Phase 4
N=40
Effect of Tranexamic Acid on Postoperative Bleeding Following Sinus and Nasal Surgery
Chronic Sinusitis · Nasal Obstruction · Turbinate; Hypertrophy Mucous Membrane · Deviated Nasal Septum - Congenital · Deviated Nasal Septum Acquired
Bottom Line
View on ClinicalTrials.gov: NCT04754230 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Apr 2023
Primary outcome: Primary: Bleeding VAS - POD1 — 5.03; 4.82 score on a scale — p=0.8
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Tranexamic Acid 1,000 Mg/10 mL (100 Mg/mL) INTRAVEN VIAL (ML) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Stanford University
- Primary completion
- Feb 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Bleeding VAS - POD1 |
5.03; 4.82 | 0.8 |
| PRIMARY Bleeding VAS - POD2 |
4.47; 3.89 | — |
| PRIMARY Bleeding VAS - POD3 |
2.93; 2.29 | — |
| PRIMARY Bleeding VAS - POD4 |
2.12; 1.44 | — |
| PRIMARY Bleeding VAS - POD5 |
1.32; 1.15 | — |
| PRIMARY Bleeding VAS - POD6 |
1.36; 0.76 | — |
| PRIMARY Bleeding VAS - POD7 |
0.97; 0.72 | — |
| PRIMARY Guaze Saturation VAS Though POD7 |
5.16; 4.56; 3.03; 2.09; 1.74; 0.76 | — |
| SECONDARY Frequency of Participant Follow-up |
0; 0; 0; 1; 2; 2 | — |
Summary
The purpose of the research is to assess the effectiveness of a dose of intravenous tranexamic acid (TXA) given intraoperatively to reduce postoperative bleeding after endoscopic sinus or nasal surgery (e.g. septoplasty, endoscopic sinus surgery, turbinate surgery). This medication has been shown to decrease blood loss during this type of surgery, but the implications for bleeding following surgery are unclear. Any impact on postoperative bleeding will be assessed over the first 7 days following surgery leading up to the first scheduled postoperative clinic visit. Patients will keep a standardized daily diary of their bleeding experience by indicating on a 0-10 visual analog scale (VAS) their impression of their bleeding.
The primary outcome is the patient-reported visual analog scale (VAS) bleeding score on each day after surgery. The secondary outcomes include the the frequency with which the otolaryngology resident service is requested to evaluate patients in the recovery unit for postoperative bleeding concerns and the frequency of interventions such as application of hemostatic materials, packing, cautery, and/or return to the operating room.
Eligibility Criteria
Inclusion Criteria
- Scheduled to undergo elective sinus or nasal surgery (e.g. septoplasty, inferior turbinate reduction, endoscopic sinus surgery)
- Age 18 or greater
- English-speaking
- Able to provide consent
Exclusion Criteria
- Minors (age<18)
- Pregnant or may become pregnant by time of surgery
- Prisoners
- Non-English speaking
- Foreign citizens
- Unable to provide consent
- Known pro-thrombotic coagulation disorders
- Active intranasal drug use (e.g. cocaine)
- Surgery is for a sinonasal tumor or other sinus pathology not described in inclusion criteria
- Enrollment is in conflict with existing study participation
Data sourced from ClinicalTrials.gov (NCT04754230). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.