factor
