Intraoperative tranexamic acid use in major spine surgery in adults: a multicentre, randomized, placebo-controlled trial

Abstract

Abstract15 Background. Perioperative tranexamic AQ5 acid (TXA) use can reduce bleeding and transfusion requirements in several types of surgery, but level I evidence proving its effectiveness in major spine surgery is lacking. This study was designed to investigate the hypothesis that TXA reduces perioperative blood loss and transfusion requirements in patients undergoing major spine procedures. Methods. We conducted a multicentre, prospective, randomized double-blind clinical trial, comparing TXA with placebo in 20 posterior instrumented spine surgery. Efficacy was determined based on the total number of blood units transfused and the perioperative blood loss. Other variables such as the characteristics of surgery, length of hospital stay, and complications were also analysed. Results. Ninety-five patients undergoing posterior instrumented spine surgery (fusion of >3 segments) were enrolled and randomized: 44 received TXA (TXA group) and 51 received placebo (controls). The groups were comparable for duration of 25 surgery, number of levels fused, and length of hospitalization. Transfusion was not required in 48% of subjects receiving TXA compared with 33% of controls (P ¼ 0.05). Mean number of blood units transfused was 0.85 in the TXA group and 1.42 with placebo (P ¼ 0.06). TXA resulted in a significant decrease in intraoperative bleeding (P ¼ 0.01) and total bleeding (P ¼ 0.01) relative to placebo. The incidence of adverse events was similar in the two groups. Conclusions. TXA did not significantly reduce transfusion requirements, but significantly reduced perioperative blood loss 30 in adults undergoing major spinal surgery.Clinical trial registration. NCT01136590.

Tranexamic Acid in Neuroanesthesia and Neurocritical Care: Time for Its Critical Appraisal

“…A recent multicenter, prospective randomized double-blind trial compared TxA with placebo in posterior instrumentation spine surgery (> 3 segmental fusions) for efficacy based on number of transfused units and perioperative blood loss. 74 There was significant reduction in the need for transfusion (42% in TxA vs. 67% in placebo group; p < 0.05) and intraoperative blood loss.…”

Efficacy and safety of antifibrinolytic agents in spinal surgery

“…The full manuscripts were obtained and analyzed, and we ultimately selected 30 RCT studies [16–45] with 2087 patients for the analysis using the pre-defined inclusion and exclusion criteria. Of the 30 RCTs, 26 were 2-arm controlled trials comparing active intervention (4 RCTs of aprotinin, [40–42,45] 3 of EACA, [34,39,44] 9 of TXA1, [16,18–20,22,23,32,35,37] 10 of TXA2 [17,21,24,25,29–31,33,36,38] ) to placebo; 1 was a 2-arm trial comparing EACA to TXA2, [28] 3 were 3-arm trials (2 RCTs of TXA1 vs. EACA vs. placebo, [26,27,43] 1 was EACA vs. aprotinin vs. placebo [43] ). Figure 1 shows the flowchart for study selection process.…”

Zukunft der operativen Therapie degenerativer Wirbelsäulenerkrankungen: Kontra: Die Operationszahl wird zunehmen aufgrund technischer Verbesserungen und Fortschritte

“…Zunehmend bessere und sicherere perioperative Patientenführung, die maßgeblich mitbeteiligt ist an einer Reduktion perioperativer Komplikationen, werden zu einer weiteren Steigerung von Eingriffen führen, die derzeit noch aufgrund des interventionsspezifischen Risikopotenzials als kritisch angesehen werden. Erwähnt seien hierbei zu erwartende Fortschritte im Bereich der Thromboembolieund Infektionsprophylaxe oder aber auch Verbesserungen im Bereich der Hämostase mit deutlich reduziertem perioperativem Blutverlust [9,10].…”