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A Study on Perioperative Bleeding Interventions for Total Knee Arthroplasty in Patients with Knee Osteoarthritis in Tibet Region

A Study on Perioperative Bleeding Interventions for Total Knee Arthroplasty in Patients with Knee Osteoarthritis in Tibet Region

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500105388
Enrollment
Unknown
Registered
2025-07-02
Start date
2025-07-07
Completion date
Unknown
Last updated
2025-07-07

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

Conditions

Knee Osteoarthritis

Interventions

Control group:Conventional treatment + conventional tranexamic acid (intravenous infusion at 10mg/kg 15 minutes before surgery and during the operation for 30 minutes)
Test Group A:Conventional treatment + systemic continuous administration of tranexamic acid (intravenous infusion at 10mg/kg 15 minutes before surgery, 30 minutes during surgery, 2 hours after surgery
Test Group B:Conventional treatment + Fresh Frozen Plasma (200ml of fresh frozen plasma was administered 30 minutes before the operation)

Sponsors

The Second Affiliated Hospital of Army Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
50 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Age range: 50–80 years old, gender not restricted; 2. Diagnosed with end-stage osteoarthritis, Kellgren-Lawrence grade (KL) 3–4, standard conservative treatment ineffective for >6 months; 3. Resided in high-altitude areas for >3 months; 4. Within three months of the perioperative period, no joint cavity puncture or drug injection, no joint surrounding dressing, etc., were performed, and the infection risk assessment was low; 5. The participants/their guardians can understand the research purpose, have sufficient compliance, and are willing to participate in this study and sign the informed consent form (ICF).

Exclusion criteria

Exclusion criteria: 1. Those allergic to tranexamic acid; 2. Those with liver or kidney dysfunction as detected before the operation; 3. Those who received anticoagulant treatment due to concurrent cardiovascular or cerebrovascular diseases before the operation; 4. Those diagnosed as having suppurative infection of the knee joint through tissue culture or case diagnosis during or after the operation; 5. Those with a clear diagnosis of rheumatoid arthritis, gouty arthritis, or traumatic arthritis; 6. Those with a history of thrombosis; 7. Those who refused to participate in or withdrew from this study by themselves or their family members.

Design outcomes

Primary

MeasureTime frame
Average total blood loss;

Secondary

MeasureTime frame
Blood routine examination;C-reactive protein;Erythrocyte sedimentation rate;Anteroposterior and lateral radiographs of the knee joint;Full-length X-ray of both lower limbs;

Countries

China

Contacts

Public ContactZhang Yuan

The Second Affiliated Hospital of Army Medical University

zhangyuan@tmmu.edu.cn+86 135 9401 0680

Outcome results

None listed

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