Intraprostatic Injection of Tranexamic Acid Decrease Blood Loss During Monopolar TURP

NCT ID: NCT05913466

Last Updated: 2023-06-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-20
• Study Completion Date: 2024-06-20

Brief Summary

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

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.

Conditions

Benign Prostatic Hyperplasia; Transurethral Resection of the Prostate; Tranexamic Acid

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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

Group Type: EXPERIMENTAL

Tranexamic Acid group

Intervention Type: DRUG

Patients in this group will receive 1 gm of Tranexamic Acid (Cyklokapron) that will be dissolved in 50 ml of injectable 0.9% saline

Distilled water group

This group will receive 10 mL of distilled water (placebo) in 1 L of irrigation solution sterile wash (glycine).

Group Type: PLACEBO_COMPARATOR

Distilled water group

Intervention Type: DRUG

This group will receive 10 mL of distilled water (placebo) in 1 L of irrigation solution sterile wash (glycine).

Interventions

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

Intervention Type: DRUG

Distilled water group

This group will receive 10 mL of distilled water (placebo) in 1 L of irrigation solution sterile wash (glycine).

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Benha University

OTHER

Sponsor Role: lead

Responsible Party

Tamer Abd El-Wahab Diab

Lecturer of Urology, Faculty of Medicine, Benha University, Benha, Egypt

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Tamer Diab, MD

Role: CONTACT

tamer.diab@fmed.bu.edu.eg

01003583264 ext. +2

References

Diab T, El Hamshary SA, Abou Elezz A, El-Dakhakhny AS. Intraprostatic Injection of Tranexamic Acid Decrease Blood Loss During Monopolar Transurethral Resection of the Prostate: A Randomized Controlled Clinical Trial. Urology. 2024 Sep;191:119-126. doi: 10.1016/j.urology.2024.05.015. Epub 2024 May 22.

Reference Type: DERIVED

PMID: 38788904 (View on PubMed)

Other Identifiers

Rc 5-5-2022

Identifier Type: -

Identifier Source: org_study_id