Clinical Research Directory

A Phase III Study of Hemofence for Hemostasis in Patients With Uncontrolled Exudative Hemorrhage During Spinal Or Orthopedic Surgery

This Phase 3 study was conducted to evaluated the efficacy and safety of Hemofence compared with Floseal Hemostatic Matrix in patients undergoing spinal or orthopedic surgery who required hemostasis for exudative bleeding that could not be adequately controlled by conventional procedures. Eligible participants were randomly assigned in a 1:1 ratio to receive either Hemofence or Floseal Hemostatic Matrix. The primary objective was to demonstrate the non-inferiority of Hemofence to Floseal Hemostatic Matrix based on the proportion of participants who achieved successful hemostasis within 10 minutes after the initial application of the assigned treatment at the first bleeding site. Safety was assessed through adverse events, clinical laboratory tests, vital signs, electrocardiograms, and physical examinations.

TEG Use in Children Undergoing Procedures With High Anticipated Blood Loss

The research team proposes a prospective, observational study to better understand how TEG can be useful in guiding clinical practice in the Main OR for subject's undergoing high transfusion risk surgeries. Intraoperatively, transfusion of blood products is frequently required to restore oxygen carrying capacity, perfusion and improve coagulation. Both under and over transfusion pose significant risks, particularly to pediatric patients with small starting intravascular volumes. Thromboelastography (TEG) is a validated method of dynamically assessing intraoperative coagulopathy via functional assay. However, while FDA approved and widely used in the adult setting, TEG is not commonly utilized in the setting of bleeding pediatric patients. Recently, TEG has been made available at BCH for clinical purposes and is being used solely in the cardiac surgery setting. The investigators aim to provide TEG data for non-cardiac pediatric surgical cases with a high risk of intraoperative blood loss in order to assess the impact of this tool on intraoperative management.