Intraprostatic Injection of Tranexamic Acid Decrease Blood Loss During Monopolar TURP

This study aims to assess the role of intraprostatic injection of tranexamic acid in decreasing the blood loss during Transurethral resection of the prostate.

Study Overview

• Status: Not yet recruiting
• Conditions: Benign Prostatic Hyperplasia; Tranexamic Acid; Transurethral Resection of the Prostate
• Intervention / Treatment: Drug: Tranexamic Acid group; Drug: Distilled water group

Detailed Description

Benign prostatic hyperplasia (BPH) is a process in which the pathology results in increased number of both stromal and epithelial cells in the area of the prostate around the urethra, which is pathologically known as hyperplasia, and not hypertrophy.

The accurate cause is not well known; however, "reactivation" of embryonic processes is one of the hypotheses that may cause benign prostatic hyperplasia (BPH). Benign prostatic hyperplasia (BPH) is a common condition that affects elderly men. Recently, many noninvasive and mini-invasive modalities have become popular for the management of men with voiding symptoms.

Transurethral resection of the prostate (TURP) is one of the most common and well-developed techniques used to treat benign prostatic hyperplasia (BPH), recognized as the 'gold standard' of the surgical treatments of enlarged prostates. The most relevant complications are the inability to void (5.8%), surgical revision (5.6%), urinary tract infection (UTI) (3.6%), bleeding requiring transfusions (2.9%), and Transurethral resection syndrome (1.4%). As the prostate has a rich blood supply, bleeding is one of the most common complications of Transurethral resection of the prostate.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tamer Diab, MD; Phone Number: +2 01003583264; Email: tamer.diab@fmed.bu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patient with an age between 50 and 85 years old
• who had benign prostatic hyperplasia (aged 50-85 years) with a prostate weight of 50-80 g.
• undergoing Transurethral resection of the prostate

Exclusion Criteria:

• Patient refusal.
• Patients hypersensitive to Tranexamic Acid, or on antiplatelet and anticoagulant drugs.
• Patients with a history of thrombotic events, bleeding disorders, chronic kidney disease.
• Patients with abnormal liver function test.
• Patients with cardiovascular disease and receiving with a drug-eluting stent, bladder stone, urethral stricture, or with previous prostate surgery, prostate cancer, with a UTI or who receiving 5α-reductase inhibitors.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tranexamic Acid group; Patients in this group will receive 1 gm of Tranexamic Acid (Cyklokapron) that will be dissolved in 50 ml of injectable 0.9% saline	Drug: Tranexamic Acid group; Patients in this group will receive 1 gm of Tranexamic Acid (Cyklokapron) that will be dissolved in 50 ml of injectable 0.9% saline
Placebo Comparator: Distilled water group; This group will receive 10 mL of distilled water (placebo) in 1 L of irrigation solution sterile wash (glycine).	Drug: Distilled water group; This group will receive 10 mL of distilled water (placebo) in 1 L of irrigation solution sterile wash (glycine).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Amount of Blood Loss During Monopolar transurethral resection of the prostate	The efficacy of intraprostatic injection of tranexamic acid in reducing intraoperative bleeding will be assessed in litter.	2 weeks Postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hemoglobin (Hb) level	This outcome evaluates the changes in hemoglobin (Hb) level before and after the monopolar transurethral resection of the prostate (TURP) procedure.	2 weeks Postoperatively
Hematocrit (HCT) Level	This outcome evaluates the changes in hematocrit (HCT) level before and after the monopolar transurethral resection of the prostate (TURP) procedure.	2 weeks Postoperatively
Postoperative hospital stay length	Postoperative hospital stay length will be assessed in days	2 weeks Postoperatively

Collaborators and Investigators

• Sponsor: Benha University

Study record dates

Study Major Dates

• Study Start (Estimated): June 20, 2023
• Primary Completion (Estimated): June 20, 2024
• Study Completion (Estimated): June 20, 2024

Study Registration Dates

• First Submitted: June 5, 2023
• First Submitted That Met QC Criteria: June 12, 2023
• First Posted (Actual): June 22, 2023

Study Record Updates

• Last Update Posted (Actual): June 22, 2023
• Last Update Submitted That Met QC Criteria: June 12, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Hyperplasia; Hyperplasia; Molecular Mechanisms of Pharmacological Action; Fibrin Modulating Agents; Antifibrinolytic Agents; Hemostatics; Coagulants; Tranexamic Acid
• Other Study ID Numbers: Rc 5-5-2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The study protocol will be available under a clear request for the primary investigator
• IPD Sharing Time Frame: One year after the end of the trial
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No