Orthopedic surgery
Conditions
Interventions
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 adm
Sponsors
Otsuka Takashi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion 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.
Exclusion criteria
Exclusion 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hemoglobin decrease (preoperative hemoglobin minus the lowest postoperative hemoglobin level) | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Contacts
Public ContactTakashi Otsuka
Seirei Miketahara General Hospital
Outcome results
None listed