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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tranexamic Acid Group | Experimental | 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 |
|
| Placebo Group | Placebo Comparator | Patients undergoinf to videolaparoscopic surgery will receive physcological saline as placebo under the same conditions of the tranexamic acid group. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tranexamic acid | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Estimated volume of bleeding | Total blood loss will be assessed by the volume aspirated during surgery. | During surgery |
| Transfusion rate of red blood cell concentrates | The amount of red blood cells concentrate transfused will be evaluated. |
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Inclusion Criteria:
Exclusion Criteria:
Patients diagnosed with localized prostate cancer
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Caio Brambilla, MD | Contact | +554499167029 | caiobram@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Rafael Ferreira Coelho, MD, PhD | Instituto do Câncer do Estado de São Paulo | Principal Investigator |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33538338 | Background | Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4. | |
| 18027095 | Background | Etzioni R, Tsodikov A, Mariotto A, Szabo A, Falcon S, Wegelin J, DiTommaso D, Karnofski K, Gulati R, Penson DF, Feuer E. Quantifying the role of PSA screening in the US prostate cancer mortality decline. Cancer Causes Control. 2008 Mar;19(2):175-81. doi: 10.1007/s10552-007-9083-8. Epub 2007 Nov 20. |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
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| ID | Term |
|---|---|
| D014148 | Tranexamic Acid |
| ID | Term |
|---|---|
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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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.
|
| Placebo | Other | Patients randomized to placebo group will receive physiological saline and will undergo to the radical video laparoscopu prostatectomy normally |
|
| 12 and 24 hours after surgery |
| Adverse effects tranexamic acid | The adverse effects tranexamic acid administration will be evaluated. | Up to 30 days after surgery |
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| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |