Randomized, placebo-controlled, double-blind clinical trial to evaluate efficacy and safety of topical tranexamic acid in saving blood loss in patients undergoing prosthetic knee surgery
Revista espanola de cirugia ortopedica y traumatologia. 2022
OBJECTIVE Knee arthroplasty is a major surgery with potential significant blood loss. Assess the efficacy and safety of topical administration of 3 gr of tranexamic acid (TXA) in terms of reducing blood loss in knee arthroplasty. MATERIAL AND METHOD A randomized, phase III, double-blind, placebo-controlled clinical trial has been conducted. We included 150 patients in two parallel treatment groups (75 per arm). The solution was administered topically intra-articular after cementation and prior to capsular closure. Analytical determinations were made before and after surgery to quantify blood loss. RESULTS Total blood loss (TBL) for the placebo group was 831.5 ml and 662.3 ml for the TXA group. The difference between the two groups was 169.2 ml; which means a save of 20.4 per cent; this difference being statistically significant (p<0.001). There were no differences in terms of the onset of ambulation, days of admission or Visual Analogue Scale at one month of surgery. Ten patients were rejected for presurgical urinary tract infection, metal allergy, selection failure, patellar weakening, prosthetic instability, intrasurgical tibial fracture, change of indication to unicompartimental prosthesis and a loss of follow-up. There was only one complication unrelated to the investigational drug (bladder balloon). CONCLUSION The administration of TXA topically after cementation of the prosthetic components in total knee arthroplasty in a single dose has demonstrated being safe and effective.
Application of Different Doses of Tranexamic Acid Plus Traditional Chinese Medicine in Hip Arthroplasty in Patients with Diabetes and Its Influence on Intraoperative Blood Loss and Postoperative Drainage
Evidence-based complementary and alternative medicine : eCAM. 2022;2022:1197495
OBJECTIVE To evaluate the efficacy of different doses of tranexamic acid plus traditional Chinese medicine (TCM) in hip arthroplasty in diabetic patients and the effect on intraoperative hemorrhage and postoperative drainage. METHODS One hundred patients admitted to our hospital from January 2019 to September 2021 were randomly divided into group B (n = 50) and group A (n = 50), and tranexamic acid was injected intravenously at a dose of 10 mg/kg and 20 mg/kg 30 min before skin incision, and then tranexamic acid 1.0 g was injected into the joint cavity through the drainage after incision closure, followed by 3 h of drainage clamping. The amount of blood loss, coagulation index, postoperative drainage, and incidence of venous thromboembolism (VTE) were compared between the groups. RESULTS Group A had significantly less total blood loss, dominant blood loss, and hidden blood loss than group B (P < 0.05). No significant difference in postoperative coagulation indexes and postoperative drainage flow was found between the two groups (P > 0.05). Serological examination results demonstrated no statistical difference in D-dimer (D-D) levels between the two groups. The absence of VTE in both groups was determined by imaging. CONCLUSION Tranexamic acid is effective in reducing intraoperative hemorrhage in diabetic patients undergoing hip arthroplasty. The dose of 20 mg/kg outperforms 10 mg/kg in terms of clinical efficacy with a favorable safety profile, which can be applied according to the patient's actual condition.
Assessment of Short-Term Outcomes of Total Knee Arthroplasty Performed With and Without a Tourniquet
BACKGROUND Tourniquet use has been advocated for better visualization of the surgical field as it exsanguinates most of the blood from the limbs to the central compartment. On the contrary, its use may increase postoperative pain and recovery of quadriceps function, thereby increasing the length of stay (LOS). The study aims to assess short-term outcomes of total knee arthroplasty (TKA) performed with and without a tourniquet. METHODOLOGY Eighty-six patients scheduled for TKA either with or without a tourniquet were selected and divided into two groups using simple random sampling. Knee replacements were performed with a tourniquet in group I and without a tourniquet in group II. In all cases, blood loss was estimated. A visual analog scale (VAS) was used for the assessment of postoperative pain. In the study, range of motion (ROM) and quadriceps lag were also assessed on postoperative day 2 and discharge. RESULTS There were 23 (26.7%) males and 20 (23.2%) females in group I and 28 (32.5%) males and 15 (17.4%) females in group II (p = 0.07). On comparing mean age and body mass index (BMI), statistically insignificant results were obtained. In group I and group II, a statistically significant difference was obtained in the estimation of mean total blood loss as 780.4 ± 152.49 and 1146.2 ± 193.14 ml, respectively (p = 0.02). Neither on postoperative day 2 nor at the time of discharge, no significant results were obtained in observing the ROM at the knee joint and quadriceps lag. CONCLUSION It was found that tourniquet use is associated with lower blood loss and similar postoperative pain, ROM, quadriceps lag, and LOS.
