The FINISH-3 trial: a phase 3, international, randomized, single-blind, controlled trial of topical fibrocaps in intraoperative surgical hemostasis.

Background: This Phase 3, international, randomized, single-blind, controlled trial (FINISH-3) compared the efficacy and safety of Fibrocaps, a ready-to-use, dry-powder fibrin sealant containing human plasma-derived thrombin and fibrinogen, vs gelatin sponge alone for use as a hemostat for surgical bleeding in 4 indications (ie, spinal, hepatic, vascular, soft tissue dissection).

Study Design: Adults with mild to moderate surgical bleeding (randomized 2:1; Fibrocaps vs gelatin sponge) were treated at a single bleeding site (day 1). Time to hemostasis (TTH) during 5 minutes was compared (log-rank statistic) within each indication.

Persistence of antibodies to the topical hemostat bovine thrombin.

Background: Immunoassays that detect antibovine thrombin product antibodies are not widely available. However, knowing whether these antibodies are present preoperatively would be useful because re-exposure to bovine thrombin-containing products is contraindicated in patients with pre-existing antiproduct antibodies due to the risk of developing immune-mediated coagulopathies. In these exploratory analyses, we characterized one aspect of immune sensitization, the persistence of circulating antibodies after exposure to bovine thrombin product.

A phase 3b, open-label, single-group immunogenicity and safety study of topical recombinant thrombin in surgical hemostasis.

Background: The immunogenicity and safety of recombinant human thrombin (rThrombin) were evaluated in this phase 3b, open-label, single-group, multisite study of 209 adult vascular and spinal operation patients at high risk for preexisting anti-bovine thrombin product antibodies.

Study Design: Patients received rThrombin applied as a topical hemostat during a surgical procedure (day 1). Immunogenicity samples were collected at baseline and approximately 1 month after operation (day 29) and were analyzed after study participation.

Building an immune-mediated coagulopathy consensus: early recognition and evaluation to enhance post-surgical patient safety.

Topical hemostats, fibrin sealants, and surgical adhesives are regularly used in a variety of surgical procedures involving multiple disciplines. Generally, these adjuncts to surgical hemostasis are valuable means for improving wound visualization, reducing blood loss or adding tissue adherence; however, some of these agents are responsible for under-recognized adverse reactions and outcomes. Bovine thrombin, for example, is a topical hemostat with a long history of clinical application that is widely used alone or in combination with other hemostatic agents.

Randomized, prospective, and controlled clinical trial of pulsed electromagnetic field stimulation for cervical fusion.

Background Context: Multilevel fusions, the use of allograft bone, and smoking have been associated with an increased risk of nonunion after anterior cervical discectomy and fusion (ACDF) procedures. Pulsed electromagnetic field (PEMF) stimulation has been shown to increase arthrodesis rates after lumbar spine fusion surgery, but there are minimal data concerning the effect of PEMF stimulation on cervical spine fusion.

Purpose: To determine the efficacy and safety of PEMF stimulation as an adjunct to arthrodesis after ACDF in patients with potential risk factors for nonunion.

A phase 3, randomized, double-blind comparative study of the efficacy and safety of topical recombinant human thrombin and bovine thrombin in surgical hemostasis.

Background: Plasma-derived bovine thrombin is used as a topical agent to improve surgical hemostasis, but development of antibodies to bovine hemostatic proteins has been associated with increased bleeding and thrombotic complications. Recombinant human thrombin could reduce the risk of these complications.

Study Design: The objective of this randomized, double-blind, comparative trial was to compare the efficacy, safety, and antigenicity of recombinant human thrombin (rhThrombin) and bovine thrombin as adjuncts to hemostasis in liver resection, spine, peripheral arterial bypass, and dialysis access surgery.

Unstable thoracolumbar burst fractures: anterior-only versus short-segment posterior fixation.

Operative management of a thoracolumbar burst fracture varies according to many factors. Fracture morphology, neurologic status, and surgeon preference play major roles in deciding upon anterior, posterior, or combined approaches. Optimizing neural decompression while providing stable internal fixation over the least number of spinal segments is the goal.

A multicenter, prospective, randomized trial evaluating a new hemostatic agent for spinal surgery.

Study Design: A prospective, randomized trial comparing Proceed, a gelatin-based hemostatic sealant (treatment), with Gelfoam-thrombin (control) in stopping intraoperative bleeding during spinal surgery.

Objectives: To determine the effectiveness and safety of Proceed.

Summary Of Background Data: Proceed has been tested in animal models to determine its safety and effectiveness as a hemostatic agent.

Patterns of recurrence in glioma patients after interstitial irradiation and chemotherapy: report of three cases.

Three patients with malignant gliomas who developed dissemination of tumor at the time of recurrence are presented. All three patients received combination therapy including conventional radiotherapy and interstitial radiation therapy followed by systemic BCNU chemotherapy. A review of the literature on the development of glioma metastases and an analysis of the possible mechanisms of this uncommon growth pattern are presented.