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17.07.2020 | Original Paper

Combined use of tranexamic acid and rivaroxaban in posterior lumbar interbody fusion safely reduces blood loss and transfusion rates without increasing the risk of thrombosis—a prospective, stratified, randomized, controlled trial

verfasst von: Lu Zhang, Yanming Li, Dong Liu, Xing Xiao, Tingjin Guan, Hongwei Yue, Haipeng Xue, Hongming Zhou, Guangjun Jiao, Wenliang Wu, Hongliang Wang, Haichun Liu, Chunyang Meng, Zhaozhong Sun, Yunzhen Chen

Erschienen in: International Orthopaedics | Ausgabe 10/2020

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Abstract

Purpose

This prospective, stratified, randomized, single-blind, placebo-controlled multicentre study investigated the safety and effectiveness of reducing blood loss and preventing venous thromboembolism (VTE) during posterior lumbar interbody fusion (PLIF) in patients with stenosis or spondylolisthesis using the combination of tranexamic acid (TXA) and rivaroxaban.

Methods

The Autar score was evaluated in patients after admission. Patients with an Autar score ≤ 10 were randomized to group A or B. Group A was the placebo-controlled group. Patients in group B were treated with 1 g TXA via intravenous injection and 1 g TXA for external use. Patients with an Autar score > 10 were randomized to group C or D. Patients in group C were treated with 10-mg rivaroxaban qd for 35 days after surgery. Patients in group D received the same treatment as those in group B intra-operatively and as those in group C post-operatively.

Results

A total of 599 patients from eight hospitals participated in this clinical trial. The total blood loss, intra-operative blood loss, and drainage volume were reduced by the administration of TXA (group A vs group B, P < 0.01; group C vs group D, P < 0.01), and the blood transfusion rate was also decreased (group A vs group B, P < 0.01; group C vs group D, P < 0.01). There were no significant differences (P > 0.05) in the VTE incidence rates among group A and group B. In patients with high-risk thrombosis, the number of patients with VTE was only three and seven after the application of rivaroxaban. Epidural haematoma was not discovered in any patients in our trial.

Conclusion

The combined application of tranexamic acid and rivaroxaban significantly reduced the amount of blood loss and the transfusion rate during PLIF surgery and avoided an increase in the probability of thrombosis and the occurrence of epidural haematoma.

Trial registration number and date of registration

ChiCTR-1800016430

2018-06-01

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Titel: Combined use of tranexamic acid and rivaroxaban in posterior lumbar interbody fusion safely reduces blood loss and transfusion rates without increasing the risk of thrombosis—a prospective, stratified, randomized, controlled trial
verfasst von: Lu Zhang
Yanming Li
Dong Liu
Xing Xiao
Tingjin Guan
Hongwei Yue
Haipeng Xue
Hongming Zhou
Guangjun Jiao
Wenliang Wu
Hongliang Wang
Haichun Liu
Chunyang Meng
Zhaozhong Sun
Yunzhen Chen
Publikationsdatum: 17.07.2020
Verlag: Springer Berlin Heidelberg
Erschienen in: International Orthopaedics / Ausgabe 10/2020
Print ISSN: 0341-2695
Elektronische ISSN: 1432-5195
DOI: https://doi.org/10.1007/s00264-020-04699-3

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Abstract

Purpose

Methods

Results

Conclusion

Trial registration number and date of registration

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