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A prospective, randomized, controlled study on the efficacy and safety of different strategies of tranexamic acid in patients undergoing total knee arthroplasty

A prospective, randomized, controlled study on the efficacy and safety of different strategies of tranexamic acid in patients undergoing total knee arthroplasty

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000030624
Enrollment
Unknown
Registered
2020-03-08
Start date
2020-05-01
Completion date
Unknown
Last updated
2021-01-05

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

Conditions

knee osteoarthritis

Interventions

intravenous group:1g of TXA intravenously inject ten minutes before skin incision, and 1g at 3h and 6h postoperatively
topical irrigation group:3g of TXA in 75 ml of normal saline and irrigate the joint cavity for 5 min before tourniquet deflation.
topical injection group:After the joint capsule closure, 3g of TXA in 75 ml of normal saline and inject into the periarticular soft tissue before wound closure.
drainage injection group:After the wound closure, 3g of TXA in 75 ml of normal saline inject into the articular cavity through a drainage tube
control group:Patients undergoing TKA without TXA

Sponsors

General Hospital of Ningxia Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1. The patients with knee osteoarthritis ongoing total knee arthroplasty. 2. Aged 18 -100 years.

Exclusion criteria

Exclusion criteria: 1. Patients allergic to TXA; 2. With preoperative hepatic or renal dysfunction; 3. With serious cardiac or respiratory disease, including coronary artery stent placement or bypass; 4. With congenital or acquired coagulopathy, as evidenced by an international normalized ratio (INR) of >1.4 or a partial thromboplastin time (PTT) of > 1.4 times normal; 5. With a preoperative platelet count of < 150,000/mm3; 6. With history of a prothrombotic condition; 7. Pregnancy or breastfeeding; 8. Patients with infectious arthritis; 9. With a preoperative hemoglobin level of <10 g/dL.

Design outcomes

Primary

MeasureTime frame
blood loss;blood transfusion rate;Plasminogen activator inhibitor 1, PAI-1;prothrombin fragment 1+2, F1+2;thrombin-antithronbin complex, TAT;

Secondary

MeasureTime frame
Drainage volume;D-dimer;wound complication;length of hospital stay;deep vein thrombosis, DVT;

Countries

China

Contacts

Public ContactJin Qunhua

General Hospital of Ningxia Medical University

jqhnyfy@163.com+86 13709593699

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 16, 2026