Can a clotting gauze and drug cut blood loss in knee surgery?
NCT ID NCT05504577
First seen Jul 22, 2026 · Last updated Jul 23, 2026 · Updated 1 time
Summary
This trial investigates whether placing a kaolin-based clotting gauze inside the knee joint, combined with an intravenous dose of tranexamic acid, can reduce total blood loss during total knee replacement. About 140 adults with advanced knee osteoarthritis will be randomly assigned to receive either the special gauze plus the drug or standard surgical gauze plus the drug. The goal is to see if the combination leads to less bleeding and fewer blood transfusions.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- tranexamic acid injection and kaolin-based hemostatic gauze
- What this could lead to
- If effective, this combination could reduce the need for blood transfusions after knee replacement, making surgery safer.
- What could go wrong
- This is a single-center trial with 140 patients, so results may not apply broadly. There is also a small risk of blood clots with tranexamic acid.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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140 people
The number who actually took part.
- Started
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Mar 2022
- Finished
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Oct 2023
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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50 to 90 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Patients with advanced osteoarthritis of the knee and undergo primary unilateral minimally invasive TKA * Age \> 50 years and \< 90 years * Failure of medical treatment or rehabilitation * Hemoglobin ≧ 11g/dl * No use of non-steroid anti-inflammatory agent, antiplatelets or anticoagulants at least 3 days before operation Exclusion Criteria: 1. Preoperative Hemoglobin \<11 g/dl 2. History of infection or intraarticular fracture of the affective knee 3. Renal function deficiency (GFR \<30 ml/min/1.73m2) 4. Elevated liver enzyme (AST/ALT level are more than twice normal range) , history of liver cirrhosis, impaired liver function(elevated total bilirubin level) and coagulopathy (including long-term use anticoagulant) 5. History of deep vein thrombosis, ischemic heart disease or stroke, in which life-long oral anticoagulant are required. 6. Contraindications of tranexamic acid, or rivaroxaban 7. Allergy to tranexamic acid, kaolin, rivaroxaban, or the excipients 8. History of heparin-induced thrombocytopenia (HIT) 9. Coagulopathy or bleeding tendency caused by organ dysfunction, such as cirrhosis, bone marrow suppression etc. 10. Patient who have active bleeding disorder, such as intracranial hemorrhage, upper GI bleeding, hematuria..
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Kaohsiung Chang Gung Memorial Hospital
Kaohsiung, Taiwan, Taiwan
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