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 @ 5:01 AM
Ignite Modification Date:
2025-12-25 @ 5:01 AM
NCT ID:
NCT01260818
Eligibility Criteria:
Inclusion Criteria:
* Patient who are to undergo elective total hip arthroplasty.
* Must be primary arthroplasty.
* Must be single-side arthroplasty.
* Must be older than 18 years.
Exclusion Criteria:
* Cemented arthroplasty.
* Patients with a platelet count less than 100, 000/mm3 or history of thrombocytopenia .
* Patients with known coagulopathy (APTT or PT outside normal range pre-operatively).
* Patients who have a past medical history of thrombi-embolism at any time.
* Patients with anemia (hemoglobin levels less than 8 mg/dl or hematocrit \<24%).
* Patients with documented DVT or PE at screening or in past three months.
* Patients having known hypersensitivity to tranexamic acid or any other. constituent of the product.
* Patients with any associated major illness (e.g., severe cardiac \[New York Heart Association Class III or IV\] or respiratory disease).
* Anticoagulants (other than LMWH or heparin in prophylactic doses to prevent deep vein thrombosis), direct thrombin inhibitors or thrombolytic therapy administered or completed within last week.
* Jehovah's Witnesses, or any other group of patients with ethical objections to receiving blood products.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
90 Years
Study:
NCT01260818
Study Brief:
Protocol Section:
NCT01260818