search
Back to results

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

Primary Purpose

Tranexamic Acid, Fibrinolysis, Inflammatory

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Tranexamic acid
Sponsored by
Hebei Medical University Third Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tranexamic Acid

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Hebei Medical University Third Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

TXA group

Normal saline group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Incision drain output (mL)
Incision drain output of post-operative day 1 and 2
Outcomes of laboratory test
White blood cell (10^9/L)
Outcomes of laboratory test
Neutrophil count (10^9/L)
Outcomes of laboratory test
Hemoglobin (g/L)

Secondary Outcome Measures

Incidence of surgical related complications
Complications included oozing of the blood, hematoma, or deep infection etc.

Full Information

First Posted
October 22, 2022
Last Updated
October 27, 2022
Sponsor
Hebei Medical University Third Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT05598086
Brief Title
Anti-fibrinolytic and Anti-inflammatory Effects of Local Infiltration of Tranexamic Acid in Patients With Calcaneal Fractures
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
April 1, 2019 (Actual)
Primary Completion Date
September 30, 2020 (Actual)
Study Completion Date
May 15, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hebei Medical University Third Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tranexamic Acid, Fibrinolysis, Inflammatory, Fracture

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
113 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TXA group
Arm Type
Experimental
Arm Description
Postoperative 1g TXA was infiltrated locally around the incision immediately for patients in TXA group.
Arm Title
Normal saline group
Arm Type
Placebo Comparator
Arm Description
1 g 0.9% saline was infiltrated locally around the incision immediately after surgery for patients in normal saline group.
Intervention Type
Drug
Intervention Name(s)
Tranexamic acid
Other Intervention Name(s)
Normal saline
Intervention Description
local infiltration of TXA or normal saline in the post-operation would
Primary Outcome Measure Information:
Title
Incision drain output (mL)
Description
Incision drain output of post-operative day 1 and 2
Time Frame
2 days
Title
Outcomes of laboratory test
Description
White blood cell (10^9/L)
Time Frame
4 days
Title
Outcomes of laboratory test
Description
Neutrophil count (10^9/L)
Time Frame
4 days
Title
Outcomes of laboratory test
Description
Hemoglobin (g/L)
Time Frame
4 days
Secondary Outcome Measure Information:
Title
Incidence of surgical related complications
Description
Complications included oozing of the blood, hematoma, or deep infection etc.
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Hebei Medical University Third Hospital
City
Shijiazhuang
State/Province
Hebei
ZIP/Postal Code
050051
Country
China

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs