Tranexamic Acid's Effects in Patients Undergoing Laparoscopic Radical Prostatectomy

Prostate Cancer Clinical Trial

— Transamin  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05816668
• Other study ID #: NP2011/2021
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: April 2023
• Est. completion date: September 2024

Study information

• Verified date: April 2023
• Source: Instituto do Cancer do Estado de São Paulo
• Contact: Caio Brambilla, MD
• Phone: +554499167029
• Email: caiobram[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 122
• Est. completion date: September 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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:
• Placebo
Patients randomized to placebo group will receive physiological saline and will undergo to the radical video laparoscopu prostatectomy normally

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Instituto do Cancer do Estado de São Paulo

References & Publications (33)

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* Note: There are 33 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in serum Hemoglobin levels from preoperative to post operative levels	The serum hemoglobin drop will be evaluated	Baseline (Before) and 12 and 24 hours after surgery
Secondary	Estimated volume of bleeding	Total blood loss will be assessed by the volume aspirated during surgery.	During surgery
Secondary	Transfusion rate of red blood cell concentrates	The amount of red blood cells concentrate transfused will be evaluated.	12 and 24 hours after surgery
Secondary	Adverse effects tranexamic acid	The adverse effects tranexamic acid administration will be evaluated.	Up to 30 days after surgery