Tranexamic Acid Infusion in Low Dose Versus in High Dose for Reducing Blood Loss in Radical Cystectomy Operations

NCT ID: NCT04537533

Last Updated: 2020-09-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-30
• Study Completion Date: 2022-03-31

Brief Summary

Bladder cancer is one of the most common cancers of the genitourinary tract in adults, and its incidence distinctly increases with age . In almost two-thirds of cases, the disease is superficial at presentation and involves the mucosal and sub mucosal layers or the lamina propria of the bladder, whereas ∼20% to 30% of patients have muscle-invasive tumors. Superficial bladder cancer is treated by transurethral endoscopic resection, which can be followed by endovesical therapy for patients at risk of disease recurrence and progression . In contrast, muscle-invasive bladder cancer is generally treated by radical cystectomy with pelvic lymph node dissection and then creation of urinary diversion to create an alternate route for urine passage, which demonstrates 10-year recurrence-free survival rates of 50% to 59% and overall survival rates of ∼45% .

These major surgeries have a prolonged operative times and are associated with significant risk of complications including high risk of perioperative bleeding and subsequent need for blood transfusion with significant postoperative complications, which are reportedly in the range of 24% to 64% .

Detailed Description

Among individual surgeons at institutions that perform many procedures, median intraoperative blood loss is between 600 and 1700 mL. The incidence of at least one intraoperative blood transfusion is 9 to 67%, and the postoperative transfusion risk is at least 15%. Among cystectomy patients who receive transfusion, a median of 2 units of blood cells are given. Therefore, it is very important to establish surgical and anesthetic protocols aimed at minimizing intraoperative blood loss and subsequent blood transfusion requirements in order to improve postoperative outcomes.

Venous thromboembolism (VTE) in radical cystectomy can account for up to 22% of total deaths after surgery . In the bladder cancer literature, symptomatic thromboembolic events occur in up to 8.3% of patients , but subclinical deep vein thrombosis (DVT) rates can be as high as 24.4% when examining an ultrasonography (US)-screened population . In fact, undergoing a RC is a significant, independent risk factor on multivariable analysis for developing a deep venous thrombosis.

Lysine analog drugs are synthetic derivatives of the amino acid lysine that reversibly block lysine-binding sites on plasminogen molecules. This action prevents the conversion of plasminogen to plasmin, the active enzyme that degrades fibrin clots. Therefore, lysine analogs decrease the breakdown of clots and are considered anti-fibrinolytics. There are two commonly studied lysine analogs, tranexamic acid and epsilon-aminocaproic acid. Both of these drugs have been shown to decrease blood loss and blood transfusion need during some surgeries without a significant increase in adverse events.

Conditions

Bleeding

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

first group

1st group (A) will include 30 patients: each one will receive 15mg/kg of I.V tranexemic acid as a bolus over 10 minutes (loading dose) then 10mg/kg/hour of I.V tranexemic acid as infusion all through the operation.

Group Type: EXPERIMENTAL

Tranexamic acid

Intervention Type: DRUG

Intraoperative infusion

Normal saline

Intervention Type: OTHER

intravenous infusion

second group

2nd group (B) will include 30 patients: : each one will receive 5mg/kg of I.V tranexemic acid as a bolus over 10 minutes (loading dose) then 1mg/kg/hour of I.V tranexemic acid as infusion all through the operation.

Group Type: ACTIVE_COMPARATOR

Tranexamic acid

Intervention Type: DRUG

Intraoperative infusion

Normal saline

Intervention Type: OTHER

intravenous infusion

Third group

3rd group (C){controlled group} will include 30 patients: each one will receive saline (placebo) injection and infusion all through the operation.

Group Type: PLACEBO_COMPARATOR

Normal saline

Intervention Type: OTHER

intravenous infusion

Interventions

Tranexamic acid

Intraoperative infusion

Intervention Type: DRUG

Normal saline

intravenous infusion

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Age: 18 - 70 years old
• Gender: Males and females
• ASA grade I - II
• Patients undergoing radical cystectomy for bladder cancer regardless of tumor stage and histology.
• Patients who have undergone previous surgery, radiation, or chemotherapy may be included.
• All forms of urinary diversion are allowed

Exclusion Criteria

• Patient refusal.
• Patient with allergy to tranexamic acid.
• Patients have thromboembolic disease (active or diagnosed within 1 year), such as deep vein thrombosis (DVT), pulmonary embolism (PE), cerebral thrombosis or MI.
• Pregnancy.
• Patients with hematuria.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Dalia Mohamed Abbas

principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Mohamed Reda Abdelaziz, Professor

Role: CONTACT

mohamed.hassan19@med.au.edu.eg

01003919165

Ahmed Mokhtar Fathy, Lecturer

Role: CONTACT

ahmedmokhtar_80@aun.edu.eg

01063317380

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Other Identifiers

BRC

Identifier Type: -

Identifier Source: org_study_id