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.
Current Concepts on Tissue Adhesive Use for Meniscal Repair-We Are Not There Yet: A Systematic Review of the Literature
The American journal of sports medicine. 2021;:3635465211003613
BACKGROUND Tissue adhesives (TAs) represent a promising alternative or augmentation method to conventional tissue repair techniques. In sports medicine, TA use has been suggested and implemented in the treatment of meniscal tears. The aim of this review was to present and discuss the current evidence and base of knowledge regarding the clinical usage of TAs for meniscal repair. STUDY DESIGN Systematic review; Level of evidence, 4. METHODS A systematic literature search was performed using the PubMed, Embase, and Cochrane Library databases for studies reporting on clinical outcomes of TA usage for meniscal repair in humans in the English language published before January 2020. RESULTS Ten studies were eligible for review and included 352 meniscal repairs: 94 (27%) were TA-based repairs and 258 (73%) were combined suture and TA repairs. Concomitant anterior cruciate ligament reconstruction was performed in 224 repairs (64%). All included studies utilized fibrin-based TA. Of the 10 studies, 9 were evidence level 4 (case series), and 8 reported on a cohort of ≤40 meniscal repairs. Rates of meniscal healing were evaluated in 9 of 10 studies, with repair failure seen in 39 repairs (11%). CONCLUSION The use of TAs, specifically fibrin-based TAs, for meniscal repair shows good results as either an augmentation or primary repair of various configurations of meniscal tears. However, this review reveals an absence of comparative high-quality evidence supporting the routine use of TAs for meniscal repair and emphasizes the lack of an ideal TA designed for that purpose. Further high-quality research, basic science and clinical, will facilitate the development of new materials and enable testing their suitability for use in meniscal repair.
Results of a randomized phase III/IV trial comparing intermittent bolus versus continuous infusion of antihaemophilic factor (recombinant) in adults with severe or moderately severe haemophilia A undergoing major orthopaedic surgery
Haemophilia : the official journal of the World Federation of Hemophilia. 2021
INTRODUCTION In patients with haemophilia A undergoing surgery, factor VIII (FVIII) replacement therapy by continuous infusion (CI) may offer an alternative to bolus infusion (BI). AIM: To compare the perioperative haemostatic efficacy and safety of antihaemophilic factor (recombinant) (ADVATE(®) ; Baxalta US Inc., a Takeda company, Lexington, MA, USA) CI or BI administration. METHODS In this multicentre, phase III/IV, controlled study (NCT00357656), 60 previously treated adult patients with severe or moderately severe disease undergoing elective unilateral major orthopaedic surgery (knee replacement, n = 48; hip surgery, n = 4; other, n = 8) requiring drain placement were randomized to receive antihaemophilic factor (recombinant) CI (n = 29) or BI (n = 31) through postoperative day 7. Primary outcome measure was cumulative packed red blood cell (PRBC)/blood volume in the drainage fluid within 24 h after surgery, used to establish non-inferiority of CI to BI. RESULTS CI:BI ratio of cumulative PRBC volume in the 24-h drainage fluid was 0.92 (p-value <.001 for non-inferiority; 95% confidence interval, 0.82-1.05). Total antihaemophilic factor (recombinant) dose per kg body weight received in the combined trans- and postoperative periods was similar with CI and BI to maintain targeted FVIII levels during/after surgery. Treatment-related adverse events (AEs) were reported in five patients treated by CI (eight events) and five treated by BI (six events), including two serious AEs in each arm. CONCLUSION CI administration of antihaemophilic factor (recombinant) is a viable alternative to BI in patients with haemophilia A undergoing major orthopaedic surgery, providing comparable efficacy and safety.
Is Intra-Articular Administration of Fibrinogen Effective in Postoperative Total Knee Arthroplasty Blood Loss? A Randomized Clinical Trial
Anesthesiology and pain medicine. 2021;11(1):e107431
OBJECTIVES The purpose of this study was to evaluate the effect of intra-articular injection of fibrinogen on postoperative bleeding following total knee arthroplasty. METHODS A double-blind randomized clinical trial was conducted on 40 patients aged 40 - 70 years under spinal anesthesia candidate for total knee arthroplasty in Golestan hospital, Ahwaz, Iran, in 2017-2018. Patients were divided into fibrinogen intra-articular injection (n = 20) and control (n = 20) groups. The amounts of blood loss and blood transfusion requirement were recorded. Hemoglobin (Hb), hematocrit (HCT), international normalized ratio (INR), platelet (PLT), prothrombin time (PT), and partial thromboplastin time (PTT) were recorded before and after the surgery. RESULTS There was no significant difference in the average amount of intraoperative blood loss between the groups (P > 0.05). The average amount of blood loss 24 hours after the surgery was significantly lower in the fibrinogen group than in the control group (fibrinogen group 350.61 ± 120.32 cc; control group 540.00 ± 170.21 cc; P = 0.0002). There were significant differences in transfusion between the groups (fibrinogen group 250 ± 20 cc; control group 350 ± 50 cc; P < 0.0001). There was a significant difference between the two groups in 24 h postoperative Hb and HCT (P < 0.001). CONCLUSIONS Intra-articular fibrinogen administration may reduce acute bleeding and can be used as an effective intervention to prevent further bleeding and the need for transfusion in patients undergoing total knee arthroplasty.
