Tranexamic Acid in Percutaneous Nephrolithotomy

NCT05947435 | Completed

• 1 other identifier: 108-2021
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

blood loss; percutaneous nephrolithotomy; tranexamic acid; visual image quality

Outcome Measures

Primary Outcomes (2)

• Hemoglobin decrease

  Hemoglobin decrease after postoperative first and second day relevant to preoperative values

  postoperative 48 hours

• Blood product requirement

  number of packed red blood cell use

  postoperative 48 hours

Secondary Outcomes (1)

• surgical visual score

  intraoperative

Study Arms (3)

Tranexamic acid IV

EXPERIMENTAL

Group A received an IV infusion of 10 mg/kg tranexamic acid for 20 minutes just before the surgical incision.

Drug: Tranexamic acid

Tranexamic acid irrigation

EXPERIMENTAL

10 mg/kg tranexamic acid was placed in the first irrigation solution

Drug: Tranexamic acid

Control

NO INTERVENTION

The control group did not receive tranexamic acid in either way

Interventions

Tranexamic acid DRUG

Tranexamic acid was administered in intravenous or locally within irrigation fluid

Also known as: Transamin®

Tranexamic acid IV; Tranexamic acid irrigation

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old
• ASA I-III patients
• scheduled for PCNL surgery

You may not qualify if:

• tranexamic acid hypersensitivity
• history of subarachnoid haemorrhage
• previous cerebrovascular event
• a history of arterial-venous embolism or a tendency to thromboembolism
• abnormal liver function tests
• unstable cardiovascular disease
• acute or chronic renal failure
• the presence of any haematological disease and known colour blindness

Sponsors & Collaborators

• Haseki Training and Research Hospital: lead

Study Sites (1)

Haseki Training and Research Hospital

Istanbul, Sultangazi, 34000, Turkey (Türkiye)

Location

Related Publications (2)

• Ersin M, Demirel M, Buget MI, Edipoglu IS, Atalar AC, Ersen A. The effect of intravenous tranexamic acid on visual clarity during arthroscopic rotator cuff repair: A randomized, double-blinded, placebo-controlled pilot study. Acta Orthop Traumatol Turc. 2020 Nov;54(6):572-576. doi: 10.5152/j.aott.2020.19164.

  PMID: 33423986 BACKGROUND

• Kim J, Alrumaih A, Donnelly C, Uy M, Hoogenes J, Matsumoto ED. The impact of tranexamic acid on perioperative outcomes in urological surgeries A systematic review and meta-analysis. Can Urol Assoc J. 2023 Jun;17(6):205-216. doi: 10.5489/cuaj.8254.

  PMID: 36952300 RESULT

MeSH Terms

Conditions

Hemorrhage

Interventions

Tranexamic Acid

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Randomisation was designed as 3 (n= 25) named Groups A, B, and Group C in a 1:1:1 ratio with a computer-based algorithm and sealed in opaque envelopes by the surgeon assigned to the study. The investigative anesthesiologist selected an envelope in the order of numbers on it, and Group A continued with an IV infusion of 10 mg/kg tranexamic acid for 20 minutes just before the surgical incision. In Group B, 10 mg/kg tranexamic acid was placed in the first irrigation solution, and in Group C, no drug was given in either way. The urologist was blind to the study groups and was the evaluator of an intraoperative visual score. Postoperative Hb and Hct values and complications were followed by the surgeons who were also blinded to the groups, and the decision of blood replacement was made according to the Hct values according to our standard protocol of the urology department.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: July 7, 2023
• First Posted: July 17, 2023
• Study Start: January 1, 2022
• Primary Completion: May 1, 2023
• Study Completion: June 1, 2023
• Last Updated: July 19, 2023

Record last verified: 2023-07

Locations

TU (1)