A prospective randomized double blind placebo controlled trail.
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.
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.
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.
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).
Batroxobin and combination of batroxobin with tranexamic acid significantly reduced perioperative blood loss when compared with placebo.
Level of Evidence: 2
Department of Spine Surgery, Ganga Hospital, Coimbatore, Tamil Nadu, India.
Address correspondence and reprint requests to Ajoy P. Shetty, MS, Department of Spine Surgery, Ganga Hospital, 313, Mettupalayam Road, Coimbatore, Tamil Nadu, India; E-mail: firstname.lastname@example.org
Received 5 April, 2017
Revised 18 May, 2017
Accepted 14 June, 2017
The device(s)/drug(s) is/are FDA-approved or approved by corresponding national agency for this indication.
AO Spine India research grant funds were received in support of this work.
No relevant financial activities outside the submitted work.