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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05598086
Other study ID # TXA01
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


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
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