HeLiX
Trial question
What is the role of tranexamic acid in patients undergoing liver resection for a cancer-related indication?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
40.0% female
60.0% male
N = 1245
1245 patients (495 female, 750 male).
Inclusion criteria: patients undergoing liver resection for a cancer-related indication.
Key exclusion criteria: severe anemia, arterial or venous thrombosis within the prior 3 months; active treatment with anticoagulants; DIC; CrCl < 30 mL/min; history of seizure disorder; inability to receive blood products.
Interventions
N=619 tranexamic acid (1 g bolus followed by 1 g infusion over 8 hours starting at anesthesia induction).
N=626 placebo (normal saline 1 g bolus followed by 1 g infusion over 8 hours starting at anesthesia induction).
Primary outcome
Rate of red blood cell transfusion within 7 days of surgery
16.3%
14.5%
16.3 %
12.2 %
8.2 %
4.1 %
0.0 %
Tranexamic
acid
Placebo
No significant
difference ↔
No significant difference in the rate of RBC transfusion within 7 days of surgery (16.3% vs. 14.5%; OR 1.15, 95% CI 0.84 to 1.56).
Secondary outcomes
No significant difference in intraoperative RBC transfusion (9.2% vs. 10.2%; OR 0.89, 95% CI 0.61 to 1.3).
No significant difference in postoperative RBC transfusion (9.9% vs. 7.7%; OR 1.32, 95% CI 0.89 to 1.96).
No significant difference in mean intraoperative blood loss (817.3 mL vs. 836.7 mL; AD -19.4 mL, 95% CI -137.5 to 98.8).
Safety outcomes
No significant difference in VTE and death.
Significant differences in surgical complications (43.8% vs. 37.9%), major complications (16.8% vs. 12.5%).
Conclusion
In patients undergoing liver resection for a cancer-related indication, tranexamic acid was not superior to placebo with respect to the rate of RBC transfusion within 7 days of surgery.
Reference
Paul J Karanicolas, Yulia Lin, Stuart A McCluskey et al. Tranexamic Acid in Patients Undergoing Liver Resection: The HeLiX Randomized Clinical Trial. JAMA. 2024 Oct 1;332(13):1080-1089.
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