Study on the effectiveness and safety of intravenous tranexamic acid in modified radical mastoidectomy under microscope

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2100049183

Enrollment

Unknown

Registered

2021-07-24

Start date

2021-08-20

Completion date

Unknown

Last updated

2022-04-04

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

Conditions

Modified radical mastoidectomy under a microscope for the treatment of otitis media

Interventions

Experimental group:Tranexamic acid was pumped intravenously ten minutes before the skin incision

Control group:Normal saline was pumped intravenously ten minutes before the skin incision

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 65 years; 2. Modified radical mastoidectomy under microscope for otitis media; 3. Active inflammation exists before surgery; 4. ASA classification I-II; 5. Sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Abnormal coagulation function; 2. Fibrinogen 400mg/dL; 3. Take anticoagulant or antiplatelet drugs (aspirin, clopidogrel, warfarin, etc.) within 2 weeks before surgery; 4. Preoperative systolic blood pressure>160mmHg; 5. Preoperative application of glucocorticoids; 6. Allergy to local anesthetics; 7. Severe liver and kidney disease; 8. History of epilepsy; 9. Female patients who are pregnant or breastfeeding.

Design outcomes

Primary

Measure	Time frame
The Modena Bleeding Score classification of surgical field;	—

Secondary

Measure	Time frame
The same surgeon scores the satisfaction of the surgical conditions (0-10 scale);Hemoglobin content;operation time;	—

Countries

China

Contacts

Public ContactAn Haiyan

Peking University People's Hospital

anhaiyan2020@163.com+86 13521553036

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 6, 2026