Intravenous and subsequent long-term oral tranexamic acid in enhanced-recovery primary total knee arthroplasty without the application of a tourniquet: a randomized placebo-controlled trial

Abstract

BackgroundTo assess the efficacy and safety of intravenous and subsequent long-term oral tranexamic acid (TXA) following total knee arthroplasty (TKA) without a tourniquet.MethodsIn this double-blinded trial, 118 patients undergoing primary TKA were randomized into two groups: the patients in group A received intravenous TXA at 20-mg/kg 10 min before the surgery and 3 h postoperatively, and then oral 1 g TXA from postoperative day (POD) 1 to POD 14, and the patients in group B received intravenous TXA at 20-mg/kg 10 min before surgery and 3 h postoperatively, and then oral 1 g placebo from postoperative day (POD) 1 to POD 14. The primary outcome was total blood loss. Secondary outcomes included ecchymosis area and morbidity, postoperative transfusion, postoperative laboratory values, postoperative knee function and length of hospital stay. Complications, and patient satisfaction were also recorded.ResultsThe mean total blood loss was lower in Group A than in Group B (671.7 ml vs 915.8 ml, P = 0.001). There was no significant difference in the transfusion rate between the two groups. Group A had a higher hemoglobin than Group B on POD 3 (106.0 g/L vs 99.7 g/L, P = 0.001). However, no significant difference was found for Hb or hematocrit on POD 1 or POD 14 between the two groups. Patients in Group A had less ecchymosis morbidity (7 vs 38, P = 0.001), smaller ecchymosis area (1.6 vs 3.0, P = 0.001) than Group B. The blood coagulation level as measured by fibrinolysis (D-Dimer) was lower in Group A than in Group B on POD 1 and POD 3 (4.6 mg/L vs. 8.4 mg/L, respectively, P = 0.001; 1.5 mg/L vs. 3.3 mg/L, respectively, P = 0.001). However, there was no significant difference on POD 14, and the fibrin degradation products showed the same trend. Patients in Group A had less swelling than those in Group B on POD 3 and POD 14. The circumference of the knee was 43.1 cm vs. 46.1 cm (POD 3, P = 0.001) and 41.4 cm vs. 44.9 cm (POD 14, P = 0.001) in Group A vs Group B, respectively. Nevertheless, the circumference of the knee in the two groups was similar on POD 1 and POD 3 M. No significant differences were identified in knee function, pain score, or hospital stay. No significant differences were identified in thromboembolic complications, infection, hematoma, wound healing and patients satisfaction between the two groups.ConclusionIntravenous and subsequent long-term oral TXA produced less blood loss and less swelling and ecchymosis compared with short-term TXA without increasing the risk of complications.Trial registrationThe trial was registered in the Chinese Clinical Trial Registry (ChiCTR-IPR-17012264).

A Randomized Controlled Study on the Safety and Effectiveness of Total Knee Arthroplasty Operated At Different Times under ERASA.

“…al. (23). As can be seen from the results of this study, the pain during the follow-up period has been greatly reduced compared with before the operation.…”

The effect of limited versus no tourniquet use on rapid recovery in total knee replacement--a randomized controlled trial

“…The application of tourniquet in total knee arthroplasty can effectively reduce intraoperative bleeding, provide a clean and clear surgical eld, and also facilitate the application of bone cement technology [6], but its postoperative complications such as early postoperative pain, lower limb swelling, and tension blisters make its use value controversial [7,8]. As the concept of enhanced recovery was put forward [9][10][11], more and more scholars proposed the restrictive use of tourniquets as well as the optimal use of tourniquets [12][13][14] There are a wide variety of studies on tourniquets, such as the timing of tourniquet release [15,16], the location of tourniquet installation and the pressure of tourniquet [17], and the timely and long tim ing of tourniquet use [18], and most scholars agree that the length of tourniquet use has a signi cant correlation with postoperative complications: Barker, T et al [19] concluded that the use of tourniquets for more than 100 min in total knee arthroplasty will increase the risk of postoperative wound infection, deep vein thrombosis, pulmonary embolism, and nerve injury. Jawhar et al [20] found that surgery longer than 120 min with a tourniquet increased the risk of deep ve in thrombosis.…”

Comparison of the effectiveness and safety of intravenous and topical regimens of tranexamic acid in complex tibial plateau fracture: a retrospective study

“…Our research focus has always been on blood loss reduction during orthopedic surgery. Patients who have not developed anemia and have higher hemoglobin levels show better performance during rehabilitation training and may have additional bene ts such as a better QoL 8,27 . An effective blood preservation strategy is the key to ERAS after orthopedic surgery.…”

“…Anti brinolytic therapy, an important aspect of blood management that is considered to be closely related to the concept of enhanced recovery after surgery (ERAS), has emerged as a particular research focus 7,8 .…”