Rotator cuff injury
Conditions
Interventions
Control group:Preoperative injection of normal saline (20ml)
Experimental group:Preoperative injection of tranexamic acid (1 gram diluted in 20 mL of 25% glucose solution)
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
40 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. The diagnosis of partial or full-thickness rotator cuff tear was confirmed by shoulder joint magnetic resonance imaging (MRI), and the degree of tear was consistent with clinical symptoms (shoulder pain, limited range of motion, and decreased muscle strength). 2. It is planned to perform the first arthroscopic rotator cuff repair surgery in our hospital, and the surgical method is clear. 3. The patient is conscious, able to understand the purpose, process and potential risks of the study, voluntarily signs the written informed consent form, and undertakes to cooperate in completing the preoperative assessment, surgery, postoperative follow-up and various data collection. 4. No severe hepatic or renal insufficiency (eGFR >=60 mL/min, Child-Pugh Class A), normal coagulation function (INR = 100 × 10?/L), and no uncontrolled hypertension (systolic blood pressure >= 150 mmHg); 5. Age: 40-70 years old.
Exclusion criteria
Exclusion criteria: 1. Diagnostic-related exclusions: (1) Acute traumatic rotator cuff tear (based on disease course) or massive tear (tear range > 5cm); (2) Complicated with other shoulder joint diseases such as frozen shoulder, acromioclavicular joint dislocation, and labral injury; (3) Unclear MRI diagnosis or mismatch with clinical symptoms; 2. Treatment-related exclusions: (1) A history of previous shoulder joint surgery or tranexamic acid use; (2) Allergies to tranexamic acid, glucose solution, or normal saline; (3) Planned use of non-standardized surgical procedures; 3. Safety-related exclusions: (1) Coagulation dysfunction (INR > 1.4, platelet count < 100×10?/L) or history of thromboembolism (such as deep vein thrombosis, pulmonary embolism, cerebral infarction); (2) Severe organ dysfunction (eGFR/min, Child-Pugh class B/C cirrhosis, heart failure); (3) Poorly controlled hypertension (systolic blood pressure = 150 mmHg), history of epilepsy (tranexamic acid may induce epileptic seizures); (4) Pregnant or lactating women;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The clarity of the surgical field; | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse event monitoring;Coagulation function;Operation time;Complete blood count;Postoperative pain assessment; | — |
Countries
China
Contacts
Public ContactXin Tang
West China Hospital of Sichuan University
Outcome results
None listed