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

Hebei Medical University Third Hospital

Status: Completed

Conditions: Fibrinolysis; Fracture; Tranexamic Acid; Inflammatory

Treatments: Drug: Tranexamic acid

Study type: Interventional

Funder types: Other

Identifiers

NCT05598086

TXA01

Details and patient eligibility

About

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.

Enrollment: 113 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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113 participants in 2 patient groups, including a placebo group

TXA group

Experimental group

Description:

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

Treatment:

Drug: Tranexamic acid

Normal saline group

Placebo Comparator group

Description:

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

Treatment:

Drug: Tranexamic acid