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The effects of tranexamic acid on the inflammatory response and immune function after primary total knee arthroplasty: a prospective randomized controlled trial.

The effects of tranexamic acid on the inflammatory response and immune function after primary total knee arthroplasty: a prospective randomized controlled trial.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-INR-17011500
Enrollment
Unknown
Registered
2017-05-26
Start date
2017-05-24
Completion date
Unknown
Last updated
2017-06-05

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:No use of TXA and dexamethasone before and after surgery
group B:Single bolus of 20mg/kg TXA and 20mg dexamethasone before surgery
group C:A bolus of 20mg/kg TXA before surgery, another bolus of 1 g TXA 3, 7, 12, 18, 24 hours later, no use of dexamethasone
group D:A bolus of 20mg/kg TXA and 20mg dexamethasone before surgery, another bolus of 1 g TXA 3, 7, 12, 18, 24 hours later and another bolus of 10 mg dexamethasone 24, 48 hours later

Sponsors

West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) Primary unilateral total knee artropasty; (2) Patients with knee osteoartritis; (3) Normal platelet and coagulation function preoperatively; (4) Normal intravenous ultrasound in the lower extremities preoperatively; (5) Able and willing to provide signed informed consent.

Exclusion criteria

Exclusion criteria: (1) Systemic infections such as pulmonary infection or urinary tract infection are not controlled preoperatively; (2) Abnormal immune function or combined immune-related disease preoperatively; (3) Abnormal inflammatory index preoperatively (C-reactive protein >20 mg/L); (4) Abnormal fibrinolysis index preoperatively (FDP > 5mg/L); (5) Discontinuation of oral anticoagulants or aspirin less than 1 week; (6) Allergy to tranexamic acid (TXA) or dexamethasone or have contraindications; (7) Patients at high risk of thrombosis; (8) History of deep vein thrombosis (VTE, calf muscle vein thrombosis or superficial vein thrombosis, pulmonary embolism); (9) serious liver and kidney dysfunction.

Design outcomes

Primary

MeasureTime frame
fibrinolysis index (D-Dimer, FDP);inflammatory index(CRP, IL-1ß, IL-6, TNF-a);immune index (CD3, CD4, CD8, complement C3 and C4);

Secondary

MeasureTime frame
blood loss;Hb drop;transfusion;VAS pain score;opioid consumption;Knee circumference;Range of motion;postoperative hospital stay;

Countries

China

Contacts

Public ContactFuxing Pei

West China Hospital, Sichuan University

peifuxinghx@163.com+86 18980601380

Outcome results

None listed

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