Periarticular and intravenous TXA comparable in blood loss and transfusion rates after TKA .
OrthoEvidence Journal (OE Journal) - ACE Report
OE Journal. 2016;4(20):5 BMC Musculoskelet Disord. 2016 Jul 26;17:313.60 patients scheduled for unilateral total knee arthroplasty were randomized to be administered either periarticular or intravenous tranexamic acid (TXA). The purpose of this study was to compare blood loss and adverse events throughout the first 48-hours post-surgery. The results from this trial demonstrated non-significant differences between groups for postoperative blood loss volume, hematocrit levels, hemoglobin concentration, the number of patients requiring transfusion, VAS pain scores, and thigh/leg circumference when evaluated at 24- or 48-hours postoperatively.
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)?
Ja = 1
Ungewiss = 0.5
Nicht relevant = 0
Nein = 0
Die Bewertung der Berichtskriterien bewertet die Transparenz, mit der die Autoren die methodischen und studienspezifischen Merkmale der Studie in der Veröffentlichung angeben. Die Bewertung ist in fünf Kategorien unterteilt, die im Folgenden vorgestellt werden.
1/4
Randomization
2/4
Outcome Measurements
4/4
Inclusion / Exclusion
4/4
Therapy Description
4/4
Statistics
Detsky AS, Naylor CD, O'Rourke K, McGeer AJ, L'Abbé KA. J Clin Epidemiol. 1992;45:255-65
Der Fragilitätsindex ist ein Instrument, das bei der Interpretation signifikanter Ergebnisse hilft und ein Maß für die Stärke eines Ergebnisses liefert. Der Fragilitätsindex gibt die Anzahl der aufeinanderfolgenden Ereignisse an, die zu einem dichotomen Ergebnis hinzugefügt werden müssen, damit das Ergebnis nicht mehr signifikant ist. Eine kleine Zahl steht für ein schwächeres Ergebnis und eine große Zahl für ein stärkeres Ergebnis.
Warum wurde diese Studie jetzt benötigt?
Intravenous tranexamic acid remains a popular mode of reducing postoperative blood loss after total knee arthroplasty. Despite its well-established anti-fibrinolytic efficacy, potential drawbacks such as thrombus formation and venous thromboembolism (VTE) still remain major concerns with the intravenous administration method. As a result, it has been suggested that other methods of application, such as topical administration or periarticular injection, may offer similar outcomes while reducing the risk of developing these complications.
Was war die wichtigste Forschungsfrage?
In patients undergoing unilateral total knee arthroplasty, did the periarticular injection of tranexamic acid (TXA) produce comparable results to conventional intravenous TXA in terms of postoperative blood loss, hemoglobin concentration, and the need for blood transfusion during the first 48 hours post-surgery?
- The volume of blood present in Hemovac drain (postoperative blood loss) was not significantly different between periarticular and intravenous groups when compared at the 24-hour follow-up (300+/-128 vs. 334+/-124mL, respectively; p=0.279) or 24-48 hour follow-up (145+/-92 vs. 186+/-106mL, respectively; p=0.094).
- Hematocrit levels for periarticular and intravenous groups were not significantly different when compared at 24 hours (29.7 vs 30.4; p=0.550) and 48 hours (31.0 vs. 31.8; p=0.352) postoperatively.
- Hemoglobin concentrations were not significantly different between periarticular and intravenous groups when compared at 24 hours (9.60 vs 10.09; p=0.215) and 48 hours (10.16 vs 10.40; p=0.693) postoperatively.
- The number of patients requiring blood transfusion was not significantly different between periarticular and intravenous groups (9 vs. 7, p=0.928).
- Differences between periarticular and intravenous groups for thigh and leg circumference were not significant at 48 hours (p=0.398 and 0.052 respectively).
- VAS pain scores measured at 24 hours (p=0.889) and 48 hours (p=0.724), Knee flexion at time of hospital discharge(p=0.087), and total length of hospital stay ( p=0.276) were comparable between periarticular and intravenous groups.
Was sollte ich mir besonders merken?
For patients undergoing total knee arthroplasty, periarticular and intravenous administration of tranexamic acid (TXA) resulted in comparable postoperative blood loss volume, hematocrit levels, hemoglobin concentration, the number of patients requiring transfusion, VAS pain scores, and thigh/leg circumference throughout a 48-hour postoperative period.
Wie wird sich dies auf die Behandlung meiner Patienten auswirken?
The results of this study demonstrated comparable effects of either periarticular or intravenous tranexamic acid on postoperative blood loss and clinical outcomes for patients undergoing unilateral TKA. Further investigation with dose-response analyses, a control group, and larger patient populations is recommended to both determine optimal dosing of either periarticular or intravenous TXA dosing and to determine if differences in safety outcomes exist.
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