1.
Efficacy and Safety of a Thrombin-Containing Collagen-based Haemostatic Agent in Spinal Surgery: A Randomized Clinical Trial
Park SM, Kang DR, Lee JH, Jeong YH, Shin DA, Yi S, Ha Y, Kim KN
World neurosurgery. 2021
Abstract
OBJECTIVE When common haemostatic methods, such as suturing, cautery, and compression, fail to arrest bleeding during surgery, various local haemostatic agents are used. We aimed to evaluate the haemostatic efficacy and safety of CollaStat® (Dalim Tissen Co. Ltd., Korea), a novel thrombin-containing collagen-based topical haemostatic agent used in spinal surgery, by comparing it with Floseal® (Baxter Healthcare, USA). METHODS We performed a randomised controlled trial in 78 patients who underwent spinal surgery. The participants were randomly assigned to either an intervention group (use of CollaStat®) or a control group (use of Floseal®). We compared successful haemostasis rate, time to haemostasis, length of hospital stay, amount of fluid drainage, and rate of adverse events between the two groups. RESULTS The haemostasis success rate was 94.87% in the intervention group and 97.44% in the control group. The haemostatic efficacy and safety of CollaStat® were found to be non-inferior to those of Floseal® since the higher limit (11.09%) of the confidence interval (CI) for the difference with Floseal® was greater than the pre-specified non-inferiority margin of -13%. There were no statistically significant differences at the 5% level in haemostasis time, number of haemostatic agents used, hospitalisation period, and amount of drainage between the two groups. Also, there was no incidence of medical device-related serious adverse events (SAEs) or adverse events (AEs) in both groups. CONCLUSION The haemostatic efficacy and safety of CollaStat® were found to be non-inferior to those of Floseal®. Therefore, CollaStat® can be safely and effectively used in spinal surgery.
2.
Minimal effective dosage of recombinant human erythropoietin in spinal surgery
Lee JH, Lee SH, Oh JH
Clinical Orthopaedics and Related Research. 2003;412:71-6.
Abstract
Preoperative autologous blood donation is one of the most widely used methods of autotransfusion. However securing a predetermined amount of blood (3 units of whole blood) may be difficult in patients with a low preoperative hematocrit. To determine the minimum effective pretreatment dosage of recombinant human erythropoietin required to secure an adequate amount of preoperative blood for autologous transfusion during posterior decompression and instrumentation fusion using the pedicle screw-rod system in the lumbar spine, a prospective randomized clinical trial was done. Forty-five patients who had a preoperative hematocrit less than 40% were selected and were divided blindly into three groups. Fifty units per kilogram of recombinant human erythropoietin seems to be the minimal effective dosage for securing an adequate amount of preoperative autologous blood donation.