Effect of Tranexamic Acid on Postoperative Bleeding Following Sinus and Nasal Surgery
Overview
- Phase
- Phase 4
- Intervention
- Tranexamic Acid 1,000 Mg/10 mL (100 Mg/mL) INTRAVEN VIAL (ML)
- Conditions
- Chronic Sinusitis
- Sponsor
- Stanford University
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Bleeding VAS - POD3
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief 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.
Investigators
Zara M. Patel
Associated Professor
Stanford University
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
Arms & Interventions
1,000mg IV Tranexamic acid
Participants in this arm will be given a 1,000mg dose of intravenous tranexamic acid via saline infusion 15 minutes prior to the completion of surgery. They will keep a bleeding diary with daily entries each day until their first routine scheduled postoperative follow-up clinic visit one week after surgery.
Intervention: Tranexamic Acid 1,000 Mg/10 mL (100 Mg/mL) INTRAVEN VIAL (ML)
Outcomes
Primary Outcomes
Bleeding VAS - POD3
Time Frame: Postoperative Day 3
Patient-reported Visual Analog Scale - Bleeding Score Day 3. Score range: 0 (no bleeding) to 10 (uncontrolled bleeding).
Bleeding VAS - POD4
Time Frame: Postoperative Day 4
Patient-reported Visual Analog Scale - Bleeding Score Day 4. Score range: 0 (no bleeding) to 10 (uncontrolled bleeding).
Bleeding VAS - POD5
Time Frame: Postoperative Day 5
Patient-reported Visual Analog Scale - Bleeding Score Day 5. Score range: 0 (no bleeding) to 10 (uncontrolled bleeding).
Bleeding VAS - POD6
Time Frame: Postoperative Day 6
Patient-reported Visual Analog Scale - Bleeding Score Day 6. Score range: 0 (no bleeding) to 10 (uncontrolled bleeding).
Bleeding VAS - POD7
Time Frame: Postoperative Day 7
Patient-reported Visual Analog Scale - Bleeding Score Day 7. Score range: 0 (no bleeding) to 10 (uncontrolled bleeding).
Guaze Saturation VAS Though POD7
Time Frame: Postoperative Day 2 through Postoperative Day 7
Patient-reported Visual Analog Scale - Guaze Saturation Score through Postoperative Day 7. Score range: 0 (not at all) to 10 (dripping blood).
Bleeding VAS - POD2
Time Frame: Postoperative Day 2
Patient-reported Visual Analog Scale - Bleeding Score Day 2. Score range: 0 (no bleeding) to 10 (uncontrolled bleeding).
Bleeding VAS - POD1
Time Frame: Postoperative Day 1 (assessed within first 24 hours following surgery)
Patient-reported Visual Analog Scale - Bleeding Score Day 1. Score range: 0 (no bleeding) to 10 (uncontrolled bleeding).
Secondary Outcomes
- Frequency of Participant Follow-up(Day of surgery through 1 week)