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
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 |
Verified date | October 2022 |
Source | Hebei Medical University Third Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
China | Hebei Medical University Third Hospital | Shijiazhuang | Hebei |
Lead Sponsor | Collaborator |
---|---|
Hebei Medical University Third Hospital |
China,
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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