Tranexamic acid combined with compression dressing reduces blood loss in gluteal muscle contracture surgery
BMC surgery. 2022;22(1):46
BACKGROUND Blood loss and incision-related complications caused by the surgical procedure to release gluteal muscle contracture (GMC) put negative effects on the surgical outcomes. Current procedures to prevent blood loss and complications are not satisfactory. The current study aimed to determine whether tranexamic acid (TXA) in combination with pressure dressing reduce the amount of blood loss, the rate of incision-related complications, and the rate of readmission for patients undergoing surgeries to release GMC. METHODS 49 GMC patients were finally included in the study and were randomly divided into two groups: study group and control group. Patients in both groups received minimally invasive surgery to release GMC except that in the study group, patients were administered a dosage of 20 mg/kg of intravenous TXA preoperatively, and 2 subsequent dosages of TXA at 10 mg/kg at two time points: 3 and 6 h after the first dose. Gauze soaked with TXA was used to pack the wound for 10 min before the incision closure. Then the wound was pressure-wrapped with a hip-spica bandage for 24 h after the surgery in the study group. RESULTS The level of UBL in the study group was significantly lower compared to that in the control group. Similar results were also found for UMHD and UMAD. The incision-related postoperative complications were greatly decreased in the study group compared to those of the control group as well. So was the 30-day readmission rate. All patients in both groups reached "excellent" or "good" level with respect to the postoperative function evaluation. CONCLUSIONS Intravenous and topical application of TXA combined with 24 h pressure hip-spica bandage reduces perioperative blood loss, rate of incision-related complications, and the rate of readmission for GMC patients undergoing minimally invasive surgical releasing procedure. Trial Registration Chinese Clinical and Trial Registry ChiCTR2000039216, registration date 2020/10/22, retrospectively registered.
Effect of Oral Tranexamic Acid on the Blood Transfusion Rate and the Incidence of Deep Vein Thromboembolism in Patients after TKA
Evidence-based complementary and alternative medicine : eCAM. 2022;2022:6041827
PURPOSE To explore the effect of oral tranexamic acid treatment on the blood transfusion rate and the incidence of deep vein thromboembolism after total knee arthroplasty (TKA). METHODS 90 patients undergoing TKA admitted to First People's Hospital of Changshu City from January 2019 to January 2020 were selected and randomized into the control group and the experimental group accordingly (45 cases in each group). The control group intravenously received 20 mL/kg tranexamic acid before the incision was closed. The experimental group was given 1 g of tranexamic acid orally before anesthesia, 6 h and 12 h after the operation. RESULTS The experimental group witnessed better perioperative indexes in relation to the control group. The experimental group displayed better postoperative coagulation function indexes as compared to the control group (P < 0.05). Remarkably lower postoperative vascular endothelial function indexes in the experimental group than in the control group were observed. The experimental group experienced a markedly lower incidence of deep vein thromboembolism in comparison with the control group (P < 0.05). The postoperative knee society score (KSS) score of the experimental group was significantly higher than that of the control group. A significantly higher postoperative modified rivermead mobility index (MRMI) score was yielded in the experimental group in contrast to the control group (P < 0.05). The experimental group obtained lower numerical rating scale (NRS) scores at T2 and T3 as compared to the control group. CONCLUSION Oral tranexamic acid is a suitable alternative for patients undergoing TKA in terms of reducing the blood transfusion rate, relieving pain, and accelerating the recovery of the patient's limbs.
