Tranexamic AcidNCT05138913
Arthroscopic Treatment Combine With TXA for Elbow Stiffness
A study testing TXA and Saline in people with Tranexamic Acid and Elbow Stiffness, run by Beijing Jishuitan Hospital at 1 site in China.
Trial summary
This study is a prospective randomized controlled study of different arthroscopic treatments for elbow stiffness combined with tranexamic acid(TXA) injection. The patients with stiffness were randomly divided into groups before the operation. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Tranexamic Acid, Elbow Stiffness
- What is being tested?
- TXA and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2020to 30 Dec 2023
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Clinically diagnosed patients with elbow stiffness Young and middle-aged patients aged 18 to 60 with failed nonoperated treatment Voluntarily accept randomized controlled grouping, cooperate with treatment and follow up patients No other comorbidities or medical diseases affect the surgical patients -
Who cannot join
- Elderly people older than 60 years old and patients younger than 18 years old With severe comorbidities or medical diseases affect the surgical patients
- -
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Jishuitan hospital
Beijing, Beijing Municipality, 100000
Shangzhe Li, M.D., +86 13826162999, 562744381@qq.com
About this study
Official title: Prospective Randomized Controlled Study on Arthroscopic Treatment Combine With TXA for Elbow Stiffness
This study is a prospective randomized controlled study of different arthroscopic treatments for elbow stiffness combined with tranexamic acid(TXA) injection. The patients with stiffness were randomly divided into groups before the operation. After the arthroscopic operation was completed, they were divided into a local TXA injection group and a control group (normal saline) to perform additional operations for reduction of hemorrhage. In different time periods, the quantitative and qualitative indicators including pain, functional score, range of motion, level of Hemoglobin, the circumference of the limb 10cm above and below the elbow, amount of hemorrhage, etc. were compared between groups at the same time period to evaluate the difference in the effect of arthroscopic treatment combined with TXA on the treatment of reduction of hemorrhage. Determine the effectiveness of TXA.
- Conditions
- Tranexamic Acid, Elbow Stiffness
- Being tested
- TXA, Saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TXADrug
After the arthroscopic operation was completed, a local TXA injection was performed
SalineDrug
After the arthroscopic operation was completed, a local saline injection was performed
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | Arthroscopic treatment with TXA injection Receives: Drug: TXA |
| Control group | Placebo comparator | Arthroscopic treatment with normal saline injection Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mayo Elbow Performance Score
A score used to evaluated the elbow function
Measured: baseline-6 months postoperatively
Secondary outcomes (4)
Visual analogue scale
A score used to evaluated the pain
Measured: baseline-6 months postoperatively
Circumference of upper extremity
Measured: baseline-6 months postoperatively
change of hemoglobin
Measured: baseline-6 months postoperatively
range of motion
flexion, extension, pronation and supination of elbow
Measured: baseline-6 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2021
- Study start1 Dec 2020
- Primary completion30 Dec 2022 (estimated)
- Study completion30 Dec 2023 (estimated)
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, Care provider, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Jishuitan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yi Lu, Beijing Jishuitan Hospital
- Investigators
- Yi Lu, Principal investigator, Sports Medicine Service, Beijing Jishuitan hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05138913
- Sponsor's protocol ID
- YLu
- Status last verified
- Nov 2021
- First submitted
- 18 Nov 2021
- Last updated
- 1 Dec 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Controlled Study on Arthroscopic Treatment Combine With TXA for Elbow Stiffness
- ClinicalTrials.gov ID
- NCT05138913
- Acronym / sponsor ID
- YLu
- Conditions
- Tranexamic Acid, Elbow Stiffness
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Beijing Jishuitan HospitalUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 30 Dec 2022 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 1 Dec 2021 (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.
This study is a prospective randomized controlled study of different arthroscopic treatments for elbow stiffness combined with tranexamic acid(TXA) injection. The patients with stiffness were randomly divided into groups before the operation. After the arthroscopic operation was completed, they were divided into a local TXA injection group and a control group (normal saline) to perform additional operations for reduction of hemorrhage. In different time periods, the quantitative and qualitative indicators including pain, functional score, range of motion, level of Hemoglobin, the circumference of the limb 10cm above and below the elbow, amount of hemorrhage, etc. were compared between groups at the same time period to evaluate the difference in the effect of arthroscopic treatment combined with TXA on the treatment of reduction of hemorrhage. Determine the effectiveness of TXA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Drug: TXAArthroscopic treatment with TXA injection |
| Control group | Placebo comparator | Drug: SalineArthroscopic treatment with normal saline injection |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Clinically diagnosed patients with elbow stiffness Young and middle-aged patients aged 18 to 60 with failed nonoperated treatment Voluntarily accept randomized controlled grouping, cooperate with treatment and follow up patients No other comorbidities or medical diseases affect the surgical patients -
Key exclusion criteria (2 listed)
- Elderly people older than 60 years old and patients younger than 18 years old With severe comorbidities or medical diseases affect the surgical patients
- -
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 |
|---|---|---|
| TXAAfter the arthroscopic operation was completed, a local TXA injection was performed | Drug | Study group |
| SalineAfter the arthroscopic operation was completed, a local saline injection was performed | Drug | Control group |
Primary outcome
Mayo Elbow Performance Score
Time frame: baseline-6 months postoperatively
A score used to evaluated the elbow function
4 secondary outcomes
Visual analogue scale
Time frame: baseline-6 months postoperatively
Circumference of upper extremity
Time frame: baseline-6 months postoperatively
change of hemoglobin
Time frame: baseline-6 months postoperatively
range of motion
Time frame: baseline-6 months postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2021.
- Individual participant dataSharing planned: No
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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.
Yi Lu principal investigator
Sports Medicine Service, Beijing Jishuitan hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TXA and Saline in people with Tranexamic Acid and Elbow Stiffness, run by Beijing Jishuitan 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 1 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 1 Dec 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shangzhe Li, M.D. (+86 13826162999, 562744381@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mayo Elbow Performance Score (time frame: baseline-6 months postoperatively). 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 1 Dec 2021.