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:
2025-12-25 @ 4:10 AM
Ignite Modification Date:
2025-12-25 @ 4:10 AM
NCT ID:
NCT00985920
Eligibility Criteria:
Inclusion Criteria:
* All adult patients (greater than 18 years old).
* Patients scheduled for primary unilateral total knee arthroplasty.
Exclusion Criteria:
* Allergy to tranexamic acid
* Acquired disturbances of color vision
* Preoperative anemia (hemoglobin \<110 in females; hemoglobin \<120 in males)
* Refusal of blood products (Jehovah's witnesses),
* Preoperative use of anticoagulant therapy - coumadin, heparin within 5 days of surgery, fibrinolytic disorders requiring intraoperative antifibrinolytic treatment,
* Coagulopathy (preoperative platelet count \< 150,000/mm3, INR \>1.4, prolonged PTT (\>1.4 x normal))
* A previous history of thromboembolic disease (e.g. CVA, DVT or PE)
* Pregnancy
* Breastfeeding
* Significant co-morbidities:
* severe ischemic heart disease; NYHA Class III, IV,
* previous myocardial infarction
* severe pulmonary disease, e.g. FEV1\<50% normal,
* plasma creatinine greater than 115 µmol/l in males and more than 100 µmol/l in females
* hepatic failure
* Intraoperative surgical/medical/anesthetic complications occur, e.g. MI, intraoperative bone fracture or neurovascular injury
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00985920
Study Brief:
Protocol Section:
NCT00985920