Shoulder arthroscopy. MedDRA version: 20.0 Level: LLT Classification code 10077421 Term: Shoulder arthroscopy System Organ Class: 100000004848
Conditions
Interventions
Trade Name: EXACYL
Pharmaceutical Form: Solution for injection
INN or Proposed INN: TRANEXAMIC ACID
Other descriptive name: TRANEXAMIC ACID
Concentration unit: mg/kg milligram(s)/kilogram
Concentratio
Sponsors
Polyclinique Jean Villar - Bruges
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1 - Male or female aged 18 years old or more; 2- Patient requiring shoulder arthroscopy; 3 - Patient affiliated to a social security scheme; 4 - Patient informed on the study and who has signed the informed consent form. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 150 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 70
Exclusion criteria
Exclusion criteria: 1 - Tranexamic acid contraindications (Hypersensitivity to the active substance or to any of the excipients, Acute venous or arterial thrombosis, Severe renal impairment, History of convulsions); 2 - Pregnant or breastfeeding patient; 3 - Patient under legal protection; 4 - Patient taking part simultaneously to another clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess whether the use of intraoperative IV tranexamic acid during arthroscopic shoulder surgery results in a greater reduction in shoulder pain compared to the placebo group, 24 hours after surgery.;Secondary Objective: 1 - To assess the shoulder post-operative pain in both groups. 2 - To assess the patients' satisfaction in both groups. 3 - To assess the shoulder function in both groups. 4 - To assess safety of study treatments.;Primary end point(s): Opioid use (yes/no) during the first 24 hours after shoulder arthroscopy.;Timepoint(s) of evaluation of this end point: 24 postoperative hours. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1 - Shoulder pain is assessed through a Visual Analog Scale 2 - Satisfaction will be assessed through an EVAN-G questionnaire. 3 - Shoulder function will be assessed through Subjective Shoulder Value (SSV) and Constant Score (CS). 4 - Safety will be assessed by collecting adverse events.;Timepoint(s) of evaluation of this end point: 1 - at 24 hours and 7 days after surgery. 2 - The day after the surgery. 3 - Before surgery and 30 days after surgery. 4 - Continuously from surgery up to 30 days after surgery. | — |
Countries
France
Contacts
Public ContactStudy coordinator
Cellule de Recherche Clinique Nouvelle Aquitaine
Outcome results
None listed