Clincosm LogoSign in Get a demo

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

Sponsor
Hebei Medical University Third Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT05598086
Collaborator
(none)
113
Enrollment
1
Location
2
Arms
37.5
Actual Duration (Months)
3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Tranexamic acid
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
113 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Apr 1, 2019
Actual Primary Completion Date :
Sep 30, 2020
Actual Study Completion Date :
May 15, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: TXA group

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

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

    		•
    Placebo Comparator: Normal saline group

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

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Incision drain output (mL) [2 days]

      Incision drain output of post-operative day 1 and 2

    2. Outcomes of laboratory test [4 days]

      White blood cell (10^9/L)

    3. Outcomes of laboratory test [4 days]

      Neutrophil count (10^9/L)

    4. Outcomes of laboratory test [4 days]

      Hemoglobin (g/L)

    Secondary Outcome Measures

    1. Incidence of surgical related complications [30 days]

      Complications included oozing of the blood, hematoma, or deep infection etc.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hebei Medical University Third Hospital Shijiazhuang Hebei China 050051

    Sponsors and Collaborators

    • Hebei Medical University Third Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hebei Medical University Third Hospital
    ClinicalTrials.gov Identifier:
    NCT05598086
    Other Study ID Numbers:
    • TXA01
    First Posted:
    Oct 28, 2022
    Last Update Posted:
    Oct 28, 2022
    Last Verified:
    Oct 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Fractures, Bone
    Tranexamic Acid

    Study Results

    No Results Posted as of Oct 28, 2022