Does a thrombin-based topical haemostatic agent reduce blood loss and transfusion requirements after total knee revision surgery? A randomized, controlled trial
Knee Surgery, Sports Traumatology, Arthroscopy. 2015;23((11)):3337-42.
PURPOSE The aim of the present study was to assess the efficacy of a thrombin-based topical haemostatic in reducing blood requirements after total knee replacement (TKR) revision surgery. METHODS This prospective, randomized, controlled study was designed to evaluate the haemostatic efficacy and safety of a thrombin-based topical haemostatic (Floseal) versus standard treatment in patients receiving total knee revision arthroplasty. The decrease in haemoglobin values postsurgery and the blood units transfused were recorded. The decision to transfuse was made by a surgeon blinded to the patient's group allocation. RESULTS Forty-eight patients were enroled in the study; twenty-four patients each were randomized to the treatment and control groups, respectively. The median decrease in haemoglobin concentration on the first postoperative day was 2.2 g/dL in the treatment group and 2.7 g/dL in the control group. A significant reduction in units of blood transfused was also observed in the treatment group compared with the control group [1.1 +/- 1.13 (range 0-4) vs. 1.9 +/- 1.41 (range 0-5) blood units; P = 0.04]. No major treatment-related adverse events were recorded in the study. CONCLUSIONS This study shows that a thrombin-based topical haemostatic reduces the need for blood transfusion in TKR revision surgery. CLINICAL RELEVANCE A thrombin-based topical haemostatic agent can be an appropriate solution to enhance haemostasis and vessel sealing at the operative site in TKR revision surgery, in order to reduce the need for blood transfusion after surgery. LEVEL OF EVIDENCE II.
Medical and economic impact of a haemostatic sealant on the rate of transfusion after total knee arthroplasty . French
Transfusion Clinique et Biologique. 2015;22((1):):22-9.
OBJECTIVES Blood loss reduction in total knee arthroplasty (TKA) contributes to the prevention of morbidity and mortality and in the management of health care costs. Fibrin haemostatic sealant have controversial effectiveness in reducing postoperative blood loss and transfusion requirements. Our study evaluated the medical and economic benefits of this treatment with the assumption that it decreases the frequency of blood transfusion after TKA. METHODS AND PATIENTS Our single-center and randomized study included 60 patients pose unilateral primary TKA for osteoarthritis. Distribution was done in 2 groups of 30 patients each. Group 1 patients treated with a dose of 5mL Evicel(), compared to untreated group 2. Were collected the number of patients transfused. The treatment cost was compared to the sealant cost. RESULTS Results are not statistically significant. Two patients were transfused in group 1 and 3 in group 2 (P=0.64). The treatment cost for 30 patients is 13,500 , for a savings of cells packed at 187 , an additional cost of 13,313 in group 1. CONCLUSION The use of fibrin haemostatic sealant in TKA did not induce a significant difference in terms of blood or transfusion savings, with a significant cost. We do not recommend its routine use in TKA.Copyright 2015 Elsevier Masson SAS. All rights reserved.
Prophylactic administration of fibrinogen concentrate in perioperative period of total hip arthroplasty: a randomized clinical trial study
Acta Medica Iranica. 2014;52((11):):804-810.
According to limitations in blood product resources and to prevent unnecessary transfusions and afterwards complications in perioperative period of total hip arthroplasty, authors administered fibrinogen concentrate in a pilot randomized clinical trial to evaluate bleeding and need to blood transfusion in preoperative period. Thirty patients (3-75 years old) with ASA physical status class I or II and candidate for total hip arthroplasty consequently enrolled in this study and randomly assigned into two groups: taking fibrinogen concentrate and control. Two groups were similar in serum concentration of fibrinogen, hemoglobin, and platelet preoperatively. After induction of general anesthesia 30mg/kg fibrinogen concentrate was administered in the fibrinogen group. Blood loss, need to blood transfusion and probable complications were compared between two groups. The mean operation time was 3.3 + 0.8 hours in the fibrinogen group and 2.8 + 0.6 hours in the placebo group, and this difference was statistically significant (P=0.04). There was a significant correlation between operation time and blood loss during surgery (P=0.002). The mean transfused blood products in the fibrinogen and control group was 0.8 + 1.01 units and 1.06 + 1.2 units respectively (P=0.53). The mean of perioperative blood loss was 976 + 553 ml in the fibrinogen group and 1100 + 350 ml in the control group, but this difference was not significant between two groups. By adjusting time factor for two groups, we identified that the patients in fibrinogen group had lower perioperative bleeding after adjusting time factor for two groups (P=0.046). None of the patients had complications related to fibrinogen concentrate administration. The prophylactic administration of fibrinogen concentrate was safe and effective in reducing bleeding in the perioperative period of total hip arthroplasty.
