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Trial Title:
Tranexamic Acid's Effects in Patients Undergoing Laparoscopic Radical Prostatectomy
NCT ID:
NCT05816668
Condition:
Prostate Cancer
Conditions: Official terms:
Prostatic Neoplasms
Tranexamic Acid
Conditions: Keywords:
prostate cancer
radical prostatectomy
video laparoscopic prostatectomy
tranexamic acid
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Prevention
Masking:
Triple (Participant, Care Provider, Investigator)
Masking description:
Just ICESP's Clinical Research Pharmacy team will be not blinded. The surgical and
anesthetic teams will be blinded in relation to the placebo or tranexamic acid
intervention during the preoperative period and during the postoperative follow-up and,
if any case loses the blinding, it will be excluded from the analysis. The preparation of
packaging, dilution and dispensing or the material containing tranexamic acid or placebo
will be carried out by the ICESP's Clinical Research Pharmacy division.
Intervention:
Intervention type:
Drug
Intervention name:
Tranexamic acid
Description:
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.
Arm group label:
Tranexamic Acid Group
Other name:
Transamin
Intervention type:
Other
Intervention name:
Placebo
Description:
Patients randomized to placebo group will receive physiological saline and will undergo
to the radical video laparoscopu prostatectomy normally
Arm group label:
Placebo Group
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.
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.
Criteria for eligibility:
Criteria:
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.
Gender:
Male
Gender based:
Yes
Gender description:
Patients diagnosed with localized prostate cancer
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
April 2023
Completion date:
September 2024
Lead sponsor:
Agency:
Instituto do Cancer do Estado de São Paulo
Agency class:
Other
Source:
Instituto do Cancer do Estado de São Paulo
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05816668
