NCT07442643

Brief Summary

This single-center randomized controlled trial was designed to compare epinephrine-added irrigation fluid with an intravenous tranexamic acid (TXA) protocol during arthroscopic rotator cuff repair. The primary outcome measure was surgeon-rated surgical field visibility. Secondary outcome measures included arthroscopic pump pressure, total irrigation volume, and early postoperative shoulder soft-tissue edema assessed at 24 hours.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2021

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

January 15, 2026

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 2, 2026

Completed
Last Updated

March 2, 2026

Status Verified

February 1, 2026

Enrollment Period

2.7 years

First QC Date

January 15, 2026

Last Update Submit

February 27, 2026

Conditions

Rotator Cuff Tear

Keywords

rotator cuff repairshoulder arthroscopyepinephrinetranexamic acid

Outcome Measures

Primary Outcomes (1)

  • Surgical field visibility

    Surgical field visibility assessed using a 0-10 visual analog scale (VAS), calculated as the mean of scores independently assigned by two surgeons.

    Intraoperative (during arthroscopic rotator cuff repair)

Secondary Outcomes (6)

  • Mean arthroscopic pump pressure (mmHg)

    Intraoperative (during procedure; mean value recorded)

  • Total irrigation volume (liters)

    Intraoperative (total volume used during procedure)

  • Axillary circumference change (cm)

    Preoperative and postoperative 24 hours

  • Deltoid circumference change (cm)

    Preoperative and postoperative 24 hours

  • Early postoperative complications

    Up to 24 hours postoperatively (or during hospitalization)

  • +1 more secondary outcomes

Study Arms (2)

ARM 1: Epinephrine-Added Irrigation Group

ACTIVE COMPARATOR

Participants underwent arthroscopic rotator cuff repair using irrigation fluid containing epinephrine at a concentration of 0.33 mg/L throughout the procedure.

Drug: Epinephrine in irrigation fluid

ARM2: Intravenous Tranexamic Acid (TXA) Group

EXPERIMENTAL

Participants received an intravenous tranexamic acid protocol consisting of a 15 mg/kg bolus administered 10 minutes before surgery, followed by continuous infusion at 10 mg/kg/hour during arthroscopic rotator cuff repair.

Drug: Tranexamic acid, intravenous

Interventions

Epinephrine in irrigation fluidDRUG

Description: Epinephrine added to irrigation fluid at a concentration of 0.33 mg/L during arthroscopic rotator cuff repair.

ARM 1: Epinephrine-Added Irrigation Group
Tranexamic acid, intravenousDRUG

Description: Intravenous tranexamic acid administered as a 15 mg/kg bolus before surgery followed by continuous infusion at 10 mg/kg/hour during arthroscopic rotator cuff repair.

ARM2: Intravenous Tranexamic Acid (TXA) Group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18-70 years
  • MRI-confirmed full-thickness rotator cuff tear
  • Planned primary arthroscopic rotator cuff repair
  • Written informed consent obtained

You may not qualify if:

  • Age \>70 years
  • Advanced cardiovascular disease (advanced heart failure, uncontrolled hypertension, active ischemic heart disease)
  • Significant renal impairment
  • History of thromboembolic disease
  • Contraindication to tranexamic acid
  • Irreparable massive tear with advanced fatty degeneration or severe muscle atrophy
  • Revision surgery
  • Planned concomitant open surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Umraniye Training and Research Hospital

Istanbul, 34766, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Rotator Cuff Injuries

Interventions

EpinephrineTranexamic Acid

Condition Hierarchy (Ancestors)

RuptureWounds and InjuriesShoulder InjuriesTendon Injuries

Intervention Hierarchy (Ancestors)

EthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesBiogenic MonoaminesBiogenic AminesCatecholaminesCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsCyclohexanecarboxylic AcidsAcids, CarbocyclicCarboxylic Acids

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
No additional parties were masked other than the blinded outcome assessor.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Parallel assignment design in which participants were randomized to receive either epinephrine-added irrigation or an intravenous tranexamic acid protocol during arthroscopic rotator cuff repair.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 15, 2026

First Posted

March 2, 2026

Study Start

May 1, 2021

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

March 2, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared.

Locations

TU(1)