Ignite Creation Date:
2024-05-06 @ 6:52 PM
Last Modification Date:
2024-10-26 @ 2:56 PM
Study NCT ID:
NCT05816668
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-04-18
First Post:
2022-12-22
Brief Title:
Tranexamic Acids Effects in Patients Undergoing Laparoscopic Radical Prostatectomy
Sponsor:
Instituto do Cancer do Estado de São Paulo
Organization:
Instituto do Cancer do Estado de São Paulo
Study Overview
Official Title:
Tranexamic Acids Effects in Patients Undergoing Laparoscopic Radical Prostatectomy a Randomized Double-blind Placebo-controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Transamin
Brief Summary:
The study is randomized placebo-controlled double-blind clinical trial that aims to check whether tranexamic acids use in videolaparoscopic radical prostatectomy intraoperative is effective in decrease serum hemoglobin drop and the amount of bloods transfusion
Detailed Description:
The study aims to check whether tranexamic acids use in videolaparoscopic radical prostatectomy intraoperative is effective in decrease serum hemoglobin drop and the amount of bloods 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 10g of tranexamic acid IV during anesthetic induction followed by a maintenance dose of 10 mgkghour 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
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 10g of tranexamic acid IV during anesthetic induction followed by a maintenance dose of 10 mgkghour 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None