Skip to main content
OpenTrials
Completed

NCT Number: NCT05598086

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Tranexamic Acid Fibrinolysis Fracture Fractures, Bone Inflammatory Wounds and Injuries

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hebei Medical University Third Hospital

Shijiazhuang, Hebei, 050051, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tranexamic Acid

Drug

local infiltration of TXA or normal saline in the post-operation would

Other names: Normal saline

Primary outcomes

  1. Incision drain output (mL)

    Time frame: 2 days

    Incision drain output of post-operative day 1 and 2

  2. Outcomes of laboratory test

    Time frame: 4 days

    White blood cell (10^9/L)

  3. Outcomes of laboratory test

    Time frame: 4 days

    Neutrophil count (10^9/L)

  4. Outcomes of laboratory test

    Time frame: 4 days

    Hemoglobin (g/L)

Secondary outcomes

  1. Incidence of surgical related complications

    Time frame: 30 days

    Complications included oozing of the blood, hematoma, or deep infection etc.

Sponsors and collaborators

Lead sponsor

Hebei Medical University Third Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2022
First posted
Oct 28, 2022
Registry last updated
Oct 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.