Intravenous Tranexamic Acid in Diabetic Macular TRD Surgeries

NCT06560073 | Completed

• 2 other identifiers: 202101U1111-1311-5449
• Study Type: observational
• Target: 102
• Locations: 1 country
• Sites: 1

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?

Conditions

Diabetic Retinopathy; Macular Traction Retinal Detachment

Keywords

tranexamic acid; diabetes mellitus; macular TRD

Outcome Measures

Primary Outcomes (1)

• Number of systemic adverse events

  Safety of intravenous tranexamic acid

  intraoperatively and postoperatively 24 hours

Secondary Outcomes (9)

• Number of systemic adverse events in patients having Chronic kidney disease

  intraoperatively and postoperatively 24 hours

• Surgical time for vitrectomy

  intraoperatively

• Any relation between intraoperative use of Tranexamic acid and labetalol

  intraoperatively

• Number of vitrectomies converted intraoperatively to bimanual technique

  intraoperatively

• Number of surgeries in which retinectomy required

  intraoperatively

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ahalia Foundation Eye Hospital: lead

Study Sites (1)

Ahaliafoundation Eye Hospital

Palakkad, Kerala, 678557, India

Location

MeSH Terms

Conditions

Diabetic Retinopathy; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Endocrine System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• RAJKUMAR MAHESHWARI, MS

  Ahalia Foundation Eye Hospital

  STUDY DIRECTOR

• SAURAV MAHAJAN, MS

  Ahalia Foundation Eye Hospital

  PRINCIPAL INVESTIGATOR

• AANCHAL MAINGI, DNB

  AHALIA DIABETES HOSPITAL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director Retina

Study Record Dates

• First Submitted: August 15, 2024
• First Posted: August 19, 2024
• Study Start: January 15, 2021
• Primary Completion: April 30, 2022
• Study Completion: October 31, 2022
• Last Updated: August 19, 2024

Record last verified: 2024-08

Locations

IN (1)