Serum Levels of VWF, t-PA, TNF-α, and ICAM-1 in Patients Receiving Hemocoagulase Combined with Platelet-Rich Plasma during Total Hip Replacement
Genetics research. 2022;2022:2766215
OBJECTIVES This study aimed to investigate the effect of hemocoagulase combined with platelet-rich plasma (PRP) in total hip replacement (THR) on reducing bleeding and improving knee joint function in the patients with osteoarthritis. METHODS From February 2018 to February 2020, 80 osteoarthritis patients undergoing THR were included in the study, of which 40 cases were treated with PRP and hemocoagulase (test group) in the joint capsule in THR and the other 40 cases received saline and thrombin in the joint capsule after THR (control group). Postoperative drainage and corresponding functional exercise were performed for the two groups 12 hours after operation. The outcome measures including operation time, soft-tissue release, blood routine, drainage volume, perioperative blood loss, postoperative incision inflammation, deep vein thrombosis (DVT), and range of motion (ROM) of the joint were recorded. RESULTS The hemoglobin and hematocrit values of the test group on the second postoperative day were significantly higher than those of the control group (P < 0.05). The postoperative drainage volume and perioperative blood loss were significantly lower than those of the control group (P < 0.05). The test group was better than the control group in the ROM of the joint at 7 and 15 days after the operation (P < 0.05). A lower value of prothrombin time and activated partial thromboplastin time was revealed in the test group compared with the control group (P < 0.05). No significant difference in the operation time, intraoperative soft-tissue release, postoperative incision inflammation, incidence of DVT, incidence of deep infection, and ROM at day 90 after THR was found in the two groups (P > 0.05). CONCLUSIONS The application of hemocoagulase combined with PRP in THR can reduce perioperative blood loss, increase wound healing speed and quality, and improve coagulation and immune function. It is a safe and effective method for the patients with knee osteoarthritis who underwent THR.
Injection of leukocyte-poor platelet-rich plasma for moderate-to-large rotator cuff tears do not improve clinical outcomes but reduce retear rates and fatty infiltration: A prospective single-blinded randomized study
Arthroscopy : the journal of arthroscopic & related surgery : official publication of the Arthroscopy Association of North America and the International Arthroscopy Association. 2022
OBJECTIVES To determine whether leukocyte-poor platelet-rich plasma (Lp-PRP) reduced retear rates, reduced fatty infiltration and improved functional outcomes in patients with degenerative moderate-to-large RCTs. METHODS This was a randomized controlled study at a single centre. Consecutive series of 104 patients with moderate-to-large rotator cuff tears were enrolled and randomly allocated to a control group (double-row suture-bridge arthroscopic rotator cuff repair alone, n=52) and a study group (double-row suture-bridge repair followed by three Lp-PRP injections at the tendon repair site during surgery, at days 7 and 14 after surgery, n=52). All patients were followed up for 27.2 months (range 24-36 months), with UCLA shoulder rating scale, the Constant score and a visual analog scale (VAS) evaluated respectively. The integrity and fatty infiltration of repaired tissue were assessed by MRI using the Sugaya classification and Goutallier grade classification at 24 months after surgery. Statistical analysis was performed based on T-test, chi-square test and the Kendall tau-b correlation coefficient. RESULTS 4 patients refused follow-up, and 11 patients had incomplete data. Eventually, a total of 89 patients were available for 24 months follow-up. The mean UCLA score increased from 14.802.53 to 29.372.06 in control group and from 13.743.30 to 30.142.32 in study group (p=0.103). The mean Constant score increased from 46.565.90 to 86.834.94 in control group and from 44.377.92 to 88.804.92 in study group (p=0.063). The VAS score decreased from 3.221.24 to 0.971.12 in control group and in 3.491.52 to 1.160.99 in study group (p=0.41). All differences of UCLA score, Constant score and VAS between pre- and post-operation achieve minimal clinically important difference (MCID) proposed for arthroscopic rotator cuff repair. Of the 89 patients, 76 had MRI performed at 24 months after surgery. The retear rate was 17.6% in study group, which was lower than that in control group (38.1%, p=0.049). And the Goutallier grade was found to be significant difference between groups postoperatively (Kendall tau-b -0.24, p=0.03), but no significant difference preoperatively (Kendall tau-b -0.18, p=0.11). There were no complications in all patients. CONCLUSION Our procedures, involving repeated injections of Lp-PRP during surgery and at days 7 and 14, as described in this study, has positive effects on reducing retear rate and promoting Goutallier grade by patients following arthroscopic RCR, and could also provide substantial clinical outcomes that reaching MCID for surgical treatment. However, given the numbers available for analysis, it did not promote better clinical results when compared with the control group.
