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

NCT05598086 | Completed

• 1 other identifier: TXA01
• Study Type: interventional
• Target: 113
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Tranexamic Acid; Fibrinolysis; Inflammatory; Fracture

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• Incidence of surgical related complications

  30 days

Study Arms (2)

TXA group

EXPERIMENTAL

Postoperative 1g TXA was infiltrated locally around the incision immediately for patients in TXA group.

Drug: Tranexamic acid

Normal saline group

PLACEBO COMPARATOR

1 g 0.9% saline was infiltrated locally around the incision immediately after surgery for patients in normal saline group.

Drug: Tranexamic acid

Interventions

Tranexamic acid DRUG

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

Also known as: Normal saline

Normal saline group; TXA group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hebei Medical University Third Hospital: lead

Study Sites (1)

Hebei Medical University Third Hospital

Shijiazhuang, Hebei, 050051, China

Location

MeSH Terms

Conditions

Fractures, Bone

Interventions

Tranexamic Acid; Saline Solution

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2022
• First Posted: October 28, 2022
• Study Start: April 1, 2019
• Primary Completion: September 30, 2020
• Study Completion: May 15, 2022
• Last Updated: October 28, 2022

Record last verified: 2022-10

Locations

CN (1)