Tranexamic Acid's Effects in Patients Undergoing Laparoscopic Radical Prostatectomy: a Randomized, Double-blind, Placebo-controlled Trial
Trial Snapshot
- Phase
- Phase 3
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 122
- Primary Endpoint
- Change in serum Hemoglobin levels from preoperative to post operative levels
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- 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.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
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
Intervention: Tranexamic acid (Drug)
Placebo Group
Patients undergoinf to videolaparoscopic surgery will receive physcological saline as placebo under the same conditions of the tranexamic acid group.
Intervention: Placebo (Other)
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Estimated volume of bleeding(During surgery)
- Adverse effects tranexamic acid(Up to 30 days after surgery)
- Transfusion rate of red blood cell concentrates(12 and 24 hours after surgery)
Investigators
CAIO BRAMBILLA
MD
Instituto do Cancer do Estado de São Paulo