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

NCT ID: NCT05598086

Last Updated: 2022-10-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 113 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-01
• Study Completion Date: 2022-05-15

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

TXA group

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

Group Type: EXPERIMENTAL

Tranexamic acid

Intervention Type: DRUG

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

Normal saline group

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

Group Type: PLACEBO_COMPARATOR

Tranexamic acid

Intervention Type: DRUG

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

Interventions

Tranexamic acid

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

Intervention Type: DRUG

Other Intervention Names

Normal saline

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hebei Medical University Third Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hebei Medical University Third Hospital

Shijiazhuang, Hebei, China

Countries

China

Other Identifiers

TXA01

Identifier Type: -

Identifier Source: org_study_id