Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:44 PM
Ignite Modification Date:
2025-12-24 @ 4:44 PM
NCT ID:
NCT03011866
Eligibility Criteria:
Inclusion Criteria:
* American Society of Anesthesiologists(ASA)classification of physical status I-II.
* Aged over 50yrs.
* Patients suffering from spinal stenosis or intervertebral disc displacement and require multilevel decompression and bone graft fusion surgeries.
* Written informed consent.
Exclusion Criteria:
* ASA III-IV.
* Ageā¤ 50yrs.
* History of chronic renal dysfunction (preoperative blood creatinine\> 120mmol/L), liver dysfunction (preoperative blood aspartate or alanine aminotransferase\> 50 units/L) or history of coronary artery disease with stent placement.
* Abnormal preoperative coagulation profile (preoperative prothrombin time elongation\> 3s, activated partial thromboplastin time elongation\> 10s, platelet counts\< 100\*10\^9/L or \>400\*10\^9/L, or INR\> 1.4).
* Pre-existing anemia (male\< 12g/dL, female\<11g/dL).
* Long-term medications of aspirin and/or other anticoagulants.
* Patients known as allergic to TXA.
* Patients who have religious and/or other beliefs limiting blood transfusion.
* Dura mater laceration and/or unexpected massive bleeding during operation.
* Cell saver application during operation.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Study:
NCT03011866
Study Brief:
Protocol Section:
NCT03011866