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OpenTrials
Completed

NCT Number: NCT06560073

Intravenous Tranexamic Acid in Diabetic Macular TRD 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?

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Key information

Conditions

Diabetic Retinopathy Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Endocrine System Diseases Eye Diseases Glucose Metabolism Disorders Macular Traction Retinal Detachment Metabolic Diseases Nutritional and Metabolic Diseases Retinal Diseases Vascular Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ahaliafoundation Eye Hospital

Palakkad, Kerala, 678557, India

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Number of systemic adverse events

    Time frame: intraoperatively and postoperatively 24 hours

    Safety of intravenous tranexamic acid

Secondary outcomes

  1. Number of systemic adverse events in patients having Chronic kidney disease

    Time frame: intraoperatively and postoperatively 24 hours

    Safety of intravenous tranexamic acid in Patients also having Chronic Kidney Disease

  2. Surgical time for vitrectomy

    Time frame: intraoperatively

    Surgical time for vitrectomy that is less view blurring because of intraoperative bleed

  3. Any relation between intraoperative use of Tranexamic acid and labetalol

    Time frame: intraoperatively

    labetalol dose needed

  4. Number of vitrectomies converted intraoperatively to bimanual technique

    Time frame: intraoperatively

    Highly complex surgeries

  5. Number of surgeries in which retinectomy required

    Time frame: intraoperatively

    Instances where it bleeds profusely and surgery could yet be completed successfully

  6. Number of surgeries in which Perfluorocarbon liquid had to be used

    Time frame: intraoperatively

    PFCL acts as third hand- denotes complexity of surgery

  7. Number of surgeries in which Internal Limiting Membrane peeling done

    Time frame: intraoperatively

    ilm peeling done after staining retina with Brilliant blue

  8. Number of eyes having preretinal bleed at the end of surgery

    Time frame: immediate postoperatively

    to find efficacy of Tranexamic acid in decreasing immediate post operative bleed

  9. Visual acuity change after surgery

    Time frame: 6 months postoperatively

    improvement in visual acuity

Sponsors and collaborators

Lead sponsor

Ahalia Foundation Eye Hospital

Other

Registry information

Official study title

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

Acronym: TXA-DMTRD

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Aug 19, 2024
Registry last updated
Aug 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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