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

Fracture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05598086
• Other study ID #: TXA01
• Status: Completed
• Phase: N/A
• Start date: April 1, 2019
• Est. completion date: May 15, 2022

Study information

• Verified date: October 2022
• Source: Hebei Medical University Third Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 113
• Est. completion date: May 15, 2022
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fibrinolysis
• Fracture
• Fractures, Bone
• Inflammatory
• Tranexamic Acid

Intervention

Drug:
• Tranexamic acid
local infiltration of TXA or normal saline in the post-operation would

Locations

Country	Name	City	State
China	Hebei Medical University Third Hospital	Shijiazhuang	Hebei

Sponsors (1)

Lead Sponsor	Collaborator
Hebei Medical University Third Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incision drain output (mL)	Incision drain output of post-operative day 1 and 2	2 days
Primary	Outcomes of laboratory test	White blood cell (10^9/L)	4 days
Primary	Outcomes of laboratory test	Neutrophil count (10^9/L)	4 days
Primary	Outcomes of laboratory test	Hemoglobin (g/L)	4 days
Secondary	Incidence of surgical related complications	Complications included oozing of the blood, hematoma, or deep infection etc.	30 days