Meeting research needs with postmortem biospecimen donation: summary of recommendations for postmortem recovery of normal human biospecimens for research.

Normal human tissues, bodily fluids, and other biospecimens of known quality are essential for research to understand the development of cancer and other diseases and to develop new diagnostics and therapies. However, obtaining normal biospecimens appropriate for contemporary large-scale molecular and genomic research is one of the most challenging biospecimen acquisition problems for scientists and biospecimen resources that support research. Recognizing this challenge, the U.S. National Cancer Institute recently convened a series of workshops and meetings focused on the acquisition of normal tissues for research and produced an extensive document, Recommendations for Postmortem Recovery of Normal Human Biospecimens for Research. This article summarizes these recommendations, addressing key ethical, operational, and scientific elements for collecting normal reference biospecimens from postmortem donors in the U.S. Awareness of these recommendations can foster more effective collaborations and mitigate potential logistical challenges, while promoting postmortem biospecimen donation options for families and increasing the availability of high quality normal biospecimens for research. The recommendations have been put into practice in the collection of normal human biospecimens for the NIH Genotype-Tissue Expression Program (GTEx), a pilot study of human gene expression and regulation in multiple tissues which will provide valuable insights into the mechanisms of gene regulation and, in the future, its disease-related perturbations (http://commonfund.nih.gov/GTEx/).

Experience improves successful use of fibrin sealant in total knee arthroplasty: implications for surgical education.

This study evaluating fibrin sealant application in total knee arthroplasty (TKA) found significant differences in the decline in adjusted hemoglobin loss at 48 hours postoperatively in the treatment group (FS) relative to the control group (C) when the groups were segregated into early and late subgroups. The decline between the late C, 3.53 +/- 0.22 g/dL, and the late FS, 3.01 +/- 0.20 g/dL, was 0.52 g/dL (p = 0.04). The decline between the early C, 3.51 +/- 0.21 g/dL, and the early FS, 3.25 +/- 0.22 g/dL, was 0.26 g/dL (p = 0.34). This study demonstrates the importance of experience and education in successful application of tissue adhesives.

Fibrin sealant reduces perioperative blood loss in total hip replacement.

Patients (n = 81) undergoing total hip replacement (THR) were randomized to receive either standard of care plus fibrin sealant (FS) (10 mL total) or standard of care alone to evaluate the efficacy of FS for reducing blood loss in THR. Considering the 81 intent-to-treat patients, adjusted perioperative blood loss was reduced significantly in the FS group, by 197 mL [95% CI: 45 mL, 319 mL] or 23.5% [95% CI: 5.4%, 38.1%] (p = 0.014). When protocol violators were eliminated, leaving 73 patients, the adjusted FS group perioperative bleeding was reduced by 221 mL [95% CI: 63 mL, 351 mL] or 27.1% [95% CI: 7.6%, 42.5%] (p = 0.0098).

Fibrin sealant facilitates hemostasis in arteriovenous polytetrafluoroethylene grafts for renal dialysis access.

A prospective randomized study was performed to evaluate the efficacy of fibrin sealant (FS) in patients undergoing upper-extremity polytetrafluoroethylene (PTFE) graft placement for dialysis. This procedure appears to be a reproducible and clinically relevant model for evaluating FS in vascular surgery. Consenting adult patients (n = 28) undergoing placement of a PTFE graft (6 mm) were randomized to either the treatment group using FS (Hemaseel APR, Haemacure Corp., Sarasota, FL) or control comparator groups (four) of bovine thrombin (T) (Thrombogen, GenTrac Inc., Middleton, WI), pressure (P), bovine thrombin (Thrombogen, GenTrac Inc.) -soaked cellulose sponges (TG) (Gelfoam, Upjohn Co., Kalamazoo, MI), or oxidized regenerated cellulose (S) (Surgicel, Johnson & Johnson, New Brunswick, NJ). All patients received heparin (3000 IU intravenous push) before placement of vascular clamps. The mean time to hemostasis was 29.3 seconds for FS, 147.4 seconds for T, 872.2 seconds for P, 346 seconds for TG, and 1044.5 seconds for S. There were no significant adverse events. FS appeared to be a superior hemostatic agent in these vascular procedures. No complications from FS were noted.