A Randomized Controlled Study on the Use of Tourniquet in Primary Total Knee Arthroplasty
The journal of knee surgery. 2022
BACKGROUND The use and the optimal timing of tourniquet during primary total knee arthroplasty (TKA) is controversial. Most previous studies failed to show clinically significant differences in different strategies. The aim of this study was to determine how three strategies of tourniquet application affect the outcome in TKA patients. METHODS This was a prospective randomized controlled study. Patients who undergo TKA were randomized into one of the three groups (1:1:1 ratio): tourniquet inflated from skin incision to cement hardening, tourniquet from cement application to hardening, and tourniquet from skin incision to skin closure. The perioperative blood loss, limb swelling, and complications were recorded. The level of hemoglobin, hematocrit, C-reactive protein (CRP), interleukin (IL)-6, creatine kinase (CK), and lactate dehydrogenase (LDH) were determined. Patients' thigh and TKA wound pain, Knee Society knee score (KSKS) and Knee Society functional assessment (KSFA) scores, and rehabilitation parameters were evaluated. RESULTS A total of 90 patients were enrolled. The baseline characteristics were comparable. We only found significant difference in the intraoperative blood loss (skin to cement: 58.7 ± 36.1 mL, cement-only: 147.8 ± 107.9 mL, skin to skin: 16.3 ± 13.1 mL, p < 0.0001). There were no statistical differences in postoperative drainage, thigh/knee circumference, change of hemoglobin/hematocrit, CRP, IL-6, CK, and LDH on day 1 to day 4 after surgery. The thigh/TKA wound Visual Analogue Scale scores, KSKS score, KSFA score, and rehabilitation parameters were not significantly different at up to 6-month follow-up. No thromboembolic events were noted. CONCLUSION Our results revealed that there was no best tourniquet strategy in TKA. Different tourniquet methods can be utilized based on surgeon preference without affecting outcomes.
Efficacy of extended oral tranexamic acid on blood loss in primary total knee arthroplasty
Acta ortopedica brasileira. 2022;30(spe1):e247197
INTRODUCTION Tranexamic acid is widely used for patients undergoing total knee arthroplasty (TKA). However, the duration of systemic tranexamic acid (TXA) administration varies in many reports. Hence, this study aims to compare blood loss between a single intravenous (IV) TXA dose, and one dose of IV TXA combined with oral TXA, during 48-hour postoperative care in primary TKA. METHODS Ninety-four patients with primary osteoarthritis, who underwent primary TKA, were randomized into two groups. The first group consisted of 47 patients and received a dose of 750 mg IV TXA and 750 mg oral TXA postoperatively at 8-hour intervals for 48 hours. In the second group, 47 patients received a single dose of IV TXA and a placebo at the same intervals for the same time duration. Hemoglobin (Hb) was measured at 4, 24 and 72 hours after operation. RESULTS The mean total blood loss were not different between the two groups (p=0.37). There was no difference in total Hb reduction or closed suction drainage outputs (p=0.9 and 0.07, respectively). CONCLUSION The extended use of oral TXA for 48-hour postoperative care did not decrease the total blood loss following TKA compared with a single dose of IV TXA. Level Of Evidence I; High quality randomized trial .
The effect of tranexamic acid on the reduction of intraoperative and postoperative blood loss and thromboembolic risk in patients with hip fracture
Open medicine (Warsaw, Poland). 2022;17(1):857-862
The aim of this study is to determine whether the use of tranexamic acid (TXA) in patients with hip fracture reduces intraoperative and postoperative blood loss, and on the other hand, whether it increases thromboembolic risk. The study was performed on patients with hip fracture for a period of one year. Patients were divided into two groups (1:1): the first group receiving TXA and the second group receiving placebo. The amount of blood aspiration during the surgery was measured as well as drainage in the postoperative period of 24 h. The occurrence of deep vein thrombosis (DVT) was monitored before and after the surgery by ultrasound of the lower extremities. The amount of total blood loss was two times lower in patients who received TXA (291.8 ± 65.5 mL of blood vs 634.7 ± 150.5 mL of blood). Among the patients who developed DVT, one patient was from the group that did not receive TXA, and two patients were from the group that received TXA. The use of TXA in patients with hip fracture significantly reduces intraoperative and postoperative blood loss, without a significant thromboembolic risk.