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The first high dose combined with postoperative multiple doses of tranexamic acid to prevent bleeding and inflammation after total knee arthroplasty: a clinical randomized double-blind controlled study

The first high dose combined with postoperative multiple doses of tranexamic acid to prevent bleeding and inflammation after total knee arthroplasty: a clinical randomized double-blind controlled study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200064365
Enrollment
Unknown
Registered
2022-10-04
Start date
2022-10-01
Completion date
Unknown
Last updated
2023-05-15

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

Conditions

total knee arthroplasty

Interventions

High dose group:First tranexamic acid 60 mg/kg
Conventional dose group:First tranexamic acid 20 mg/kg

Sponsors

Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
55 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Age 55-80 years old, gender is not limited; 2. Diagnosed with osteoarthritis, hospitalization option in general anesthesia under unilateral knee replacement surgery cases, no contraindications to surgery, agree to participate in this test; 3. The American Association of Anesthesiologists (ASA) is graded as Grade I or II.

Exclusion criteria

Exclusion criteria: 1. Those who have a history of deep vein thrombosis, arterial thrombosis, cardiovascular and cerebrovascular thrombosis or infarction, and pulmonary embolism in the past 6 months; 2. Color Doppler ultrasound examination of both lower extremities before surgery, showing thrombosis of the popliteal vein and its proximal vein, or obvious stenosis of the atherosclerosis of the lower limbs; 3. Allergic constitution: allergic to dextran, tranexamic acid, threxin and anticoagulants; 4. Coagulation dysfunction; 5. Patients who cannot stop using double antiplatelet drugs: such as those who wear pacemakers, have a history of cardiac bypass surgery or arterial stenting, etc.; 6. People with ischemic heart disease or cardiac insufficiency; 7. Those who have malignant tumors and are in the treatment period; 8. ASA grade IV or above; 9. After treatment of patients with hypertension, the systolic blood pressure > 160mmHg or the diastolic > 100mmHg; 10. Preoperative liver and kidney insufficiency; 11. Women planning to become pregnant, pregnant and lactating; 12. Participate in other clinical studies at the same time 3 months before surgery or during the study period; 13.Patients with mental disorders, non-cooperation, or who are considered unsuitable to participate in this study.

Design outcomes

Primary

MeasureTime frame
Blood loss;

Secondary

MeasureTime frame
Coagulation function;Incidence of arteriovenous thrombosis in both lower extremities;Incision healing condition;Probability of blood transfusion;Blood transfusion volume;Pain score;AKS knee score;Joint range of motion score;

Countries

China

Contacts

Public ContactZhong Sheng

Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine

drcyan@foxmail.com+86 18616347794

Outcome results

None listed

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