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Efficacy of tranexamic acid for the recurrence of heterotopic ossification after open elbow arthrolysis: a prospective randomized controlled trial

Efficacy of tranexamic acid for the recurrence of heterotopic ossification after open elbow arthrolysis: a prospective randomized controlled trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300068106
Enrollment
Unknown
Registered
2023-02-07
Start date
2023-02-28
Completion date
Unknown
Last updated
2023-09-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post-traumatic elbow stiffness

Interventions

Group 1:Intravenous infusion of 100mL normal saline+2g tranexamic acid mixture within 15~30 min before skin incision
Group 2:Intravenous infusion of 100mL normal saline within 15~30 min before skin incision

Sponsors

Shanghai Sixth People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Non-surgical treatment for at least 6 months did not restore the required arc of motion (=18 years; 3. Elbow stiffness caused by ectopic ossification, which is mature.

Exclusion criteria

Exclusion criteria: 1. Known allergy to tranexamic acid; 2. Known bleeding disorders (e.g., hemophilia); 3. Concomitant severe comorbidities (e.g., kidney failure, severe lung disease, myocardial infarction, coronary artery disease, myocardial infarction, history of thrombosis); 4. Patients with abnormal preoperative inflammatory indexes (CRP>10 mg/L); 5. Patients with abnormal preoperative fibrinolysis indexes (FDP>5mg/L or D-dimer >1.0mg/L); 6. Patients at high risk of thrombosis (including atrial fibrillation, pacemaker and stent implantation); 7. Patients with combined burns or central nervous system trauma or ectopic ossification; 8. Patients could not return to the hospital for follow-up after surgery.

Design outcomes

Primary

MeasureTime frame
the recurrence of heterotopic ossification;

Secondary

MeasureTime frame
function score of elbow joint valued by Mayo Elbow Performance Score (MEPS) ;elbow ROM;C-reactive protein;ESR;IL-6;IL-1ß;IL-13;

Countries

China

Contacts

Public ContactCui Haomin

Shanghai Sixth People's Hospital

1323326816@qq.com+86 187 0185 9872

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 7, 2026