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Intraprostatic Injection of Tranexamic Acid Decrease Blood Loss During Monopolar TURP

Primary Purpose

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

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Tranexamic Acid group
Distilled water group
Sponsored by
Benha University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Benign Prostatic Hyperplasia

Eligibility Criteria

50 Years - 85 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Tranexamic Acid group

    Distilled water group

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

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

    Full Information

    First Posted
    June 5, 2023
    Last Updated
    June 12, 2023
    Sponsor
    Benha University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05913466
    Brief Title
    Intraprostatic Injection of Tranexamic Acid Decrease Blood Loss During Monopolar TURP
    Official Title
    Intraprostatic Injection of Tranexamic Acid Decrease Blood Loss During Monopolar TURP
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    June 20, 2023 (Anticipated)
    Primary Completion Date
    June 20, 2024 (Anticipated)
    Study Completion Date
    June 20, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Benha University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Benign Prostatic Hyperplasia, Transurethral Resection of the Prostate, Tranexamic Acid

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Tranexamic Acid group
    Arm Type
    Experimental
    Arm Description
    Patients in this group will receive 1 gm of Tranexamic Acid (Cyklokapron) that will be dissolved in 50 ml of injectable 0.9% saline
    Arm Title
    Distilled water group
    Arm Type
    Placebo Comparator
    Arm Description
    This group will receive 10 mL of distilled water (placebo) in 1 L of irrigation solution sterile wash (glycine).
    Intervention Type
    Drug
    Intervention Name(s)
    Tranexamic Acid group
    Intervention Description
    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
    Intervention Name(s)
    Distilled water group
    Intervention Description
    This group will receive 10 mL of distilled water (placebo) in 1 L of irrigation solution sterile wash (glycine).
    Primary Outcome Measure Information:
    Title
    Amount of Blood Loss During Monopolar transurethral resection of the prostate
    Description
    The efficacy of intraprostatic injection of tranexamic acid in reducing intraoperative bleeding will be assessed in litter.
    Time Frame
    2 weeks Postoperatively
    Secondary Outcome Measure Information:
    Title
    Hemoglobin (Hb) level
    Description
    This outcome evaluates the changes in hemoglobin (Hb) level before and after the monopolar transurethral resection of the prostate (TURP) procedure.
    Time Frame
    2 weeks Postoperatively
    Title
    Hematocrit (HCT) Level
    Description
    This outcome evaluates the changes in hematocrit (HCT) level before and after the monopolar transurethral resection of the prostate (TURP) procedure.
    Time Frame
    2 weeks Postoperatively
    Title
    Postoperative hospital stay length
    Description
    Postoperative hospital stay length will be assessed in days
    Time Frame
    2 weeks Postoperatively

    10. Eligibility

    Sex
    Male
    Gender Based
    Yes
    Gender Eligibility Description
    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.
    Minimum Age & Unit of Time
    50 Years
    Maximum Age & Unit of Time
    85 Years
    Accepts Healthy Volunteers
    No
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Tamer Diab, MD
    Phone
    01003583264
    Ext
    +2
    Email
    tamer.diab@fmed.bu.edu.eg

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing 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

    Learn more about this trial

    Intraprostatic Injection of Tranexamic Acid Decrease Blood Loss During Monopolar TURP

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