Trials / Completed
CompletedNCT04754230
Effect of Tranexamic Acid on Postoperative Bleeding Following Sinus and Nasal Surgery
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 40 (actual)
- Sponsor
- Stanford University · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Chronic Sinusitis
- Nasal Obstruction
- Turbinate; Hypertrophy Mucous Membrane
- Deviated Nasal Septum - Congenital
- Deviated Nasal Septum Acquired
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Tranexamic Acid 1,000 Mg/10 mL (100 Mg/mL) INTRAVEN VIAL (ML) | Medication administered 15 minutes prior to end of surgery. |
Timeline
- Start date
- 2021-06-17
- Primary completion
- 2022-02-20
- Completion
- 2022-02-20
- First posted
- 2021-02-15
- Last updated
- 2023-04-05
- Results posted
- 2023-04-05
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04754230. Inclusion in this directory is not an endorsement.