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TKA: Drain-clamping with tranexamic acid decreased drained blood volume/ transfusions
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June 2013
TKA: Drain-clamping with tranexamic acid decreased drained blood volume/ transfusions
Study Type:Therapy
OE Level Evidence:1
Journal Level of Evidence:N/A
Temporary clamping of drain combined with tranexamic acid reduce blood loss after total knee arthroplasty: a prospective randomized controlled trial
BMC Musculoskelet Disord. 2012 Jul 20;13:124. doi: 10.1186/1471-2474-13-124Did you know you're eligible to earn 0.5 CME credits for reading this report? Click Here
Synopsis
240 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.
Publication Funding Details
+
Funding:
Not Reported
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.
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
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?
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.
What was the principal research question?
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?
Study Characteristics
-
Population:
240 patients diagnosed with primary osteoarthritic knees undergoing a unilateral primary TKA.
Intervention:
Group B: Patients received non-clamping of the drain (following the release of tourniquet pressure, the drain was immediately released) and tranexamic acid (10mg/kg was administered at 10 minutes before inflating the tourniquet and 10 mg/kg at 3 hours postoperatively; then, 1500 mg per day of oral-formed tranexamic acid was provided for 5 days after operation) (n = 60).
Group C: Patients received clamping of the drain (following the release of tourniquet pressure, the drain was clamped with a 3-hour interval clamping technique) and placebo (equivalent volume of physiological saline combined with a starch capsule) (n = 60).
Group D: Patients received clamping of the drain (as described in group C) and same dosage of tranexamic acid (n = 60).
Comparison:
Group A: Patients received non-clamping of the drain (as described in group B) and same dosage of placebo (n = 60).
Outcomes:
The Hb levels and the amount of drained blood were recorded. Patients were provided with transfusion of one unit of packed red cells (PRC), if their Hb levels decreased to <10 g/dL or if the compromised clinical criteria (e.g. tachycardia, hypotension, or symptoms of anemia that were relative to the preoperative medical condition of the patient) necessitated transfusion. Clinical thromboembolic events and wound complications were also examined.
Methods:
RCT: Double-blind; Prospective
Time:
The amount of drained blood was recorded at 48 hours while Hb levels were determined preoperatively and 12 hours postoperatively (entire study lasted 6 months).
What were the important findings?
- 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.
What should I remember most?
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.
How will this affect the care of my patients?
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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