Gomez-Barrena, J Bone Joint Surg Am 2014 - Topical Intra-Articular Compared with Intravenous Tranexamic Acid to Reduce Blood Loss in Primary Total Knee Replacement

Topical Intra-Articular Compared with Intravenous Tranexamic Acid to Reduce Blood Loss in Primary Total Knee Replacement

Gomez-Barrena, Figueredo-Zalve, et al.·J Bone Joint Surg Am·2014·214 citations·RCT

Background

Abundant literature regarding the use of intravenous tranexamic acid (TXA) in primary total knee replacement is available. Randomized controlled trials have confirmed the efficacy of topical TXA compared with placebo, but the comparison between topical and intravenous TXA is unclear. The present study was designed to verify noninferior efficacy and safety of topical intra-articular TXA compared with intravenous TXA in primary total knee replacement with cemented implants.

Methods

A Phase-III, single-center, double-blind, randomized, controlled clinical trial was performed to compare topical intra-articular TXA (3 g of TXA in 100 mL of physiological saline solution) with 2 intravenous doses of TXA (15 mg/kg in 100 mL of physiological saline solution, one dose before tourniquet release and another 3 hours after surgery) in a multimodal protocol for blood loss prevention.
The primary outcome was the blood transfusion rate, and the secondary outcomes included visible blood loss (as measured in the drain) at 24 hours postoperatively and invisible blood loss (as estimated from the Nadler formula) at 48 hours postoperatively.
The sample size of 78 patients was calculated to give a statistical power of 99% for demonstrating noninferiority.
39 patients each were allocated to receive topical intra-articular TXA (the experimental group) and intravenous TXA (the control group); there were no significant differences in demographics or preoperative laboratory values between the groups.
Noninferiority was estimated by comparing the confidence intervals with a delta of 10%.
Student t and Mann-Whitney tests were used to assess the significance of any differences.

Results

The transfusion rate was zero in both groups; thus, noninferiority was demonstrated for the primary efficacy end point, suggesting equivalence.
Noninferiority was also demonstrated for the secondary efficacy end points.
Drain blood loss at 24 hours was 315.6 mL (95% confidence interval [CI], 248.5 to 382.7 mL) in the experimental group and 308.1 mL (95% CI, 247.6 to 368.5 mL) in the control group (p = 0.948, Mann-Whitney).
Also, estimated blood loss at 48 hours was 1259.0 mL (95% CI, 1115.6 to 1402.3 mL) in the experimental group and 1317.9 mL (95% CI, 1175.4 to 1460.4 mL) in the control group (p = 0.837, Mann-Whitney).
No significant safety differences were seen between groups.

Conclusions

Topical administration of TXA according to the described protocol demonstrated noninferiority compared with intravenous TXA, with no safety concerns. This randomized controlled trial supports the topical intra-articular administration of TXA in primary total knee replacement with cemented implants.

Level of evidence: Therapeutic Level I. Copyright remains with the authors and publisher.

Core

Topical Intra-Articular Compared with Intravenous Tranexamic Acid to Reduce Blood Loss in Primary Total Knee Replacement

Gomez-Barrena, Figueredo-Zalve, et al.J Bone Joint Surg Am2014214 citationsRCT