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      The efficacy of a thrombin-based hemostatic agent in primary total knee arthroplasty: a meta-analysis

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          Abstract

          Purpose

          Total knee arthroplasty (TKA) is a popular procedure in severe osteoarthritis. But perioperative bleeding remains a problem. Floseal® is a mixture of thrombin and bovine gelatin which can benefit a lot on reducing intraoperative and postoperative bleeding. However, there is no enough evidence judging its safety and efficiency. So a meta-analysis is conducted by us to evaluate the efficacy and safety of a thrombin-based hemostatic agent compared with conventional methods in TKA.

          Method

          Two independent reviewers selected literatures published before August 2014 from MEDLINE, Embase, and The Cochrane Central Register of Controlled Trials. Other internet databases were also performed to identify trials according to the Cochrane Collaboration guidelines. High-quality randomized controlled trials (RCTs), prospective control trials (PCTs), and case controlled trials (CCTs) were selected. The meta-analysis was undertaken using RevMan 5.1 for Windows.

          Results

          Three RCTs, one PCT, and one CCT met the inclusion criteria. There were significant differences in hemoglobin decline and calculated total blood loss between the Floseal® group and control group. There were no significant differences in postoperative drainage volume, rate of transfusion requirement, incidence of wound infection, deep vein thrombosis (DVT), and pulmonary embolism (PE) between treatment and control groups.

          Conclusions

          The present meta-analysis indicates that a thrombin-based hemostatic agent can reduce hemoglobin decline and calculated total blood loss after TKA and is not related to adverse reactions or complications such as wound infection, DVT, and PE.

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          Most cited references16

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          Effect of tourniquet use on activation of coagulation in total knee replacement.

          Total knee replacement often is performed with tourniquet application. The advantages of a dry field, including fixation, are well known, but it still is debatable if tourniquet application increases deep vein thrombosis. Measurement of coagulation markers is a well accepted method of studying thrombogenesis activation intraoperatively and postoperatively. Twenty patients undergoing total knee replacement with subarachnoid anesthesia were assigned randomly to two groups: either with tourniquet application (Group I) or without tourniquet application (Group II). There were no differences between patients in the two groups in terms of age, gender, diagnosis (all had osteoarthritis), operative time, and total (intraoperative and postoperative) blood loss. Markers for thrombin generation and fibrinolysis were measured. Blood samples were drawn at four times: baseline before the operation; after bone cuts; after cement fixation (Group II) or 2 minutes after tourniquet deflation (Group I); and 1 hour after surgery. Markers of thrombin generation and fibrinolysis showed a significant increase from baseline in all the patients. In Group II these markers started to increase during surgery, whereas in Group I the increase occurred at the end of the procedure when the tourniquet was deflated. The total amount of thrombin generation was significantly higher in Group II (without tourniquet), whereas fibrinolysis was significantly greater in Group I. Total knee replacement is accompanied by a hypercoagulative state with or without the use of a tourniquet, but it seems to be higher when the tourniquet is not used. In addition, tourniquet application may increase fibrinolysis.
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            Tranexamic acid reduces blood loss and blood transfusion after TKA: a prospective randomized controlled trial.

            TKA may be associated with considerable blood loss, and transfusion carries substantial risk of immunologic reaction and disease transmission. Blood transfusion also involves additional cost, therefore a reduction in its use is important. Several methods reportedly reduce postoperative blood loss and avoid homologous blood transfusion with traditional TKA approaches, but it is unclear these reductions apply to a minimally invasive technique. We asked whether tranexamic acid administration could reduce blood loss and blood transfusion requirements after TKA. Between March 2008 and May 2008, we enrolled 100 patients with primary osteoarthritis undergoing a unilateral cemented TKA in a prospective, randomized, double-blind study. Patients were randomized into one of two groups: the control group received a placebo and the study group received tranexamic acid intravenously (10 mg/kg) 10 minutes before inflation of the tourniquet and 3 hours postoperatively and orally (250 mg/capsule; two capsules three times daily) for 5 days. We measured volume of drained blood 48 hours postoperatively, decrease in hemoglobin levels 12 hours postoperatively, amount of blood transfused, and number of patients requiring allogenic blood transfusion. The minimum followup was 6 months (mean, 10.4 months; range, 6-12 months). Mean (± SD) postoperative volume of drained blood was lower in the group receiving tranexamic acid (727.50 ± 234 mL) than in control subjects (1208.77 ± 421 mL). The mean hemoglobin decrease 12 hours postoperatively was lower in patients receiving tranexamic acid (2.12 ± 0.64 g/dL) than in control subjects (3.33 ± 0.88 g/dL). The amount of blood transfused and number of patients requiring blood transfusion were lower in patients receiving tranexamic acid than in control subjects. Tranexamic acid reduced postoperative blood loss after TKA, as reflected in reduction in the number of blood transfusions. We did not observe any change in symptomatic thromboembolic phenomenon. Level 1, therapeutic study. See the Guidelines for Authors for a complete description of levels of evidence.
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              Outcomes of total knee arthroplasty in relation to preoperative patient-reported and radiographic measures: data from the osteoarthritis initiative.

