Kidney Week

Abstract: SA-PO633

The Effect of Intravenous Tranexamic Acid in Percutaneous Renal Biopsy: A Randomized Controlled Trial

Session Information

• Glomerular Diseases: ANCA, Anti-GBM, Kidney Biopsy
  November 09, 2019 | Location: Exhibit Hall, Walter E. Washington Convention Center
  Abstract Time: 10:00 AM - 12:00 PM

Category: Pharmacology (PharmacoKinetics, -Dynamics, -Genomics)

• 1800 Pharmacology (PharmacoKinetics, -Dynamics, -Genomics)

Authors

• Izawa, Junichi, Kyoto University, Kyoto, Japan

Junichi Izawa,

• Matsuzaki, Keiichi, Kyoto University, Kyoto, Japan

Keiichi Matsuzaki,

• Raita, Yoshihiko, Okinawa Chubu Hospital, Uruma, Japan

Yoshihiko Raita,

• Uehara, Genta, Okinawa Chubu Hospital, Uruma, Japan

Genta Uehara,

• Nishioka, Norihiro, Okinawa Chubu Hospital, Uruma, Japan

Norihiro Nishioka,

• Yano, Hiroyuki, Okinawa Chubu Hospital, Uruma, Japan

Hiroyuki Yano,

• Sudo, Ko, Okinawa Chubu Hospital, Uruma, Japan

Ko Sudo,

• Katsuren, Masato, Okinawa Chubu Hospital, Uruma, Japan

Masato Katsuren,

• Ohigashi, Tomohiro, Tokyo University of Science, Tokyo, Japan

Tomohiro Ohigashi,

• Sozu, Takashi, Tokyo University of Science, Tokyo, Japan

Takashi Sozu,

• Kawamura, Takashi, Kyoto University, Kyoto, Japan

Takashi Kawamura,

• Miyasato, Hitoshi, Okinawa Chubu Hospital, Uruma, Japan

Hitoshi Miyasato,

Group or Team Name

• The TRANEPSY Trial Group

Background

Tranexamic acid is an anti-fibrinolytic agent, and the evidence of its benefit for major surgery and trauma has accumulated. We aimed to assess whether intravenous tranexamic acid reduces hematoma sizes after percutaneous renal biopsy.

Methods

We conducted a randomized, triple-blind, placebo-controlled trial at a teaching hospital in Japan between January 2016 and July 2018. We included adult patients who had a clinical indication of percutaneous renal biopsy. High-dose tranexamic acid (500 mg), low-dose tranexamic acid (250 mg) or counterpart saline (placebo) was intravenously injected twice, with bolus just before the biopsy and continuous infusion initiated just after the biopsy. On the morning of the biopsy day, patients were randomly assigned to either of the three groups. The primary outcome was the post-biopsy perirenal hematoma size measured by ultrasound on the next morning of the biopsy. According to the predefined protocol, a closed testing procedure with Wilcoxon rank sum test was used to adjust the multiple comparisons of the tranexamic acid groups (high-dose and low-dose) with the placebo control group. Thus, if the high-dose group was statistically significant against the control group, the low dose group was compared with the placebo group. All analyses were done on an intention-to-treat basis. The trial was registered with UMIN-CTR, number UMIN000019830.

Results

We randomly allocated 56 patients into the three groups: 20 in the high dose group, 19 in the low dose group, and 17 in the placebo group. The median post-biopsy hematoma sizes were 200 mm² (IQR 21–650) in the high dose group, 52 mm² (0–139) in the low dose group, and 0 mm² (0–339) in the placebo group. The results of Wilcoxon rank sum test for the comparison of the high dose group with the placebo group was p=0.047 and that of the low dose group with the placebo group was p=0.80.

Conclusion

High dose tranexamic acid compared to placebo increased perirenal hematoma size after percutaneous renal biopsy. Since the mechanism of increased bleeding in this drug is unknown, we need to confirm the findings in further large randomized controlled trials.