MedDataX Logo

Comparison of the Efficacy of Irrigation With Epinephrine or Tranexamic Acid on Visual Clarity

NCT ID: NCT04628676

Last Updated: 2020-11-13

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-01

Study Completion Date

2020-01-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The primary aim of this report is to determine whether there is a difference between Epinephrine and Tranexamic acid in providing visual clarity during arthroscopic rotator cuff tear repair.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Rotator Cuff Tears

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

shoulder arthroscopy irrigation epinephrine image quality tranexamic acid cuff tear repair visual clarity

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

TXA group

tranexamic acid added to irrigation solution

Group Type EXPERIMENTAL

tranexamic acid

Intervention Type DRUG

Tranexamic acid is added to the irrigation fluid used in arthroscopic shoulder surgery.

EPN group

epinephrine added to irrigation solution

Group Type EXPERIMENTAL

Epinephrine

Intervention Type DRUG

Epinephrine is added to the irrigation fluid used in arthroscopic shoulder surgery.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

tranexamic acid

Tranexamic acid is added to the irrigation fluid used in arthroscopic shoulder surgery.

Intervention Type DRUG

Epinephrine

Epinephrine is added to the irrigation fluid used in arthroscopic shoulder surgery.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

TRANSAMINE %5 5 ml 250 mg ADRENALIN 0,5 mg/1 m

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* • Age \> 18 years

* American Society of Anesthesiologist Physical Status Classification System : 1-2
* Undergoing a full arthroscopic double-row repair due to full-thickness cuff tear
* Being willing to participate the study

Exclusion Criteria

* • Age \< 18 years

* American Society of Anesthesiologist Physical Status Classification System ≥3
* Concomitant cardiac diseases
* Concomitant bleeding disorder or coagulopathy
* Diabetes mellitus
* Being pregnant
* Use of contraceptive pills
* A history of previous shoulder surgery
* Uncontrolled hypertension during the operation (\>180/110 mm Hg)
* Unrepairable rotator cuff tears
* Being unwilling to participate the study
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Haseki Training and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

erhan bayram

medical doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Haseki Training and Research Hospital

Istanbul, , Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

saglik bilimleri university

Identifier Type: -

Identifier Source: org_study_id