              Total knee arthroplasty (TKA) is the preferred surgical treatment for end-stage osteoarthritis. However, substantial numbers of patients still experience poor outcomes. Consequently, it is important to identify which patient characteristics are predictive of outcomes in order to guide clinical decisions. Our hypothesis is that preoperative patient-reported outcome measures and radiographic measures may help to predict TKA outcomes. Using cohort data from the Osteoarthritis Initiative, we studied 172 patients who underwent TKA. For each patient, we compiled pre- and postoperative Western Ontario and McMaster University Arthritis Index (WOMAC) scores. Radiographs were measured for knee joint angles, femorotibial angles, anatomical lateral distal femoral angles, and anatomical medial proximal tibial angles; Kellgren and Lawrence (KL) grades were assigned to each compartment of the knee. All studied measurements were compared to WOMAC outcomes. Preoperative WOMAC disability, pain, and total scores were positively associated with postoperative WOMAC total scores (P = .010, P = .010, and P = .009, respectively) and were associated with improvement in WOMAC total scores (P < .001, P < .001, and P < .001, respectively). For radiographic measurements, preoperative joint angles were positively associated with improvements in postoperative WOMAC total scores (P = .044). Combined KL grades (medial and lateral compartments) were negatively correlated with postoperative WOMAC disability and pain scores (P = .045 and P = .044) and were positively correlated with improvements in WOMAC total scores (P = .001). All preoperative WOMAC scores demonstrated positive associations with postoperative WOMAC scores, while among the preoperative radiographic measurements only combined KL grades and joint angles showed any correlation with postoperative WOMAC scores. Higher preoperative KL grades and joint angles were associated with better (lower) postoperative WOMAC scores, demonstrating an inverse correlation.
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                Author and article information

                Contributors
                850283129@qq.com
                2008021116@tijmu.edu.cn
                2008021102@tijmu.edu.cn
                2008021103@tijmu.edu.cn
                2008021203@tijmu.edu.cn
                2008021130@tijmu.edu.cn
                2008021123@tijmu.edu.cn
                Journal
                J Orthop Surg Res
                J Orthop Surg Res
                Journal of Orthopaedic Surgery and Research
                BioMed Central (London )
                1749-799X
                15 October 2014
                15 October 2014
                2014
                : 9
                : 1
                : 90
                Affiliations
                [ ]Biomechanics Labs of Orthopaedics Institute, Tianjin Hospital, Tianjin, 300050 People’s Republic of China
                [ ]Tianjin Medical University, Tianjin, 300070 People’s Republic of China
                [ ]Department of Orthopedics, Tianjin Hospital, Tianjin, 300211 People’s Republic of China
                [ ]General Hospital of Tianjin Medical University, Tianjin, 300052 People’s Republic of China
                Article
                90
                10.1186/s13018-014-0090-7
                4212119
                25316253
                b0ffb18d-bc81-47c6-a9be-8e759dfbedb0
                © Wang et al.; licensee BioMed Central Ltd. 2014

                This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

                History
                : 1 September 2014
                : 22 September 2014
                Categories
                Research Article
                Custom metadata
                © The Author(s) 2014

                Surgery
                floseal®,thrombin,arthroplasty,meta-analysis
                Surgery
                floseal®, thrombin, arthroplasty, meta-analysis

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