ARTHROPLASTY
Efficacy of low-dose intra-articular tranexamic acid in total knee replacement; a prospective triple-blinded randomized controlled trial
OrthoEvidence Journal (OE Journal) - ACE Report
OE Journal. 2014;2(6):8 BMC Musculoskelet Disord. 2013 Dec 5;14:340. doi: 10.1186/1471-2474-14-340135 patients scheduled for total knee arthroplasty were randomized to three different hemostasis protocols with 2 hour postoperative drain clamping: 1) a 250mg intra-articular tranexamic acid (IA-TXA) injection (low-dose), 2) a 500mg IA-TXA injection (high-dose), or 3) a placebo injection. The purpose was to determine the effect of different TXA doses on reducing blood loss and transfusion needs. The results indicated that both TXA doses significantly reduced calculated blood loss and transfusion requirements compared to the placebo group. Furthermore, blood loss was similar between TXA groups, although fewer transfusions were needed in those who received 500mg TXA. The latter of the two findings may have been impacted by significantly lower preoperative hemoglobin levels in the 250mg TXA group.
Was the allocation sequence adequately generated?
Was allocation adequately concealed?
Blinding Treatment Providers: Was knowledge of the allocated interventions adequately prevented?
Blinding Outcome Assessors: Was knowledge of the allocated interventions adequately prevented?
Blinding Patients: Was knowledge of the allocated interventions adequately prevented?
Was loss to follow-up (missing outcome data) infrequent?
Are reports of the study free of suggestion of selective outcome reporting?
Were outcomes objective, patient-important and assessed in a manner to limit bias (ie. duplicate assessors, Independent assessors)?
Was the sample size sufficiently large to assure a balance of prognosis and sufficiently large number of outcome events?
Was investigator expertise/experience with both treatment and control techniques likely the same (ie.were criteria for surgeon participation/expertise provided)?
はい = 1
不確実＝0.5
無関係 = 0
いいえ = 0
報告基準評価では、著者が出版物内で試験の方法論的特徴や試験特性を報告する際の透明性を評価します。評価は以下の5つのカテゴリーに分類されます。
3/4
Randomização
4/4
Medidas de resultado
4/4
Inclusão/Exclusão
4/4
Descrição do tratamento
4/4
Estatística
Detsky AS, Naylor CD, O'Rourke K, McGeer AJ, L'Abbé KA. J Clin Epidemiol. 1992;45:255-65
Fragility Indexは、重要な所見の解釈を助けるツールで、結果の強さの尺度を提供します。Fragility Indexは、その所見が有意でなくなるために、二項対立の結果に追加する必要がある連続した事象の数を表します。数値が小さいほど弱い所見を表し、数値が大きいほど強い所見を表します。
なぜ今この研究が必要なのですか？
Total knee arthroplasty is associated with considerable perioperative blood loss, oftentimes requiring allogenic transfusion. To reduce the requirement for transfusion with such procedures, tranexamic acid (TXA) has been used extensively. Due the risk of potential venous thromboembolic complications with intravenous TXA, intra-articular injections (IA-TXA) are becoming more popular. However, guidelines on IA-TXA use have yet to be established, particularly with regards to dosage.
主な研究課題は何ですか？
Does low dose IA-TXA (250mg) reduce perioperative blood loss and transfusion requirements compared to placebo and, if so, how does its efficacy compare to high dose IA-TXA (500mg)?
重要な知見は？
- Mean total Hb loss among both the TXA 250mg (2.2g/dL) and TXA 500mg (2.2g/dL) groups was significantly lower compared to the control group (2.7g/dL) (both p<0.001). However, the difference in mean drainage blood loss did not reach significance between the TXA 250mg group (475.0mL) and control group (546.9mL), nor between the TXA 500mg group (430.2mL) and control group (p=0.09).
- The mean calculated total blood loss was measured at 239.7mL for the TXA 250mg group and 217.2mL for the TXA 500mg group, both of which were significantly lower than that calculated in the control group (329.2mL).
- The requirement for allogeneic blood transfusion was significantly lower in the TXA 500mg group, with 0 patients needing transfusion compared to 6 patients of the TXA 250mg group (13%) and 10 patients of the control group (27%) (p=0.005).
- Accumulated drainage volume (ADV) was significantly lower in the TXA 250mg group compared to the control group for 12 hours following clamp release, and in the TXA 500mg compared to the control group for 20 hours following clamp release (both p<0.05).
- Mean drainage blood loss rate (DBLR) was significantly lower in the TXA 250mg group compared to the control group for the first 2 hours after clamp release and in the TXA 500mg group compared to the control groups for 4 hours following clamp release (both p<0.05). After the first 4 hour time interval following clamp release, the mean DBLR was significantly greater in both TXA groups compared to the control group from 8-20 hours (p<0.05).
- Four cases of VTE were documented in the control group (1 PE; 3 DVT), one case in the TXA 250mg group (1 DVT), and two cases in the TXA 500mg group (2 DVT). The incidences of VTE were not significantly different from group to group.
- There were no significant differences between groups in functional outcome (on both KSKS and WOMAC) over the 1-year follow-up of these measurements.
- The TXA-500 group showed significantly higher preoperative Hb levels compared with TXA-250 group (p=0.02).
最も覚えておくべきことは？
Both intra-articular low dose (250mg) and high dose (500mg) tranexamic acid with a 2-hour clamping protocol significantly reduced total blood loss and the requirement for allogenic blood transfusion following total knee arthroplasty compared to placebo injection.
それが私の患者ケアにどのように影響するか？
In total knee arthroplasty, intra-articular tranexamic acid, 250mg of 500mg, followed by 2 hour postoperative drain clamping appears to be an effective hemostasis protocol. Total blood loss was calculated to be significantly reduced, without an increase in postoperative complications. Transfusions were needed less often in the 500mg TXA group compared to the 250mg group, although preoperative hemoglobin levels may have impacted this finding. Further research should be conducted to definitely characterize the efficacy and safety profiles of low- and high-dose tranexamic acid protocols.
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