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Quality of life and cost-effectiveness analysis of topical tranexamic acid and fibrin glue in femur fracture surgery
Merchán-Galvis A, Posso M, Canovas E, Jordán M, Aguilera X, Martinez-Zapata MJ
BMC musculoskeletal disorders. 2022;23(1):827
Abstract
BACKGROUND We assessed quality of life (QoL) of patients undergoing surgery for proximal femur fracture and performed a cost-effectiveness analysis of haemostatic drugs for reducing postoperative bleeding. METHODS We analysed data from an open, multicentre, parallel, randomized controlled clinical trial (RCT) that assessed the efficacy and safety of tranexamic acid (TXA group) and fibrin glue (FG group) administered topically prior to surgical closure, compared with usual haemostasis methods (control group). For this study we conducted a cost-effectiveness analysis of these interventions from the Spanish Health System perspective, using a time horizon of 12 months. The cost was reported in $US purchasing power parity (USPPP). We calculated the incremental cost-effectiveness ratio (ICER) per QALY (quality-adjusted life-year). RESULTS We included 134 consecutive patients from February 2013 to March 2015: 42 patients in the TXA group, 46 in the FG group, and 46 in the control group. Before the fracture, EuroQol visual analogue scale (EQ-VAS) health questionnaire score was 68.6. During the 12 months post-surgery, the intragroup EQ-VAS improved, but without reaching pre-fracture values. There were no differences between groups for EQ-VAS and EuroQol 5 dimensions 5 levels (EQ-5D-5L) health questionnaire score, nor in hospital stay costs or medical complication costs. Nevertheless, the cost of one FG treatment was significantly higher (399.1 $USPPP) than the cost of TXA (12.9 $USPPP) or usual haemostasis (0 $USPPP). When comparing the cost-effectiveness of the interventions, FG was ruled out by simple dominance since it was more costly (13,314.7 $USPPP) than TXA (13,295.2 $USPPP) and less effective (utilities of 0.0532 vs. 0.0734, respectively). TXA compared to usual haemostasis had an ICER of 15,289.6 $USPPP per QALY). CONCLUSIONS There were no significant differences between the intervention groups in terms of postoperative changes in QoL. However, topical TXA was more cost-effective than FG or usual haemostasis. TRIAL REGISTRATION ClinicalTrials.gov: NCT02150720. Date of registration 30/05/2014. Retrospectively registered.
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Prevention of postoperative bleeding in hip fractures treated with prosthetic replacement: efficacy and safety of fibrin sealant and tranexamic acid. A randomised controlled clinical trial (TRANEXFER study)
Jordan M, Aguilera X, Gonzalez JC, Castillon P, Salomo M, Hernandez JA, Ruiz L, Mora JM, Camacho-Carrasco P, Prat-Fabregat S, et al
Archives of orthopaedic and trauma surgery. 2018
Abstract
INTRODUCTION We assessed the efficacy of fibrin sealant (FS) and tranexamic acid (TXA) administered topically in patients with a hip fracture treated with prosthetic replacement. MATERIALS AND METHODS Parallel, multicentre, open label, randomised, clinical trial. We compared three interventions to reduce blood loss: (1) 10 ml of FS, (2) 1 g of topical TXA, both administered at the end of the surgery, and (3) usual haemostasis (control group). The main outcome was blood loss collected in drains. Other secondary variables were total blood loss, hidden blood loss, transfusion rate, average hospital stay, complications, adverse events, and mortality. RESULTS A total of 158 patients were included, 56 in the FS group, 52 in the TXA group, and 50 in the control group. The total amount of blood collected in drains was lower in the TXA group (148.6 ml, SD 122.7 in TXA; 168.2 ml, SD 137.4 in FS; and 201.5 ml, SD 166.5 in control group) without achieving statistical significance (p = 0.178). The transfusion rate was lower in the TXA group (32.7%), compared with FS group (42.9%) and control group (44.0%), without statistical significance (p = 0.341). There were no complications or adverse effects related to the evaluated interventions. CONCLUSIONS The use of TXA and FS administered topically prior to surgical closure in patients with a sub-capital femoral fracture undergoing arthroplasty did not significantly reduce either postoperative blood loss or transfusion rate, compared with a group that only received usual haemostasis.
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Topical and intravenous tranexamic acid reduce blood loss compared to routine hemostasis in total knee arthroplasty: a multicenter, randomized, controlled trial
Aguilera X, Martinez-Zapata MJ, Hinarejos P, Jordan M, Leal J, Gonzalez JC, Monllau JC, Celaya F, Rodriguez-Arias A, Fernandez JA, et al
Archives of Orthopaedic & Trauma Surgery. 2015;135((7)):1017-25.
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Full text
Abstract
INTRODUCTION Tranexamic acid (TXA) is becoming widely used in orthopedic surgery to reduce blood loss and transfusion requirements, but consensus is lacking regarding the optimal route and dose of administration. The aim of this study was to compare the efficacy and safety of topical and intravenous routes of TXA with routine hemostasis in patients undergoing primary total knee arthroplasty (TKA). MATERIALS AND METHODS We performed a randomized, multicenter, parallel, open-label clinical trial in adult patients undergoing primary TKA. Patients were divided into three groups of 50 patients each: Group 1 received 1 g topical TXA, Group 2 received 2 g intravenous TXA, and Group 3 (control group) had routine hemostasis. The primary outcome was total blood loss. Secondary outcomes were hidden blood loss, blood collected in drains, transfusion rate, number of blood units transfused, adverse events, and mortality. RESULTS One hundred and fifty patients were included. Total blood loss was 1021.57 (481.09) mL in Group 1, 817.54 (324.82) mL in Group 2 and 1415.72 (595.11) mL in Group 3 (control group). Differences in total blood loss between the TXA groups and the control group were clinically and statistically significant (p < 0.001). In an exploratory analysis differences between the two TXA groups were not statistically significant (p = 0.073) Seventeen patients were transfused. Transfusion requirements were significantly higher in Group 3 (p = 0.005). No significant differences were found between groups regarding adverse events. CONCLUSION We found that 1 g of topical TXA and 2 g of intravenous TXA were both safe strategies and more effective than routine hemostasis to reduce blood loss and transfusion requirements after primary TKA. LEVEL OF EVIDENCE I.
