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Surgicel Alleviaes bloos loss after Total Knee Arthroplasty: A Prospective Randomized Controlled Trial

Surgicel Alleviaes bloos loss after Total Knee Arthroplasty: A Prospective Randomized Controlled Trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300072799
Enrollment
Unknown
Registered
2023-06-26
Start date
2023-06-26
Completion date
Unknown
Last updated
2023-07-02

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

Conditions

Osteoarthritis and total knee arthroplasty

Interventions

surgicel group:Use of surgicel for wound coverage and intravenous infusion of TXA (Tranexamic Acid) during Total Knee Arthroplasty
Negative control group:Use of Tranexamic Acid (TXA) solution for wound cavity soak prior to joint cavity closure + intravenous infusion of TXA
Control group:Use of Tranexamic Acid (TXA) intravenously only --- a commonly used method for hemostasis in perioperative clinical practice currently.

Sponsors

West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) A definitive diagnosis of unilateral or bilateral primary knee osteoarthritis and meets surgical indications. (2) The patient has no past history of open trauma, fracture, or surgery on both knees. (3) Age is =18 years old. (4) Preoperative tests and examinations are essentially normal, with no obvious surgical contraindications; (5) The patient and their family members are willing to participate in this research study, and have signed an informed consent form preoperatively.

Exclusion criteria

Exclusion criteria: (1) Anemia (females <120 g/L, males <130 g/L); (2) Patients with a history of Deep Vein Thrombosis (DVT) or Pulmonary Embolism (PE); (3) Patients with cardiovascular-related diseases; (4) Patients with congenital or acquired coagulation disorders, or with coagulation abnormalities; (5) Infections: Preoperative presence of an infection focus at the knee joint or elsewhere in the body; (6) Recent use of anticoagulants such as aspirin; (7) The patient or their family members refuse to participate in this research study or refuse to sign the treatment consent form.

Design outcomes

Primary

MeasureTime frame
Total perioperative blood loss blood loss;invisible blood loss;Knee joint color Doppler ultrasound results;

Secondary

MeasureTime frame
Intraoperative dominant blood loss;Number of blood transfusions;Hemoglobin, hematocrit, and albumin;Inflammation markers (C-reactive protein, interleukin-6, erythrocyte sedimentation rate);visual analogue scale;

Countries

China

Contacts

Public ContactXiaojun Shi

West China Hospital, Sichuan University

shixjoint@scu.edu.cn+86 189 8060 6872

Outcome results

None listed

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