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A randomized, controlled clinical study of the effect of sequential application of hemagglutinin and tranexamic acid to Agkistrodon agkistrodon for injection on blood loss during primary total knee replacement

A randomized, controlled clinical study of the effect of sequential application of hemagglutinin and tranexamic acid to Agkistrodon agkistrodon for injection on blood loss during primary total knee replacement

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200058554
Enrollment
Unknown
Registered
2022-04-10
Start date
2022-04-01
Completion date
Unknown
Last updated
2024-01-08

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

Conditions

knee osteoartritis

Interventions

Group A:2 units of Suling were administered 15-20 minutes before surgery and completed before the operation began. Method of administration: slow intravenous infusion no less than 3min. 1g tranexamic
Group B:Tranexamic acid injection was administered intravenously at the rate of 40mg/kg 15-20 minutes before surgery. The first administration was completed before surgery. 1g tranexamic acid was inje

Sponsors

West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-80 years, no gender limit; 2. Patients with knee osteoarthritis who have surgical indications and indications of total knee replacement and need to undergo primary unilateral total knee replacement; 3. Voluntarily sign informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with a history of deep vein thrombosis, arterial thrombosis, cardio-cerebrovascular thrombosis or infarction, or pulmonary embolism within the last 6 months; 2. Preoperative color Doppler ultrasonography of lower limbs showed thrombus formation in popliteal vein and its proximal vein, or significant stenosis in lower limb atherosclerosis; 3. Allergic constitution: allergic to dextran, tranexamic acid, sulin and anticoagulants; 4. Patients with coagulation dysfunction; 5. Patients with dual antiplatelet therapy that cannot be replaced; 6. Patients diagnosed with coronary atherosclerotic heart disease or AHA cardiac function grade ?; 7. Patients with previous or present history of malignant tumor; 8. ASA grade ? or above; 9. Patients with systolic blood pressure > 160mmHg or diastolic blood pressure > 100mmHg; 10. Patients with severe impairment of liver and kidney function before surgery; 11. A female patient or a male patient's spouse planning to become pregnant, pregnant and lactating; 12. Participate in other clinical studies 3 months before surgery or during the study; 13. Patients with mental illness and uncooperative patients; 14. Patients considered by the investigators to be unsuitable for this study.

Design outcomes

Primary

MeasureTime frame
Total operative blood loss;

Secondary

MeasureTime frame
Intraoperative blood loss;Coagulation function;Incidence of arteriovenous thrombosis of both lower limbs;Incision healing;Blood transfusion rate;Blood transfusion volume;Visual Analogue Scale Score;American Hospital for Special Surgery Knee Score;Blood and fluid oozing from the wound;

Countries

China

Contacts

Public ContactPei Fuxing

West China Hospital, Sichuan University

huaxipeifx@126.com+86 18980601380

Outcome results

None listed

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