Effectiveness and Safety of Batroxobin, Tranexamic Acid and a Combination in Reduction of Blood Loss in Lumbar Spinal Fusion Surgery

Effectiveness and Safety of Batroxobin, Tranexamic Acid and a Combination in Reduction of Blood... Study Design.A prospective randomized double blind placebo controlled trail.Objective.To evaluate and compare the efficacy and safety of batroxobin (botropase), tranexamic acid (TXA), and their combination in reduction of perioperative blood loss in lumbar spine single level fusion surgeries.Summary of Background Data.Spinal surgeries are associated with significant blood loss leading to perioperative anemia and increased need for allogenic transfusion. TXA competitively inhibits plasmin and batroxobin converts fibrinogen to fibrin and theoretically their combination is synergistic. Though TXA is widely studied in controlling blood loss, there is little information on use of batroxobin and their combination. Thus, we aimed to study effect and safety of individual drugs and their combination in controlling blood loss in spinal surgery.Methods.Hundred patients were randomized into four groups. Group B received batroxobin, group T received TXA, group BT received batroxobin and TXA and group P received placebo. Outcomes assessed are intraoperative and postoperative blood loss, hematocrit, allogenic blood transfusion, and deep vein thrombosis (DVT), postoperatively.Result.Mean intraoperative blood loss in Group B, T, BT, and P were 268.32 ± 62.92 mL, 340.72 ± 182.75 mL, 256.96 ± 82.64 mL, and 448.44 ± 205.86 mL, respectively. Postoperative surgical site drain collection in Group B, T, BT, and P were 218.00 ± 100.54 mL, 260.40 ± 100.85 mL, 191.00 ± 87.84 mL, and 320.00 ± 125.83 mL, respectively. Intraoperative blood loss of Group P was statistically higher than Groups B and BT (P < 0.001). Mean postoperative surgical site drain collection was statistically significant (P < 0.001). No statistically significant differences in fluid administration (P = 0.751), blood transfusion (P = 1.000), preoperative and postoperative hemoglobin (P = 0.090, P = 0.134, respectively), and deep vein thrombosis (P = 1.000).Conclusion.Batroxobin and combination of batroxobin with tranexamic acid significantly reduced perioperative blood loss when compared with placebo.Level of Evidence: 2 http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Spine Wolters Kluwer Health

Effectiveness and Safety of Batroxobin, Tranexamic Acid and a Combination in Reduction of Blood Loss in Lumbar Spinal Fusion Surgery

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Publisher
Wolters Kluwer Health
Copyright
Copyright © 2018 Wolters Kluwer Health, Inc. All rights reserved.
ISSN
0362-2436
eISSN
1528-1159
D.O.I.
10.1097/BRS.0000000000002315
Publisher site
See Article on Publisher Site

Abstract

Study Design.A prospective randomized double blind placebo controlled trail.Objective.To evaluate and compare the efficacy and safety of batroxobin (botropase), tranexamic acid (TXA), and their combination in reduction of perioperative blood loss in lumbar spine single level fusion surgeries.Summary of Background Data.Spinal surgeries are associated with significant blood loss leading to perioperative anemia and increased need for allogenic transfusion. TXA competitively inhibits plasmin and batroxobin converts fibrinogen to fibrin and theoretically their combination is synergistic. Though TXA is widely studied in controlling blood loss, there is little information on use of batroxobin and their combination. Thus, we aimed to study effect and safety of individual drugs and their combination in controlling blood loss in spinal surgery.Methods.Hundred patients were randomized into four groups. Group B received batroxobin, group T received TXA, group BT received batroxobin and TXA and group P received placebo. Outcomes assessed are intraoperative and postoperative blood loss, hematocrit, allogenic blood transfusion, and deep vein thrombosis (DVT), postoperatively.Result.Mean intraoperative blood loss in Group B, T, BT, and P were 268.32 ± 62.92 mL, 340.72 ± 182.75 mL, 256.96 ± 82.64 mL, and 448.44 ± 205.86 mL, respectively. Postoperative surgical site drain collection in Group B, T, BT, and P were 218.00 ± 100.54 mL, 260.40 ± 100.85 mL, 191.00 ± 87.84 mL, and 320.00 ± 125.83 mL, respectively. Intraoperative blood loss of Group P was statistically higher than Groups B and BT (P < 0.001). Mean postoperative surgical site drain collection was statistically significant (P < 0.001). No statistically significant differences in fluid administration (P = 0.751), blood transfusion (P = 1.000), preoperative and postoperative hemoglobin (P = 0.090, P = 0.134, respectively), and deep vein thrombosis (P = 1.000).Conclusion.Batroxobin and combination of batroxobin with tranexamic acid significantly reduced perioperative blood loss when compared with placebo.Level of Evidence: 2

Journal

SpineWolters Kluwer Health

Published: Mar 1, 2018

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