ARTHROPLASTY
Reduction of blood loss in primary hip arthroplasty with tranexamic acid or fibrin spray
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OrthoEvidence Journal (OE Journal) - ACE Report
OE Journal. 2013;1(2):19 Acta Orthop. 2011 Dec;82(6):660-3. Epub 2011 Oct 1766 patients undergoing primary unilateral cemented total hip replacement were randomized to receive treatment with either tranexamic acid, fibrin spray, or to the control group which received neither. The primary objective of this trial was compare total blood loss between these treatments. The results indicated that both tranexamic acid and fibrin spray were more effective in reducing the total blood loss than the control group. Neither of these active treatments were superior to one another.
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。
1/4
Randomization
3/4
Outcome Measurements
4/4
Inclusion / Exclusion
3/4
Therapy Description
3/4
Statistics
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?
Various methods to achieve blood conservation following arthroplasty procedures of the lower limb have been used. Previous studies have shown that both tranexamic acid and fibrin spray are effective in reducing blood loss following total hip arthoplasties; however, direct comparisons of these two treatment have yet to be assessed.
主な研究課題は何ですか?
What is the effectiveness of fibrin spray compared to tranexamic acid on total blood loss, in patients undergoing total hip arthroplasty, measured post-operatively?
重要な知見は?
- The calculated median total blood loss values are as follows: Control group= 1.20L (95% CI: 0.82-1.4; IQR: 0.50), tranexamic acid group=0.93L (95% CI: 0.69-1.1; IQR: 0.35), and the fibrin spray group=0.82L (95% CI 0.72-1.1; IQR: 0.33).
- There was no significant difference in the total blood loss when comparing the two active treatment groups (p=1.0).
- The tranexamic group had significantly lower blood loss compared to the control group (22% lower, p=0.02).
- The fibrin spray group had a significantly lower blood loss than the control group (32% lower, p=0.02).
最も覚えておくべきことは?
In patients undergoing total hip arthroplasty, both tranexamic acid and fibrin spray significantly reduced total blood loss in comparison to the control group. There were no differences in blood loss between tranexamic acid and fibrin spray groups.
それが私の患者ケアにどのように影響するか?
The use of either fibrin spray or tranexamic acid appear to be safe and efficacious treatments for blood conservation following total hip arthroplasty and should be considered as future treatment options. Further research is required to determine if these results extend to patients with uncemented total hip arthroplasties or arthroplasties in other joints.
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