Tranexamic Acid's Effects in Patients Undergoing Laparoscopic Radical Prostatectomy
NCT ID: NCT05816668
Last Updated: 2023-04-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
122 participants
INTERVENTIONAL
2023-04-30
2024-09-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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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
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.
Placebo Group
Patients undergoinf to videolaparoscopic surgery will receive physcological saline as placebo under the same conditions of the tranexamic acid group.
Placebo
Patients randomized to placebo group will receive physiological saline and will undergo to the radical video laparoscopu prostatectomy normally
Interventions
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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.
Placebo
Patients randomized to placebo group will receive physiological saline and will undergo to the radical video laparoscopu prostatectomy normally
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
MALE
No
Sponsors
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Instituto do Cancer do Estado de São Paulo
OTHER
Responsible Party
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CAIO BRAMBILLA
MD
Principal Investigators
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Rafael Ferreira Coelho, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Instituto do Câncer do Estado de São Paulo
Central Contacts
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References
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Other Identifiers
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NP2011/2021
Identifier Type: -
Identifier Source: org_study_id
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