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

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

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.

Study Overview

• Status: Completed
• Conditions: Fibrinolysis; Fracture; Tranexamic Acid; Inflammatory
• Intervention / Treatment: Drug: Tranexamic acid

• Study Type: Interventional
• Enrollment (Actual): 113
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Hebei
    • Shijiazhuang, Hebei, China, 050051
      • Hebei Medical University Third Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hebei Medical University Third Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2019
• Primary Completion (Actual): September 30, 2020
• Study Completion (Actual): May 15, 2022

Study Registration Dates

• First Submitted: October 22, 2022
• First Submitted That Met QC Criteria: October 27, 2022
• First Posted (Actual): October 28, 2022

Study Record Updates

• Last Update Posted (Actual): October 28, 2022
• Last Update Submitted That Met QC Criteria: October 27, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone; Molecular Mechanisms of Pharmacological Action; Fibrin Modulating Agents; Antifibrinolytic Agents; Hemostatics; Coagulants; Tranexamic Acid
• Other Study ID Numbers: TXA01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No