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Randomized Controlled Trial
. 2018 Oct 2;13(10):e0204551.
doi: 10.1371/journal.pone.0204551. eCollection 2018.

Is topical or intravenous tranexamic acid preferred in total hip arthroplasty? A randomized, controlled, noninferiority clinical trial

Kai-di Zhou  1 , Hong-Yi Wang  1   2 , Yi Wang  1   2 , Zhi-Hong Liu  1   2 , Chuan He  1   2 , Jian-Min Feng  1   2
Affiliations
Randomized Controlled Trial

Is topical or intravenous tranexamic acid preferred in total hip arthroplasty? A randomized, controlled, noninferiority clinical trial

Kai-di Zhou et al. PLoS One. .

Abstract

Purpose: The present study aimed to confirm the efficacy and safety of topical and intravenous tranexamic acid (TXA) compared with that of topical placebo and to assess the noninferiority between the two application methods of TXA in patients undergoing unilateral primary total hip arthroplasty.

Methods: Our randomized controlled trial investigated 170 patients with 1:1:1 allocation to two doses of 10-mg/kg intravenous TXA, 3-g topical TXA, and topical placebo of 60-ml physiological saline groups. The primary outcome, total blood loss, was calculated with Nadler and Gross formula. The secondary outcomes included allogeneic blood transfusion requirement, drain blood loss, decreased hemoglobin level. Noninferiority would be established when the upper limit 95% CI is lower than 250 ml of the noninferiority margin for the mean difference of total blood loss between topical and intravenous TXA. Thromboembolic complication incidence was considered as a safety outcome.

Results: The total blood loss of patients administered intravenous (mean±standard deviation, 1125±514 ml) and topical TXA (1211±425 ml) was significantly reduced compared with that of those administered topical placebo (1464±556 ml) (p = 0.0012). Drain blood loss and hemoglobin level reduction in patients administered with TXA were also significantly lower than those in patients administered topical placebo. The mean difference of total blood loss between topical and intravenous TXA is 86 ml (95% CI, -88 to 260 ml). The complications were comparable between patients managed with TXA and patients with topical placebo.

Conclusion: The noninferiority of topical TXA to intravenous TXA can not be concluded. Considering no significant difference was found in all efficacy outcomes between the two administration methods. Any of the two TXA administration methods can be adopted for blood loss prevention in total hip arthroplasty.

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Conflict of interest statement

The authors have declared that no competing interests exist.

Figures

Fig 1
Fig 1. CONSORT diagram for this clinical trial.
Fig 2
Fig 2. Total blood loss and hemoglobin level.
(A) Total blood loss in ml (and 95% CI) in each group. (B) Hemoglobin level in g/l (mean±SD) based on the time in each treatment group.
Fig 3
Fig 3. The mean difference in ml (with 95% CI) of total blood loss in patients administered with tTXA compared with total blood loss in patients administered with ivTXA.
The upper limit of 95% CI for the mean difference is greater than 250 ml of the noninferiority margin.
See this image and copyright information in PMC

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