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?Clinical Study Protocol for a Multicenter, Non-Inferiority, Randomized Controlled Trial: Topically Applied Hemocoagulase versus Tranexamic Acid in Reducing Perioperative Blood Loss during Primary Total Hip Arthroplasty?

?Clinical Study Protocol for a Multicenter, Non-Inferiority, Randomized Controlled Trial: Topically Applied Hemocoagulase versus Tranexamic Acid in Reducing Perioperative Blood Loss during Primary Total Hip Arthroplasty?

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500104916
Enrollment
Unknown
Registered
2025-06-25
Start date
2025-07-24
Completion date
Unknown
Last updated
2025-06-30

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

Conditions

total hip arthroplasty

Interventions

tranexamic acid group: To use 2 g of TXA + 50 ml of normal saline to suture the deep fascia and inject into the joint cavity
Hemocoagulase low-dose group:Use 4 U of batrotine + 50 ml of normal saline to suture the deep fascia and inject into the joint cavity
Hemocoagulase high-dose group:Use 10 U of batrotine + 50 ml of normal saline to suture the deep fascia and inject into the joint cavity
Placebo group:50 ml of normal saline is injected into the joint cavity after suturing the deep fascia

Sponsors

West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) Diagnosed with end-stage hip joint disease such as hip osteoarthritis or femoral head necrosis (Ficat stage III or IV), the patient plans to undergo primary total hip replacement surgery; (2) ASA LEVELS I-III; (3) The preoperative platelet and coagulation function were judged to be abnormal, and there was no clinical significance; (4) The preoperative venous color ultrasound of both lower limbs was judged to be abnormal, and there was no clinical significance; (5) Age>= 18 years old, gender is not limited; (6) Fully understand the study and sign the informed consent form, with good compliance.

Exclusion criteria

Exclusion criteria: (1) History of thromboembolism (including deep vein thrombosis, pulmonary embolism, cerebral infarction, transient ischemic attack, coronary artery disease, myocardial infarction or angina within 6 months); (2) Congenital or acquired coagulopathy; (3) Hypersensitivity to haemocoagulase from Bothrops atrox venom; (4) Use of anticoagulants, antiplatelet agents, or other coagulation-affecting medications within 7 days preoperatively (excluding perioperative prophylactic anticoagulation); (5) Severe hepatic/renal insufficiency or cardiovascular/cerebrovascular diseases; (6) Acute traumatic fractures with active bleeding (e.g., femoral neck fracture); (7) Pregnancy, postpartum (<6 weeks), or lactating women; (8) Undergone other surgical procedures within 30 days; (9) Participation in other clinical trials within 90 days; (10) Refusal to sign informed consent; (11) Preoperative hemoglobin (Hb) <11 g/dL.

Design outcomes

Primary

MeasureTime frame
total blood loss;

Secondary

MeasureTime frame
Coagulation Parameters;Perioperative transfusion rate and volume;Postoperative inflammatory markers (CRP, IL-6);hospital stay;

Countries

China

Contacts

Public ContactZhou Zongke

Department of Orthopedics and Orthopedic Research Institute, West China Hospital, Sichuan University

zhouzongke@scu.edu.cn+86 189 8060 1028

Outcome results

None listed

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