Efficacy and Safety of Fibrin Sealant in Reducing Post-Biopsy Perinephric Hematoma in Percutaneous Kidney Biopsy: An Open-Label Randomized Controlled Trial

Efficacy and Safety of Fibrin Sealant in Reducing Post-Biopsy Perinephric Hematoma in Percutaneous Kidney Biopsy: An Open-Label Randomized Controlled Trial [KIDNEY-SEAL]

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

TCTR

Registry ID

TCTR20250218017

Enrollment

Registered

2025-02-18

Start date

2025-06-26

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Preventing perinephric hematoma by fibrin sealant in percutaneous native and transplant kidney biopsy Percutaneous kidney biopsy, fibrin sealant, fibrin sealant TRCS, kidney biopsy complication, perinephric hematoma

Interventions

Fibrin sealant TRCS (Thai Red Cross Society) composed of 1) Human fibrinogen 60 mg/mL and Synthetic Aprotinin 2) Human thrombin 500 IU/mL and Calcium Chloride Solution. The intervention group received

Experimental Biological/Vaccine,No Intervention No treatment

Fibrin sealant group,Control group

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Patients aged 18 years and older with indications for a percutaneous (native or transplanted) kidney biopsy, 2. All screened participants must undergo a complete blood count, coagulogram, blood urea nitrogen, serum creatinine and serology tests (Anti-HIV, HBsAg, Anti-HCV, Treponemal Ab).

Exclusion criteria

Exclusion criteria: 1. Coagulopathy (INR > 1.5 or aPTT > 40 sec) or thrombocytopenia (platelet < 100,000 /uL) or anemia (hemoglobin < 8 g/dL), 2. BUN > 80 mg/dL or serum creatinine > 3.0 mg/dL or eGFR CKD-EPI < 30 ml/min/1.73m2, 3. Small-sized kidneys (length of kidney < 8 cm), 4. Structural abnormality: single kidney, renal cancer/tumor, hydronephrosis, polycystic kidney, horseshoe kidney, 5. Uncontrolled hypertension (BP > 160/100 mmHg after anti-hypertensive treatment), 6. morbid obesity (BMI> 35 kg/m2), 7. Active infection: skin infection at biopsy site, pyelonephritis, urinary tract infection, renal/perirenal abscess., 8. Current antiplatelet or anticoagulant use, 9. Pregnancy or breastfeeding, 10. Refusal to sign the informed consent

Design outcomes

Primary

Measure	Time frame
Incidence rate of post-biopsy perinephric hematoma (any size) at 0 and 6 hours after kidney biopsy Incidence rate , post-biopsy ultrasonography by ultrasonographer	—

Secondary

Measure	Time frame
Mortality rate related to biopsy complication at 0, 6, 24 hours and 7 days after kidney biopsy Mortality rate,Significant bleeding requiring intervention: Arteriovenous fistula, Hypotension/Shock, Blood transfusion need, Angioembolization, Nephrectomy at 0, 6, 24 hours and 7 days after kidney biopsy Incidence rate,Drop of hemoglobin at 6 and 24 hours after kidney biopsy Percentage,Size of perinephric hematoma on post-biopsy ultrasonography at 0 and 6 hours after kidney biopsy post-biopsy ultrasonography by ultrasonographer,Length of hospitalization within 30 days after end of the intervention Discharge of summary,Pain score at 0, 6, 24 hours and 7 days after kidney biopsy Visual analog scale	—

Measure

Time frame

Mortality rate related to biopsy complication at 0, 6, 24 hours and 7 days after kidney biopsy Mortality rate,Significant bleeding requiring intervention: Arteriovenous fistula, Hypotension/Shock, Blood transfusion need, Angioembolization, Nephrectomy at 0, 6, 24 hours and 7 days after kidney biopsy Incidence rate,Drop of hemoglobin at 6 and 24 hours after kidney biopsy Percentage,Size of perinephric hematoma on post-biopsy ultrasonography at 0 and 6 hours after kidney biopsy post-biopsy ultrasonography by ultrasonographer,Length of hospitalization within 30 days after end of the intervention Discharge of summary,Pain score at 0, 6, 24 hours and 7 days after kidney biopsy Visual analog scale

—

Countries

Thailand

Contacts

Public ContactThanawat Sevaphai

Chulalongkorn University

thanawat.sevaphai@gmail.com022564000

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026