Tranexamic AcidNCT05598086
Anti-fibrinolytic and Anti-inflammatory Effects of Local Infiltration of Tranexamic Acid in Patients With Calcaneal Fractures
A study testing Tranexamic acid in people with Tranexamic Acid and Fibrinolysis, run by Hebei Medical University Third Hospital at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Tranexamic Acid, Fibrinolysis, Inflammatory
- What is being tested?
- Tranexamic acid
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 113 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2019to 15 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Tranexamic Acid, Fibrinolysis, Inflammatory, Fracture
- Being tested
- Tranexamic acid
- Medical subject headings
- Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic acidDrug
Also called Normal saline
local infiltration of TXA or normal saline in the post-operation would
| Study group | Role | What they receive |
|---|---|---|
| TXA group | Experimental | Postoperative 1g TXA was infiltrated locally around the incision immediately for patients in TXA group. Receives: Drug: Tranexamic acid |
| Normal saline group | Placebo comparator | 1 g 0.9% saline was infiltrated locally around the incision immediately after surgery for patients in normal saline group. Receives: Drug: Tranexamic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incision drain output (mL)
Incision drain output of post-operative day 1 and 2
Measured: 2 days
Outcomes of laboratory test
White blood cell (10^9/L)
Measured: 4 days
Outcomes of laboratory test
Neutrophil count (10^9/L)
Measured: 4 days
Outcomes of laboratory test
Hemoglobin (g/L)
Measured: 4 days
Secondary outcomes (1)
Incidence of surgical related complications
Complications included oozing of the blood, hematoma, or deep infection etc.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2022
- Study start1 Apr 2019
- Primary completion30 Sep 2020
- Study completion15 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tranexamic AcidStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hebei Medical University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05598086
- Sponsor's protocol ID
- TXA01
- Status last verified
- Oct 2022
- First submitted
- 22 Oct 2022
- Last updated
- 28 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05598086
- Acronym / sponsor ID
- TXA01
- Conditions
- Tranexamic Acid, Fibrinolysis, Inflammatory, Fracture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- Hebei Medical University Third HospitalUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 15 May 2022 (actual)
- First posted
- 28 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TXA group | Experimental | Drug: Tranexamic acidPostoperative 1g TXA was infiltrated locally around the incision immediately for patients in TXA group. |
| Normal saline group | Placebo comparator | Drug: Tranexamic acid1 g 0.9% saline was infiltrated locally around the incision immediately after surgery for patients in normal saline group. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tranexamic acidAlso: Normal salinelocal infiltration of TXA or normal saline in the post-operation would | Drug | Normal saline group, TXA group |
Primary outcome
Incision drain output (mL)
Time frame: 2 days
Incision drain output of post-operative day 1 and 2
Outcomes of laboratory test
Time frame: 4 days
White blood cell (10^9/L)
Outcomes of laboratory test
Time frame: 4 days
Neutrophil count (10^9/L)
Outcomes of laboratory test
Time frame: 4 days
Hemoglobin (g/L)
1 secondary outcome
Incidence of surgical related complications
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tranexamic acid in people with Tranexamic Acid and Fibrinolysis, run by Hebei Medical University Third Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incision drain output (mL) (time frame: 2 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2022.