Intraprostatic Injection of Tranexamic Acid Decrease Blood Loss During Monopolar TURP

NCT05913466 | Unknown

• 1 other identifier: Rc 5-5-2022
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Hemoglobin (Hb) level

  2 weeks Postoperatively

• Hematocrit (HCT) Level

  2 weeks Postoperatively

• Postoperative hospital stay length

  2 weeks Postoperatively

Study Arms (2)

Tranexamic Acid group

EXPERIMENTAL

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

Distilled water group

PLACEBO COMPARATOR

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

Drug: Distilled water group

Interventions

Tranexamic Acid group 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

Tranexamic Acid group

Distilled water group DRUG

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

Distilled water group

Eligibility Criteria

• Age: 50 Years - 85 Years
• Gender Eligibility Details: 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.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Benha University: lead

Related Publications (1)

• 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.

  PMID: 38788904 DERIVED

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Central Study Contacts

Tamer Diab, MD

CONTACT

01003583264; tamer.diab@fmed.bu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Urology, Faculty of Medicine, Benha University, Benha, Egypt

Study Record Dates

• First Submitted: June 5, 2023
• First Posted: June 22, 2023
• Study Start: June 20, 2023
• Primary Completion: June 20, 2024
• Study Completion: June 20, 2024
• Last Updated: June 22, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: One year after the end of the trial