NIPH Clinical Trials Search

Evaluation of the Efficacy of Tranexamic Acid in MAKO-Assisted Joint Arthroplasty

Basic Information

Recruitment status	Pending
Health condition(s) or Problem(s) studied	Orthopedic surgery
Date of first enrollment	13/03/2026
Target sample size	140
Countries of recruitment
Study type	Interventional
Intervention(s)	Control Group Tranexamic acid will not be administered at the time of surgical incision. Instead, normal saline will be administered as a placebo. Intervention Group Tranexamic acid (2 g) will be administered at the time of surgical incision.

Outcome(s)

Primary Outcome

Hemoglobin decrease (preoperative hemoglobin minus the lowest postoperative hemoglobin level)

Secondary Outcome

Estimated total blood loss (Total blood loss) Blood transfusion rate (presence or absence of transfusion) and transfusion volume Intraoperative blood loss (recorded in the anesthesia record) Drain output volume Postoperative external blood loss Surgical procedure (TKA , THA , TSA), operative time, anesthesia time, and diagnosis Additional hemostatic interventions Use of bone cement Symptomatic deep vein thrombosis (DVT) or pulmonary embolism (PE) confirmed by examinations performed as part of routine clinical care D-dimer levels (exploratory marker measured preoperatively and at predefined postoperative time points) Adverse events related to tranexamic acid (safety outcome) Baseline characteristics (age, sex, height, weight, body mass index ) Postoperative pain scores using the Numeric Rating Scale (NRS) at 12, 24, and 48 hours after surgery

Key inclusion & exclusion criteria

Age minimum	>= 50age old
Age maximum	Not applicable
Gender	Both
Include criteria	Inclusion criteria Patients aged 50 years or older who are scheduled to undergo MAKO-assisted total knee arthroplasty (TKA), total hip arthroplasty (THA), or total shoulder arthroplasty (TSA) under general anesthesia. Patients who have provided written informed consent to participate in this study. Rationale TKA, THA, and TSA are commonly performed in older adults, and it is well recognized that advanced age is associated with increased intraoperative blood loss and a higher risk of blood transfusion. Therefore, in this study, patients aged 50 years or older were selected in order to evaluate the clinical usefulness of tranexamic acid administration in a population in which its benefit is expected to be clinically meaningful.
Exclude criteria	Patients who are unable or unwilling to provide informed consent for participation in this study. Patients undergoing revision surgery . Patients with active thromboembolic disease . Patients with a known hypersensitivity to tranexamic acid or a history of severe adverse reactions to tranexamic acid. Patients with a history of severe seizure disorders. Patients with severe renal dysfunction . Patients who cannot discontinue anticoagulant therapy. Patients judged by the attending physician to be inappropriate for participation in this study.