Comparison of the efficacy of rivaroxaban and dabigatran etexilate in preventing venous thrombosis after arthroplasty: A protocol of randomized controlled trial

Abstract

Background:: New oral anticoagulants (NOAC) are gradually accepted by clinical practice for its convenient route of administration and stable effect. Both rivaroxaban and dabigatran etexilate have been used in the prevention and treatment of venous embolism after arthroplasty, but there is a lack of direct comparison between the 2 effects. Therefore, the purpose of this randomized controlled trial was to evaluate the efficacy and safety of 2 new oral anticoagulants, rivaroxaban, and dabigatran etexilate, in the prevention of venous thromboembolism after joint replacement.

Methods:: This is a prospective randomized controlled trial to study the efficacy and safety of rivaroxaban and dabigatran etexilate in the prevention of venous thromboembolism after joint replacement, and is approved by the clinical research ethics of our hospital. Patients were randomly divided into 1 of 2 treatment regimens:

1. (A)

   rivaroxaban oral group and

2. (B)

   dabigatran etexilate oral group.

Patients, doctors, nurses, and data collection assistants were blinded to group allocation. The indicators of observation include:

1. (1)

   validity indicators: asymptomatic deep venous thrombosis (DVT), symptomatic DVT, symptomatic pulmonary embolism (PE) incidence, all-cause mortality;

2. (2)

   safety indicators: incidence of major bleeding and clinically related non-major bleeding events and other adverse events.

Data were analyzed using the statistical software package SPSS version 25.0 (Chicago, IL).

Discussion:: This study will evaluate the efficacy and safety of rivaroxaban and dabigatran etexilate in preventing venous thrombosis after joint replacement. The results of this experiment will provide clinical basis for the use of rivaroxaban or dabigatran etexilate to prevent venous thrombosis after joint replacement.

Ethics and dissemination:: Private information from individuals will not be published. This systematic review also does not involve endangering participant rights. Ethical approval was not required. The results may be published in a peer-reviewed journal or disseminated at relevant conferences.

OSF Registration number:: DOI 10.17605/OSF.IO/QVDCW.