Tranexamic Acid's Effects in Patients Undergoing Laparoscopic Radical Prostatectomy (Transamin)

April 17, 2023 updated by: CAIO BRAMBILLA, Instituto do Cancer do Estado de São Paulo

Tranexamic Acid's Effects in Patients Undergoing Laparoscopic Radical Prostatectomy: a Randomized, Double-blind, Placebo-controlled Trial

The study is randomized, placebo-controlled, double-blind clinical trial that aims to check whether tranexamic acid's use in videolaparoscopic radical prostatectomy intraoperative is effective in decrease serum hemoglobin drop and the amount of blood's transfusion.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The study aims to check whether tranexamic acid's use in videolaparoscopic radical prostatectomy intraoperative is effective in decrease serum hemoglobin drop and the amount of blood's transfusion.

Therefore it will be a randomized, placebo-controlled, double-blind clinical trial that intends to recruit 122 patients with radical prostatectomy indication who agreed to consent study inclusion.

Patients randomized to intervention group will receive 1,0g of tranexamic acid IV during anesthetic induction, followed by a maintenance dose of 1,0 mg/kg/hour of surgery. Control group will be operated normally.

Data as hemoglobin drop, estimated bleeding volume, need to transfusion, side effects, and presence of lymphocele will be compared between the two groups.

Study Type

Interventional

Enrollment (Anticipated)

122

Phase

  • Phase 3

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

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients over 18 years olds;
  • Who accept to participate and sign the consent form;
  • Compliance with the study follow-up protocol;
  • Diagnosed with localized prostate cancer with surgical indication without or with lymphadenectomy.

Exclusion Criteria:

  • Coronary artery disease treated with drug-using stent;
  • Previous coronary procedures or coronary disease using a stent;
  • Acute or chronic liver failure;
  • Severe chronic renal failure (ClCr < 30 mL/Kg.h, according to the Modification of Diet in Renal Disease formula);
  • Suspected allergy to tranexamic acid;
  • Known coagulopathies and refusal to sign consent form.

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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tranexamic Acid Group
Patients will receive an attack solution of 1,0 g of tranexamic acid 20 minutes before the surgery beginning, followed by a maintence dose of 1,0 mg/kg/h in pump surgery infusion
Drug: Tranexamic acid
Patients with prostate cancer and radical video laparoscopy prostatectomy indication will receive 1,0g of Tranexamic Acid solution IV in bolus 20 minutes before of anesthetic induction, followed by a maintenance hose of 1,0mg/kg/h of surgery.
Other Names:
  • Transamin
Placebo Comparator: Placebo Group
Patients undergoinf to videolaparoscopic surgery will receive physcological saline as placebo under the same conditions of the tranexamic acid group.
Other: Placebo
Patients randomized to placebo group will receive physiological saline and will undergo to the radical video laparoscopu prostatectomy normally

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in serum Hemoglobin levels from preoperative to post operative levels
Time Frame: Baseline (Before) and 12 and 24 hours after surgery
The serum hemoglobin drop will be evaluated
Baseline (Before) and 12 and 24 hours after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Estimated volume of bleeding
Time Frame: During surgery
Total blood loss will be assessed by the volume aspirated during surgery.
During surgery
Transfusion rate of red blood cell concentrates
Time Frame: 12 and 24 hours after surgery
The amount of red blood cells concentrate transfused will be evaluated.
12 and 24 hours after surgery
Adverse effects tranexamic acid
Time Frame: Up to 30 days after surgery
The adverse effects tranexamic acid administration will be evaluated.
Up to 30 days after surgery

Collaborators and Investigators

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

Sponsor

Instituto do Cancer do Estado de São Paulo

Investigators

  • Principal Investigator: Rafael Ferreira Coelho, MD, PhD, Instituto do Cancer do Estado de Sao Paulo

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)

April 1, 2023

Primary Completion (Anticipated)

April 1, 2024

Study Completion (Anticipated)

September 1, 2024

Study Registration Dates

First Submitted

December 22, 2022

First Submitted That Met QC Criteria

April 17, 2023

First Posted (Actual)

April 18, 2023

Study Record Updates

Last Update Posted (Actual)

April 18, 2023

Last Update Submitted That Met QC Criteria

April 17, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NP2011/2021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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