Impact of Tranexamic Acid Use in Percutaneous Nephrolithotomy

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02966236
• Date of registration: 15/11/2016
• Prospective Registration: No
• Primary sponsor: University of Sao Paulo
• Public title: Impact of Tranexamic Acid Use in Percutaneous Nephrolithotomy
• Scientific title: Impact of Tranexamic Acid Use in Transfusion Rate in Patients With Complex Kidney Stone Undergoing Percutaneous Nephrolithotomy: Randomised, Double-blind, Placebo Controlled Trial
• Date of first enrolment: June 2016
• Target sample size: 192
• Recruitment status: Unknown status
• URL: https://clinicaltrials.gov/show/NCT02966236
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 4

Countries of recruitment

Brazil

Contacts

• Name: Carlos A Batagello, MD

Key inclusion & exclusion criteria

Inclusion Criteria:

- Complex kidney stone (staghorn calculi GUYS III and IV)

Exclusion Criteria:

- Coronary artery disease - stent

- Severe chronic renal failure

- Congenital or acquired thrombophilia/thrombosis event

- Known or suspected allergy



Age minimum: N/A
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Nephrolithiasis

Staghorn Calculus

Intervention(s)

Drug: Tranexamic Acid

Drug: Placebos

Primary Outcome(s)

blood transfusion rate [Time Frame: two years]

Secondary Outcome(s)

blood loss [Time Frame: two years]

complications [Time Frame: two years]

stone free rate [Time Frame: two years]

surgical time [Time Frame: two years]

Secondary ID(s)

TXA

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Fundação de Amparo à Pesquisa do Estado de São Paulo