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

Study Overview
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Brief Summary
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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.

Official Title
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Anti-fibrinolytic and Anti-inflammatory Effects of Local Infiltration of Tranexamic Acid in the Post-operation of Displaced Intra-articular Calcaneal Fractures: a Randomized Controlled Study

Conditions
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Tranexamic Acid, Fibrinolysis, Inflammatory, Fracture

Intervention / Treatment
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* Drug: Tranexamic acid


Participation Criteria
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Eligibility Criteria
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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 surgery Exclusion 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TXA group<br>Postoperative 1g TXA was infiltrated locally around the incision immediately for patients in TXA group. | Drug: Tranexamic acid<br>* local infiltration of TXA or normal saline in the post-operation would<br>* Other names: Normal saline;|
| Placebo Comparator: Normal saline group<br>1 g 0.9% saline was infiltrated locally around the incision immediately after surgery for patients in normal saline group. | Drug: Tranexamic acid<br>* local infiltration of TXA or normal saline in the post-operation would<br>* Other names: Normal saline;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incision drain output (mL) | Incision drain output of post-operative day 1 and 2 | 2 days | 
| Outcomes of laboratory test | White blood cell (10^9/L) | 4 days | 
| Outcomes of laboratory test | Neutrophil count (10^9/L) | 4 days | 
| Outcomes of laboratory test | Hemoglobin (g/L) | 4 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of surgical related complications | Complications included oozing of the blood, hematoma, or deep infection etc. | 30 days |