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Intravenous Versus Intra-articular Tranexamic Acid for Visual Clarity During Arthroscopic Rotator Cuff Repair

29. juni 2026 opdateret af: Konkuk University Medical Center

The Effect of Intravenous Versus Intra-articular Tranexamic Acid on Visual Clarity During Arthroscopic Rotator Cuff Repair: A Prospective, Randomized, Double-blind Controlled Trial

This single-center, prospective, randomized, double-blind controlled trial evaluated whether intravenous (IV) or intra-articular (IA) administration of tranexamic acid (TXA) improves intraoperative visual clarity, compared with a no-TXA control, during arthroscopic rotator cuff repair. Patients with full-thickness rotator cuff tears were randomly allocated to one of three groups: a control group receiving no TXA; an IA group in which 500 mg of TXA was added to each 1 L of normal-saline irrigation fluid; and an IV group receiving 1000 mg of TXA intravenously 10 minutes before surgery. The operating surgeon graded visual clarity on a 0-10 numeric scale at the end of each of six predefined surgical stages. Secondary outcomes included total operative time, estimated blood loss, irrigation-fluid volume, the number of irrigation-pressure increases, postoperative shoulder swelling, and postoperative day 1 pain.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

122

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Sydkorea
    • Seoul
      • Seoul, Seoul, Sydkorea, 05030
        • Konkuk University Medical Center

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  • Age 18-80 years
  • Diagnosed with a rotator cuff tear
  • Failure of conservative treatment for more than 3 months
  • Rotator cuff deemed repairable on magnetic resonance imaging

Exclusion Criteria:

  • Known hypersensitivity to tranexamic acid
  • Previous cerebrovascular accident
  • Coronary stent or other history of thromboembolic disease
  • Anticoagulant therapy
  • Uncontrolled hypertension (systolic pressure > 180 mmHg)
  • Abnormal prothrombin time or activated partial thromboplastin time
  • Acute traumatic rotator cuff tear
  • Irreparable rotator cuff tear

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Ingen indgriben: Control
No tranexamic acid; arthroscopic rotator cuff repair performed with plain normal-saline irrigation.
Eksperimentel: Intra-articular TXA
Tranexamic acid 500 mg added to each 1 L of normal-saline irrigation fluid during arthroscopic rotator cuff repair.
Medicin: Tranexamic acid (intra-articular)
500 mg of tranexamic acid added per 1 L of normal-saline irrigation fluid.
Eksperimentel: Intravenous TXA
Tranexamic acid 1000 mg administered intravenously 10 minutes before surgery; plain normal-saline irrigation as in the control group.
Medicin: Tranexamic acid (intravenous)
1000 mg of tranexamic acid administered intravenously 10 minutes before surgery.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Intraoperative visual clarity
Tidsramme: Intraoperatively, at the end of each of the six surgical stages
Surgeon-rated clarity of the arthroscopic surgical field on a 0-10 numeric scale (0 = poorest visualization, 10 = optimal visualization), scored at the end of each of six surgical stages: glenohumeral procedure, subacromial bursectomy, acromioplasty, rotator cuff inspection, medial-row repair, and lateral-row repair.
Intraoperatively, at the end of each of the six surgical stages

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Total operative time
Tidsramme: Intraoperative (duration of surgery)
Total duration of the surgical procedure.
Intraoperative (duration of surgery)
Estimated blood loss
Tidsramme: From immediately before surgery to immediately after the end of surgery
Estimated blood loss calculated from serum hemoglobin measured before and after surgery using the formula described by Good et al.
From immediately before surgery to immediately after the end of surgery
Irrigation-fluid volume
Tidsramme: Intraoperatively, from skin incision to skin closure (duration of surgery)
Total volume of irrigation fluid used during the procedure.
Intraoperatively, from skin incision to skin closure (duration of surgery)
Number of irrigation-pressure increases
Tidsramme: Intraoperatively, from skin incision to skin closure (duration of surgery)
Number of times the irrigation pump pressure was increased to control bleeding affecting the surgical field
Intraoperatively, from skin incision to skin closure (duration of surgery)
Postoperative shoulder swelling
Tidsramme: Baseline (pre-operative) and postoperative day 1
Shoulder circumference and diameter measured at the axillary and deltoid sites with the arm abducted ~30 degrees, compared between pre-operative and postoperative day 1
Baseline (pre-operative) and postoperative day 1
Postoperative pain
Tidsramme: Pain assessed using the Visual Analog Scale (VAS) for pain, ranging from 0 (no pain) to 10 (worst imaginable pain); higher scores indicate worse outcome, on postoperative day 1
Pain assessed using a visual analog scale (VAS) on postoperative day 1
Pain assessed using the Visual Analog Scale (VAS) for pain, ranging from 0 (no pain) to 10 (worst imaginable pain); higher scores indicate worse outcome, on postoperative day 1

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Konkuk University Medical Center

Efterforskere

  • Ledende efterforsker: Seok Won Chung, MD, Konkuk University Medical Center

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

18. maj 2022

Primær færdiggørelse (Faktiske)

25. august 2023

Studieafslutning (Faktiske)

26. august 2023

Datoer for studieregistrering

Først indsendt

17. juni 2026

Først indsendt, der opfyldte QC-kriterier

29. juni 2026

Først opslået (Faktiske)

7. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

7. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

29. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2022-12-017

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

There is no plan to share individual participant data.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Betingelser

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