TKA: Drain-clamping with tranexamic acid decreased drained blood volume/ transfusions .
OrthoEvidence Journal (OE Journal) - ACE Report
OE Journal. 2013;1(7):4 BMC Musculoskelet Disord. 2012 Jul 20;13:124. doi: 10.1186/1471-2474-13-124240 patients undergoing total knee arthroplasty (TKA) were randomized to examine the efficacy of temporary clamping of the drain with or without tranexamic acid for haemostasis. Patients were divided into four groups; a control group fitted with a drain (no clamping) and a placebo injection, a group undergoing drain clamping and a placebo injection, a group fitted with a drain (no clamping) and an injection of tranexamic acid, or a group receiving both clamping of the drain and tranexamic acid. Results after the first 48 hours demonstrated that patients who received both treatments had the lowest mean postoperative volumes of drained blood and amount of blood transfusions required.
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)?
Sì = 1
Incerto = 0,5
Non rilevante = 0
No = 0
La valutazione dei criteri di segnalazione valuta la trasparenza con cui gli autori riportano le caratteristiche metodologiche e sperimentali dello studio all'interno della pubblicazione. La valutazione è suddivisa in cinque categorie che vengono presentate di seguito.
3/4
Randomization
4/4
Outcome Measurements
2/4
Inclusion / Exclusion
4/4
Therapy Description
3/4
Statistics
Detsky AS, Naylor CD, O'Rourke K, McGeer AJ, L'Abbé KA. J Clin Epidemiol. 1992;45:255-65
L'Indice di Fragilità è uno strumento che aiuta l'interpretazione dei risultati significativi, fornendo una misura della forza di un risultato. L'Indice di Fragilità rappresenta il numero di eventi consecutivi che devono essere aggiunti a un risultato dicotomico per rendere il risultato non più significativo. Un numero piccolo rappresenta un risultato più debole, mentre un numero grande rappresenta un risultato più forte.
Perché questo studio era necessario ora?
While total knee arthroplasty (TKA) is an effective treatment for severe osteoarthritic knee, the procedure is associated with significant blood loss which is problematic due to the requirement of postoperative blood transfusion. Drain clamping and tranexamic acid administration have been individually proposed as a method to reduce postoperative TKA blood loss in previous studies; however, no study has compared the efficacy of drain clamping combined with tranexamic acid administration in the control of bleeding after TKA.
Qual era la domanda di ricerca principale?
Would temporary clamping of the drain combined with tranexamic acid lead to lower amount of post-TKA blood loss and transfusions than with either of these processes alone?
- Group A (1182 +/- 411 ml) had significantly higher (p < 0.001) volume of drained blood than groups B (724 +/- 246 ml), C (821 +/-337 ml), and D (526 +/- 222 ml) but there were no significant differences in those between group B and C (p = 0.37).
- The lowest drained-blood volume was found in group D (p < 0.001).
- Group B (2.1 +/- 0.6 g/dl), C (2.8 +/- 0.8 g/dl), D (1.8 +/- 0.7 g/dl) had significantly lower (p < 0.05) levels of decreasing Hb than those in group A (3.3 +/- 0.9).
- While group B and D could maintain the Hb level better than group C (p < 0.001), there was no significant difference between group B and D (p = 0.07).
- The amount of PRC transfusion units required in group B and D were significantly lower than group A and C (p < 0.001); there was no significant difference between group A and C (p = 0.05).
- Those who received the least blood transfusion (0.4 +/- 0.5 unit) were in group D (significantly lower than group B, p < 0.04).
- No wound infections or clinical venous thromboembolisms were detected in all groups.
Che cosa devo ricordare di più?
This study demonstrated the effectiveness of combining drain-clamping technique with tranexamic acid administration to reduce postoperative blood loss after TKA. Compared to the control group, the use of this combination could reduce the volume of drained blood significantly more than using either tranexamic acid or drain clamping alone. Furthermore, the combined method required the lowest amount of transfusion unit.
Come influenzerà l'assistenza ai miei pazienti?
The use of combining the two treatments displayed better hemostatic effect than using tranexamic acid or drain clamping alone. However, future studies with larger sample sizes are required to further study the effects of these treatments, especially as this study focused only on the efficacy in controlling blood loss.
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