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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05598086

Enrollment

113

Registered

2022-10-28

Start date

2019-04-01

Completion date

2022-05-15

Last updated

2022-10-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fibrinolysis, Fracture, Inflammatory, Tranexamic Acid

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.

Interventions

DRUGTranexamic acid

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Incision drain output (mL)	2 days	Incision drain output of post-operative day 1 and 2
Outcomes of laboratory test	4 days	White blood cell (10\^9/L)

Secondary

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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026