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CompletedNCT04628676Updated Nov 13, 2020

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

An interventional study of tranexamic acid and Epinephrine in Rotator Cuff Tears, sponsored by Haseki Training and Research Hospital. Completed at 1 site in Turkey. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-11-13.

Sponsored by Haseki Training and Research Hospital · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Registered 3 years 8 months after the study started (first participant enrolled Feb 2017, registered Oct 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Rotator Cuff Tears

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Keywords

  • shoulder arthroscopy
  • irrigation
  • epinephrine
  • image quality
  • tranexamic acid
  • cuff tear repair
  • visual clarity
03

In context

Rotator Cuff Injuries

734 studies on the registry are indexed under Rotator Cuff Injuries; 161 are open to participants now.

This study's enrollment of 100 is above the median of 60 across 538 interventional studies indexed under Rotator Cuff Injuries.

Browse Rotator Cuff Injuries studies →

Lead sponsor

Haseki Training and Research Hospital is the lead sponsor of 75 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
100 participants (actual)

Study arms

  • Experimental
    TXA group

    tranexamic acid added to irrigation solution

    Drug: tranexamic acid

  • Experimental
    EPN group

    epinephrine added to irrigation solution

    Drug: Epinephrine

Interventions

  • Drugtranexamic acid

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

    Also known as: TRANSAMINE %5 5 ml 250 mg

  • DrugEpinephrine

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

    Also known as: ADRENALIN 0,5 mg/1 m

06

What researchers measure

Primary outcomes

  1. Visual analog scale

    Visual analog scale will be rated by surgeon. While 0 is the worst score with no clear vision, 10 was noted as the best score for visual clarity.

    Time frame: through study completion, an average of 2 year

Secondary outcomes

  1. total operating time

    period in minutes from the time the arthroscope was inserted into the glenohumeral joint until the termination of the arthroscopic procedure

    Time frame: through study completion, an average of 2 year

  2. average mean arterial pressure

    mean arterial pressure per operation.

    Time frame: through study completion, an average of 2 year

07

Study locations

1 site
  • Haseki Training and Research Hospital
    Istanbul, Turkey
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 13, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04628676
Lead sponsor
Haseki Training and Research Hospital
Responsible party
erhan bayram (medical doctor, Haseki Training and Research Hospital) — Principal investigator
First posted
Nov 13, 2020
Start date
Feb 1, 2017
Primary completion
Dec 30, 2019
Completion
Jan 30, 2020
Last update
Nov 13, 2020

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.

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