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RCT
ACE Report #3123

Tranexamic acid and fibrin spray equally effective in reducing blood loss following THA


Study Type:Therapy
OE Level Evidence:2
Journal Level of Evidence:N/A

Reduction of blood loss in primary hip arthroplasty with tranexamic acid or fibrin spray

Acta Orthop. 2011 Dec;82(6):660-3. Epub 2011 Oct 17

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Synopsis

66 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.

Publication Funding Details +
Funding:
Not Reported
Conflicts:
None disclosed

Risk of Bias

6/10

Reporting Criteria

14/20

Fragility Index

N/A

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

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

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?

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.

What was the principal research question?

What is the effectiveness of fibrin spray compared to tranexamic acid on total blood loss, in patients undergoing total hip arthroplasty, measured post-operatively?

Study Characteristics -
Population:
66 patients undergoing primary unilateral cemented total hip arthroplasty.
Intervention:
Group 1: Patients given a 10mg/kg single dose of tranexamic acid at the beginning of surgery (n=22). Group 2: Patients received 10mL of fibrin spray given in divided doses peri-operatively (n=22).
Comparison:
Control group which did not receive either intervention treatment (n=22).
Outcomes:
The primary outcome was total blood loss (calculated using total blood volume and the change in hematocrit; pre-operative to post-operative).
Methods:
Randomized controlled trial; Single Centre; Multi-surgeon; Single Blind
Time:
Hematocrit, measured on second day after surgery, to determine the change in hematrocit levels, in order to calculate blood loss.

What were the important findings?

  • 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).

What should I remember most?

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.

How will this affect the care of my patients?

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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