Intravenous Tranexamic Acid in Diabetic Macular TRD Surgeries

NCT ID: NCT06560073

Last Updated: 2024-08-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

102 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-15

Study Completion Date

2022-10-31

Brief Summary

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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?

Detailed Description

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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.

Conditions

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Diabetic Retinopathy Macular Traction Retinal Detachment

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ahalia Foundation Eye Hospital

OTHER

Sponsor Role lead

Responsible Party

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Dr. Saurav Mahajan

Director Retina

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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RAJKUMAR MAHESHWARI, MS

Role: STUDY_DIRECTOR

Ahalia Foundation Eye Hospital

SAURAV MAHAJAN, MS

Role: PRINCIPAL_INVESTIGATOR

Ahalia Foundation Eye Hospital

AANCHAL MAINGI, DNB

Role: PRINCIPAL_INVESTIGATOR

AHALIA DIABETES HOSPITAL

Locations

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Ahaliafoundation Eye Hospital

Palakkad, Kerala, India

Site Status

Countries

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India

Other Identifiers

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U1111-1311-5449

Identifier Type: REGISTRY

Identifier Source: secondary_id

202101

Identifier Type: -

Identifier Source: org_study_id

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