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Tranexamic Acid in Percutaneous Nephrolithotomy

NCT05947435 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2023-07-19

No results posted yet for this study

Summary

Tranexamic acid, once a randomly used antifibrinolytic agent, has been in standard protocols for many specific surgeries. Studies are still needed to standardize the dose and route of tranexamic acid administration, examine its possible contributions in urological surgery, and establish a protocol for its use.

To contribute to this goal, the study was designed as a prospective, randomized, double-blind study on 75 patients with one control and 2 study groups (n=25) who underwent percutaneous nephrolithotomy. Group Tranexamic acid received 10 mg/kg intravenous tranexamic acid preoperatively. And Group Irrigation received the same amount in the initial irrigation fluid. Primarily,the total amount of blood transfusion and the changes in haemoglobin and haematocrit values during two postoperative days were observed. Distinctively, continuous intraoperative haemoglobin saturation was monitored. Secondarily, surgical visual clarity with a standard visual score was questioned to reveal its contribution to surgical practicality, operative time, and residual fragment quantity.

Conditions

  • Percutaneous Nephrolithotomy
  • Intraoperative Use of Tranexamic Acid

Interventions

DRUG

Tranexamic acid

Tranexamic acid was administered in intravenous or locally within irrigation fluid

Sponsors & Collaborators

  • Haseki Training and Research Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-01
Primary Completion
2023-05-01
Completion
2023-06-01

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05947435 on ClinicalTrials.gov