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

October 27, 2022 updated by: Hebei Medical University Third Hospital

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

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

113

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Hebei
      • Shijiazhuang, Hebei, China, 050051
        • Hebei medical university third hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hebei Medical University Third Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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