The effectiveness and safety of tranexamic acid in posterior lumbar interbody fusion: a placebo-controlled randomized study

English Keywords:Tranexamic acid  Posterior lumbar intervertebral fusion  Blood loss  Fibrinolysis markers  Inflammation markers

English Abstract:

  【Abstract】 Objectives: To assess the efficacy and safety of intravenous tranexamic acid(TXA) during posterior lumbar interbody fusion(PLIF). Methods: From January 2017 to July 2017, single level PLIF surgery was performed in 58 patients with lumbar stenosis who met the inclusion criteria, after failure of conservative treatment in our hospital. They were divided into TXA group(30 cases, 16 males and 14 females, average age 60.5±6.3 years) and control group(28 cases, 15 males and 13 females, average age 62.1±4.2 years) by using random number table method. In the TXA group, an intravenous TXA at the dosage of 15mg/kg was respectively given at 15 minutes before skin incisions and 8 hours later. The equal amount of normal saline was given in the control group. The base line information, the operation time, total blood loss, visible blood loss, hidden blood loss, intraoperative blood loss, drainage volume within 24 hours after surgery and drainage volume form 24 hours after operation to the drainage pulling out were recorded. The blood cell analyses, coagulation function, pre-thrombosis markers, liver and renal function, inflammation markers were also recorded. The operative outcomes were evaluated by Japanese Orthopaedic Association(JOA), Oswestry disability index(ODI), visual analogue scale(VAS) and the rate of intervertebral bone graft fusion. Results: There were significantly less total blood loss(894±324ml), visible blood loss(380±109ml), intraoperative blood loss(197±70ml), drainage volume within 24 hours after surgery(134±58ml), drainage volume form 24 hours after operation to the drainage pulling out(50±28ml) in the TXA group than those(1339±330ml, 815±226ml, 266±78ml, 381±136ml and 168±66ml) in the control group(P＜0.05). However, there was no significantly difference between the two groups in hidden blood loss. There was no significant difference in live and renal function, coagulation function or inflammation markers between the two groups during the perioperative period, while the fibrinogen degradation product was significantly lower in the TXA group. There was no serious complication occurred in the two groups. There was no significant difference in the JOA, ODI or VAS score at preoperation, 1 month, 3 months and 12 months after operation between the two groups. And there was no difference in the rate of intervertebral bone graft fusion between the two groups at 12 months after operation. Conclusions: Intravenous TXA can effectively decrease perioperative blood loss without increasing the risk of complication in PLIF surgery.