ABSTRACT
The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) established the Collaborative Islet Transplant Registry (CITR) in September 2001. In its inaugural year, CITR represents the efforts of 12 collaborating North American islet transplant centers reporting 86 islet transplant recipients' data (1999-2003) and 173 processed pancreata leading to 158 infusion procedures. Recipient median age was 42.2 years, duration of diabetes was 30 years, and over 66% of the recipients were female. Twenty-eight patients received a total of 1 islet infusion, 44 patients received 2 islet infusions, and 14 patients received 3 islet infusions. The median age of the deceased donor was 44 years and body mass index was 28.2. Median time from cross clamp to pancreas recovery was 27 minutes, while duration of cold ischemia was 7 hours. Over 77% of the processing facilities used a density gradient for islet purification. For recipients of only 1 infusion, approximately 8665 total islet equivalents/kg were infused; recipients of 2 infusions received 14,102 islet equivalents/kg, and recipients of 3 infusions received 22,922 islet equivalents/kg. At 6 months after the last infusion, 61.1% of the recipients were reported to be insulin independent; at 12 months, 57.9% were reported to be insulin independent. There have been no deaths reported to CITR; 45 serious adverse events were reported. Through its collaboration with the islet transplant community and its interaction with professional societies and federal agencies, CITR is positioned to provide current and comprehensive information on clinically significant outcome measures in islet transplantation.
Subject(s)
Diabetes Mellitus, Type 1/surgery , Islets of Langerhans Transplantation/statistics & numerical data , Adult , Body Mass Index , Female , Humans , Islets of Langerhans Transplantation/adverse effects , Islets of Langerhans Transplantation/methods , Male , Middle Aged , National Institutes of Health (U.S.) , Postoperative Complications/classification , Postoperative Complications/epidemiology , Registries , Retrospective Studies , Treatment Outcome , United StatesABSTRACT
The Collaborative Islet Transplant Registry (CITR) was established in 2001 with support from the National Institute of Diabetes and Digestive Diseases to collect and analyze information on islet transplants in North America. Thirteen of 27 invited islet transplant centers from the United States and Canada were already participants as of January 2004 with 5 additional centers awaiting IRB approval. In October 2003, CITR had preliminary data on 58 recipients of 107 islet transplants performed at the 13 member centers. These islet recipients averaged 41 years of age (SD 8.9), had diabetes for almost 28 years (SD 10.2) and were predominantly (67%) female. Islets were procured from 118 deceased donors whose average age was 42 (SD 12.2), weight was 90 kg (SD 23.5), and BMI was 30.5 (SD 7.9). The time from cross-clamp to pancreas recovery averaged 56 minutes (SD 134.6). An average of 7,127 islets (SD 2,973) were infused per kg of the recipient's weight. Outcome data are still pending as the Registry prepares its first annual report. Here we describe the organization, goals and design of the data collection instruments for CITR.
Subject(s)
Islets of Langerhans Transplantation , Registries , Data Collection , Humans , Quality Control , United StatesABSTRACT
OBJECTIVES: Infants of =1250 g birth weight receive multiple erythrocyte transfusions during their hospitalization. We hypothesized that early erythropoietin (Epo) and iron therapy would 1) decrease the number of transfusions received (infants 401-1000 g birth weight; trial 1) and 2) decrease the percentage of infants who received any transfusions (1001-1250 g birth weight; trial 2). METHODS: A total of 172 infants in trial 1 and 118 infants in trial 2 were randomized to treatment (Epo, 400 U/kg 3 times weekly) or placebo/control. Therapy was initiated by 4 days after birth and continued through the 35th postmenstrual week. All infants received supplemental parenteral and enteral iron. Complete blood and reticulocyte counts were measured weekly, and ferritin concentrations were measured monthly. Transfusions were administered according to protocol. Phlebotomy losses and transfusion data were recorded. RESULTS: Treated and placebo/control infants in trial 1 received a similar number of transfusions (4.3 +/- 3.6 vs 5.2 +/- 4.2, respectively). A similar percentage of treated and control infants in trial 2 received at least 1 transfusion (37% vs 46%). Reticulocyte counts were higher in treated infants during each week of the study in both trials. Hematocrits were higher among treated infants from week 2 on in both trials. Ferritin concentrations were higher in placebo/controls than in treated infants at weeks 4 and 8 in trial 1 and at week 4 in trial 2. No adverse effects of Epo or supplemental iron occurred. CONCLUSION: The combination of early Epo and iron as administered in this study stimulated erythropoiesis in infants who were =1250 g at birth. However, the lack of impact on transfusion requirements fails to support routine use of early Epo.neonate, intravenous iron, donor exposure.