Prospective, randomized trial to evaluate efficacy of a thrombin-based hemostatic agent in total knee arthroplasty
Journal of Arthroplasty. 2014;29((10):):1950-5.
Total knee arthroplasty (TKA) can be associated with substantial blood loss, leading to increased morbidity and transfusion rates. The study objective was to evaluate routine use of a thrombin-based topical hemostatic matrix in reducing blood loss and transfusion requirements in primary TKA. 108 patients were enrolled in a prospective, randomized, single-center trial. Patients receiving the hemostatic agent demonstrated a lower mean calculated blood loss (1325.2+464.8mL vs. control, 1509.3+432.8mL; P=0.02), drain output (415.6+202.0mL vs. control, 579.9+306.7mL; P=0.008), and length of stay (3.3+0.8days vs. control, 3.7+1.1days; P=0.03), without a statistically significant difference in mean hemoglobin loss or transfusion requirements. The clinical utility of this hemostatic agent to reduce transfusions after uncomplicated, primary TKA continues to remain unclear. Published by Elsevier Inc.
Efficacy of intra-articular injection of thrombin-based hemostatic agent in the control of bleeding after primary total knee arthroplasty
Knee Surgery & Related Research. 2014;26((4):):236-40.
PURPOSE To evaluate the hemostatic effect of intraarticular injection of a thrombin-based hemostatic agent in total knee arthroplasty (TKA). MATERIALS AND METHODS We performed a prospective randomized controlled trial on the use of a thrombin-based hemostatic agent in patients undergoing unilateral TKA. A total of 100 TKA patients were enrolled, with 50 patients randomized into the study group and the other 50 patients into the controlled group. Drain output, hemoglobin level, total red blood cell loss for 24 hours after surgery, transfusion rates, and complications were assessed. RESULTS Postoperative drain output was 525 mL in the study group and 667 mL in the control group (p=0.01). Nine patients in the study group and eighteen in the control group received blood transfusion (p=0.043). But, there was no significant difference between two groups in terms of hemoglobin level change and total red blood cell loss (p>0.05). CONCLUSIONS The thrombin-based hemostatic agent demonstrated efficacy in reducing drain output and blood transfusion rates. Thus, we believe the use of a thrombin-based hemostatic agent should be considered as an option in orthopedic surgery that involves massive bleeding. IS 2234-0726
Intraarticular fibrinogen does not reduce blood loss in TKA: a randomized clinical trial
Clinical Orthopaedics & Related Research. 2014;472((1):):272-6.
BACKGROUND Bleeding remains an ongoing concern after total knee arthroplasty (TKA). Intraarticular application of human fibrinogen with a topical thrombin has been described to stop diffuse bleeding in knee arthroplasty. QUESTIONS/PURPOSES It was hypothesized that the use of human fibrinogen as a topical agent would result in a reduction of bleeding and transfusions required after TKA; secondary end points included comparison of early clinical results including pain scores and range of motion (ROM) at 6weeks and complications after surgery. METHODS Two hundred patients undergoing TKA were randomized into a double-blind clinical trial to receive either intraarticular fibrinogen 2 minutes before tourniquet release or no such treatment. Postoperative hemoglobin and hematocrit levels, drain output, and transfusion requirements were recorded and blood loss was calculated. Clinical outcomes and adverse events were tracked prospectively. Descriptive analysis was performed using a two-sample t-test. RESULTS There were no differences in calculated blood loss between the fibrinogen and the control groups; the mean postoperative drain output was 780+/-378mL in the fibrinogen group compared with 673+/-301mL in the control group (p=0.029), but the hemoglobin drop at Day 2 was 3.47+/-1.53g/L in the fibrinogen group and 3.84+/-1.24g/Ll in the control group (p=0.051). There were no differences in in transfusions, early ROM, visual analog pain scores, or complications between the groups. CONCLUSIONS The use of fibrinogen in TKA did not lead to a significant reduction of blood loss or transfusions in primary TKA for osteoarthritis. Given the lack of benefits and the costs this procedure adds to TKA, its routine use cannot be justified during primary TKA for osteoarthritis. LEVEL OF EVIDENCE Level I, therapeutic study. See Guidelines for Authors for a complete description of levels of evidence.