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 @ 12:00 AM
Ignite Modification Date:
2025-12-25 @ 12:00 AM
NCT ID:
NCT03088358
Eligibility Criteria:
Inclusion Criteria:
* Male or female, age ≥ 18 years;
* Planned total knee replacement surgery;
* Signed informed consent form;
* Willing to comply with the protocol;
* Willing to use adequate contraception during the trial.
Exclusion Criteria:
* Surgery for acute fracture 4 weeks before screening; history of septic inflammation in the joint; prosthesis revision or one leg missing
* History of venous thrombosis of any location or PE
* History of heparin induced thrombocytopenia or other thrombocytopathy; hemorrhagic diathesis
* History of evident coagulopathy or in a relative
* Congenital thrombophilia
* Bleeding within 6 months of screening; increased risk of bleeding
* BMI less than 18,5 or more than 40 kg/m2
* Systolic BP \> 180 mmHg and/or diastolic BP \> 110 mmHg registered twice within 15-30 minutes
* Hb ≤ 10.5 g/dL in female or ≤ 11.5 g/dL in male
* Platelets \< 100 000/mm3
* Clinical significant abnormalities of APTT and/or INR
* GFR \< 30 ml/min/1.73 m2
* ALT or AST ≥ 2 x ULN or total bilirubin ≥1,5 x ULN
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03088358
Study Brief:
Protocol Section:
NCT03088358