Intravenous Tranexamic Acid in Diabetic Macular TRD Surgeries (TXA-DMTRD)

Safety & Results of Peroperative and Intraoperative Intravenous Tranexamic Acid in Diabetic Macular Tractional Retinal Detachment Surgeries

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?

Study Overview

• Status: Completed
• Conditions: Diabetic Retinopathy; Macular Traction Retinal Detachment

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 0.5 g was added upto maximum of 2 g. In Chronic kidney Disease patients dose was kept as maximum of 1.5 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 Type: Observational
• Enrollment (Actual): 102

Contacts and Locations

Study Locations

• India
  • Kerala
    • Palakkad, Kerala, India, 678557
      • Ahaliafoundation Eye Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

diabetic patients having Macular tractional retinal detachment who visited Retina department, Ahalia foundation eye hospital, palakkad, underwent surgery and gave informed written consent to be included in study

Description

Inclusion Criteria:

• Eyes of Diabetic patients having Macular Tractional Retinal detachment confirmed on Indirect Ophthalmoscope or B scan when associated with Vitreous hemorrhage or Optical Coherence Tomography

Exclusion Criteria:

• Pregnancy, lactation, Oral Contraceptive use, within 6 months thromboembolic disease ,Underlying cardiac arrhythmia where anticoagulation is indicated ,Seizures Severe liver disease,previous history of variceal bleeding ,Allergic history to Tranexamic acid

Ophthalmic exclusion criteria Previous vitreoretinal surgery Combination of tractional and rhegmatogenous retinal detachment Coexisting macular hole Macular dystrophies Arterial or venous occlusions Age related macular degeneration Extensive macular scarring Posterior segment inflammation

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of systemic adverse events	Safety of intravenous tranexamic acid	intraoperatively and postoperatively 24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of systemic adverse events in patients having Chronic kidney disease	Safety of intravenous tranexamic acid in Patients also having Chronic Kidney Disease	intraoperatively and postoperatively 24 hours
Surgical time for vitrectomy	Surgical time for vitrectomy that is less view blurring because of intraoperative bleed	intraoperatively
Any relation between intraoperative use of Tranexamic acid and labetalol	labetalol dose needed	intraoperatively
Number of vitrectomies converted intraoperatively to bimanual technique	Highly complex surgeries	intraoperatively
Number of surgeries in which retinectomy required	Instances where it bleeds profusely and surgery could yet be completed successfully	intraoperatively
Number of surgeries in which Perfluorocarbon liquid had to be used	PFCL acts as third hand- denotes complexity of surgery	intraoperatively
Number of surgeries in which Internal Limiting Membrane peeling done	ilm peeling done after staining retina with Brilliant blue	intraoperatively
Number of eyes having preretinal bleed at the end of surgery	to find efficacy of Tranexamic acid in decreasing immediate post operative bleed	immediate postoperatively
Visual acuity change after surgery	improvement in visual acuity	6 months postoperatively

Collaborators and Investigators

• Sponsor: Ahalia Foundation Eye Hospital
• Investigators: Study Director: RAJKUMAR MAHESHWARI, MS, Ahalia Foundation Eye Hospital; Principal Investigator: Saurav Mahajan, MS, Ahalia Foundation Eye Hospital; Principal Investigator: AANCHAL MAINGI, DNB, AHALIA DIABETES HOSPITAL

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2021
• Primary Completion (Actual): April 30, 2022
• Study Completion (Actual): October 31, 2022

Study Registration Dates

• First Submitted: August 15, 2024
• First Submitted That Met QC Criteria: August 15, 2024
• First Posted (Actual): August 19, 2024

Study Record Updates

• Last Update Posted (Actual): August 19, 2024
• Last Update Submitted That Met QC Criteria: August 15, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: tranexamic acid; diabetes mellitus; macular TRD
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Endocrine System Diseases; Diabetic Angiopathies; Diabetes Complications; Diabetes Mellitus; Retinal Diseases; Diabetic Retinopathy; Retinal Detachment
• Other Study ID Numbers: 202101; U1111-1311-5449 (Registry Identifier: WHO UTN)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No