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Safety and efficacy of tranexamic acid in internal fixation of ankle fractures: a prospective randomized controlled trial

Safety and efficacy of tranexamic acid in internal fixation of ankle fractures: a prospective randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100052258
Enrollment
Unknown
Registered
2021-10-24
Start date
2021-11-30
Completion date
Unknown
Last updated
2022-10-17

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

Conditions

foot and ankle fracture

Interventions

Experimental group:tranexamic acid
Control group:blank or placebo

Sponsors

West China Hospital of Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Closed fresh pilon fracture, calcaneus fracture, ankle fracture; 2. Able to tolerate anesthesia and surgery; 3. Willing to cooperate with surgery and regular follow-up.

Exclusion criteria

Exclusion criteria: 1. Patients with a history of epilepsy; 2. Severe renal disease (creatinine clearance <30mL/min); 3. Bleeding diseases/coagulation disorders; 4. Pregnancy; 5. Major bleeding in the upper urinary tract (risk of ureteral obstruction due to thrombosis); 6. Acute thromboembolic disease (deep vein thrombosis [DVT]); 7. Pulmonary embolism; 8. Myocardial infarction; 9. Cerebrovascular accident; 10. Open fracture; 11. Allergy to tranexamic acid.

Design outcomes

Primary

MeasureTime frame
hematological indicators;swelling of softtissue;complication;pain score;quality of life;skin temperature;other functional results;—

Countries

China

Contacts

Public ContactZhang Hui

West China Hospital of Sichuan University

caesarzh@163.com+86 18980601437

Outcome results

None listed

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