Intraprostatic Injection of Tranexamic Acid Decrease Blood Loss During Monopolar TURP

• Sponsor: Benha University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05913466
• Collaborator: (none)
• Enrollment: 60
• Arms: 2
• Anticipated Duration (Months): 12

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Benign Prostatic Hyperplasia; Transurethral Resection of the Prostate; Tranexamic Acid	Drug: Tranexamic Acid group; Drug: Distilled water group	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Intraprostatic Injection of Tranexamic Acid Decrease Blood Loss During Monopolar TURP
• Anticipated Study Start Date: Jun 20, 2023
• Anticipated Primary Completion Date: Jun 20, 2024
• Anticipated Study Completion Date: Jun 20, 2024

Arms and Interventions

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).

Outcome Measures

Primary Outcome Measures

1. Amount of Blood Loss During Monopolar transurethral resection of the prostate [2 weeks Postoperatively]

   The efficacy of intraprostatic injection of tranexamic acid in reducing intraoperative bleeding will be assessed in litter.

Secondary Outcome Measures

1. Hemoglobin (Hb) level [2 weeks Postoperatively]

   This outcome evaluates the changes in hemoglobin (Hb) level before and after the monopolar transurethral resection of the prostate (TURP) procedure.

2. Hematocrit (HCT) Level [2 weeks Postoperatively]

   This outcome evaluates the changes in hematocrit (HCT) level before and after the monopolar transurethral resection of the prostate (TURP) procedure.

3. Postoperative hospital stay length [2 weeks Postoperatively]

   Postoperative hospital stay length will be assessed in days

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years to 85 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Benha University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Tamer Abd El-Wahab Diab, Lecturer of Urology, Faculty of Medicine, Benha University, Benha, Egypt, Benha University
• ClinicalTrials.gov Identifier: NCT05913466
• Other Study ID Numbers: Rc 5-5-2022
• First Posted: Jun 22, 2023
• Last Update Posted: Jun 22, 2023
• Last Verified: Jun 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Prostatic Hyperplasia; Hyperplasia; Tranexamic Acid

Study Results

No Results Posted as of Jun 22, 2023