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Effects of tranexamic acid and bipolar sealer alone or in combination in primary total knee arthroplasty: a prospective, randomized, controlled trial.

ABSTRACT: BACKGROUND:The purpose of this study was to compare 2 blood management interventions, tranexamic acid (TXA) and bipolar sealer system (BSS) used independently or in combination with a control group during primary total knee arthroplasty (TKA). METHODS:A total of 127 TKA patients were enrolled and randomized into 4 groups: Intravenous TXA plus the BSS (N = 29, group 1); TXA only (N = 29, group 2); BSS only (N = 31, group 3); and intravenous normal saline as a control group (N = 32, group 4). RESULTS:Changes in hemoglobin from baseline to postoperative follow-up were significantly lower among patients who received TXA plus BSS and those receiving TXA only when compared with the control. BSS only did not differ significantly when compared to the control group. In addition, TXA plus BSS was as efficacious as TXA only in preserving postoperative hemoglobin. CONCLUSIONS:In other terms, using bipolar sealer did not add to the effect of TXA in reducing the postoperative hemoglobin drop in primary TKA.

SUBMITTER: Seviciu A

PROVIDER: S-EPMC4957169 | biostudies-literature | 2016 Jun

REPOSITORIES: biostudies-literature

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Effects of tranexamic acid and bipolar sealer alone or in combination in primary total knee arthroplasty: a prospective, randomized, controlled trial.

Seviciu Alexandru A Gross Irwin I Fathima Samreen S Walsh Stephen M SM

Arthroplasty today 20160331 2

<h4>Background</h4>The purpose of this study was to compare 2 blood management interventions, tranexamic acid (TXA) and bipolar sealer system (BSS) used independently or in combination with a control group during primary total knee arthroplasty (TKA).<h4>Methods</h4>A total of 127 TKA patients were enrolled and randomized into 4 groups: Intravenous TXA plus the BSS (N = 29, group 1); TXA only (N = 29, group 2); BSS only (N = 31, group 3); and intravenous normal saline as a control group (N = 32, ...[more]

PMID: 28326403

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Project description:BackgroundWhether bipolar sealer (BS) is superior to standard electrocautery in patients with primary total knee arthroplasty (TKA) remains controversial. Thus, we conducted this meta-analysis involving comparative studies (S) to evaluate whether administration with BS (I) was associated with less blood loss (O) than standard electrocautery (C) after primary TKA (P).MethodsPubMed (1950-January 2017), EMBASE (1974-January 2017), the Cochrane Library (January 2017 Issue 3), and the Google database (1950-January 2017) were systematically searched. Studies were included in accordance with Population, Intervention, Comparison, Outcomes, and Setting including criteria. Only the patients prepared for primary TKA and administrated with BS as the intervention group and standard electrocautery as control group were included in this meta-analysis. Outcomes include need for transfusion, total blood loss, blood loss in drainage, hemoglobin at discharge, hemoglobin drop, and length of hospital stay. Continuous outcomes and discontinuous outcomes were expressed as weighted mean difference (WMD) and risk ratio (RR) with corresponding confidence intervals (CIs), respectively. Stata 13.0 software was used for relevant data calculation.ResultsA total of 7 clinical trials with 718 patients (398 patients in BS group and 320 in standard electrocautery group) were finally included in this meta-analysis. The pooled results indicated that administration with BS was associated with little reduction of total blood loss (WMD = -123.80, 95%CI -236.56 to -11.04, P = .031). There was no significant difference between the need for transfusion, blood loss in drainage, hemoglobin at discharge, hemoglobin drop, and length of hospital stay (P > .05).ConclusionBased on the current meta-analysis, we found no evidence to support the routine use of bipolar sealer in the management of blood loss in primary TKA. Since the poor quality of the included studies, more randomized controlled trials are still needed to further identify the efficacy of BS after primary TKA.

Project description:BackgroundThis study aimed to assess the efficacy of tranexamic acid (TXA) mixed in a periarticular multimodal cocktail (PAMC) as a topical administration and to determine whether combined use of intravenous and topical administration is more effective than a single administration of TXA.MethodsA total of 240 patients who underwent primary total knee arthroplasty (TKA) was enrolled for this prospective randomized controlled study. Patients were divided into three groups of 80 patients each. Baseline data were comparable for all groups. Average follow-up was 18.7 months. Group 1 consisted of patients who received intravenous (IV) TXA, Group 2 patients were those who received TXA in a PAMC injection for topical administration, and Group 3 consisted of patients who received a combination of both intravenous and topical administration of TXA. Primary outcomes were postoperative hemoglobin drop and amount of suction drainage. Secondary outcomes were estimated blood loss (EBL), postoperative transfusion rate, and complications.ResultsThe mean postoperative hemoglobin drop was significantly lower in Group 3 (2.13 ± 0.77 g/dL, p=0.004), and there was no difference between Group 1 and Group 2 (2.56 ± 1.07 g/dL vs 2.55 ± 0.86 g/dL, p=0.999). The mean drainage amount was significantly lower in Group 3 (326.58 ± 57.55 ml, p<0.001), and there was no difference between Group 1 and Group 2 (367.93 ± 87.26 ml vs 397.66 ± 104.10 ml, p=0.072). Similarly, the mean EBL was significantly lower in Group 3 (p=0.003), and there was no significant difference between Group 1 and Group 2 (p=0.992). There were no significant differences in requirement for postoperative transfusion rate or incidence of complications among the three groups.ConclusionTXA mixed in a PAMC injection showed a similar effect to IV administration of TXA following TKA. Furthermore, combined use of both IV and PAMC injection provided better perioperative bleeding control with similar safety in patients without relevant comorbidities.Trial registrationWHO ICTRP identifier KCT0005703 . Retrospectively registered: 12/24/2020.

Dataset Information

Effects of tranexamic acid and bipolar sealer alone or in combination in primary total knee arthroplasty: a prospective, randomized, controlled trial.

Publications

Effects of tranexamic acid and bipolar sealer alone or in combination in primary total knee arthroplasty: a prospective, randomized, controlled trial.

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