Intraprostatic Injection of Tranexamic Acid Decrease Blood Loss During Monopolar TURP

Benign Prostatic Hyperplasia Clinical Trial

Official title:

Intraprostatic Injection of Tranexamic Acid Decrease Blood Loss During Monopolar TURP

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05913466
• Other study ID #: Rc 5-5-2022
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 20, 2023
• Est. completion date: June 20, 2024

Study information

• Verified date: June 2023
• Source: Benha University
• Contact: Tamer Diab, MD
• Phone: 01003583264
• Email: tamer.diab[@]fmed.bu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: June 20, 2024
• Est. primary completion date: June 20, 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years to 85 Years

Eligibility

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 5a-reductase inhibitors.

Related Conditions & MeSH terms

• Benign Prostatic Hyperplasia
• Hyperplasia
• Prostatic Hyperplasia
• Tranexamic Acid

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Benha University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Postoperative hospital stay length	Postoperative hospital stay length will be assessed in days	2 weeks Postoperatively