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Kidney Week

Abstract: TH-PO1066

Efficacy and Safety of Fibrin Sealant in Reducing Perinephric Hematoma After Percutaneous Kidney Biopsy: An Open-Label Randomized Controlled Trial (KIDNEY-SEAL)

Session Information

Category: Pathology and Lab Medicine

  • 1700 Pathology and Lab Medicine

Authors

  • Sevaphai, Thanawat, King Chulalongkorn Memorial Hospital Division of Nephrology, Bangkok, Thailand
  • Wuttiputhanun, Thunyatorn, King Chulalongkorn Memorial Hospital Division of Nephrology, Bangkok, Thailand
  • Tungsanga, Somkanya, King Chulalongkorn Memorial Hospital Division of Nephrology, Bangkok, Thailand
  • Avihingsanon, Yingyos, King Chulalongkorn Memorial Hospital Division of Nephrology, Bangkok, Thailand
Background

Percutaneous kidney biopsy is a key diagnostic procedure in nephrology but is frequently complicated by perinephric hematoma or major bleeding. Currently, no established preventive strategy exists. Fibrin sealant, a hemostatic agent composed of fibrinogen and thrombin, promotes fibrin clot formation and is approved by the U.S. and Thai FDA for surgical uses. However, evidence in kidney biopsy remains limited. This study provides one of the first evidence evaluating the efficacy and safety of fibrin sealant in kidney biopsy.

Methods

The KIDNEY-SEAL trial was an open-label, randomized controlled trial at King Chulalongkorn Memorial Hospital. Adult participants undergoing percutaneous kidney biopsy (native or allograft) were randomized in a 1:1 ratio to receive fibrin sealant (TRCS) injection via coaxial needle after biopsy or standard care. The primary outcome was the occurrence of perinephric hematoma at 6 hours. Secondary outcomes included hematoma size, major bleeding requiring intervention, hemoglobin change, and drug-related adverse events.

Results

Sixty-six participants were randomized equally between groups with comparable baseline characteristics. Perinephric hematoma at 6 hours was significantly lower in the fibrin sealant group compared with the control group (18.2% vs. 51.5%; Risk difference -33.3%, 95%CI -54.9% to -11.8%, p=0.004). Median hematoma size was smaller in the intervention group. Hemoglobin change over time was comparable between groups. No major bleeding, infectious complications or drug-related adverse events were observed. In subgroup analysis, the treatment effect was greater among those with eGFR ≥45 mL/min/1.73 m2 and native kidney biopsy.

Conclusion

Fibrin sealant (TRCS) injection following kidney biopsy significantly reduced early perinephric hematoma without compromising safety, supporting its role as a local hemostatic strategy. Further multicenter studies and cost-effectiveness analyses are warranted to inform real-world clinical practice.

Acknowledgment

We acknowledge the nephrology fellows, consultants, radiologists, nurses, staff at King Chulalongkorn Memorial Hospital for their support in study coordination and procedural care. We also thank the National Blood Center, Thai Red Cross Society for assistance with fibrin sealant preparation, and all participants for their valuable contribution.

Funding

  • Government Support – Non-U.S.