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Periarticular and intravenous TXA comparable in blood loss and transfusion rates after TKA
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October 2016
Periarticular and intravenous TXA comparable in blood loss and transfusion rates after TKA
Study Type:Therapy
OE Level Evidence:2
Journal Level of Evidence:N/A
Peri-articular tranexamic acid injection in total knee arthroplasty: a randomized controlled trial
BMC Musculoskelet Disord. 2016 Jul 26;17:313.Did you know you're eligible to earn 0.5 CME credits for reading this report? Click Here
Synopsis
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.
Publication Funding Details
+
Funding:
Non-funded
Conflicts:
None disclosed
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)?
Yes = 1
Uncertain = 0.5
Not Relevant = 0
No = 0
The Reporting Criteria Assessment evaluates the transparency with which authors report the methodological and trial characteristics of the trial within the publication. The assessment is divided into five categories which are presented below.
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
The Fragility Index is a tool that aids in the interpretation of significant findings, providing a measure of strength for a result. The Fragility Index represents the number of consecutive events that need to be added to a dichotomous outcome to make the finding no longer significant. A small number represents a weaker finding and a large number represents a stronger finding.
Why was this study needed now?
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.
What was the principal research question?
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?
Study Characteristics
-
Population:
60 patients (50-80 years) with knee osteoarthritis scheduled for total knee arthroplasty were included. Patients who reported daily aspirin use were asked to stop medication at least seven days prior to scheduled surgery. All patients received cemented, posterior-stabilized, fixed bearing prostheses without patella resurfacing. All procedures were performed via a medial parapatellar approach under tourniquet control.
Intervention:
Periarticular group: patients received 750 mg periarticular tranexamic acid injection (15 cc of 250 mg/5mL Transamin, OLIC Thailand Ltd) to soft tissues surrounding the medial capsule, lateral capsule, and quadriceps muscle (n=30; 67.63+/-7.96, 25F/5M).
Comparison:
Intravenous group: patients received 750 mg intravenous tranexamic acid injection (15 cc of 250 mg/5mL solution) (n=30; 69.97+/-7.55, 23F/7M).
Outcomes:
The primary outcomes included drain volume of postoperative blood loss, changes in serum hemoglobin, and requirement of blood transfusion. The requirement of blood transfusion was defined as a hemoglobin concentration less than 10 g/dL, or if patients demonstrated clinical symptoms of anemia (chest pain, heart failure, idiopathic tachycardia or hypotension). Secondary outcomes included knee diameter (swelling), local soft tissue complications, skin necrosis, venous thromboembolism (VTE), and VAS pain.
Methods:
RCT: prospective, un-blinded, pilot study
Time:
Outcomes were assessed at 24 and 48 hours postoperatively.
What were the important findings?
- 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.
What should I remember most?
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.
How will this affect the care of my patients?
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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