Osteoarthritis, Knee
Conditions
Keywords
Tranexamic Acid, Total Knee Arthroplasty, Rivaroxaban
Brief summary
The purpose of the study, therefore, is to conduct a prospective randomized controlled trial to investigate the blood-conservation effect of TXA in different TKA patients groups with rivaroxaban for VTE prophylaxis, first group by topical application, second group by infusion and a third group of placebo and observe whether there is difference in the occurrence of venous thromboembolism in those patient groups by venographic study
Detailed description
Investigators previous experiences in minimally invasive (MIS) TKA showed that intraoperative infusion of TXA reduced 45% of postoperative blood loss and needs for transfusion from 20% to 4%. However, most of the orthopedic surgeons still hesitate to use TXA systemically in TKAs especially in high risk patients with a potential increase in thromboembolic events following surgery. Because of this concern, recently, there were few reports demonstrating the cost-effectiveness of topical application of TXA in TKA patients. However, most of the reports compared the topical TXA with placebo in TKA patients, not with intravenous TXA. Recently, Georgiadis et al. conducted a double-blind, randomized controlled clinical trial are demonstrated similar transfusion rate and perioperative blood loss between topical administration and intravenous injection of TXA in TKA patients. There were no significant safety differences between the two groups. Low-molecular weight heparin (LMWH) was used for thromboembolism prophylaxis in that study. Recently, chemical VTE prophylaxis such as rivaroxaban has been approved as a standard care after TKA because of its superior convenience and efficacy on VTE prophylaxis to LMWH in TKAs. However, because of direct blockage of the formation of thrombin from prothrombin by rivaroxaban, an increased postoperative bleeding has been reported. There have been little studies investigating the blood-conservation effect of TXA on TKA patients either by infusion or by topical application when rivaroxaban used as VTE prophylaxis.
Interventions
DRUGTranexamic Acid 5%,5ml/amp
Intraarticular application of tranexamic acid 3g (60ml) in 100 ml normal saline into knee joint after closure of the joint capsule
Oral rivaroxabam (10mg) QD on PostOp Day 1 to 14.
DRUG0.9% Normal Saline
Primary total knee replacement with intravenous normal saline (20 ml) administration before deflation of the tourniquet
Sponsors
Chang Gung Memorial Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* End-stage arthritis of the knee * Failure of medical treatment or rehabilitation * Hemoglobin \> 10g/dl * No use of non-steroid anti-inflammatory agent one week before operation
Exclusion criteria
* Preoperative Hemoglobin ≦10 g/dl * History of infection or intraarticular fracture of the affective knee * Renal function deficiency (GFR \< 55 ml/min/1.73m2)which is relative contraindicated for venography * Elevated liver enzyme, history of liver cirrhosis, impaired liver function and coagulopathy (including long-term use anticoagulant) * History of deep vein thrombosis, ischemic heart disease or stroke
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of any deep-vein thrombosis, non-fatal pulmonary embolism, or all-cause mortality | within 15 days after surgery (2 days after the last dose of rivaroxaban ) | Primary efficacy outcome is the composite of any deep-vein thrombosis, non-fatal pulmonary embolism, or all-cause mortality |
| Incidence of major bleeding after the first dose of rivaroxaban and all death related to postoperative bleedings | within 15 days after surgery (2 days after the last dose of rivaroxaban ) | Primary safety outcome is the composite of major bleeding after the first dose of rivaroxaban and all death related to postoperative bleedings Major bleeding was defined as bleeding that was fatal, that involved a critical organ, or that required reoperation or clinically overt bleeding outside the surgical site that was associated with a decrease in the hemoglobin level of 2 g or more per deciliter or requiring infusion of 2 or more units of blood |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of major venous thromboembolism | within 15 days after surgery (2 days after the last dose of rivaroxaban ) | the secondary efficacy outcomes include major venous thromboemolism defined as the composite of proximal deep-vein thrombosis, non-fatal pulmonary embolism, and VTE related death |
| Incidence of wound complications after surgery | within 30 days of the procedure | composite of hematoma, superficial wound infection, and deep infection requiring return to surgery |
| Secondary safety outcome was composite of any non-major bleeding and all wound complications after operation | within 15 days after surgery (2 days after the last dose of rivaroxaban ) | non-major bleeding including hemorrhagic wound complications (excessive wound hematoma or bleeding at the surgical site |
| Total blood loss after surgery | From the operation to the postoperative day 4 | Total blood loss was calculated according to Nadler et al., which used maximum postoperative reduction of the Hb level adjust for weight and height of the patient. The formula is as follows, Total blood loss = (Total blood volume x \[change in Hb level / preoperative Hb level\])x1000+volume transfused. |
Other
| Measure | Time frame |
|---|---|
| Incidence of venographic positive deep-vein thrombosis (any, proximal, distal) | on the second day after last dose of rivaroxaban (postoperative day 15) |
| Incidence of positive finding of pulmonary embolism by computed tomography | on the second day after last dose of rivaroxaban (postoperative day 15) |
Countries
Taiwan
Contacts
Primary ContactJun-Wen Wang, MD
Outcome results
None listed