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Completed NCT05598086

Anti-fibrinolytic and Anti-inflammatory Effects of Local Infiltration of Tranexamic Acid in Patients With Calcaneal Fractures

Conditions: Tranexamic Acid, Fibrinolysis, Inflammatory, Fracture

Sex: All
Ages: 18 Years – 70 Years
Phase: NA
Enrollment: 113
Sponsor: Hebei Medical University Third Hospital

Location: China

Summary

Background. Consensus is lacking regarding the use of tranexamic acid (TXA) in calcaneal fracture surgery. This study aims to investigate the hypothesis that local infiltration of TXA in the post-operation would maintain hemoglobin (Hb) level, reduce incision drainage volume and risk of infection in patients with displaced intra-articular calcaneal fractures. Methods. A total of 120 patients with displaced intra-articular calcaneal fractures who received extensible lateral L-shaped approach were included in this trial and equally randomized to receive one single dose of 1g TXA or 1g normal saline after closing incision. The demographic data and fracture characteristics, intra-operative indicators, laboratory tests and Visual Analogue Scale (VAS) scores, incision drainage volume, and incision-related complications were collected and compared between the two groups.

Eligibility Criteria

Inclusion Criteria:adult patients with age of eighteen years or older;diagnosis of closed and unilateral displaced intra-articular calcaneal fracture;agreement to receive one of the two treatment strategies;agreement to participate in regular follow-up after surgeryExclusion Criteria:open calcaneal fractures;polytrauma of the ipsilateral lower limb;systemic inflammatory or infectious diseases;previous history of calcaneal fracture or bone tumor;allergies to drugs used, or refused to accept the specified treatment strategy.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05598086). StuddyBuddy aggregates publicly available trial information.