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The Efficacy and Safety of Using Tranexamic Acid to Reduce Blood Loss During Simultaneous Bilateral Total Knee Replacement: a Randomized, Double-blind, Controlled Trial

The Efficacy and Safety of Using Tranexamic Acid to Reduce Blood Loss During Simultaneous Bilateral Total Knee Replacement: a Randomized, Double-blind, Controlled Trial

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IPR-15006572
Enrollment
Unknown
Registered
2015-06-11
Start date
2014-04-01
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary osteoarthritis of knee

Interventions

treatment group:1.0 g of tranexamic acid in 100 mL of saline is administered immediately before making incision
control group:standard fluid management

Sponsors

Department of Orthopaedics, Xijing Hospital, The Fourth Military Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Adult patients who plan to undergo primary TKA on simultaneous bilateral knee joint with a diagnosis of osteoarthritis or aseptic bone necrosis, but not of rheumatoid arthritis; 2. All patients have normal preoperative platelet count, normal prothrombin time, normal partial thromboplastin time, and normal international normalized ratio; 3. The use of only balanced electrolyte solutions and/or albumin for plasma volume restitution.

Exclusion criteria

Exclusion criteria: 1. Allergy to tranexamic acid; 2. Receiving warfarin or heparin; had a history of hemophilia, deep venous thrombosis, pulmonary embolism, or renal impairment; or were pregnant; 3. Patients with any cardiovascular problems (such as myocardiac infarction history, atrial fibrillation, angina); 4. Patients with cerebrovascular conditions (such as previous stroke or vascular surgery history); 5. Patients with thromboembolic disorders, or those exhibiting a deteriorating general condition; 6. Preoperative anemia (a hemoglobin value of 1.4, or a prolonged partial thromboplastin time [>1.4 times normal]).

Design outcomes

Primary

MeasureTime frame
Proportion of patients who were transfused with allogeneic blood;Amounts of allogeneic blood transfused;

Secondary

MeasureTime frame
Amount of drainage;Average amounts of blood loss;Complications (myocardial infarction, stroke, deep vein thrombosis, pulmonary embolism, any thrombosis, renal failure): CE + DU (Postoperative Day 5);Active range of motion (pre-operation and post-operative Day 7);Decreased Hb;Post-operative Hb (post-operative Day 1,3,5);Thigh girth (at 1st week after surgery);Calf girth (at 1st week after surgery);KSS score (at 6th week after surgery);VAS (everyday after surgery);Calculated blood loss;

Countries

China

Contacts

Public ContactZhu jinyu
zhujinyu@hotmail.com+86 02984775280

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026