Prostate Cancer
Conditions
Keywords
prostate cancer, radical prostatectomy, video laparoscopic prostatectomy, tranexamic acid
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.
Interventions
DRUGTranexamic 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.
OTHERPlacebo
Patients randomized to placebo group will receive physiological saline and will undergo to the radical video laparoscopu prostatectomy normally
Sponsors
Instituto do Cancer do Estado de São Paulo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, 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
Sex/Gender
MALE
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in serum Hemoglobin levels from preoperative to post operative levels | Baseline (Before) and 12 and 24 hours after surgery | The serum hemoglobin drop will be evaluated |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Estimated volume of bleeding | During surgery | Total blood loss will be assessed by the volume aspirated during surgery. |
| Transfusion rate of red blood cell concentrates | 12 and 24 hours after surgery | The amount of red blood cells concentrate transfused will be evaluated. |
| Adverse effects tranexamic acid | Up to 30 days after surgery | The adverse effects tranexamic acid administration will be evaluated. |
Contacts
Primary ContactCaio Brambilla, MD
Outcome results
None listed