Clinical Commentary
Dr. Antony Palmer, University of Oxford
What is known?
Total Knee Arthroplasty (TKA) represents the mainstay of treatment for severe osteoarthritis with over 80,000 procedures performed in the UK last year. TKA gives rise to significant blood loss and tranexamic acid is proposed as a strategy for blood conservation. Tranexamic acid is a synthetic lysine analogue that competitively inhibits plasminogen activation and acts as an anti-fibrinolytic. It is increasingly used in elective surgery, supported by a number of studies that demonstrate a reduction in blood loss and transfusion rates. However, the optimal dosing strategy and route of delivery for TKA remains unknown. The vast majority of studies comparing intravenous and intraarticular delivery have not demonstrated a difference in efficacy or adverse event profile, however, the dose and mode of administration vary significantly between studies.
What did this paper set out to examine?
This manuscript presents the results of an open-label randomised controlled study comparing blood loss in patients receiving routine haemostasis (50 patients: control group) or routine haemostasis and tranexamic acid (100 patients: treatment group) at the time of primary total knee arthroplasty. Patients receiving tranexamic acid were divided into two groups: Group 1 received 1g of tranexamic acid applied topically across the surgical field after prosthesis cementation. Group 2 received 1g of tranexamic acid intravenously 15-30 minutes prior to tourniquet inflation and again once the tourniquet was deflated.
What did they show?
The primary outcome measure was total blood loss, and this was significantly lower in the intravenous and topical tranexamic acid groups compared with the control group. There was no statistically significant difference between intravenous and topical administration. The authors considered a 200ml reduction in blood loss within drains to be clinically significant, and this was demonstrated in both tranexamic groups compared with the control group, but again there was no difference between routes of administration. The frequency and nature of adverse events was comparable across groups.
What are the implications for practice and for future work?
The results from this study suggest that 1g of tranexamic acid administered topically to the surgical field after implant cementation, or 1g of tranexamic acid delivered intravenously prior to tourniquet inflation and on tourniquet deflation, are both safe and effective means of achieving a clinically-significant reduction in total blood loss associated with primary total knee arthroplasty surgery. As with the majority of previous studies, no difference was detected between the different routes of administration and the study may have lacked power for this analysis. The optimal dose and timing of tranexamic acid administration remains unknown and the regimes adopted in this study may be suboptimal. A recent meta-analysis suggested that the efficacy of topical tranexamic acid might be greater when doses exceeding 2g are administered. The role of intraarticular administration warrants further investigation given this route may overcome systemic contraindications. There are a number of benefits from reducing the blood loss associated with total knee arthroplasty surgery. These have not yet been demonstrated in terms of functional recovery or length of hospital stay and this represents a further area for future research.
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Efficacy and safety of fibrin glue and tranexamic acid to prevent postoperative blood loss in total knee arthroplasty: a randomized controlled clinical trial
Aguilera X, Martinez-Zapata MJ, Bosch A, Urrutia G, Gonzalez JC, Jordan M, Gich I, Maymo RM, Martinez N, Monllau JC, et al
Journal of Bone & Joint Surgery - American Volume. 2013;95((22):):2001-7.
Abstract
BACKGROUND Postoperative blood loss in patients after total knee arthroplasty may cause local and systemic complications and influence clinical outcome. The aim of this study was to assess whether fibrin glue or tranexamic acid reduced blood loss compared with routine hemostasis in patients undergoing total knee arthroplasty. METHODS A randomized, single-center, parallel, open clinical trial was performed in adult patients undergoing primary total knee arthroplasty. Patients were divided into four groups. Group 1 received fibrin glue manufactured by the Blood and Tissue Bank of Catalonia, Group 2 received Tissucol (fibrinogen and thrombin), Group 3 received intravenous tranexamic acid, and Group 4 (control) had no treatment other than routine hemostasis. The primary outcome was total blood loss collected in drains after surgery. Secondary outcomes were the calculated hidden blood loss, transfusion rate, preoperative and postoperative hemoglobin, number of blood units transfused, adverse events, and mortality. RESULTS One hundred and seventy-two patients were included. The mean total blood loss (and standard deviation) collected in drains was 553.9 +/- 321.5 mL for Group 1, 567.8 +/- 299.3 mL for Group 2, 244.1 +/- 223.4 mL for Group 3, and 563.5 +/- 269.7 mL for Group 4. In comparison with the control group, Group 3 had significantly lower total blood loss (p < 0.001), but it was not significantly lower in Groups 1 and 2. The overall rate of patients who had a blood transfusion was 21.1% (thirty-five of 166 patients analyzed per protocol). Two patients required transfusion in Group 3 compared with twelve patients in Group 4 (p = 0.015). No significant difference was observed between the two fibrin glue groups and the control group with regard to the need for transfusion. There was no difference between groups with regard to the percentage of adverse events. CONCLUSIONS Neither type of fibrin glue was more effective than routine hemostasis in reducing postoperative bleeding and transfusion requirements, and we no longer use them. However, this trial supports findings from previous studies showing that intravenous tranexamic acid can decrease postoperative blood loss. LEVEL OF EVIDENCE Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.