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The antifibrinolytic and anti-inflammatory effect and safety of a loading high-dose intravenous tranexamic acid followed by multiple doses in peri-operative period of total hip/knee arthroplasty: a prospective, randomized, controlled trial

The antifibrinolytic and anti-inflammatory effect and safety of a loading high-dose intravenous tranexamic acid followed by multiple doses in peri-operative period of total hip/knee arthroplasty: a prospective, randomized, controlled trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800016494
Enrollment
Unknown
Registered
2018-06-04
Start date
2018-06-04
Completion date
Unknown
Last updated
2018-06-11

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

Conditions

hip and knee joint disease

Interventions

one dose of 20mg IV-dexamethasone after the general anesthesia was well performed by an analgesist
B:one bolus of 60 mg/kg IV-TXA prior to skin incision, 5 boluses of 1g IV-TXA 3, 6, 12, 18 and 24 hours later
C:one bolus of 60 mg/kg IV-TXA prior to skin incision, 5 boluses of 1g IV-TXA 3, 12 and 24 hours later
D:one bolus of 60 mg/kg IV-TXA prior to skin incision, one dose of 2g IV-TXA 3 hours later

Sponsors

West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: All patients, aged 18 years or older, who were scheduled to have primary unilateral THA/TKA for osteoarthritis (OA) or ANFH were considered eligible for included in the trial.

Exclusion criteria

Exclusion criteria: Patients with anemia (<120 g/L for female, <130 g/L for male), cardiovascular problems (history of myocardial infraction, angina, and atrial fibrillation), cerebrovascular conditions (history of previous stroke), thromboembolic disorders (history of deep-vein thrombosis (DVT) or pulmonary embolism (PE)), clotting disorders, known allergy to TXA

Design outcomes

Primary

MeasureTime frame
inflammatory index (CRP IL-6 IL-10) ;fibrinolysis index (D-Dimer, FDP) ;total blood loss;Hidden blood loss;Hb drop;immune indices (C3, C4, IgG, IgA, IgM, CD3, CD4, CD8);VAS score;

Secondary

MeasureTime frame
transfusion;Range of motion;Length of hospital stay ;swelling ratio;readmission rate;

Countries

China

Contacts

Public ContactFuxing Pei

West China Hospital, Sichuan University

809084355@qq.com+86 13560370152

Outcome results

None listed

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