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Prospective randomized controlled trial to evaluate the effect of tranexamic acid in irrigant solution on perioperative blood loss during mini-percutaneous nephrolithotomy

Prospective randomized controlled trial to evaluate the effect of tranexamic acid in irrigant solution on perioperative blood loss during mini-percutaneous nephrolithotomy

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
TCTR
Registry ID
TCTR20211021003
Enrollment
50
Registered
2021-10-21
Start date
2021-10-27
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

Patients who have renal calculi and undergo mini-percutaneous nephrolithotomy Tranexamic acid Irrigant solution Mini-Percutaneous nephrolithotomy Perioperative blood loss

Interventions

Tranexamic acid 1 g (10ml) in normal saline solution 1,000 ml, Nss 10 ml in normal saline solution 1,000 ml
Active Comparator Drug,Active Comparator Drug
Tranexamic acid in irrigant solution,Placebo in irrigant solution

Sponsors

None listed

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: Adult patients age 18 years or older who undergo mini-PCNL

Exclusion criteria

Exclusion criteria: 1) hypersensitivity to TXA 2) early pregnancy 3) disturbances of color vision 4) massive bleeding in the upper tract 5) acute arterial or venous thrombosis 6) severe renal impairment 7) history of convulsion 8) subarachnoid hemorrhage 9) intrathecal and intraventricular injection

Design outcomes

Primary

MeasureTime frame
Perioperative blood loss during mini-PCNL 24 hr post op Hemoglobin loss, requirement of blood transfusion

Secondary

MeasureTime frame
Complication from mini-PcNL 3-5 days Fever, pneumothorax, bowel perforate

Countries

Thailand

Contacts

Public ContactChinnakhet Ketsuwan

Faculty of Medicine Ramathibodi hospital, Mahidol university

chinnake@yahoo.com0863456901

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026