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

Not Applicable

Completed

• Conditions: Tranexamic Acid; Fibrinolysis; Inflammatory; Fracture
• Interventions: Drug: Tranexamic acid

• Registration Number: NCT05598086
• Lead Sponsor: Hebei Medical University Third Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-04-01
• Primary Completion: 2020-09-30
• Study Completion: 2022-05-15
• Status Verified: 2022-10
• Study First Submitted: 2022-10-22
• Study First Submitted QC: 2022-10-27
• Last Update Submitted: 2022-10-27
• Study First Posted: 2022-10-28
• Last Update Posted: 2022-10-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 113

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Normal saline group	Tranexamic acid	1 g 0.9% saline was infiltrated locally around the incision immediately after surgery for patients in normal saline group.
TXA group	Tranexamic acid	Postoperative 1g TXA was infiltrated locally around the incision immediately for patients in TXA group.

Primary Outcome Measures

Name	Time	Method
Incision drain output (mL)	2 days	Incision drain output of post-operative day 1 and 2
Outcomes of laboratory test	4 days	Hemoglobin (g/L)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hebei Medical University Third Hospital; 🇨🇳 Shijiazhuang, Hebei, China