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

August 30, 2020 updated by: Dalia Mohamed Abbas, Assiut University

Intraoperative Tranexamic Acid Infusion in Low Dose Versus in High Dose for Reducing Blood Loss and Its Effect on Postoperative Thromboembolic Complications in Radical Cystectomy Operations

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% .

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: Tranexamic acid
Intraoperative infusion
Other: Normal saline
intravenous infusion
Active Comparator: 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.
Drug: Tranexamic acid
Intraoperative infusion
Other: Normal saline
intravenous infusion
Placebo Comparator: Third group
3rd group (C){controlled group} will include 30 patients: each one will receive saline (placebo) injection and infusion all through the operation.
Other: Normal saline
intravenous infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect of low dose and high dose tranexemic acid infusion on Intraoperative blood loss .
Time Frame: within the first 15 days
Estimated Blood Loss and perioperative need for blood transfusion within the first 15 days .
within the first 15 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative thromboembolic events
Time Frame: within the first 15 days
Post operative complications as deep venous thrombosis, pulmonary embolism, MI, cerebral stroke, blurred vision and seizures within the first 15 days .
within the first 15 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 1, 2020

Primary Completion (Anticipated)

September 1, 2021

Study Completion (Anticipated)

March 1, 2022

Study Registration Dates

First Submitted

August 30, 2020

First Submitted That Met QC Criteria

August 30, 2020

First Posted (Actual)

September 3, 2020

Study Record Updates

Last Update Posted (Actual)

September 3, 2020

Last Update Submitted That Met QC Criteria

August 30, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BRC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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