Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06560073
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-08-15
Brief Title:
Intravenous Tranexamic Acid in Diabetic Macular TRD Surgeries
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Safety Results of Peroperative and Intraoperative Intravenous Tranexamic Acid in Diabetic Macular Tractional Retinal Detachment Surgeries
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TXA-DMTRD
Brief Summary:
The goal of this observational study is to learn about safety and results of peroperative and intraoperative intravenous Tranexamic acid for diabetic macular tractional detachment eye surgeries The main question it aims to answer is
Adverse events and their frequency immediate postoperative bleeding incidence effective vitrectomy time
Adverse events and their frequency immediate postoperative bleeding incidence effective vitrectomy time
Detailed Description:
all Patients who agreed and gave informed consent forsurgery as well as to be included in study were included
Patients injected INTRAVENOUS TRANEXAMIC ACID 500 mg diluted to 10 ml with normal saline slowly in immediate preoperative period Accordingly whenever bleeding was anticipated before removing active taut membranes or when bleeder was noted TXA 05 g was added upto maximum of 2 g In Chronic kidney Disease patients dose was kept as maximum of 15 g
data analysis pack of microsoft excel will be used for statistical analysis descriptive statistics will be applied wherever mean of continuous variables is to be compared among subgroups unpaired students t test will be used To find any relationship among continuous variables pearsons correlation or multiple regression will be used from data analysis pack of microsoft excel
Patients injected INTRAVENOUS TRANEXAMIC ACID 500 mg diluted to 10 ml with normal saline slowly in immediate preoperative period Accordingly whenever bleeding was anticipated before removing active taut membranes or when bleeder was noted TXA 05 g was added upto maximum of 2 g In Chronic kidney Disease patients dose was kept as maximum of 15 g
data analysis pack of microsoft excel will be used for statistical analysis descriptive statistics will be applied wherever mean of continuous variables is to be compared among subgroups unpaired students t test will be used To find any relationship among continuous variables pearsons correlation or multiple regression will be used from data analysis pack of microsoft excel
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None