Combined Tranexamic Acid Use in Total Hip Replacement Surgery (NCT07610863) | Clinical Trial Compass
CompletedNot Applicable
Combined Tranexamic Acid Use in Total Hip Replacement Surgery
Czechia58 participantsStarted 2024-06-01
Plain-language summary
This prospective study evaluates whether combined intravenous and topical administration of tranexamic acid (TXA) can safely reduce blood loss in patients undergoing primary total hip replacement surgery. Tranexamic acid is commonly used during orthopedic surgery to decrease bleeding and reduce the need for blood transfusions.
Participants undergoing elective primary total hip arthroplasty are assigned to receive either intravenous TXA alone or a combination of intravenous and topical TXA applied directly around the hip joint during surgery. The study compares postoperative blood loss, changes in hemoglobin levels, transfusion requirements, length of hospital stay, and postoperative complications between the treatment groups.
The study also uses rotational thromboelastometry (ROTEM), a specialized blood coagulation monitoring method, to evaluate whether combined TXA administration affects blood clotting or increases the risk of thromboembolic complications such as deep vein thrombosis or pulmonary embolism.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Adults undergoing elective primary cementless total hip arthroplasty for primary hip osteoarthritis
* Preoperative hemoglobin level ≥130 g/L
* Ability to provide written informed consent
Exclusion Criteria:
* Post-traumatic or secondary hip arthritis
* Known allergy or hypersensitivity to tranexamic acid
* History of deep vein thrombosis or pulmonary embolism
* Current anticoagulant therapy
* Known coagulation disorder
* Body mass index (BMI) \>40 kg/m²
* Significant hepatic or renal dysfunction
* Type 1 diabetes mellitus
* Significant cardiovascular disease
* Traumatic indication for total hip arthroplasty
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Total Postoperative Blood Loss Measured by Surgical Drain Output and Hemoglobin Change
Timeframe: Up to 48 hours after surgery
Trial details
NCT IDNCT07610863
SponsorSt. Anne's University Hospital Brno, Czech Republic